Drug containing device of solid oral preparation and oral administration delivery device containing same

文档序号：1698658 发布日期：2019-12-13 浏览：34次中文

阅读说明：本技术 固体口服制剂的药物容置装置及含其的口服给药递送装置 (Drug containing device of solid oral preparation and oral administration delivery device containing same ) 是由董良昶雷杨吴刚张世忠石劲敏陈溪山于 2019-09-30 设计创作，主要内容包括：本发明公开了一种固体口服制剂的药物容置装置及含其的口服给药递送装置。药物容置装置包括过滤部件和支撑部件,过滤部件和支撑部件相互配合形成用于承载药物颗粒或多丸的空间,过滤部件具有一个或多个允许液体通过的孔道；孔道在过滤部件的内部以上下错综交叉的方式分布,和/或,过滤部件上设有一水溶性高分子材料层。或者,药物容置装置为顶端开口、底部为筛网的筒状结构,筛网的内表面设有一水溶性高分子材料层,其上方的筒状结构的内腔用于容纳药物颗粒或多丸。本发明的药物容置装置能够克服药物颗粒或多丸泄漏和啜吸时流体阻力大的问题。(The invention discloses a medicine containing device of a solid oral preparation and an oral administration delivery device containing the same. The medicine containing device comprises a filter component and a support component, wherein the filter component and the support component are mutually matched to form a space for bearing medicine particles or pills, and the filter component is provided with one or more pore passages for allowing liquid to pass; the pore channels are distributed in the filter component in an up-down crisscross mode, and/or a water-soluble polymer material layer is arranged on the filter component. Or the medicine containing device is a cylindrical structure with an opening at the top end and a screen at the bottom, a water-soluble polymer material layer is arranged on the inner surface of the screen, and an inner cavity of the cylindrical structure above the water-soluble polymer material layer is used for containing medicine particles or multiple pills. The drug containing device of the invention can overcome the problems of leakage and high fluid resistance during sipping of drug particles or multiple pills.)

1. A drug containing device for solid oral dosage form, comprising a filter element and a support element for supporting said filter element, said filter element and said support element cooperating to define a space for holding particles or pellets of drug, said filter element having one or more channels for allowing passage of liquid; the thickness of the filter component is more than 0.5mm, and the pore channels are distributed in the filter component in an up-down crisscross mode, so that the medicine particles or multiple pills cannot pass through the pore channels.

2. The medication containment device of claim 1, wherein said filter member is a filter membrane;

the shape of the filter membrane is preferably a cylindrical structure;

the thickness of the filter membrane is preferably 0.5 to 20mm, more preferably 0.5 to 15mm, and further more preferably 0.5 to 10 mm;

Preferably, the pore channels on the upper surface, the lower surface and the interior of the filter membrane are all arranged into an irregular and crisscross structure, more preferably a spongy porous structure, or a fluffy structure formed by randomly stacking and pressing multiple layers of fibers;

The pore diameter of the filter membrane is preferably 1-500 μm, more preferably 20-400 μm, and further more preferably 40-300 μm;

The effective diameter of the filter membrane is preferably 4-20mm, more preferably 6-15mm, and further more preferably 8-12 mm;

And/or the presence of a gas in the gas,

The particle size of the medicine particles or pills is 1-5000 μm, preferably 25-2000 μm, more preferably 50-1000 μm;

Preferably, when the particle size of the drug particles or pellets is in the range of 50-1000 μm, the pore size of the filter member is 40-300 μm;

And/or the presence of a gas in the gas,

the drug particles or pellets comprise an active pharmaceutical ingredient including, but not limited to, one or more of the following: dabigatran etexilate or a pharmaceutically acceptable salt thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudoephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, dimercaptobutanedioic acid, amlodipine, and esmolol.

3. the drug containment device of claim 1, wherein the support member is configured to: the filter element is arranged on the upper surface and the lower surface of the filter element and clamps the filter element in the middle; or the filter element is wrapped inside in a cage-like structure;

preferably, the structure of the support member is any one of the following structures:

the support component comprises an upper support component and a lower support component, the upper support component and the lower support component can cover each other and clamp the filter component in the middle, and the upper space of the upper support component and the upper space of the filter component are used for containing medicine particles or pills;

Or, the support component comprises a filter component accommodating component and a medicine accommodating component, the filter component accommodating component and the medicine accommodating component are both provided with a hole-shaped structure end and an open end, the hole-shaped structure end is provided with one or more holes allowing liquid to pass through, and the open end of the filter component accommodating component and the hole-shaped structure end of the medicine accommodating component can be covered to form a cavity for accommodating the filter component; the open end of the medicine containing part is of an open tubular structure and is used for containing medicine particles or multiple pills;

Or, the support component comprises a cage-shaped support component with an upward opening and an upper cover matched with the cage-shaped support component, the upper cover is provided with a pore passage for the circulation of medicine particles or multiple pills and liquid, the cage-shaped support component and the upper cover can enclose to form a hollow space and limit the filter component in the space, and the space above the upper cover and the filter component is used for containing the medicine particles or multiple pills.

4. an oral administration delivery device, comprising the drug containing device according to any one of claims 1 to 3, further comprising a tubular member having two open ends and a lumen, wherein one open end is a first open end and the other open end is a second open end, and the lumen communicates the first open end and the second open end; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

5. The oral delivery device of claim 4, wherein the drug containment device is disposed outside the tubular member and is retained at the first opening of the tubular member by a retaining sleeve or a threaded connection;

and/or a top cover for sealing is arranged at the second opening;

and/or, the tubular member is a straight straw; the straight suction pipe is preferably provided with at least 1 fold part structure; preferably, the corrugated part structure has 1 pair of wing parts and 1 turning end, and the corrugated part structure can be axially stretched or contracted along the tubular member and forms turbulent flow when being stretched;

And/or the tubular component has at least 2 pipe sections which are connected in a sealing way and can be stretched or shrunk along the axial direction of the tubular component; the tubular member, when in a stretched state, forms a turbulence-generating member having at least 1 step structure;

Wherein, when the number of the pipe sections is 3: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, the outer diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or contracted along other pipe sections; or, the inner diameter of the first pipe section, the outer diameter of the second pipe section, the inner diameter of the third pipe section and the outer diameter of the first pipe section in the direction from the first opening to the second opening are gradually reduced, and each pipe section can be axially stretched or shrunk along other pipe sections;

Wherein, when the number of the pipe sections is 4: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, and the inner diameter of the second pipe section is the same as that of the fourth pipe section, wherein the inner diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or shrunk along other pipe sections; or the inner diameter of the first pipe section to the fourth pipe section in the direction from the first opening to the second opening is gradually reduced, and each pipe section can be axially stretched or contracted along other pipe sections.

