Methods and compositions for deterring abuse of orally administered pharmaceutical products
First Claim
Patent Images
1. A therapeutic pharmaceutical composition comprising (a) an opioid analgesic;
- (b) a gel forming polymer;
(c) a nasal tissue irritant; and
(d) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested.
1 Assignment
0 Petitions
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
74 Claims
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1. A therapeutic pharmaceutical composition comprising
(a) an opioid analgesic; -
(b) a gel forming polymer;
(c) a nasal tissue irritant; and
(d) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 33, 43, 45, 46, 47, 48)
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18. A method of making a therapeutic composition suitable for deterring drug abuse comprising
(a) providing a drug, a gel-forming polymer having a viscosity, a nasal tissue irritant and flushing agent; -
(b) controlling the molecular weight or viscosity of the gel forming polymer;
(c) controlling the amount of nasal tissue irritant such that nasal tissue irritation occurs if inhaled;
(d) controlling the amount of flushing agent such that flushing ensues only if more than a prescribed amount of the drug is consumed; and
(e) combining the analgesic, gel forming polymer, nasal tissue irritant and flushing agent to form a therapeutic composition;
wherein the composition deters abuse of the analgesic by forming a viscous gel upon contact with a solvent;
inducing nasal irritation if inhaled, and inducing flushing if more than a prescribed amount of the analgesic is consumed. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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34. A therapeutic pharmaceutical composition in unit dose form comprising
(a) an opioid analgesic; -
(b) a gel forming polymer comprising one or more of polyethylene oxide having average molecular weight ranging form about 300,000 to about 5,000,000, polyvinyl alcohol having a molecular weight of about 20,000 to 200,000, hydroxypropyl methyl cellulose having a molecular weight of about 10,000 to 1,500,000, and a carbomer having a molecular weight ranging of about 700,000 to 4,000,000,000;
(c) 1 to 5 percent by weight sodium lauryl sulfate; and
(d) less than about 0.01 to 0.5 gm of niacin. - View Dependent Claims (35, 36, 37, 38)
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39. A therapeutic pharmaceutical composition comprising
(a) an analgesic; -
(b) a gel forming polymer;
(c) a mucosal tissue irritant; and
(d) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested. - View Dependent Claims (40, 41, 42, 44, 49)
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50. A therapeutic pharmaceutical composition comprising
(a) an analgesic; -
(c) an emetic in sufficient amount to cause emesis if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested; and
(d) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested. - View Dependent Claims (51)
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52. A method of reducing the conversion of methamphetamine precursor compounds to methamphetamine comprising the step of mixing the methamphetamine precursor compounds with a gel forming polymer having a viscosity in a solvent, wherein upon contact with the solvent the viscosity of the gel forming polymer is sufficient to prevent at least a portion of the methamphetamine precursor compounds from solubilizing and subsequently converting to methamphetamine.
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53. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; - and
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested. - View Dependent Claims (55)
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54. A therapeutic pharmaceutical composition comprising
(a) an opioid analgesic; - and
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the analgesic of the therapeutic composition is ingested. - View Dependent Claims (56, 57)
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58. A therapeutic pharmaceutical composition comprising
(a) an opioid analgesic; -
(b) a gel forming polymer;
(c) a nasal tissue irritant; and
(d) a flushing agent in sufficient amount to cause flushing only when greater than a prescribed amount of the analgesic of the therapeutic composition is ingested.
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59. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; - and
(b) a flushing agent in a sub-therapeutic amount. - View Dependent Claims (62, 63, 64)
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60. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a second drug in a sub-therapeutic amount; and
(c) one or more abuse deterrent components selected from the group of abuse deterrents comprising 1.) a gel forming polymer;
2.) a nasal tissue irritant; and
3.) a flushing agent. - View Dependent Claims (61)
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65. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa, thereby reducing the abuse of the drug.
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66. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and causes one or more of acute sinusitis and chronic sinusitis.
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67. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and causes blockage of one or more of the sphenoid, maxillary, ethmoid and frontal sinuses. - View Dependent Claims (72, 73)
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68. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and complicates one or more of the uncinate process and ostio-meatal complex.
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69. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and blocks the interior nasal valve.
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70. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and inhibits a mucociliary cleareance system of the nasal mucosa.
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71. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; - and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and inhibits a mucociliary cleareance system of the nasal mucosa, wherein at least 95% of the gel which is adhered to the nasal mucosa is cleared via the mucociliary clearance system after about 1 day.
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74. A therapeutic pharmaceutical composition comprising
(a) a drug susceptible to abuse; -
(b) a flushing agent in sufficient amount to cause flushing if greater than a prescribed amount of the drug of the therapeutic composition is ingested; and
(c) a gel forming polymer, wherein the polymer forms a gel upon contact with nasal mucosa and inhibits a mucociliary cleareance system of the nasal mucosa, wherein the pH of the composition is between 0 and 4.
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Specification