WO2005115474B1 - Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them - Google Patents

Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them

Info

Publication number
WO2005115474B1
WO2005115474B1 PCT/US2005/018585 US2005018585W WO2005115474B1 WO 2005115474 B1 WO2005115474 B1 WO 2005115474B1 US 2005018585 W US2005018585 W US 2005018585W WO 2005115474 B1 WO2005115474 B1 WO 2005115474B1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical formulation
formulation according
proton pump
pump inhibitor
subject
Prior art date
Application number
PCT/US2005/018585
Other languages
French (fr)
Other versions
WO2005115474A1 (en
Inventor
Kay Olmstead
Warren Hall
Gerald T Proehl
Original Assignee
Santarus Inc
Kay Olmstead
Warren Hall
Gerald T Proehl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Santarus Inc, Kay Olmstead, Warren Hall, Gerald T Proehl filed Critical Santarus Inc
Priority to JP2007515351A priority Critical patent/JP2008500365A/en
Priority to CA2566655A priority patent/CA2566655C/en
Priority to EP05755940A priority patent/EP1750767A4/en
Priority to MXPA06013585A priority patent/MXPA06013585A/en
Priority to AU2005331781A priority patent/AU2005331781C1/en
Publication of WO2005115474A1 publication Critical patent/WO2005115474A1/en
Publication of WO2005115474B1 publication Critical patent/WO2005115474B1/en

Links

Classifications

    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The present invention relates to pharmaceutical formulations comprising at least one acid-labile proton pump inhibiting agent and at least one antacid, which have improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties. The present invention is directed to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a gastrointestinal disorder or disease, or the symptoms associated with, or related to, a gastrointestinal disorder or disease in a subject in need thereof.

Claims

AMENDED CLAIMS[ Received by the International Bureau on 29 December 2005 (29.12.05); Original claims 1- 34 replaced by claims 1- 47 (5 pages)]
1. A pharmaceutical formulation in a capsule or caplet oral dosage form comprising:
(a) about 5 mgs to about 200 mgs of at least one acid-labile proton pump inhibitor;
(b) at least one antacid in aa amount sufficient to increase gastric fluid pH to a pH tbat prevents acid degradation of at least some of the proton pump inhibitor in the gastric fluid; wherein the antacid comprises at least about 400 mgs of NaHCO3; and
(c) greater than about 2 wt-% of disintegrant.
2. A pharmaceutical formulation, according to claim 1 , wherein the proton pump inhibitor i omeprazole, or a free base, free acid, salt, hydrate, or prodrug thereof.
3. A pharmaceutical formulation according to claim 1, wherein the proton pump inhibitor i esomeprazole, or a free base, free acid, salt, hydrate, or prodrug thereof.
4. A pharmaceutical formulation according to claim I, wherein the proton pump inhibitor i lansoprazole, or a free base, free acid, salt, hydrate, or prodrug thereof.
5. A pharmaceutical formulation according to claim 1 comprising about 20 mgs of th proton pump inhibitor.
6. A pharmaceutical formulation according to claim 1 comprising about 40 mgs of th proton pump inhibitor.
7- A pharmaceutical formulation according to claim 1, wherein the antacid is selected fror sodium bicarbonate, potassium bicarbonate, sodium carbonate, calcium carbonate, magnesiur oxide, magnesium hydroxide, magnesium carbonate, aluminum hydroxide, and mixtures thereof.
8. A pharmaceutical formulation according to claim 1, wherein the sodium bicarbonate is present in an amount of at least about 800 mgs,
9. A pharmaceutical formulation according to claim 1, wherein the antacid is sodium bicarbonate.
10. A pharmaceutical formulation according to claim 1, wherein the antacid is present in an amount of about 400 mgs to about 1600 mgs.
11. A pharmaceutical formulation according to claim 1, wherein the antacid is present in an amount of about 5 mEq to about 20 mEq.
12. A pharmaceutical formulation according to claim 1, wherein the antacid is present in an amount of about 8 mEq to about 12 mEq.
13. A pharmaceutical formulation according to claim 1, wherein the oral dosage form is a capsule.
14. A pharmaceutical formulation according to claim 13, wherein the pharmaceutical formulation is administered as a single capsule.
15. A pharmaceutical formulation according to claim 1, wherein the disintegrant is Ac-Di- So1
16. A pharmaceutical formulation according to claim 1, wherein the disintegrant is present in an amount of about 2 wt-% to about 8 wt-%,
17. A pharmaceutical formulation according to claim 1, wherein the formulation does not comprise a binder.
18. A pharmaceutical formulation according to claim 1, further comprising a binder, wherein the disintegrant is present in at least the same wt-% as the binder.
19. A pharmaceutical formulation according to claim 18, wherein the binder is present in an amount of less than about 10 wt-%.
20. A pharmaceutical formulation according to claim 1, wherein the formulation does not comprise a flavoring agent.
21. A pharmaceutical formulation according to claim 1, wherein an initial serum concentration of the proton pump inhibitor is greater than about 0.1 μg/ml at any time within about 30 minutes after administration of the pharmaceutical formulation.
22. A pharmaceutical formulation in a capsule dosage foπn comprising:
(a) at least one acid-labile proton pump inhibitor;
(b) between about 5 to about 20 mEq of sodium bicarbonate; and
(c) between about 2 wt-% to about 5 wt-% of a disintegrant;
wherein upon oral administration to a subject: a therapeutically effective amount of the proton pump inhibitor is delivered; and Tmax of the proton pump inhibitor is obtained, within about 60 minutes.
23. A pharmaceutical formulation according to claim 22, wherein the proton pump inhibitor is omeprazole, or a free base, free acid, salt, hydrate, or prodrug thereof.
24. A pharmaceutical formulation according to claim 23, wherein the omeprazole is present in an amount of about 20 mgs.
25. A pharmaceutical formulation according to claim 23, wherein the omeprazole is present in an amount of about 40 mgs.
26. A pharmaceutical formulation according to claim 22, wherein the sodium bicarbonate is present in an amount of about 800 mgs to about 1300 mgs.
27. The pharmaceutical formulation of claim 22, wherein the sodium bicarbonate is present in an amount of about 1100 mgs,
28. A pharmaceutical formulation according to claim 22, wherein the pharmaceutical formulation is administered as a single capsule.
29. The pharmaceutical formulation of claim 22, wherein the disintegrant is Ac-Di-SoI,
30. A pharmaceutical formulation according to claim 22, wherein the formulation does not comprise a binder.
31. Cancelled.
32. A pharmaceutical formulation according to claim 22, wherein an initial serum concentration of the proton pump inhibitor is greater than about 0.1 μg/ml at any time within. about 30 minutes after administration of the pharmaceutical formulation.
33. A method of administering a compound according to claim 1, for the treatment of a gastric acid related disorder.
34. The method according to claim 33, wherein the gastric acid related disorder is duodenal ulcer disease, gastric ulcer disease, gastroesophageal reflux disease, erosive esopliagitis, poorly responsive symptomatic gastroesophageal reflux disease, pathological gastrointestinal hypersecretory disease, Zollinger Ellison syndrome, heartburn, esophageal disorder, upper GI bleeding, or acid dyspepsia.
35. A pharmaceutical foixoulation according to claim 13, wherein Tmax of the proton pump inhibitor is obtained within about 75 minutes after oral, administration of the pharmaceutical formulation to the subject.
36. A pharmaceutical formulation according to claim 13, wherein Tmax of the proton pump inhibitor is obtained within about 60 minutes after oral administration of the pharmaceutical formulation to the subject.
37. A pharmaceutical formulation according to claim 13, wherein Tmax of the proton pump inhibitor is obtained within about 45 minutes after oral administration of the pharmaceutical formulation to the subject.
38. A pharmaceutical formulation according to claim 13, wherein a serum concentration of the proton pump inhibitor is greater than about 0.3 μg/ml within about 1 hour after oral administration of the pharmaceutical formulation to the subject.
39. A pharmaceutical formulation according to claim 13 wherein a serum concentration of the proton pump inhibitor is greater than about 0.3 μg/ml within about 45 minutes after oral administration of the pharmaceutical formulation to the subject.
40. A pharmaceutical formulation according to claim 13, wherein the average Cmax of the proton pump inhibiting agent is less than about 1250 ng/ml after oral administration, of the pharmaceutical formulation to the subject.
41. A pharmaceutical formulation according to claim 13, wherein the pharmaceutical formulation substantially disintegrates within about 45 minutes after oral administration of the pharmaceutical formulation to the subject.
42. A pharmaceutical formulation according to claim 22, wherein Tmax of the proton pump inhibitor is obtained within about 45 minutes after oral administration of the pharmaceutical formulation to the subject.
43. A pharmaceutical formulation according to claim 22, wherein a serum concentration of the proton pump inhibitor is greater than about 0.3 μg/ml within about 1 hour after oral '. administration of the pharmaceutical formulation to the subject.
44. A pharmaceutical formulation according to claim 22, wherein a serum concentration of the proton pump inhibitor is greater than about 0.3 μg/ml within about 45 minutes after oral administration of the pharmaceutical formulation to the subject.
45. A pharmaceutical formulation according to claim 22, wherein the average Cmax of the proton pump inhibiting agent is less than about 1250 ng/ml after oral administration of the pharmaceutical formulation to the subject.
46. A pharmaceutical formulation according to claim 1, wherein the pharmaceutical formulation is administered to the subject pre-meal and wherein Tmax of the proton pump inhibitor is obtained within about 60 minutes after oral administration of the pharmaceutical formulation to the subject.
47. A pharmaceutical formulation according to claim 22, wherein the pharmaceutical formulation is administered to the subject pre-meal.
PCT/US2005/018585 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them WO2005115474A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2007515351A JP2008500365A (en) 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using the same
CA2566655A CA2566655C (en) 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
EP05755940A EP1750767A4 (en) 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them
MXPA06013585A MXPA06013585A (en) 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them.
AU2005331781A AU2005331781C1 (en) 2004-05-25 2005-11-28 Pharmaceutical formulations useful for inhibiting acid secretion

