CA2464322A1 - Methods of treatment using a gastric retained gabapentin dosage - Google Patents

Methods of treatment using a gastric retained gabapentin dosage Download PDF

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Publication number
CA2464322A1
CA2464322A1 CA002464322A CA2464322A CA2464322A1 CA 2464322 A1 CA2464322 A1 CA 2464322A1 CA 002464322 A CA002464322 A CA 002464322A CA 2464322 A CA2464322 A CA 2464322A CA 2464322 A1 CA2464322 A1 CA 2464322A1
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CA
Canada
Prior art keywords
dosage form
gabapentin
daily
administered
dosage
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Granted
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CA002464322A
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French (fr)
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CA2464322C (en
Inventor
Bret Berner
Sui Yuen Eddie Hou
Gloria M. Gusler
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Assertio Therapeutics Inc
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Individual
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Publication of CA2464322A1 publication Critical patent/CA2464322A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate

Abstract

A method of treatment for epilepsy and other disease states is described, which comprises the delivery of gabapentin in a gastric retained dosage form.

Claims (116)

1. A method of treating epilepsy comprising administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form to a mammal in need of such treatment.
2. The method of Claim 1 wherein the dosage form is administered once-daily.
3. The method of Claim 2 wherein the dosage form is administered with a meal.
4. The method of Claim 1 wherein the dosage form is administered twice-daily.
5. The method of Claim 4 wherein each dosage form is administered with a meal.
6. The method of Claim 1 which further comprises administering one or more additional anti-epileptics or anticonvulsants.
7. The method of Claim 1 wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is about 200-4000 mg.
8. The method of Claim 7 wherein the total amount of gabapentin in the daily dosage is about 600-2700 mg.
9. The method of Claim 8 wherein total amount of gabapentin in the daily dosage is about 900-1800 mg.
10. The method of Claim 1 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
11. The method of Claim 10 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
12. The method of Claim 11 wherein the dosage form provides administration of at least 80wt% of the gabapentin to be delivered over a period of about 5-12 hours.
13. The method of Claim 11 wherein the dosage form contains at least one hydrophilic polymer that swells to an extent such that it promotes gastric retention of the dosage form in the fed mode.
14. The method of Claim 13 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
15. The method of Claim 11 wherein the dosage form further comprises a gas generating agent.
16. The method of Claim 15 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
17. The method of Claim 1 wherein the dosage form is an adhesive tablet.
18. The method of Claim 1 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach duodenum and small intestine of the mammal.
19. The method of Claim 1 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of polyethylene oxide) and hydroxypropylmethylcellulose.
20. A method of treating neuropathic pain comprising administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form to a mammal in need of such treatment.
21. The method of Claim 20 wherein the dosage form is administered once-daily.
22. The method of Claim 21 wherein the dosage form is administered with a meal.
23. The method of Claim 20 wherein the dosage form is administered twice-daily.
24. The method of Claim 23 wherein each dosage form is administered with a meal.
25. The method of Claim 20 which further comprises administering one or more therapeutic agents selected from the group consisting of anticonvulsants, tricyclic antidepressants, opioids, and levodopa.
26. The method of Claim 20 wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is about 100-4800 mg.
27. The method of Claim 26 wherein the total amount of gabapentin in the daily dosage is about 300-3600 mg.
28. The method of Claim 27 wherein the total amount of gabapentin in the daily dosage is about 900-2400 mg.
29. The method of Claim 20 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
30. The method of Claim 29 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
31. The method of Claim 30 wherein the dosage form provides administration of at least 85wt% of the gabapentin to be delivered over a period of about 5-12 hours.
32. The method of Claim 30 wherein the dosage form contains at least one hydrophilic polymer that swells to an extent such that it promotes gastric retention of the dosage form in the fed mode.
33. The method of Claim 32 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
34. The method of Claim 30 wherein the dosage form further comprises a gas generating agent.
35. The method of Claim 34 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