6. An oral administration delivery device, comprising the drug containing device according to any one of claims 1 to 3, further comprising a tubular member having two open ends and a lumen, wherein one open end is a first open end and the other open end is a second open end, and the lumen communicates the first open end and the second open end; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

7. The oral delivery device of claim 6, wherein the diameter of the second opening is less than the smallest diameter of the drug containment device;

And/or a top cover for sealing is arranged at the second opening;

And/or the tubular member is constructed as described in claim 5.

8. a medicine containing device of a solid oral preparation is characterized in that the structure is a structure I or a structure II:

The structure I is as follows: the medicine containing device comprises a filter component and a supporting component for supporting the filter component, wherein the filter component and the supporting component are mutually matched to form a space for bearing medicine particles or pills, and the filter component is provided with one or more pore passages for allowing liquid to pass through; the filter component is also provided with a water-soluble polymer material layer, so that the drug particles or multiple pills cannot pass through the filter component;

The structure II is as follows: the medicine holding device be the tubular structure of top opening, bottom for the screen cloth, the internal surface of screen cloth is equipped with a water-soluble macromolecular material layer, the inner chamber of the tubular structure of water-soluble macromolecular material layer top is used for holding medicine granule or many pills.

9. the medication containment device of claim 8, wherein said filter member is a filter membrane;

The shape of the filter membrane is preferably a disk-shaped structure;

The thickness of the filter membrane is preferably 0.01 to 0.5mm, more preferably 0.1 to 0.3 mm;

preferably, the pore channels in the filter membrane are connected and run through the upper surface and the lower surface of the filter membrane in a linear mode;

The pore diameter of the filter membrane is preferably 1-500 μm, more preferably 20-400 μm, and further more preferably 40-300 μm;

The effective diameter of the filter membrane is preferably 4-20mm, more preferably 6-15mm, and further more preferably 8-12 mm;

And/or the presence of a gas in the gas,

the particle size of the medicine particles or pills is 1-5000 μm, preferably 25-2000 μm, more preferably 50-1000 μm;

Preferably, when the particle size of the drug particles or pellets is in the range of 50-1000 μm, the pore size of the screen in the first structure or the second structure is 40-300 μm;

And/or the presence of a gas in the gas,

The drug particles or pellets comprise an active pharmaceutical ingredient including, but not limited to, one or more of the following: dabigatran etexilate or a pharmaceutically acceptable salt thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudoephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, dimercaptobutanedioic acid, amlodipine, and esmolol.

10. The drug-containing device of claim 9, wherein the water-soluble polymer material layer is formed in two structures: forming a continuous water-soluble polymer material layer on the upper surface or the lower surface of the filter membrane, or completely blocking the pore channel of the filter membrane to form a complete and compact water-soluble polymer material layer;

And/or the dissolving time of the water-soluble polymer material layer is less than or equal to 10 s;

And/or, the molecular weight of the polymer material in the water-soluble polymer material layer is 2000-200000, preferably 2000-100000;

And/or the type of the high polymer material in the water-soluble high polymer material layer is selected from one or more of hydroxypropyl methylcellulose, copovidone, hydroxypropyl cellulose, hydroxyethyl cellulose, povidone, polyethylene glycol, gelatin, poloxamer, xanthan gum and eucalyptus;

and/or the weight of the high polymer material is increased to 0.01-60mg/cm in the forming process of the water-soluble high polymer material layer²preferably 0.5-30mg/cm²。

11. The medication containing apparatus of claim 8, wherein the support member is configured as any one of:

or, the support component comprises a filter component accommodating component and a medicine accommodating component, the filter component accommodating component and the medicine accommodating component are both provided with a hole-shaped structure end and an open end, the hole-shaped structure end is provided with one or more holes allowing liquid to pass through, and the open end of the filter component accommodating component and the hole-shaped structure end of the medicine accommodating component can be covered to form a cavity for accommodating the filter component; the open end of the medicament containing part is an open tubular structure for containing medicament particles or pellets.

12. An oral drug delivery device, comprising the drug containing device according to any one of claims 8 to 11, further comprising a tubular member having two open ends and a lumen, wherein one open end is a first open end and the other open end is a second open end, and the lumen communicates the first open end and the second open end; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

13. The oral delivery device of claim 12, wherein the drug containment device is disposed outside the tubular member and is retained at the first opening of the tubular member by a retaining sleeve or a threaded connection;

and/or a top cover for sealing is arranged at the second opening;

14. an oral drug delivery device comprising the drug containing device according to any one of claims 8 to 11, further comprising a tubular member having two open ends and a lumen, wherein one open end is a first opening and the other open end is a second opening, and the lumen communicates the first opening and the second opening; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

15. The oral delivery device of claim 14, wherein the diameter of the second opening is less than the smallest diameter of the drug containment device;

and/or a top cover for sealing is arranged at the second opening;

and/or the tubular member is constructed as claimed in claim 13.

16. A drug containing device for solid oral dosage form, comprising a filter element and a support element for supporting said filter element, said filter element and said support element cooperating to define a space for holding particles or pellets of drug, said filter element having one or more channels for allowing passage of liquid; the pore channels are distributed in the filtering component in an up-down crisscross mode, and a water-soluble polymer material layer is further arranged on the filtering component, so that the medicine particles or multiple pills cannot pass through the pore channels.

17. The medication containment device of claim 16, wherein said filter member is a filter membrane;

the shape of the filter membrane is preferably a cylindrical structure;

The thickness of the filter membrane is preferably 0.3 to 20mm, more preferably 0.5 to 15mm, and further more preferably 0.5 to 10 mm;

the pore diameter of the filter membrane is preferably 1-500 μm, more preferably 20-400 μm, and further more preferably 40-300 μm;

The effective diameter of the filter membrane is preferably 4-20mm, more preferably 6-15mm, and further more preferably 8-12 mm;

And/or the presence of a gas in the gas,

The particle size of the medicine particles or pills is 1-5000 μm, preferably 25-2000 μm, more preferably 50-1000 μm;

Preferably, when the particle size of the drug particles or pellets is in the range of 50-1000 μm, the pore size of the filter member is 40-300 μm;

And/or the presence of a gas in the gas,

18. the drug containment device according to claim 17, wherein the water-soluble polymer material layer is formed in two structures: forming a continuous water-soluble polymer material layer on the upper surface or the lower surface of the filter membrane, or completely blocking the pore channel of the filter membrane to form a complete and compact water-soluble polymer material layer;

And/or the dissolving time of the water-soluble polymer material layer is less than or equal to 10 s;

and/or, the molecular weight of the polymer material in the water-soluble polymer material layer is 2000-200000, preferably 2000-100000;

and/or the weight of the high polymer material is increased to 0.01-60mg/cm in the forming process of the water-soluble high polymer material layer²Preferably 0.5-30mg/cm²。

19. the medication containing apparatus of claim 16, wherein the support member is configured as any one of:

The support component comprises an upper support component and a lower support component, the upper support component and the lower support component can cover each other and clamp the filter component in the middle, and the upper space of the upper support component and the upper space of the filter component are used for containing medicine particles or pills;

Or, the support component comprises a filter component accommodating component and a medicine accommodating component, the filter component accommodating component and the medicine accommodating component are both provided with a hole-shaped structure end and an open end, the hole-shaped structure end is provided with one or more holes allowing liquid to pass through, and the open end of the filter component accommodating component and the hole-shaped structure end of the medicine accommodating component can be covered to form a cavity for accommodating the filter component; the open end of the medicament containing part is an open tubular structure for containing medicament particles or pellets.

20. an oral delivery device comprising the drug containment device of any of claims 16-19, the oral delivery device further comprising a tubular member having two open ends and a lumen, one open end being a first opening and the other open end being a second opening, the lumen communicating the first and second openings; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

21. the oral delivery device of claim 20, wherein the drug containment device is disposed outside the tubular member and is retained at the first opening of the tubular member by a retaining sleeve or a threaded connection;

And/or a top cover for sealing is arranged at the second opening;

And/or, the tubular member is a straight straw; the straight suction pipe is preferably provided with at least 1 fold part structure; preferably, the corrugated part structure has 1 pair of wing parts and 1 turning end, and the corrugated part structure can be axially stretched or contracted along the tubular member and forms turbulent flow when being stretched;

wherein, when the number of the pipe sections is 3: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, the outer diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or contracted along other pipe sections; or, the inner diameter of the first pipe section, the outer diameter of the second pipe section, the inner diameter of the third pipe section and the outer diameter of the first pipe section in the direction from the first opening to the second opening are gradually reduced, and each pipe section can be axially stretched or shrunk along other pipe sections;

22. An oral delivery device comprising the drug containment device of any of claims 16-19, the oral delivery device further comprising a tubular member having two open ends and a lumen, one open end being a first opening and the other open end being a second opening, the lumen communicating the first and second openings; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

23. The oral delivery device of claim 22, wherein the diameter of the second opening is less than the smallest diameter of the drug containment device;

And/or a top cover for sealing is arranged at the second opening;

And/or the tubular member is constructed as described in claim 21.

Technical Field

The invention relates to the field of medical equipment, in particular to a medicine containing device of a solid oral preparation and an oral administration delivery device containing the same.

background

tablets and capsules are the most convenient and readily acceptable oral dosage form. However, some patients, particularly children and the elderly, often have difficulty swallowing large-sized tablets and capsules; some patients are reluctant to take the drug because of unacceptable taste. Thus, the prior art proposes various administration devices which facilitate swallowing of large-sized tablets and capsules and minimize patient perception of the dose and taste of administration. The following patents and applications relating to sipping device drug containment devices are incorporated herein by reference.

EP 0383503 a1 describes an improved device in which the drug containing component is a mesh, the surface area of the mesh being greater than the cross-sectional area of the lumen of the tube, which serves to retain and locate a unit dose of therapeutic agent in the tube, the device being adapted to deliver the dose through the tube by normal sipping action by the patient.

us patent 6096003 describes a sipping device in which the drug containing part is a stopper which can be used to contain the active pharmaceutical ingredient and which is slid up the lumen by the liquid carrying the stopper, thereby completing the delivery of the drug.

us patent 6109538 discloses a sipping device having a housing in the form of a pair of rectangular mesh screens disposed in a lumen for confining a flavoring object.

us 6333050B 2 describes a sipping device having a one-way valve medicament containing part which is adapted to contain medicament when in a non-sipping state and which deforms to allow passage of liquid when in a sipping state.

us patent 8334003B 2 describes a sipping device comprising an elongate tubular member having a pair of filter means at each end of the tubular member to retain flavouring particles within the filter means to allow flavouring to be drawn into a normal beverage by normal aspiration.

Us patent 6224908B 1 describes a delivery device for an active pharmaceutical ingredient with fluid control. The fluid controller is a porous plug which has small friction with the tube wall, contains the medicine in a non-sipping state, and accelerates the medicine to be delivered into the mouth of the patient under the pushing of the fluid during sipping.

The medicament containing member of the above patent causes problems in practical use. It is well known that API-containing granules or pellets prepared by wet granulation, dry granulation, extrusion spheronization, melt granulation and the like generally have a relatively broad particle size distribution with both granules or pellets that are much larger than the average particle size and fine powder granules and pellets that are much smaller than the average particle size. Therefore, for the function of the medicine containing part, on one hand, the liquid is required to smoothly pass through the medicine containing part and has small resistance, and the patient has no effort when sipping; meanwhile, the aperture of the medicine containing part is required to be smaller than the diameter of all particles or multiple pills, so that the particles or multiple pills are ensured not to leak through the medicine containing part. The two requirements are mutually contradictory, and the pore diameter is ensured to be large enough, so that the resistance of the liquid to pass through is small; however, the larger the pore size, the greater the probability of leakage of smaller particle size particles and pellets. This limits the scope of application and materials containing particles or pellets with a size less than or equal to the pore size of the drug containing member cannot be used with this device unless they are artificially sieved, which reduces the yield and increases the cost.

disclosure of Invention

the invention aims to overcome the defects of leakage of medicine particles or multiple pills and large fluid resistance during sipping of the medicine particles or multiple pills in the device for promoting the swallowing of the medicine in the prior art, and provides a medicine containing device for solid oral preparations and an oral administration delivery device containing the same. The drug containment device of the present invention is used in conjunction with a straw as a unit for containing particles or pellets containing an active pharmaceutical ingredient having a particle size greater than, equal to, or less than the pore size of the drug containment device.

