CA2444814A1 - Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures - Google Patents

Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Download PDF

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Publication number
CA2444814A1
CA2444814A1 CA002444814A CA2444814A CA2444814A1 CA 2444814 A1 CA2444814 A1 CA 2444814A1 CA 002444814 A CA002444814 A CA 002444814A CA 2444814 A CA2444814 A CA 2444814A CA 2444814 A1 CA2444814 A1 CA 2444814A1
Authority
CA
Canada
Prior art keywords
coating layer
poly
methacrylic acid
methyl methacrylate
dosage form
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002444814A
Other languages
French (fr)
Other versions
CA2444814C (en
Inventor
Gregory Paul Dittmar
Joseph Michael Amante
Tony Ryan Cronk
Daniel Gary Newby
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Allergan Pharmaceuticals International Ltd
Original Assignee
The Procter & Gamble Company
Gregory Paul Dittmar
Joseph Michael Amante
Tony Ryan Cronk
Daniel Gary Newby
Warner Chilcott Company, Llc
Allergan Pharmaceuticals International Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=29783760&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2444814(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by The Procter & Gamble Company, Gregory Paul Dittmar, Joseph Michael Amante, Tony Ryan Cronk, Daniel Gary Newby, Warner Chilcott Company, Llc, Allergan Pharmaceuticals International Limited filed Critical The Procter & Gamble Company
Priority claimed from CA002359812A external-priority patent/CA2359812C/en
Publication of CA2444814A1 publication Critical patent/CA2444814A1/en
Application granted granted Critical
Publication of CA2444814C publication Critical patent/CA2444814C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
CA002444814A 2001-10-24 2001-10-24 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Expired - Lifetime CA2444814C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA002359812A CA2359812C (en) 2000-11-20 2001-10-24 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA002359812A Division CA2359812C (en) 2000-11-20 2001-10-24 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures

Publications (2)

Publication Number Publication Date
CA2444814A1 true CA2444814A1 (en) 2002-05-20
CA2444814C CA2444814C (en) 2009-06-09

Family

ID=29783760

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002444814A Expired - Lifetime CA2444814C (en) 2001-10-24 2001-10-24 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures

Country Status (1)

Country Link
CA (1) CA2444814C (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9597293B2 (en) 2007-05-07 2017-03-21 Evonik Röhm Gmbh Solid dosage forms comprising an enteric coating with accelerated drug release
EP3162362A1 (en) * 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Optimized high-dose tablet of mesalazine

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9597293B2 (en) 2007-05-07 2017-03-21 Evonik Röhm Gmbh Solid dosage forms comprising an enteric coating with accelerated drug release
EP2152250B1 (en) * 2007-05-07 2019-09-04 Evonik Röhm GmbH Solid dosage forms comprising an enteric coating with accelerated drug release
US10537530B2 (en) 2007-05-07 2020-01-21 Evonik Operations Gmbh Solid dosage forms comprising an enteric coating with accelerated drug release
EP3162362A1 (en) * 2015-10-30 2017-05-03 Dr. Falk Pharma Gmbh Optimized high-dose tablet of mesalazine
WO2017072050A1 (en) * 2015-10-30 2017-05-04 Dr. Falk Pharma Gmbh Optimised high-dose mesalazine-containing tablet
US11135159B2 (en) 2015-10-30 2021-10-05 Dr. Falk Pharma Gmbh Optimized high-dose mesalazine-containing tablet

Also Published As

Publication number Publication date
CA2444814C (en) 2009-06-09

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EEER Examination request
MKEX Expiry

Effective date: 20211025