CA2648594A1 - Solid oral dosage form containing an enhancer - Google Patents
Solid oral dosage form containing an enhancer Download PDFInfo
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- CA2648594A1 CA2648594A1 CA002648594A CA2648594A CA2648594A1 CA 2648594 A1 CA2648594 A1 CA 2648594A1 CA 002648594 A CA002648594 A CA 002648594A CA 2648594 A CA2648594 A CA 2648594A CA 2648594 A1 CA2648594 A1 CA 2648594A1
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- bisphosphonate
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- 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
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- 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
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
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- 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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
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- 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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/20—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
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- 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]
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
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Abstract
The invention relates to a pharmaceutical composition and oral dosage forms comprising a bisphosphonate in combination with an enhancer to enhance intestinal delivery of the bisphosphonate to the underlying circulation. Preferably, the enhancer is a medium chain fatty acid or a medium chain fatty acid derivative having a carbon chain length of from 6 to 20 carbon atoms, and the solid oral dosage form is a controlled release dosage form such as a delayed release dosage form.
Claims (100)
1. A pharmaceutical composition which is effective in delivering therapeutically effective amounts of a drug and an enhancer, each as defined below, to an intestine, said composition comprising a bisphosphonate and an enhancer wherein the enhancer comprises a medium chain fatty acid or a medium chain fatty acid derivative having a carbon chain length of from 6 to 20 carbon atoms and is solid at room temperature.
2. The composition of claim 1, wherein the carbon chain length is from 8 to 14 carbon atoms.
3. The composition of claim 1 wherein the enhancer is a sodium salt of a medium chain fatty acid.
4. The composition of claim 3, wherein the enhancer is selected from the group consisting of sodium caprylate, sodium caprate, and sodium laurate.
5. The composition of claim 1, wherein the drug and the enhancer are present in a ratio of from 1:100,000 to 10:1 (drug:enhancer).
6. The composition of claim 1 further comprising at least one auxiliary excipient.
7. The composition of claim 1, wherein the bisphosphonate is selected from the group consisting of alendronate, clodronate, etidronate, incadronate, ibandronate, minodronate, neridronate, olpadronate, pamidronate, risedronate, tiludronate, and zoledronate.
8. A solid oral dosage form comprising the composition of claim 1 wherein the bisphosphonate and the enhancer in the dosage form are each present in therapeutically effective amounts.
9. The dosage form of claim 8, wherein the dosage form is a tablet, a capsule, or a multiparticulate.
10. The dosage form of claim 8, wherein the dosage form is a delayed release dosage form.
11. The dosage form of claim 8, wherein the dosage form is a tablet.
12. The dosage form of claim 11, wherein the tablet is a multilayer tablet.
13. The dosage form of claim 8, wherein the dosage form further comprises a rate-controlling polymer material.
14. The dosage form of claim 13, wherein the rate-controlling polymer material is HPMC.
15. The dosage form of claim 13, wherein the rate-controlling polymer material is a polymer derived from acrylic or methacrylic acid and their respective esters or copolymers derived from acrylic or methacrylic acid and their respective esters.
16. The dosage form of claim 13, wherein the composition is compressed into a tablet form prior to coating with the rate-controlling polymer material.
17. The dosage form of claim 16, wherein the tablet is a multilayer tablet.
18. The dosage form of claim 8, wherein the dosage form is a multiparticulate.
19. The dosage form of claim 18, wherein the multiparticulate comprises discrete particles, pellets, minitablets, or combinations thereof.
20. The dosage form of claim 19, wherein the multiparticulate comprises a blend of two or more populations of particles, pellets, minitablets, or combinations thereof each population having different in vitro or in vivo release characteristics.
21. The dosage form of claim 18, wherein the multiparticulate is encapsulated in a gelatin capsule.
22. The dosage form of claim 21, wherein the capsule is coated with a rate-controlling polymer material.
23. The dosage form of claim 18, wherein the multiparticulate is incorporated into a sachet.
24. The dosage form of claim 19, wherein the discrete particles, pellets, minitablets, or combinations thereof are compressed into a tablet.
25. The dosage form of claim 24, wherein the tablet is coated with a rate controlling polymer material.
26. The dosage form of claim 24, wherein the tablet is a multilayer tablet.
27. The dosage form of claim 25, wherein the tablet is a multilayer tablet.
28. The solid oral dosage form of claim 8, wherein the bisphosphonate and the enhancer are present in the dosage form in a ratio of from 1:100,000 to 10:1 (drug: enhancer).
