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US 9,789,112 B2Granted
Oral pharmaceutical film formulation for bitter tasting drugs
AssigneeHexal AG
InventorsThomas Kohr, Petra Obermeier
Life of this patent
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Abstract
The invention relates to a pharmaceutical film formulation comprising one or more bitter-tasting drug(s) or pharmaceutically acceptable salts thereof, one or more film formers, a bitterness masker containing one or more inorganic and/or organic salt(s) and at least two monocyclic monoterpenes, and one or more sweetening agents.
Claims22
A pharmaceutical film formulation comprising:
- from 60% w/w to 75% w/w of sildenafil or pharmaceutically acceptable salts thereof;
- from 9% w/w to 20% w/w of hydroxypropylcellulose;
- a bitterness masker comprising:
- a) from 1% w/w to 5% w/w of one or more inorganic salt(s);
- and
- b) from 0.01% w/w to 2% w/w of monocyclic monoterpenes comprising N-ethyl-2 (isopropyl)-5-methyl cyclohexane carboxamide and menthol ethylene glycol carbonate;
- from 2% w/w to 6% w/w of one or more sweeteners;
- and
- from 0.01% w/w to 15% w/w of one or more flavoring agents,
- wherein the respective amounts are based on the dry weight of the film formulation, and
- wherein the film is substantially free of voids.
8 more elements
A pharmaceutical film formulation comprising:
- from 60% w/w to 75% w/w of sildenafil or pharmaceutically acceptable salts thereof,
- from 9% w/w to 20% w/w of hydroxypropylcellulose,
- a bitterness masker comprising:
- a) from 1% w/w to 5% w/w of one or more inorganic salt(s);
- and
- b) from 0.01% w/w to 2% w/w of monocyclic monoterpenes comprising N-ethyl-2 (isopropyl)-5-methyl cyclohexane carboxamide and menthol ethylene glycol carbonate;
- from 2% w/w to 6% w/w of one or more sweeteners;
- from 0.01% w/w to 15% w/w of one or more flavoring agents;
- and
- from 2.5 to 5% w/w of humectants comprising sorbitol and xylitol, wherein the humectants maintain the moisture content of the film formulation in a range of between 5 and 10% w/w,
- wherein the respective amounts of are based on the dry weight of the film formulation, and
- wherein the film is substantially free of voids.
9 more elements
Dependencies are inferred from the claim text.