阅读说明：本技术 用于包封活性物质的、允许控制所述活性物质的释放速率的脂质组合物 (Lipid composition for encapsulating an active substance, allowing to control the release rate of said active substance ) 是由 索菲·法赫特 S·列斐伏尔 于 2019-10-16 设计创作，主要内容包括：揭露了一种脂质组合物,每100％重量包含：-按重量计从40％至99.9％的以下复合物,该复合物每100％重量包含按重量计从90％至0％的蜂蜡以及按重量计至多10％的至少一种其他脂质赋形剂,-按重量计从0.1％至60％的至少一种亲脂性表面活性剂。(Disclosed is a lipid composition comprising, per 100% by weight: -from 40 to 99.9% by weight of a complex comprising, per 100% by weight, from 90 to 0% by weight of beeswax and up to 10% by weight of at least one other lipid excipient, -from 0.1 to 60% by weight of at least one lipophilic surfactant.)

1. A lipid composition comprising per 100% of its weight:

from 40 to 99.9% by weight of a component comprising, per 100% of its weight, from 90 to 100% by weight of beeswax and up to 10% by weight of at least one other lipid excipient,

-from 0.1 to 60% by weight of at least one lipophilic surfactant selected from polyethoxylated fatty acids, esters of fatty diacids and polyethylene glycols, esters of polyglycerols and fatty acids, esters of propylene glycol and fatty acids, mixtures of esters of propylene glycol and glycerol, fatty acid diglycerides, sterol and sterol derivatives, esters of fatty acids and sorbitan, esters of sorbitan and polyethylene glycols and fatty acids, ethers of polyethylene glycols and alkyl, sucrose esters, and polyoxyethylene-polyoxypropylene block copolymers.

2. The lipid composition of claim 1, wherein the lipid excipient is selected from the group consisting of animal waxes, vegetable waxes, mineral waxes, synthetic waxes, and hydrogenated vegetable oils.

3. The lipid composition according to any one of claims 1 and 2, wherein the lipophilic surfactant is selected from esters of fatty acids and sugars.

4. The lipid composition according to any one of claims 1 and 3, wherein the lipophilic surfactant is a lipophilic surfactant from the sorbitan ester family, more particularly an element from the group consisting of: sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate and sorbitan monooleate, and even more particularly sorbitan monopalmitate or sorbitan monostearate, and even more particularly sorbitan monostearate.

5. Lipid composition according to one of claims 1 to 4, characterized in that it comprises from 0 to 20% of one or more hydrophilic surfactants.

6. The lipid composition of claim 5, wherein the one or more hydrophilic surfactants are selected from the group consisting of soy lecithin, ethoxylated sorbitan esters, polyethoxylated alcohols, polyethoxylated acids, polyglycerol esters, glucose ethers, and block copolymers of ethylene oxide and propylene oxide.

7. A lipid composition according to claim 5, wherein the hydrophilic surfactant is a sorbitan ester and the hydrophilic surfactant is selected from a polyethoxylated sorbitan ester.

8. A lipid composition according to claim 7, wherein the composition comprises:

-75% of beeswax,

-20% sorbitan stearate, and

5% sorbitan oleate (or polysorbate 80) polyethoxylated with 20 moles of ethylene oxide.

9. A lipid composition according to claim 7, wherein the composition comprises:

-50% of beeswax,

-45% sorbitan stearate, and

5% sorbitan oleate (or polysorbate 80) polyethoxylated with 20 moles of ethylene oxide.

10. Lipid composition according to one of claims 1 to 7, characterized in that it comprises from 0 to 20% of at least one coating adjuvant.

11. A lipid composition according to claim 8, wherein one or more of the coating aids are selected from diluents, flavouring agents, appetizing agents, colouring agents, antioxidants, plasticisers, antifoaming agents and disintegrants.

12. A controlled release Composition (CA) comprising:

-at least one composition according to one of claims 1 to 11, and

-at least one active pharmaceutical, prophylactic or food substance.

13. The Composition (CA) according to claim 12, which is intended for oral administration in humans or animals.

14. The Composition (CA) according to any one of claims 12 and 13, characterized in that it is in solid form.

15. Use of the lipid composition according to one of claims 1 to 11 for encapsulating an active pharmaceutical, therapeutic, prophylactic, or food substance for humans or animals in a galenical formulation.

16. A process for manufacturing a galenical formulation comprising a Composition (CA) according to one of claims 12 to 14, comprising at least:

a) a step of preparing a lipid composition according to one of claims 1 to 11;

b) mixing and encapsulating an active pharmaceutical, prophylactic or food substance with said lipid composition prepared in step a) so as to obtain a composition (C) according to one of claims 12 to 14_A) A step of

c) Subjecting the composition (C) prepared in step b)_A) A step of galenic shaping involving mechanical stress.

17. The method of manufacturing of claim 16, wherein the mixing and encapsulating step b) comprises:

-a first sub-step: heating the lipid composition prepared in step a) to a temperature of 10 ℃ to 15 ℃ above the highest melting point of the various ingredients of the lipid composition in order to melt the lipid composition,

-a second sub-step: mixing the molten lipid composition with the active substance in dispersed or molten form, and

-a third sub-step: spraying the composition obtained in the second substep into ambient air or cooling air or into a cooling liquid, so as to obtain a composition (C)_A) The cured particles of (1).

18. The manufacturing process according to any one of claims 16 and 17, wherein the galenic forming step involving mechanical stress is selected from the group consisting of compression, forming into hard capsules, pressing, packaging, placing into sachets, forming into bars, extrusion, granulation, and pelletizing.