29. The solid oral dosage form of claim 28, wherein the ratio is from 1:1,000 to 10:1 (drug:enhancer).
30. The solid oral dosage form of claim 8 comprising about 0.5 µg to about 1,000 mg of bisphosphonate.
31. The solid oral dosage form of claim 8, wherein the bisphosphonate is alendronate.
32. The solid oral dosage form of claim 8, wherein the bisphosphonate is risedronate.
33. The solid oral dosage form of claim 8, wherein the bisphosphonate is zoledronic acid.
34. The solid oral dosage form of claim 8, wherein the bisphosphonate is ibandronate.
35. The solid oral dosage form of claim 8, wherein the composition is in the form of a delayed release enteric coated tablet.
36. The solid oral dosage form of claim 35, wherein the bisphosphonate and the enhancer are present in the dosage form in a ratio of from 1:1,000 to 10:1 (drug:enhancer).
37. The solid oral dosage form of claim 35, wherein the enhancer is sodium caprate.
38. The solid oral dosage form of claim 29, wherein the bisphosphonate is alendronate.
39. The solid oral dosage form of claim 30, wherein the bisphosphonate is alendronate.
40. The solid oral dosage form of claim 29, wherein the bisphosphonate is risedronate.
41. The solid oral dosage form of claim 30, wherein the bisphosphonate is risedronate.
42. The solid oral dosage form of claim 29, wherein the bisphosphonate is zoledronic acid.
43. The solid oral dosage form of claim 30, wherein the bisphosphonate is zoledronic acid.
44. The solid oral dosage form of claim 29, wherein the bisphosphonate is ibandronate.
45. The solid oral dosage form of claim 30, wherein the bisphosphonate is ibandronate.
46. A pharmaceutical composition which is effective in delivering therapeutically effective amounts of a bisphosphonate and an enhancer to an intestine, said composition comprising a bisphosphonate and an enhancer, wherein the enhancer comprises:
(i) a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms;
(ii) a medium chain fatty acid halide derivative, a medium chain fatty acid anhydride derivative, or a medium chain fatty acid glyceride derivative, each of said derivatives having a carbon chain length of from 6 to 20 carbon atoms;
(iii) the fatty acid salt of clause (i) having, at the end opposite the fatty acid salt, an acid halide, acid anhydride, or glyceride moiety;
(iv) an acid halide derivative of clause (ii) above having, at the end opposite of the halide portion, an acid halide, acid anhydride, or glyceride moiety;
(v) an anhydride derivative of clause (ii) above having, at the end opposite of the anhydride, an acid anhydride, acid halide, or glyceride moiety;
or (vi) a glyceride derivative of clause (ii) above having, at the end opposite of the glyceride portion, a glyceride, acid halide, or acid anhydride moiety;
and wherein the enhancer is solid at room temperature.
(i) a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms;
(ii) a medium chain fatty acid halide derivative, a medium chain fatty acid anhydride derivative, or a medium chain fatty acid glyceride derivative, each of said derivatives having a carbon chain length of from 6 to 20 carbon atoms;
(iii) the fatty acid salt of clause (i) having, at the end opposite the fatty acid salt, an acid halide, acid anhydride, or glyceride moiety;
(iv) an acid halide derivative of clause (ii) above having, at the end opposite of the halide portion, an acid halide, acid anhydride, or glyceride moiety;
(v) an anhydride derivative of clause (ii) above having, at the end opposite of the anhydride, an acid anhydride, acid halide, or glyceride moiety;
or (vi) a glyceride derivative of clause (ii) above having, at the end opposite of the glyceride portion, a glyceride, acid halide, or acid anhydride moiety;
and wherein the enhancer is solid at room temperature.
47. A pharmaceutical composition which is effective in delivering therapeutically effective amounts of a bisphosphonate and an enhancer to an intestine, said composition comprising a bisphosphonate and an enhancer, wherein the enhancer: (1) comprises a medium chain fatty acid or a medium chain fatty acid derivative having a carbon chain length of from 6 to 20 carbon atoms; (2) is the only enhancer present in the composition; and (3) enhances intestinal delivery of the bisphosphonate to the underlying circulation.
48. The composition of claim 47, wherein the enhancer is a salt of a fatty acid having a carbon chain length of from 8 to 14 carbon atoms.
49. The composition of claim 48, wherein said fatty acid salt is a sodium salt.
50. The composition of claim 49, wherein said fatty acid salt is selected from the group consisting of sodium caprylate, sodium caprate, and sodium laurate.
51. The composition of claim 47, wherein the drug and the enhancer are present in a weight ratio of from 1:100000 to 10:1 (drug:enhancer).
52. The composition of claim 47, wherein the composition is in the form of a tablet, a capsule, or a multiparticulate.
53. The composition of claim 47, wherein the enhancer is selected from the group consisting of:
(a) an acid salt, acid halide, acid anhydride, or glyceride of a fatty acid having a carbon chain length of from 6 to 20 carbon atoms; and (b) a derivative of clause (a) which is a difunctional in that it has on the end of the carbon chain opposite the acid salt group an acid halide, an acid anhydride, or a glyceride moiety.