The inventor of the invention finds that the reduction of the liquid resistance and the reduction of the medicine leakage are theoretically opposite propositions and are difficult to balance, so that the technical difficulty of the invention is to find a reasonable solution, not only ensuring the small liquid resistance, but also ensuring that the carried particles and pills do not leak.

mechanistically, the present invention allows two mechanisms for containing drug particles or pellets having a size equal to or smaller than the pore size of the filter element: one is to retain fine particles in the filter element through irregularly staggered pores in the filter element, which requires a certain thickness, for example, a thickness of 0.5mm or more; the other is to form a film on the filter part by a water-soluble polymer material to block the pores of the filter part, when the medicine is sipped, the polymer material is instantly dissolved, and water flows through to drive the medicine to enter the mouth of a patient, and the mechanism has no requirement on the thickness of the filter part.

The invention aims at providing a drug containing device of a solid oral preparation, which comprises a filter component and a supporting component for supporting the filter component, wherein the filter component and the supporting component are mutually matched to form a space for bearing drug particles or pills, and the filter component is provided with one or more pore passages for allowing liquid to pass; when the thickness of the filter component is more than 0.5mm, the pore channels are distributed in the filter component in an up-down crisscross mode, so that the medicine particles or multiple pills cannot pass through the pore channels.

Hereinafter, a mode of arranging the duct of the filter member in a structure in which the duct is zigzag is described in detail:

In the present invention, the filter element is of a type commonly used in the art, preferably a filter membrane. The filter membrane is preferably cylindrical in shape. The thickness of the filter membrane is preferably 0.5 to 20mm, more preferably 0.5 to 15mm, further more preferably 0.5 to 10mm, for example 2 mm.

That is, the filter membrane has a certain thickness, and therefore the pore channels of the filter membrane are arranged in a crisscross structure, preferably, the pore channels on the upper and lower surfaces and inside of the filter membrane are arranged in an irregular and crisscross structure, such as a sponge-like porous structure, or a fluffy structure formed by randomly stacking and pressing a plurality of layers of fibers. Thus, even if the particle size of the drug particles or pellets is smaller than or equal to the pore size of the filter membrane, the drug particles or pellets will not pass through the drug containing device directly as they would through a screen. Due to the tortuosity and the intricate intersection of the filter membrane pore channels, drug particles or pills with small particle size are accumulated on the surface and inside of the filter membrane. As the fluid passes, the drug particles or boluses that accumulate on the surface and inside of the filter membrane are delivered into the patient's mouth.

the material and pore size of the filter member (e.g., filter membrane) and the conditions for setting the production process will be specifically described below:

wherein, the material of the filter membrane is the conventional filter membrane material in the field, including but not limited to one or more of the following materials: polypropylene, polyethylene, polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate, cellulose acetate, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, glass fiber, nylon, polyethersulfone, polyvinylidene fluoride, and polytetrafluoroethylene.

wherein, the shape of the raw material of the filter membrane is conventional in the field, including but not limited to granular shape, sheet shape, fibrous shape and the like.

Wherein, the pore size of the filter membrane is conventional in the art, such as 1-500 μm, preferably 20-400 μm, more preferably 40-300 μm, such as 150 μm, 200 μm, 250 μm, 300 μm.

Wherein the diameter of the filter membrane can be conventional in the art, the diameter of the filter membrane is defined as the effective diameter for trapping solids and passing liquid, and for the design and installation process, the outermost circle of the diameter of the filter membrane is only 8mm if it is pressed in the middle by the upper and lower supporting members for fixing the filter membrane, for example, a 10mm diameter membrane, and 1mm on the side by the supporting members. The usual effective diameter range for the filter membrane is generally from 4 to 20mm, preferably from 6 to 15mm, more preferably from 8mm to 12mm, for example 10 mm.

The preparation process of the filter membrane is a conventional process in the field, and includes but is not limited to sintering, injection molding, pressing, weaving and the like.

The structure of the support member is specifically described below:

In the present invention, the support member has a conventional meaning in the art, and functions to support the filter member without affecting the filtering property and liquid permeability of the filter member. The structure is preferably as follows: the filter element is arranged on the upper surface and the lower surface of the filter element and clamped in the middle, namely the filter element is clamped in the middle like a sandwich form; or the filter element may be wrapped inside in a cage-like structure.

In a preferred embodiment of the present application, the support member comprises an upper support member and a lower support member, the upper support member and the lower support member can cover each other and clamp the filter member therebetween, and the upper space between the upper support member and the filter member is used for containing the drug particles or pellets. This structure resembles a sandwich format.

In another preferred embodiment of the present application, the support member comprises a filter member housing member and a drug housing member, the filter member housing member and the drug housing member each having a porous structure end and an open end, the porous structure end having one or more holes for allowing liquid to pass through, the open end of the filter member housing member and the porous structure end of the drug housing member being capable of covering to form a cavity for housing the filter member; the open end of the medicament containing part is an open tubular structure for containing medicament particles or pellets. It will be appreciated by those skilled in the art that the actual function of the filter housing component of this embodiment is to form a cavity with the medicament housing component for receiving the filter component, which also resembles a sandwich. In addition, the size of the pore-like structure of the medicament containing part and the filter part containing part does not influence the filterability and liquid permeability of the filter part.

In another preferred embodiment of the present application, the support member includes a cage-shaped support member with an upward opening and a cover cooperating with the cage-shaped support member, the cover having a hole for the passage of the drug particles or the pellets and the liquid, the cage-shaped support member and the cover enclosing a hollow space and confining the filter member in the space, the cover and the space above the filter member being adapted to contain the drug particles or the pellets. This structure resembles the form of a cage-like structure.

wherein, the material of the support component is conventional in the art, and includes but is not limited to one or more of the following materials: polypropylene, polyethylene, polyvinyl chloride, polyvinylidene fluoride, polytetrafluoroethylene, polyethylene terephthalate, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, ceramic, silicon dioxide and organic silicon.

wherein, the preparation process of the support component is conventional in the field, and includes but not limited to sintering, injection molding and the like.

the form and type of the drug particles or pellets are specifically described below:

In the present invention, the pharmaceutical granule or pellet has a conventional meaning in the art, and generally means a granule, powder or pellet containing an active pharmaceutical ingredient.

wherein the particle size of the medicine particles or pills is conventional in the field, and is generally 1-5000 μm, preferably 25-2000 μm, and more preferably 50-1000 μm.

preferably, when the particle size of the drug particles or pellets is in the range of 50 to 1000 μm, the pore size of the filter member is 40 to 300 μm.

