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US 10,864,204 B2Granted
Pharmaceutical composition and preparation method therefor
AssigneeShenzhen Pharmacin Co., Ltd.
InventorsZeren Wang, Yulan Zhao, Lijiang Wang, Xiao Zhang, Jun Xu, Shunqin Chen, Meili Sun, Guisheng Jiang
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Abstract
The present invention provides an oral pharmaceutical composition and a usage thereof, comprising a pharmaceutically acceptable acidic medicinal auxiliary material whose surface is modified and dabigatran etexilate or pharmaceutically acceptable salts or aquo-complexes thereof. The present invention further provides a surface modification method for a medicinal auxiliary material.
Claims21
An oral pharmaceutical composition, comprising:
- (i) a first component, wherein the first component comprises dabigatran etexilate or a pharmaceutically acceptable salt or hydrate thereof;
- and
- (ii) a second component, wherein the second component comprises:
- (a) a pharmaceutically acceptable surface-modified acidic auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified acidic auxiliary material comprises a neutral salt layer that comprises:
- 1) an anion of an acidic medicinal auxiliary material in a powdered form;
- and 2) a cation of a pharmaceutically acceptable alkaline substance for surface modification;
- or
- (b) a pharmaceutically acceptable surface-modified alkaline auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified alkaline auxiliary material comprises a neutral salt layer that comprises:
- 1) a cation of an alkaline medicinal auxiliary material in a powdered form;
- and 2) an anion of a pharmaceutically acceptable acidic substance for modification.
7 more elements
An oral pharmaceutical composition, comprising:
- (i) a first component, wherein the first component comprises dabigatran etexilate or a pharmaceutically acceptable salt or hydrate thereof;
- and
- (ii) a second component, wherein the second component comprises:
- (a) a pharmaceutically acceptable surface-modified acidic auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified acidic auxiliary material comprises a neutral salt layer formed by reacting:
- 1) a powdered form of an acidic medicinal auxiliary material;
- and 2) an aqueous solution comprising a pharmaceutically acceptable alkaline substance for surface modification,
- wherein the acidic medicinal auxiliary material is selected from the group consisting of tartaric acid, fumaric acid, succinic acid, citric acid, malic acid, glutamic acid, aspartic acid, a hydrate thereof, and an acidic salt thereof, and
- wherein the pharmaceutically acceptable alkaline substance for modification is selected from the group consisting of aqueous ammonia, meglumine, trihydroxymethylaminomethane, sodium carbonate, potassium carbonate, sodium acetate, potassium acetate, sodium stearate, potassium stearate, lysine, arginine and histidine, and a hydrate thereof;
- or
- (b) a pharmaceutically acceptable surface-modified alkaline auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified alkaline auxiliary material comprises a neutral salt layer formed by reacting:
- 1) a powdered form of an alkaline medicinal auxiliary material;
- and 2) an aqueous solution comprising a pharmaceutically acceptable acidic substance for modification,
- wherein the alkaline medicinal auxiliary material is selected from the group consisting of lysine, arginine, histidine, and a hydrate thereof, and
- wherein the pharmaceutically acceptable acidic substance for modification is selected from the group consisting of tartaric acid, fumaric acid, succinic acid, citric acid, malic acid, glutamic acid, aspartic acid, a hydrate thereof, and an acidic salt.
11 more elements
Dependencies are inferred from the claim text.