(a) an acid salt, acid halide, acid anhydride, or glyceride of a fatty acid having a carbon chain length of from 6 to 20 carbon atoms; and (b) a derivative of clause (a) which is a difunctional in that it has on the end of the carbon chain opposite the acid salt group an acid halide, an acid anhydride, or a glyceride moiety.
54. The composition of claim 47, wherein the composition is solid at room temperature.
55. The composition of claim 53, wherein the composition is solid at room temperature.
56. A process for the manufacture of a dosage form comprising the steps of:
a) providing a blend comprising a bisphosphonate and an enhancer which is solid at room temperature and enhances intestinal delivery of the bisphosphonate to the underlying circulation, wherein the enhancer comprises:
(i) a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms;
(ii) a medium chain fatty acid halide derivative, a medium chain fatty acid anhydride derivative, or a medium chain fatty acid glyceride derivative, each of said derivatives having a carbon chain length of from 6 to 20 carbon atoms;
(iii) the fatty acid salt of clause (i) having, at the end opposite the fatty acid salt, an acid halide, an acid anhydride, or glyceride moiety;
(iv) an acid halide derivative of clause (ii) above having, at the end opposite of the halide portion, an acid halide, acid anhydride, or glyceride moiety;
(v) an anhydride derivative of clause (ii) above having, at the end opposite of the anhydride, an acid anhydride, acid halide, or glyceride moiety; or (vi) a glyceride derivative of clause (ii) above having, at the end opposite of the glyceride portion, a glyceride, an acid halide, or acid anhydride moiety;
and b) forming the solid oral dosage form from the blend.
a) providing a blend comprising a bisphosphonate and an enhancer which is solid at room temperature and enhances intestinal delivery of the bisphosphonate to the underlying circulation, wherein the enhancer comprises:
(i) a salt of a medium chain fatty acid having a carbon chain length of from 6 to 20 carbon atoms;
(ii) a medium chain fatty acid halide derivative, a medium chain fatty acid anhydride derivative, or a medium chain fatty acid glyceride derivative, each of said derivatives having a carbon chain length of from 6 to 20 carbon atoms;
(iii) the fatty acid salt of clause (i) having, at the end opposite the fatty acid salt, an acid halide, an acid anhydride, or glyceride moiety;
(iv) an acid halide derivative of clause (ii) above having, at the end opposite of the halide portion, an acid halide, acid anhydride, or glyceride moiety;
(v) an anhydride derivative of clause (ii) above having, at the end opposite of the anhydride, an acid anhydride, acid halide, or glyceride moiety; or (vi) a glyceride derivative of clause (ii) above having, at the end opposite of the glyceride portion, a glyceride, an acid halide, or acid anhydride moiety;
and b) forming the solid oral dosage form from the blend.
57. The process of claim 56, wherein the forming step comprises direct compression of the blend into a tablet.
58. The process of claim 56, wherein the forming step comprises granulating the blend to form a granulate for incorporation into said solid oral dosage form.
59. The process of claim 56, wherein the forming step comprises encapsulating the blend.
60. The process of claim 56, wherein the drag and the enhancer are blended in a ratio of from 1:100,000 to 10:1 (drug:enhancer).
61. A process of claim 56 further comprising the step of coating the solid oral dosage form with an enteric coating.
62. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 1.
63. The method of claim 62, wherein the medical condition is osteoporosis.
64. The method of claim 62, wherein the medical condition is metastatic bone cancer.
65. The method of claim 62, wherein the medical condition is rheumatoid arthritis.
66. The method of claim 62, wherein the medical condition is a bone fracture.
67. The method of claim 62, wherein the administration step occurs within thirty minutes prior to the patient consuming food, medications, or beverages other than water.
68. The method of claim 62, wherein the administration step occurs at a time of day other than the morning.
69. The method of claim 62, wherein the administration step occurs in the evening.
70. The method of claim 62, wherein the administration occurs within 30 minutes prior to the patient lying down.
71. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 47.
72. The method of claim 71, wherein the administration step occurs within thirty minutes prior to the patient consuming food, medications, or beverages other than water.
73. The method of claim 71, wherein the administration step occurs within 30 minutes prior to the patient consuming food, medications, or beverages other than water.
74. The method of claim 71, wherein the administration step occurs at a time of day other than the morning.
75. The method of claim 71, wherein the administration occurs within 30 minutes prior to the patient lying down.
76. A pharmaceutical composition comprising a bisphosphonate and an enhancer, wherein the enhancer enhances intestinal delivery of the bisphosphonate to the underlying circulation, and wherein the composition delivers a therapeutically effective amount of the bisphosphonate when administered to a patient within thirty minutes prior to the patient consuming food, medications, or beverages other than water.