36. The method of Claim 20 wherein the dosage form is an adhesive tablet.
37. The method of Claim 20 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach duodenum and small intestine of the mammal.
38. The method of Claim 20 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of poly(ethylene oxide) and hydroxypropylmethylcellulose.
39. A method of treating psychiatric disorders comprising administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form to a mammal in need of such treatment.
40. The method of Claim 39 wherein the psychiatric disorder is bipolar disorder or panic disorder.
41. The method of Claim 39 wherein the dosage form is administered once-daily.
42. The method of Claim 41 wherein the dosage form is administered with a meal.
43. The method of Claim 39 wherein the dosage form is administered twice-daily.
44. The method of Claim 43 wherein each dosage form is administered with a meal.
45. The method of Claim 39 which further comprises administering one or more therapeutic agents selected from the group consisting of anticonvulsants, tricyclic antidepressants, opioids, and levodopa.
46. The method of Claim 39 wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is about 100-4800 mg.
47. The method of Claim 46 wherein the total amount of gabapentin in the daily dosage is about 900-3600 mg.
48. The method of Claim 39 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
49. The method of Claim 48 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
50. The method of Claim 49 wherein the dosage form provides administration of at least 85wt% of the gabapentin to be delivered over a period of about 5-12 hours.
51. The method of Claim 49 wherein the dosage form contains at least one hydrophilic polymer that swells to an extent such that it promotes gastric retention of the dosage form in the fed mode.
52. The method of Claim 51 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
53. The method of Claim 49 wherein the dosage form further comprises a gas generating agent.
54. The method of Claim 53 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
55. The method of Claim 39 wherein the dosage form is an adhesive tablet.
56. The method of Claim 39 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach.
57. The method of Claim 39 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of polyethylene oxide) and hydroxypropylmethylcellulose.
58. A method of treating movement disorders comprising administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form to a mammal in need of such treatment.
59. The method of Claim 58 wherein the movement disorder is restless leg syndrome, periodic movement disorder of sleep, essential tremor or acquired nystagmus.
60. The method of Claim 58 wherein the dosage form is administered once-daily.
61. The method of Claim 60 wherein the dosage form is administered with a meal.
62. The method of Claim 58 wherein the dosage form is administered twice-daily.
63. The method of Claim 62 wherein each dosage form is administered with a meal.
64. The method of Claim 58 which further comprises administering one or more therapeutic agents selected from the group consisting of anticonvulsants, tricyclic antidepressants, opioids, benzodiazepine, and dopaminergic agents.
65. The method of Claim 58 wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is about 100-4000 mg.
66. The method of Claim 65 wherein the total amount of gabapentin in the daily dosage is about 200-3000 mg.
67. The method of Claim 66 wherein the total amount of gabapentin in the daily dosage is about 500-2700 mg.
68. The method of Claim 58 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
69. The method of Claim 68 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
70. The method of Claim 69 wherein the dosage form provides administration of at least 80wt% of the gabapentin to be delivered over a period of about 5-12 hours.
71. The method of Claim 69 wherein the dosage form contains a hydrophilic polymer that swells to a size such that the dosage form is retained in the fed mode.
72. The method of Claim 71 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
73. The method of Claim 69 wherein the dosage form further comprises a gas generating agent.
74. The method of Claim 73 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
75. The method of Claim 58 wherein the dosage form is an adhesive tablet.
76. The method of Claim 58 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach.
77. The method of Claim 58 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of poly(ethylene oxide) and hydroxypropylmethylcellulose.
78. A method for the prophylactic treatment of migraine headaches comprising administering a therapeutically effective amount of gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form to a mammal in need of such treatment.
79. The method of Claim 78 wherein the dosage form is administered once-daily.
80. The method of Claim 79 wherein the dosage form is administered with a meal.
81. The method of Claim 78 wherein the dosage form is administered twice-daily.
82. The method of Claim 81 wherein each dosage form is administered with a meal.
