Methods and compositions for deterring abuse of orally administered pharmaceutical products
First Claim
Patent Images
1. A therapeutic pharmaceutical composite having at least two immediate release sequestered subunits, comprising:
- (a) a first immediate release sequestered subunit comprising a mixture of;
a gel forming polymer;
a nasal tissue irritant; and
a disintegrant; and
(b) a second immediate release sequestered subunit comprising an opioid analgesic.
1 Assignment
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Accused Products
Abstract
This invention relates to an abuse deterrent formulation of an oral dosage form of a therapeutically effective amount of any active drug substance that can be subject to abuse combined with a gel forming polymer, a nasal mucosal irritating surfactant and a flushing agent. Such a dosage form is intended to deter abuse of the active drug substance via injection, nasal inhalation or consumption of quantities of the dosage unit exceeding the usual therapeutically effective dose.
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Citations
47 Claims
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1. A therapeutic pharmaceutical composite having at least two immediate release sequestered subunits, comprising:
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(a) a first immediate release sequestered subunit comprising a mixture of;
a gel forming polymer;
a nasal tissue irritant; and
a disintegrant; and(b) a second immediate release sequestered subunit comprising an opioid analgesic. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method of making a therapeutic pharmaceutical composite suitable for deterring drug abuse comprising:
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(a) providing a first immediate release sequestered subunit comprising a mixture of;
a gel forming polymer, a nasal tissue irritant, and a disintegrant, by;i. controlling the molecular weight or viscosity of the gel forming polymer; ii. controlling the amount of nasal tissue irritant such that nasal tissue irritation occurs if inhaled; and iii. controlling the percentage by weight of disintegrant; (b) providing a second immediate release sequestered subunit comprising a drug susceptible to abuse; and (c) combining the first and second immediate release sequestered subunits to form a therapeutic pharmaceutical composite; wherein the therapeutic pharmaceutical composite deters abuse by forming a viscous gel upon contact with a solvent and inducing nasal irritation if inhaled. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A sequestered pharmaceutical composition subunit comprising:
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(a) a gel forming polymer; (b) a nasal tissue irritant; and (c) a disintegrant. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47)
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Specification