Wherein the active pharmaceutical ingredient contained in the pharmaceutical granule or pill is conventional in the art, including but not limited to one or more of the following: dabigatran etexilate or a pharmaceutically acceptable salt thereof (e.g., dabigatran etexilate mesylate), apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudoephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, dimercaptodisodium, amlodipine, and esmolol.

the preparation process of the medicine particles or the multi-pill comprises but is not limited to one or more of the following processes: wet granulation, dry granulation, extrusion spheronization, melt granulation, ion exchange resin granulation, pellet spray application.

the second purpose of the present invention is to provide an oral administration delivery device, which comprises the drug containing device of the first purpose, and further comprises a tubular member, wherein the tubular member has two openings at two ends and a lumen, one opening at one end is a first opening, and the other opening at the other end is a second opening, and the lumen is communicated with the first opening and the second opening; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

the manner in which the medicament containing device is disposed externally to the free end of the first opening is described in detail below:

In this embodiment, preferably, the drug containing device is disposed outside the tubular member and is maintained at the first opening of the tubular member by a fixing and sleeving manner or a threaded connection manner.

In this scheme, the granule or many pills that contain active pharmaceutical ingredient are arranged in the cavity of medicine holding device, and during the use, the one end of support component contacts liquid, inhales liquid in tubular member through the filter unit through sipping effect, and the granule or many pills that contain active pharmaceutical ingredient enter tubular member along with liquid in, and then in the entrance.

In this scheme, preferably, the second opening part still is equipped with a top cap that is used for sealing to guarantee that oral administration delivery device is after the medicine carrying, even bump or invert completely takes place in the transportation, medicine granule or many pills also can not leak from the second opening part. Further, the drug-loaded oral drug delivery device can be directly stored or transported after being sealed by using an independent outer package, and the waterproof and moistureproof effects are achieved.

the structure of the tubular member is specifically described below:

In a preferred embodiment of the present application, the tubular member is a straight straw. The straight suction pipe preferably has at least 1 fold structure thereon. Preferably, the fold structure has 1 pair of wing portions and 1 turning end; the corrugated portion structure may be axially stretched or contracted along the tubular member and may form turbulence when stretched.

In another preferred embodiment of the present application, the tubular member has at least 2 tubular segments, which are sealingly connected and axially stretchable or contractible along the tubular member; the tubular member forms a turbulence-generating member having at least 1 step structure when in a stretched state.

Wherein, when the number of the pipe sections is 3: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, the outer diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or contracted along other pipe sections; or the inner diameter of the first pipe section, the outer diameter of the second pipe section, the inner diameter of the third pipe section and the outer diameter of the first pipe section in the direction from the first opening to the second opening are gradually reduced, and each pipe section can be axially stretched or shrunk along other pipe sections.

The invention also provides an oral administration delivery device, which comprises the medicine containing device, a tubular member and a first end cover, wherein the tubular member is provided with two end openings and a cavity, one end opening is a first opening, the other end opening is a second opening, and the cavity is communicated with the first opening and the second opening; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

In this aspect, the diameter of the first opening is limited to be smaller than the minimum diameter of the drug-containing device, so that the drug-containing device can be maintained in the inner cavity in any manner without falling out of the first opening of the tubular member.

in this embodiment, preferably, the diameter of the second opening is smaller than the minimum diameter of the drug containing device.

In this embodiment, the structure of the tubular member is explained in the second aspect.

The fourth purpose of the present invention is to provide a drug containing device for solid oral preparations, which has a structure of one or two:

the structure I is as follows: the medicine containing device comprises a filter component and a supporting component for supporting the filter component, wherein the filter component and the supporting component are mutually matched to form a space for bearing medicine particles or pills, and the filter component is provided with one or more pore passages for allowing liquid to pass through; the filter component is also provided with a water-soluble polymer material layer, so that the drug particles or multiple pills cannot pass through the filter component;

The application range of the scheme is wide, and the scheme is particularly suitable for the situation that part of the particle diameters in the particle diameter distribution of the medicine particles or the multiple pills are smaller than or equal to the pore diameters of the pore passages.

the structure, material, pore size and setting conditions of the preparation process of the filter component in the first structure are specifically described as follows:

In the present invention, the filter element is of a type conventionally used in the art, preferably a filter membrane. The filter membrane is preferably a disc-like structure. The thickness of the filter membrane is preferably 0.01 to 0.5mm, more preferably 0.1 to 0.3mm, such as 0.2 mm. In this case, since the filter membrane is thin and functions like a mesh, when the resistance of the liquid passing through the mesh is small, the drug particles or pellets having a particle size smaller than or equal to the pore size of the filter membrane leak out of the filter member, and therefore, a layer of water-soluble polymer material is provided on the filter membrane.

Wherein, the material of the filter membrane is the conventional filter membrane material in the field, including but not limited to one or more of the following materials: polypropylene, polyethylene, polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate, cellulose acetate, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, glass fiber, nylon, polyethersulfone, polyvinylidene fluoride, and polytetrafluoroethylene. The shape of the raw material of the filter membrane includes, but is not limited to, granular, sheet-like, fibrous, and the like.

wherein the shape and structure of the channels in the filter membrane may be regular structures conventional in the art, for example, connected in a straight line and penetrating the upper and lower surfaces of the filter membrane.

Wherein, the pore size of the filter membrane is conventional in the art, such as 1-500 μm, preferably 20-400 μm, more preferably 40-300 μm, such as 150 μm, 200 μm, 250 μm, 300 μm.

Wherein the diameter of the filter membrane may be conventional in the art, the diameter of the filter membrane is defined as the effective diameter for trapping solids and passing liquid, and for design and installation process considerations, the outermost turn of the filter membrane diameter will be pressed in between by the upper and lower support members for securing the filter membrane, e.g. a 10mm diameter membrane, with 1mm on the side being pressed by the support members, and the effective diameter being only 8 mm. The usual effective diameter range for the filter membrane is generally from 4 to 20mm, preferably from 6 to 15mm, more preferably from 8mm to 12mm, for example 10 mm.

the preparation process of the filter membrane is a conventional process in the field, and includes but is not limited to sintering, injection molding, pressing, weaving and the like.

the following will specifically explain the manner of disposing the water-soluble polymer material layer:

in the present invention, the forming method of the water-soluble polymer material layer is conventional in the art, and preferably: adsorbing, coating or spraying a polymer material solution on the upper surface and/or the lower surface of the filter membrane, or immersing the filter membrane in the polymer material solution, and drying. After drying, the high molecular material is dispersed in the membrane pores and the membrane material of the filter membrane to form a skeleton with certain hardness, and the pore passages of the filter membrane are blocked, so that the medicine particles or pills with the pore diameter less than or equal to the pore diameter of the filter membrane can not leak in the storage and transportation processes.

specifically, the water-soluble polymer material layer preferably has the following two structures: the continuous water-soluble polymer material layer is formed on the upper surface or the lower surface of the filter membrane, or the polymer material completely blocks the pores of the filter membrane to form a complete and dense water-soluble polymer material layer (for example, by using a dipping method to form the structure), more preferably, the continuous water-soluble polymer material layer is formed only on the upper surface or the lower surface of the filter membrane (for example, by adsorbing, coating, or spraying only on a certain surface of the filter membrane), and still more preferably, the continuous water-soluble polymer material layer is formed on the lower surface of the filter membrane.