83. The method of Claim 78 which further comprises administering one or more therapeutic agents selected from the group consisting of anticonvulsants, tricyclic antidepressants, opioids, and levodopa.
84. The method of Claim 78 wherein the dosage form is administered once- or twice-daily and the total amount of gabapentin in the daily dosage is about 200-4000 mg.
85. The method of Claim 84 wherein the total amount of gabapentin in the daily dosage is about 500-3600 mg.
86. The method of Claim 85 wherein the total amount of gabapentin in the daily dosage is about 900-2400 mg.
87. The method of Claim 78 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
88. The method of Claim 87 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
89. The method of Claim 88 wherein the dosage form provides administration of at least 85wt% of the gabapentin to be delivered over a period of about 5-12 hours.
90. The method of Claim 88 wherein the dosage form contains at least one hydrophilic polymer that swells to an extent such that it promotes gastric retention of the dosage form in the fed mode.
91. The method of Claim 90 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
92. The method of Claim 88 wherein the dosage form further comprises a gas generating agent.
93. The method of Claim 92 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
94. The method of Claim 78 wherein the dosage form is an adhesive tablet.
95. The method of Claim 78 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach duodenum and small intestine of the mammal.
96. The method of Claim 78 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of poly(ethylene oxide) and hydroxypropylmethylcellulose.
97. An improved method of administering a therapeutically effective amount of gabapentin to a patient in need thereof, the improvement comprising administering gabapentin or a pharmaceutically acceptable salt thereof, in a gastric retained dosage form.
98. The method of Claim 97 wherein the dosage form is administered once-daily.
99. The method of Claim 98 wherein the dosage form is administered with a meal.
100. The method of Claim 97 wherein the dosage form is administered twice-daily.
101. The method of Claim 100 wherein each dosage form is administered with a meal.
102. The method of Claim 97 where the patient is being treated for epilepsy.
103. The method of Claim 97 where the patient is being treated for neuropathic pain.
104. The method of Claim 97 where the patient is being treated for psychiatric disorders.
105. The method of Claim 97 where the patient is being treated for movement disorders.
106. The method of Claim 97 where the patient is receiving prophylactic treatment for migraine headaches.
107. The method of Claim 97 wherein the dosage form is an extended release oral drug dosage form for releasing gabapentin into the stomach, duodenum and small intestine of the mammal.
108. The method of Claim 107 wherein gabapentin is administered from the dosage form for a period of at least 5 hours and at least 40wt% of the gabapentin is retained in the dosage form after 1 hour.
109. The method of Claim 108 wherein the dosage form provides administration of at least 80wt% of the gabapentin to be delivered over a period of about 5-12 hours.
110. The method of Claim 108 wherein the dosage form contains at least one hydrophilic polymer that swells to an extent such that it promotes gastric retention of the dosage form in the fed mode.
111. The method of Claim 110 wherein the polymer is selected from the group consisting of polyethylene oxides, alkyl substituted cellulose materials, and combinations thereof.
112. The method of Claim 108 wherein the dosage form further comprises a gas generating agent.
113. The method of Claim 112 wherein the gabapentin is contained in a membrane sachet with the gas generating agent.
114. The method of Claim 97 wherein the dosage form is an adhesive tablet.
115. The method of Claim 97 wherein the dosage form is a film coated dosage form or a capsule dosage form that allows for the extended release of gabapentin in the stomach.
116. The method of Claim 97 wherein the dosage form is a swellable, sustained-release tablet having a matrix comprised of poly(ethylene oxide) and hydroxypropyl methylcellulose.
CA2464322A 2001-10-25 2002-10-25 Methods of treatment using a gastric retained gabapentin dosage Expired - Lifetime CA2464322C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US33524801P 2001-10-25 2001-10-25
US60/335,248 2001-10-25
PCT/IB2002/005440 WO2003035040A1 (en) 2001-10-25 2002-10-25 Methods of treatment using a gastric retained gabapentin dosage

Publications (2)

Publication Number Publication Date
CA2464322A1 true CA2464322A1 (en) 2003-05-01
CA2464322C CA2464322C (en) 2011-10-11

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Country Status (9)

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US (10) US7438927B2 (en)
EP (2) EP1439825B2 (en)
JP (2) JP5421511B2 (en)
AU (1) AU2002348828B2 (en)
CA (1) CA2464322C (en)
DK (1) DK1439825T4 (en)
MX (1) MXPA04003946A (en)
TW (1) TWI312285B (en)
WO (1) WO2003035040A1 (en)

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