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US57466304P 2004-05-25 2004-05-25
US57464604P 2004-05-25 2004-05-25
US60/574,646 2004-05-25
US60/574,663 2004-05-25

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2005331781A Division AU2005331781C1 (en) 2004-05-25 2005-11-28 Pharmaceutical formulations useful for inhibiting acid secretion

Publications (2)

Publication Number Publication Date
WO2005115474A1 WO2005115474A1 (en) 2005-12-08
WO2005115474B1 true WO2005115474B1 (en) 2006-02-23

Family

ID=35450661

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/018585 WO2005115474A1 (en) 2004-05-25 2005-05-25 Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them

Country Status (5)

Country Link
EP (1) EP1750767A4 (en)
JP (1) JP2008500365A (en)
CA (1) CA2566655C (en)
MX (1) MXPA06013585A (en)
WO (1) WO2005115474A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008067037A2 (en) * 2006-10-05 2008-06-05 Santarus, Inc. Novel formulations of proton pump inhibitors and methods of using these formulations
MY180677A (en) * 2010-12-03 2020-12-05 Takeda Pharmaceuticals Co Orally disintegrating tablet
JP6641626B2 (en) * 2015-12-25 2020-02-05 エスエス製薬株式会社 Antacid pharmaceutical composition
KR102006777B1 (en) * 2018-01-29 2019-10-08 주식회사 종근당 Pharmaceutical formulation comprising esomeprazole and sodium bicarbonate
KR102080023B1 (en) 2018-01-29 2020-02-21 주식회사 종근당 Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate
JP2021533177A (en) * 2018-08-23 2021-12-02 チョン クン ダン ファーマシューティカル コーポレイション A pharmaceutical formulation with excellent dissolving properties, including esomeprazole and sodium bicarbonate.
WO2021020771A1 (en) * 2019-07-26 2021-02-04 주식회사 종근당 Stable pharmaceutical composition comprising esomeprazole and sodium bicarbonate
KR102573842B1 (en) * 2020-02-21 2023-09-01 주식회사 종근당 Pharmaceutical composition comprising esomeprazole and sodium bicarbonate having improved drug release properties

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2189698A (en) * 1986-04-30 1987-11-04 Haessle Ab Coated omeprazole tablets
US5622719A (en) 1993-09-10 1997-04-22 Fuisz Technologies Ltd. Process and apparatus for making rapidly dissolving dosage units and product therefrom
US6489346B1 (en) 1996-01-04 2002-12-03 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
US6645988B2 (en) * 1996-01-04 2003-11-11 Curators Of The University Of Missouri Substituted benzimidazole dosage forms and method of using same
US5840737A (en) 1996-01-04 1998-11-24 The Curators Of The University Of Missouri Omeprazole solution and method for using same
US6699885B2 (en) 1996-01-04 2004-03-02 The Curators Of The University Of Missouri Substituted benzimidazole dosage forms and methods of using same
ATE474559T1 (en) * 2001-06-01 2010-08-15 Pozen Inc PHARMACEUTICAL COMPOSITIONS FOR COORDINATED DELIVERY OF NSAIDS
CA2531564C (en) * 2003-07-18 2016-01-19 Santarus, Inc. Pharmaceutical composition for inhibiting acid secretion
CA2554271A1 (en) * 2004-02-10 2005-08-25 Santarus, Inc. Combination of proton pump inhibitor, buffering agent, and nonsteroidal anti-inflammatory agent
CA2561700A1 (en) * 2004-04-16 2005-12-15 Santarus, Inc. Combination of proton pump inhibitor, buffering agent, and prokinetic agent

Also Published As

Publication number Publication date
EP1750767A4 (en) 2010-09-22
WO2005115474A1 (en) 2005-12-08
EP1750767A1 (en) 2007-02-14
CA2566655A1 (en) 2005-12-08
MXPA06013585A (en) 2009-07-22
JP2008500365A (en) 2008-01-10
CA2566655C (en) 2013-04-16

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