77. An oral dosage form comprising the composition of claim 76.
78. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 76.
79. A pharmaceutical composition comprising a bisphosphonate and an enhancer, wherein the enhancer enhances intestinal delivery of the bisphosphonate to the underlying circulation, and wherein the composition delivers a therapeutically effective amount of the bisphosphonate when administered to a patient at a time of day other than the morning.
80. An oral dosage form comprising the composition of claim 79.
81. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 79.
82. A pharmaceutical composition comprising a bisphosphonate and an enhancer, wherein the enhancer enhances intestinal delivery of the bisphosphonate to the underlying circulation, and wherein the composition delivers a therapeutically effective amount of the bisphosphonate when administered to a patient within 30 minutes prior to the patient lying down.
83. An oral dosage form comprising the composition of claim 82.
84. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 82.
85. A pharmaceutical composition comprising a bisphosphonate and an enhancer, wherein the enhancer enhances intestinal delivery of the bisphosphonate to the underlying circulation, and wherein the composition delivers a therapeutically effective amount of the bisphosphonate when administered to a patient within six hours after consuming food, medications, or beverages other than water.
86. An oral dosage form comprising the composition of claim 85.
87. A method for the treatment or prevention of a medical condition comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 85.
88. A method for the prevention or treatment of osteoporosis comprising the step of administering orally to a patient a therapeutically effective amount of the composition of claim 1, wherein the administration step occurs weekly.
89. The method of claim 62, wherein about 1 mg to about 20 mg bisphosphonate is orally administered.
90. The method of claim 62, wherein about 2 mg to about 7 mg bisphosphonate is orally administered.
91. The method of claim 87, wherein about 1 mg to about 100 mg bisphosphonate is orally administered.
92. The method of claim 87, wherein about 1 mg to about 50 mg bisphosphonate is orally administered.
93. A pharmaceutical composition for oral administration which is effective in delivering therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising alendronate and an enhancer, wherein the composition delivers a therapeutically effective amount of the alendronate when administered to a patient at bedtime.
94. A pharmaceutical composition for oral administration which is effective in delivering a therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising alendronate and an enhancer, wherein the composition is effective in the prevention of osteoporosis with a weekly dose ofabout 1 to about 10 mg, a daily dose of about 0.1 to about 2 mg, or a monthly dose of about 3 to about 45 mg.
95. A pharmaceutical composition for oral administration which is effective in delivering therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising alendronate and an enhancer, wherein the composition delivers a therapeutically effective amount of the alendronate when administered to a patient within six hours after consuming food, medications, or beverages other than water.
96. A pharmaceutical composition for oral administration which is effective in delivering therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising alendronate and an enhancer, and wherein the composition is effective in the treatment of osteoporosis with a weekly dose of about 2 to 20 mg, a daily dose of about 0.2 to about 4mg, or a monthly dose of about 6 to about 90 mg.
97. A pharmaceutical composition for oral administration which is effective in delivering therapeutically effective amounts of a drug and an enhancer to an intestine, said composition comprising zoledronic acid and an enhancer.
98. The composition of claim 95, wherein the composition is effective in the treatment of bone cancer.
99. The composition of claim 95, wherein the composition is effective in the treatment or prevention of osteoporosis.
100. An oral dosage form comprising the composition of claim 95, wherein the dosage form comprises about 1 to about 25 mg zoledronic acid.
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KR101191322B1 (en) | 2012-10-16 |
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CA2648594C (en) | 2012-10-16 |
AU2007235251A2 (en) | 2008-11-06 |
EP2526950A1 (en) | 2012-11-28 |
IL194277A (en) | 2014-01-30 |
CN101437522A (en) | 2009-05-20 |
MX2008012678A (en) | 2008-12-17 |
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US20100247640A1 (en) | 2010-09-30 |
KR20090037851A (en) | 2009-04-16 |
JP2009533349A (en) | 2009-09-17 |
EP2007397A4 (en) | 2010-03-10 |
EP2007397B1 (en) | 2013-07-24 |
JP2016040301A (en) | 2016-03-24 |
IL194277A0 (en) | 2009-09-22 |
JP5450052B2 (en) | 2014-03-26 |
CN105232482A (en) | 2016-01-13 |
WO2007117706A3 (en) | 2008-10-16 |
AU2007235251A1 (en) | 2007-10-18 |
RU2008144136A (en) | 2010-05-20 |
US7704977B2 (en) | 2010-04-27 |
US20100022480A1 (en) | 2010-01-28 |
WO2007117706A2 (en) | 2007-10-18 |
BRPI0710503A2 (en) | 2011-08-16 |
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