Tamper resistant dosage form comprising inorganic salt
First Claim
1. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and comprising:
- a pharmacologically active ingredient (A);
an inorganic salt (B), wherein the content of the inorganic salt (B) is from 29 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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Abstract
A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N, wherein the dosage form contains 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 the matrix comprises at least a time interval during which the release follows zero order kinetics.
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Citations
22 Claims
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1. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and comprising:
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a pharmacologically active ingredient (A); an inorganic salt (B), wherein the content of the inorganic salt (B) is from 29 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, 16, 17, 18, 19, 20)
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21. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and comprising:
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a pharmacologically active ingredient (A) selected from the group consisting of tapentadol, oxymorphone, hydromorphone, oxycodone, morphine and the physiologically acceptable salts thereof; an inorganic salt (B), wherein the content of the inorganic salt (B) is from 29 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), wherein the pharmaceutical dosage form weighs between 250 mg and 1500 mg, 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, and the time interval during which the release follows zero order kinetics is at least 60% of the total release time needed for a release of 95 wt.-% of the pharmacologically active ingredient (A) that was originally contained in the pharmaceutical dosage form.
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22. A pharmaceutical dosage form exhibiting a breaking strength of at least 500 N and comprising:
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a pharmacologically active ingredient (A) selected from the group consisting of tapentadol, oxymorphone, hydromorphone, oxycodone, morphine and the physiologically acceptable salts thereof; an inorganic salt (B), wherein the content of the inorganic salt (B) is from 29 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 500,000 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), wherein the pharmaceutical dosage form weighs between 250 mg and 1500 mg, 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, and the time interval during which the release follows zero order kinetics is at least 60% of the total release time needed for a release of 95 wt.-% of the pharmacologically active ingredient (A) that was originally contained in the pharmaceutical dosage form.
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Specification