The dissolution time of the water-soluble polymer material layer is preferably less than or equal to 10s, for example, 2 s. In use, the patient sips the drug containment device in a liquid while the layer of water soluble polymer material dissolves in a very short time, the liquid passing through the drug containment device with very little resistance to deliver the drug particles or boluses into the patient's mouth. Because the water-soluble polymer material layer is dissolved quickly, the patient can not feel the change of resistance when using the water-soluble polymer material layer.

in order to enable the polymer material to be formed on the surface of the filter membrane better, the water-soluble polymer material layer is preferably made by selecting a polymer material which has better water solubility and film-forming property and small molecular weight, forming a polymer material solution and then forming the polymer material solution by a certain process.

Wherein, the molecular weight of the polymer material is preferably 2000-200000, more preferably 2000-100000. The polymeric material is preferably selected from one or more of hypromellose, copovidone, hydroxypropyl cellulose, hydroxyethyl cellulose (HEC), povidone, polyethylene glycol (PEG), gelatin, poloxamer, xanthan gum and Eudragit.

the preparation method of the high polymer material solution is a conventional method in the field, and specifically comprises the following steps: the polymer material and the solvent are mixed evenly. Wherein the solvent is a solvent which is conventional in the art and can dissolve high molecular materials and is easy to volatilize, such as water, ethanol, acetone and the like.

in the forming process of the water-soluble polymer material layer, the viscosity of a polymer material solution is a key parameter in the forming process, and the viscosity depends on three parameters, namely the concentration, the molecular weight and the chemical structure of a polymer. The viscosity range is generally from 2 centipoise (cP) to 5000 cP, preferably from 2cP to 1000 cP. The concentration of the polymer material solution is preferably 0.1% to 30%, for example, 10%, and the concentration is a mass percentage concentration. In the forming process of the water-soluble polymer material layer, the weight increment of the polymer material is generally 0.01-60mg/cm²Preferably 0.5-30mg/cm²E.g. 6.4mg/cm². Wherein "polymer material weight gain" means the weight of a water-soluble polymer material layer formed on a filter element (such as a filter membrane) or a screen per square centimeter after curing and drying,Weight units are in milligrams.

In a preferred embodiment of the present application, the solution of the polymer material is hypromellose E3 with a concentration of 10%.

the structure of the support member in the first structure will be described in detail below:

Wherein, the preparation process of the support component is conventional in the field, and includes but not limited to sintering, injection molding and the like.

The cylindrical structure in the second structure will be specifically described below:

the material and the preparation process of the cylindrical structure are the same as those of the support component part.

The size of the screen is conventional in the art, for example 200 μm.

The form and type of the drug particles or pellets are specifically described below:

In the present invention, the pharmaceutical granule or pellet has a conventional meaning in the art, and generally means a granule, powder or pellet containing an active pharmaceutical ingredient.

Wherein the particle size of the medicine particles or pills is conventional in the field, and is generally 1-5000 μm, preferably 25-2000 μm, and more preferably 50-1000 μm.

Preferably, when the particle size of the drug particles or pellets is in the range of 50-1000 μm, the pore size of the screen in the first structure or the second structure is 40-300 μm.

Wherein the active pharmaceutical ingredient contained in the pharmaceutical granule or pill is conventional in the art, including but not limited to one or more of the following: dabigatran etexilate or a pharmaceutically acceptable salt thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudoephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, dimercaptobutanedioic acid, amlodipine, and esmolol.

The preparation process of the medicine particles or the multi-pill comprises but is not limited to one or more of the following processes: wet granulation, dry granulation, extrusion spheronization, melt granulation, ion exchange resin granulation, pellet spray application.

the fifth objective of the present invention is to provide an oral administration delivery device, which comprises the drug containing device of the fourth objective, and further comprises a tubular member, wherein the tubular member has two openings at two ends and an inner cavity, one opening at one end is a first opening, and the other opening at the other end is a second opening, and the inner cavity is communicated with the first opening and the second opening; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

the manner in which the medicament containing device is disposed externally to the free end of the first opening is described in detail below:

in the present invention, the drug containing device is disposed outside the tubular member, and is preferably maintained at the first opening outside the tubular member by a fixed sleeving manner or a threaded connection manner.

In this embodiment, the particles or pellets containing the active pharmaceutical ingredient are disposed in the cavity of the drug containment device, and in use, one end of the support member contacts the liquid and draws the liquid through the filter member into the tubular member by sipping, the particles or pellets containing the active pharmaceutical ingredient entering the tubular member with the liquid and then entering the port.

in the present invention, preferably, a top cap for sealing is further disposed at the second opening to ensure that the drug particles or multiple pills do not leak from the second opening even if the oral drug delivery device bumps or is completely inverted during transportation after loading the drug.

The structure of the tubular member is specifically described below:

Wherein, when the number of the pipe sections is 3: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, the outer diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or contracted along other pipe sections; or the inner diameter of the first pipe section, the outer diameter of the second pipe section, the inner diameter of the third pipe section and the outer diameter of the first pipe section in the direction from the first opening to the second opening are gradually reduced, and each pipe section can be axially stretched or shrunk along other pipe sections.

wherein, when the number of the pipe sections is 4: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, and the inner diameter of the second pipe section is the same as that of the fourth pipe section, wherein the inner diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or shrunk along other pipe sections; or the inner diameter of the first pipe section to the fourth pipe section in the direction from the first opening to the second opening is gradually reduced, and each pipe section can be axially stretched or contracted along other pipe sections.

The sixth purpose of the present invention is to provide an oral administration delivery device, which comprises the drug containing device of the fourth purpose, and further comprises a tubular member, wherein the tubular member has two openings at two ends and an inner cavity, one opening at one end is a first opening, the other opening at the other end is a second opening, and the inner cavity is communicated with the first opening and the second opening; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

in the present invention, the diameter of the first opening is limited to be smaller than the minimum diameter of the drug containing device, so that the drug containing device can be maintained in the inner cavity in any way without falling off from the first opening of the tubular member.

In the present invention, preferably, the diameter of the second opening is smaller than the smallest diameter of the medicament containing device.

In the present invention, preferably, a top cap for sealing is further disposed at the second opening to ensure that the drug particles or multiple pills do not leak from the second opening even if the oral drug delivery device bumps or is completely inverted during transportation after loading the drug.

in the present invention, the structure of the tubular member is specifically described in the fifth section for the same purpose.

The seventh object of the present invention is to provide a drug-containing device for solid oral preparations, which comprises a filter element and a support element for supporting the filter element, wherein the filter element and the support element cooperate with each other to form a space for carrying drug particles or pills, and the filter element has one or more channels for allowing liquid to pass through; the pore channels are distributed in the filtering component in an up-down crisscross mode, and a water-soluble polymer material layer is further arranged on the filtering component, so that the medicine particles or multiple pills cannot pass through the pore channels.

The mechanism of the scheme is as follows: since the particle size distribution of the drug particles or the pellets is a range, it is impossible to completely eliminate the particles or pellets smaller than a certain particle size due to process limitations, in this case, in order to ensure less resistance during sipping, a relatively large pore size is selected when the pore structure is arranged in an up-and-down crisscross manner, and in order to meet the requirement of no leakage, it is necessary to arrange a water-soluble polymer material layer on the filter membrane while arranging the filter member (e.g., the filter membrane) in an up-and-down crisscross manner.

The structure, material, pore size, and setting conditions of the manufacturing process of the filter member are specifically described below:

in the present invention, the filter element is of a type conventionally used in the art, preferably a filter membrane. The filter membrane is preferably of cylindrical configuration. The thickness of the filter membrane is preferably 0.3 to 20mm, more preferably 0.5 to 15mm, further more preferably 0.5 to 10mm, for example 2 mm.

Wherein the shape and structure of the channels in the filter membrane may be regular structures conventional in the art, for example, connected in a straight line and penetrating the upper and lower surfaces of the filter membrane.

Wherein, the pore size of the filter membrane is conventional in the art, such as 1-500 μm, preferably 20-400 μm, more preferably 40-300 μm, such as 150 μm, 200 μm, 250 μm, 300 μm.

the preparation process of the filter membrane is a conventional process in the field, and includes but is not limited to sintering, injection molding, pressing, weaving and the like.

The following will specifically explain the manner of disposing the water-soluble polymer material layer:

Specifically, the water-soluble polymer material layer preferably has the following two structures: the continuous water-soluble polymer material layer is formed on the upper surface or the lower surface of the filter membrane, or the polymer material completely blocks the pores of the filter membrane to form a complete and dense water-soluble polymer material layer (for example, by using a dipping method to form the structure), more preferably, the continuous water-soluble polymer material layer is formed only on the upper surface or the lower surface of the filter membrane (for example, by adsorbing, coating, or spraying only on a certain surface of the filter membrane), and still more preferably, the continuous water-soluble polymer material layer is formed on the lower surface of the filter membrane.

The dissolution time of the water-soluble polymer material layer is preferably less than or equal to 10s, for example, 2 s. In use, the patient sips the drug containment device in the liquid while the layer of water soluble polymer material dissolves in a very short time, and the liquid passes through the drug containment device with very little resistance to deliver the drug particles into the patient's mouth. Because the water-soluble polymer material layer is dissolved quickly, the patient can not feel the change of resistance when using the water-soluble polymer material layer.

Among them, in order to form the polymer material solution on the surface of the filter membrane, it is preferable to select a polymer material solution having good water solubility and film-forming property and a small molecular weight. Wherein the molecular weight of the polymer material is generally 2000-200000, preferably 2000-100000. More preferably, the polymer material is selected from one or more of Hypromellose (HPMC), copovidone, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), povidone, polyethylene glycol (PEG), gelatin, poloxamer, xanthan gum and Eudragit.

The preparation method of the high polymer material solution is a conventional method in the field, and specifically comprises the following steps: the polymer material and the solvent are mixed evenly. Wherein the solvent is a solvent which is conventional in the art and can dissolve high molecular materials and is easy to volatilize, such as water, ethanol, acetone and the like.

In the forming process of the water-soluble polymer material layer, the viscosity of a polymer material solution is a key parameter in the forming process, and the viscosity depends on three parameters, namely the concentration, the molecular weight and the chemical structure of a polymer. The viscosity range is generally from 2 centipoise (cP) to 5000 cP, preferably from 2cP to 1000 cP. The concentration of the polymer material solution is preferably 0.1% to 30%, for example, 10%, and the concentration is a mass percentage concentration. The weight gain of the polymer material is generally 0.01-60mg/cm²Preferably 0.5-30mg/cm²E.g. 6.4mg/cm²。

In a preferred embodiment of the present application, the solution of the polymer material is hypromellose E3 with a concentration of 10%.

The structure of the support member is specifically described below:

in a preferred embodiment of the present application, the support member comprises an upper support member and a lower support member, the upper support member and the lower support member can cover each other and clamp the filter member therebetween, and the upper space between the upper support member and the filter member is used for containing the drug particles or pellets. This structure resembles a sandwich format.

in another preferred embodiment of the present application, the support member comprises a filter member housing member and a drug housing member, the filter member housing member and the drug housing member each having a porous structure end and an open end, the porous structure end having one or more holes for allowing liquid to pass through, the open end of the filter member housing member and the porous structure end of the drug housing member being capable of covering to form a cavity for housing the filter member; the open end of the medicament containing part is an open tubular structure for containing medicament particles or pellets. It will be appreciated by those skilled in the art that the actual function of the filter housing component of this embodiment is to form a cavity with the medicament housing component for receiving the filter component, which also resembles a sandwich. In addition, the size of the pore-like structure of the medicament containing part and the filter part containing part does not influence the filterability and liquid permeability of the filter part.

