阅读说明：本技术 用于治疗周围神经痛的、至少包含阿米替林的局部药物组合物 (Topical pharmaceutical composition comprising at least amitriptyline for the treatment of peripheral neuropathic pain ) 是由 C.格雷科 于 2018-04-18 设计创作，主要内容包括：本发明涉及一种药物组合物,其包含相对于该组合物总重量的10重量％至30重量％的阿米替林或其药学上可接受的盐或酯,所述组合物用于局部治疗由化疗引起的周围神经痛。(The present invention relates to a pharmaceutical composition comprising 10 to 30% by weight of amitriptyline or a pharmaceutically acceptable salt or ester thereof, relative to the total weight of the composition, for use in the topical treatment of peripheral neuropathic pain caused by chemotherapy.)

1. A pharmaceutical composition comprising 10 to 30% by weight of amitriptyline or a pharmaceutically acceptable salt thereof, relative to the total weight of the composition, in a pharmaceutically acceptable carrier suitable for topical administration, for the topical treatment of chemotherapy-induced peripheral neuropathic pain.

2. A composition according to claim 1 for use in the treatment of chemotherapy-induced peripheral neuropathic pain by application to peripheral sites (hands and feet).

3. Composition according to claim 1 or 2, characterized in that it comprises from 10% to 20% by weight, preferably from more than 10% to 15% by weight, of amitriptyline or a pharmaceutically acceptable salt thereof, relative to the total weight of the composition.

4. A composition according to any one of claims 1 to 3 comprising amitriptyline as the sole agent for the treatment of neuropathic pain.

5. Composition according to any one of claims 1 to 4 for prophylactic use prior to chemotherapy in order to reduce or even prevent chemotherapy-induced peripheral neuropathic pain.

6. A composition according to any one of claims 1 to 4 for use in the treatment of cancer comprising chemotherapy stages, the composition being administered between chemotherapy stages to alleviate or prevent neuropathic pain that may result from chemotherapy.

7. Composition according to any one of claims 1 to 6 for use in the treatment of cancer comprising a chemotherapy stage, the composition being administered prophylactically prior to the chemotherapy stage, followed by administration during and between chemotherapy regimens, if necessary continuing after chemotherapy depending on the status of the neuropathic pain.

8. Composition according to any one of claims 1 to 7, in the form of an oil-in-water emulsion and comprising at least a fatty substance, one or more hydrating active agents and a non-ionic surfactant.

9. Composition according to any one of the preceding claims, characterized in that it comprises one or more fatty substances, preferably chosen from synthetic oils, animal oils, mineral or vegetable oils, silicone oils, fatty acids, fatty alcohols, waxes, gums and mixtures of these compounds, more preferably chosen from mineral oils, fatty acids, waxes and mixtures of these compounds, in particular it comprises one or more mineral oils, one or more fatty acids and one or more waxes.

10. Composition according to any one of the preceding claims, characterized in that it comprises one or more nonionic surfactants chosen from sorbitan esters, glycerol esters and mixtures of these compounds.

11. Composition according to any one of the preceding claims, characterized in that it comprises one or more gelling agents, preferably chosen from carboxyvinyl polymers, cellulose-based derivatives, xanthan gums, vegetable gums, aluminium/magnesium silicates, guar gums, polyacrylamide polymers, acrylate copolymers, modified starches and mixtures of these compounds, more preferably from carboxyvinyl polymers.

12. Composition according to any one of the preceding claims, characterized in that it comprises:

-10 to 30 wt. -%, preferably 10 to 20 wt. -%, more preferably more than 10 to 15 wt. -% of amitriptyline or a pharmaceutically acceptable salt thereof,

-from 2 to 8% by weight of one or more surfactants,

-15% to 25% by weight of one or more fatty substances,

-from 0.1 to 4% by weight of one or more gelling agents,

-7 to 15% by weight of one or more hydration actives,

-optionally 0 to 3 wt% of one or more preservatives,

-optionally 0 to 1 wt% of one or more pH adjusting agents,

-water.

13. Composition according to claim 12, characterized in that it comprises:

-10 to 30 wt. -%, preferably 10 to 20 wt. -%, more preferably 10.5 to 15 wt. -% of amitriptyline or a pharmaceutically acceptable salt thereof,

-from 2% to 8% by weight of one or more surfactants selected from sorbitan esters, glycerol esters and mixtures of these compounds,

-from 15% to 25% by weight of one or more fatty substances selected from mineral oils, fatty acids, waxes and mixtures of these compounds,

-from 0.1 to 4% by weight of one or more gelling agents selected from carboxyvinyl polymers,

-7 to 15% by weight of one or more hydration actives,

-optionally 0 to 3 wt% of one or more preservatives,

-optionally 0 to 1 wt% of one or more pH adjusting agents,

-water.

14. Composition according to claim 12 or 13, characterized in that it comprises:

-10 to 30 wt. -%, preferably 10 to 20 wt. -%, more preferably 10.5 to 15 wt. -% of amitriptyline or a pharmaceutically acceptable salt thereof,

-from 2% to 8% by weight of a mixture of one or more sorbitan esters and one or more glycerides,

-15 to 25% by weight of a mixture of one or more mineral oils, one or more fatty acids and one or more waxes,

-0.1 to 4% by weight of one or more carboxyvinyl polymers

-7 to 15% by weight of glycerol,

-optionally 0 to 3 wt% of one or more preservatives,

-optionally 0 to 1 wt% of one or more pH adjusting agents,

-water.

15. Composition according to any one of the preceding claims, characterized in that it is in the form of a cream.

Examples