TAMPER RESISTANT DOSAGE FORM COMPRISING INORGANIC SALT
First Claim
1. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and containinga pharmacologically active ingredient (A);
- an inorganic salt (B), wherein the content of the inorganic salt (B) is from 5 to 70 wt.-%, based on the total weight of the dosage form;
a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol, wherein the content of the polyalkylene oxide (C) is at least 30 wt.-%, based on the total weight of the dosage form;
wherein the pharmacologically active ingredient (A) is embedded in a controlled release matrix comprising the inorganic salt (B) and the polyalkylene oxide (C), andwherein, under in vitro conditions, the release profile of the pharmacologically active ingredient (A) from said matrix comprises at least a time interval during which the release follows a zero order kinetics.
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Accused Products
Abstract
The invention relates to a pharmaceutical dosage form exhibiting a breaking strength of at least 500 N, said dosage form containing a pharmacologically active ingredient (A); an inorganic salt (B); and a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol, wherein the content of the polyalkylene oxide (C) is at least 20 wt.-%, based on the total weight of the dosage form; wherein the pharmacologically active ingredient (A) is present in a controlled-release matrix comprising the inorganic salt (B) and the polyalkylene oxide (C) and wherein, under in vitro conditions, the release profile of the pharmacologically active ingredient (A) from said matrix comprises at least a time interval during which the release follows zero order kinetics.
53 Citations
15 Claims
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1. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and containing
a pharmacologically active ingredient (A); -
an inorganic salt (B), wherein the content of the inorganic salt (B) is from 5 to 70 wt.-%, based on the total weight of the dosage form; a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol, wherein the content of the polyalkylene oxide (C) is at least 30 wt.-%, based on the total weight of the dosage form; wherein the pharmacologically active ingredient (A) is embedded in a controlled release matrix comprising the inorganic salt (B) and the polyalkylene oxide (C), and wherein, under in vitro conditions, the release profile of the pharmacologically active ingredient (A) from said matrix comprises at least a time interval during which the release follows a zero order kinetics. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification