ABUSE RESISTANT DRUG FORMULATION
First Claim
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1. Coated particles comprising:
- controlled release API-containing particles comprising an API in an amount of at least about 0.1, and a fat/wax in an amount of between about 5 and about 40% based on the weight of the particles, and a crush resistant coating containing between about 5 and about 40% of a fat/wax based on the weight of the coated particles and the coating is present in an amount of between about 20 and about 75% by weight based on the weight of the coated particles, wherein the coated particles exhibit at least one of greater crush resistance or longer API release when compared to identical coated particles that do not include a fat/wax in both the particle and the coating.
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Abstract
A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.
36 Citations
27 Claims
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1. Coated particles comprising:
- controlled release API-containing particles comprising an API in an amount of at least about 0.1, and a fat/wax in an amount of between about 5 and about 40% based on the weight of the particles, and a crush resistant coating containing between about 5 and about 40% of a fat/wax based on the weight of the coated particles and the coating is present in an amount of between about 20 and about 75% by weight based on the weight of the coated particles, wherein the coated particles exhibit at least one of greater crush resistance or longer API release when compared to identical coated particles that do not include a fat/wax in both the particle and the coating.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A pharmaceutical composition comprising:
- a matrix including particles of a fat/wax in an amount of between about 1 and about 50% by weight of the composition and API-containing particles comprising an API in an amount of at least about 0.1, and a fat/wax in an amount of between about 5 and about 40% based on the weight of the particles, and a crush resistant coating containing between about 5 and about 40% of a fat/wax based on the weight of the coated particles and the coating is present in an amount of between about 20 and about 75% by weight based on the weight of the coated particles, wherein the coated particles exhibit at least one of greater crush resistance or longer API release when compared to identical coated particles that do not include a fat/wax in both the particle and the coating.
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21. A pharmaceutical dosage form comprising:
- a matrix including particles of a fat/wax selected from the group consisting of waxes, fatty acids and fatty acid esters present in an amount of between about 1 and about 50% by weight of the dosage form, an amount of API-containing particles sufficient to provide an effective amount of the API, the particles comprising an API, a fat/wax selected from the group consisting of waxes, fatty acids and fatty acid esters in an amount of between about 5 and about 40% based on the weight of the particles, and a crush resistant coating containing between about 5 and about 40% of a fat/wax selected from the group consisting of waxes, fatty acids and fatty acid esters based on the weight of the coated particles, the coating present in an amount of between about 20 and about 75% by weight of the coated particles, wherein the coated particles exhibit at least one of greater crush resistance or longer API release when compared to identical coated particles that do not include a fat/wax in both the particle and the coating.
- View Dependent Claims (22, 23, 24, 25, 26)
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27-36. -36. (canceled)
Specification