Immediate Release Pharmaceutical Compositions with Abuse Deterrent Properties
First Claim
1. A pharmaceutical composition comprising at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, at least one low molecular weight water-soluble polymer, at least one polyglycol, at least one polysaccharide, at least one clay mineral, and, optionally, an effervescent system.
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Accused Products
Abstract
The present disclosure provides pharmaceutical compositions and processes for making solid dosage form pharmaceutical compositions that provide immediate release of active ingredients and have abuse deterrent properties. The pharmaceutical compositions provided herein comprise at least one pharmaceutically active ingredient, at least one low molecular weight water-soluble polymer, at least one polyglycol, at least one polysaccharide, at least one clay mineral, and, optionally, an effervescent system.
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Citations
20 Claims
- 1. A pharmaceutical composition comprising at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, at least one low molecular weight water-soluble polymer, at least one polyglycol, at least one polysaccharide, at least one clay mineral, and, optionally, an effervescent system.
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14. The pharmaceutical composition of claim 14, further comprising the optional effervescent system comprising a) an acid component chosen from an organic acid, an inorganic acid, and combinations thereof and b) a base component chosen from an alkali metal bicarbonate, an alkaline earth metal bicarbonate, an alkali metal carbonate, an organic carbonate, and combinations thereof;
- and the effervescent system is present in an amount from about 15% to about 50% by weight of the pharmaceutical composition.
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15. A process for preparing a solid dosage form, the process comprising:
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a) forming a mixture comprising at least one low molecular weight water-soluble polymer, at least one polyglycol, at least one polysaccharide, at least one clay mineral, and, optionally, an effervescent system; b) forming the mixture into a solid dosage unit; and c) heating the solid dosage unit to yield the solid dosage form.
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16. The process of claim 16, wherein the low molecular weight water-soluble polymer has a molecular weight of no more than about 300,000 daltons and is chosen from a polyalkylene oxide, a cellulose ether, a polyolefinic alcohol, a polyvinyl lactam, a polycarboxylic acid, and combinations thereof;
- the polyglycol is chosen from a copolymer of ethylene glycol and propylene glycol, a polyethylene glycol, a polypropylene glycol, and combinations thereof;
the polysaccharide is a gum chosen from xanthan gum, acacia gum, diutan gum, gellan gum, guar gum, fenugreek gum, locust bean gum, pullulan, welan gum, and combinations thereof;
the clay mineral is chosen from a bentonite, talc, and combinations thereof; and
the optional effervescent system comprises a) an acid component chosen from an organic acid, an inorganic acid, and combinations thereof and b) a base component chosen from an alkali metal bicarbonate, an alkaline earth metal bicarbonate, an alkali metal carbonate, an organic carbonate, and combinations thereof. - View Dependent Claims (17, 18, 19, 20)
- the polyglycol is chosen from a copolymer of ethylene glycol and propylene glycol, a polyethylene glycol, a polypropylene glycol, and combinations thereof;
Specification