Abuse Resistant Drug Formulation

摘要

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.

主权项

1. An abuse resistant tablet consisting of:
a. a plurality of coated granules, wherein each coated granule consists of:
i. a granule consisting of:
a. an opioid, and/or a salt thereof, present in an amount in the range of from 20 to 60 percent by weight of the uncoated granule;b. ethylcellulose present in an amount in the range of from 10 to 75 percent by weight of the uncoated granule;c. hydroxypropyl methyl cellulose present in an amount in the range of from 15 to 50 percent by weight of the uncoated granule; andii. a coating substantially surrounding the granule, wherein the coating consists of:
a. ethyl cellulose present in an amount in the range of from 20 to 60 percent by weight of the coated granule;b. glyceryl behenate present in an amount in the range of from 10 to 30 percent by weight of the coated granule;wherein the plurality of coated granules are present in the tablet in an amount to provide a therapeutically effective amount of the opioid, and/or a salt thereof; and b. a matrix composition comprising:
i. hydroxypropyl methyl cellulose present in an amount in the range of from 2 to 20 percent by weight of the tablet; andii. lactose present in an amount in the range of from 10 to 75 percent by weight of the tablet.