Wherein, the material of the support component is conventional in the art, and includes but is not limited to one or more of the following materials: polypropylene, polyethylene, polyvinyl chloride, polyvinylidene fluoride, polytetrafluoroethylene, polyethylene terephthalate, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, ceramic, silicon dioxide and organic silicon.

wherein, the preparation process of the support component is conventional in the field, and includes but not limited to sintering, injection molding and the like.

the form and type of the drug particles or pellets are specifically described below:

In the present invention, the pharmaceutical granule or pellet has a conventional meaning in the art, and generally means a granule, powder or pellet containing an active pharmaceutical ingredient.

Wherein the particle size of the medicine particles or pills is conventional in the field, and is generally 1-5000 μm, preferably 25-2000 μm, and more preferably 50-1000 μm.

Preferably, when the particle size of the drug particles or pellets is in the range of 50 to 1000 μm, the pore size of the filter member is 40 to 300 μm.

Wherein the active pharmaceutical ingredient contained in the pharmaceutical granule or pill is conventional in the art, including but not limited to one or more of the following: dabigatran etexilate or a pharmaceutically acceptable salt thereof, apixaban, rivaroxaban, levodopa-carbidopa, montelukast, lansoprazole, omeprazole, esomeprazole, amoxicillin, clarithromycin, azithromycin, metronidazole, rifampicin, sulfasalazine, acetaminophen, dextromethorphan, doxylamine, pseudoephedrine, diphenhydramine, amphetamine, methylphenidate, deferasirox, ivacaftor, lumacaftor, tacrolimus, diazepam, clobazam, vigabatrin, bosentan, melatonin, biotin, dimercaptobutanedioic acid, amlodipine, and esmolol.

An eighth object of the present invention is to provide an oral administration delivery device, which comprises the drug containing device of the seventh object, and further comprises a tubular member having two openings at two ends and an inner cavity, wherein one opening at one end is a first opening, and the other opening at the other end is a second opening, and the inner cavity is communicated with the first opening and the second opening; the medicine containing device is externally connected with the free end of the first opening, and the space for bearing medicine particles or multiple pills is communicated with the inner cavity.

the manner in which the medicament containing device is disposed externally to the free end of the first opening is described in detail below:

In the present invention, the drug containing device is disposed outside the tubular member, and is preferably maintained at the first opening outside the tubular member by a fixed sleeving manner or a threaded connection manner.

The structure of the tubular member is specifically described below:

Wherein, when the number of the pipe sections is 3: the inner diameter of the first pipe section from the first opening to the second opening is the same as that of the third pipe section, the outer diameter of the second pipe section is smaller than that of the first pipe section, and each pipe section can be axially stretched or contracted along other pipe sections; or the inner diameter of the first pipe section, the outer diameter of the second pipe section, the inner diameter of the third pipe section and the outer diameter of the first pipe section in the direction from the first opening to the second opening are gradually reduced, and each pipe section can be axially stretched or shrunk along other pipe sections.

The ninth object of the present invention is to provide an oral administration delivery device, which comprises the drug containing device of the seventh object, and further comprises a tubular member, wherein the tubular member has two openings at two ends and an inner cavity, one opening at one end is a first opening, and the other opening at the other end is a second opening, and the inner cavity is communicated with the first opening and the second opening; the medicine containing device is arranged in the inner cavity, is close to the first opening, and is used for communicating a space for bearing medicine particles or multiple pills with the second opening; the diameter of the first opening is smaller than the smallest diameter of the medicament containing device.

In the present invention, preferably, the diameter of the second opening is smaller than the smallest diameter of the medicament containing device.

in the present invention, the structure of the tubular member is specifically described in the eighth section of the same object.

It should be understood by those skilled in the art that the descriptions of "first opening," "second opening," "first tube segment," "second tube segment," "third tube segment," "fourth tube segment," etc. in this disclosure are for convenience of description and should not be construed as limiting to a particular position or order.

on the basis of the common knowledge in the field, the above preferred conditions can be combined randomly to obtain the preferred embodiments of the invention.

The reagents and starting materials used in the present invention are commercially available.

the positive progress effects of the invention are as follows: the drug containing device can better solve the problems of leakage and large fluid resistance when drug particles are sipped, and the oral administration delivery device formed by matching with the tubular member can be used as a drug package which is directly contacted with the drug, and has a storage function. When the oral administration delivery device is used, the liquid filled in the straw is detected to be emptied under the action of gravity only for less than 12s when the length of the straw is 20 cm.

drawings

Fig. 1 is a schematic structural view of a support member and a filter member in a medicine-containing device of example 1, where 1a is a lower support member, 1b is a filter member, and 1c is an upper support member;

fig. 2 is a schematic view showing the assembly of the support member and the filter member in the medicine-containing device of example 1, wherein 2a is before assembly and 2b is after assembly;

FIG. 3 is a schematic view of the drug containment device of example 1 assembled with a straw to form a built-in oral delivery device;

Fig. 4 is a schematic structural view of a support member and a filter member of the medicine-containing device of example 2, wherein 4a is a cage-shaped support member, 4b is a filter member, and 4c is an upper cover of the cage-shaped support member;

Fig. 5 is an assembly schematic of the support member and the filter member of the medication containing device of example 2;

FIG. 6 is a schematic view of the drug containment device of example 2 assembled with a straw to form a built-in oral delivery device;

FIG. 7 is a schematic view of the built-in oral drug delivery device of examples 1-3 during use with a straw, 7a before sipping and 7b after sipping;

Fig. 8 is a schematic view showing the construction of a filter accommodating member, a filter member and a drug accommodating member in the drug accommodating device according to example 4, wherein 8a is the filter accommodating member, 8b is the filter member, and 8c is the drug accommodating member;

Fig. 9 is an assembly schematic view of a filter accommodating member, a filter member and a drug accommodating member in the drug accommodating device of example 4, wherein 9a is before assembly and 9b is after assembly;

FIG. 10 is a schematic view of the drug containment device of example 4 assembled with a straw to form an external oral delivery device;

Fig. 11 is a schematic view of the external oral drug delivery device of example 4 during use with a sipping tube, 11a before and 11b after sipping;

FIG. 12 is a cross-sectional view of an embodiment of a filter element having an irregular, labyrinthine cross-sectional configuration of internal channels;

fig. 13 is a schematic structural view of the drug containing device of embodiment 8;

fig. 14 is a schematic structural view of an oral drug delivery device according to example 8.

Detailed Description

The invention is further illustrated by the following examples, which are not intended to limit the scope of the invention. The experimental methods without specifying specific conditions in the following examples were selected according to the conventional methods and conditions, or according to the commercial instructions.

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Drug containing device of solid oral preparation and oral administration delivery device containing same

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