CA2359812A1 - 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
CA2359812A1
CA2359812A1 CA002359812A CA2359812A CA2359812A1 CA 2359812 A1 CA2359812 A1 CA 2359812A1 CA 002359812 A CA002359812 A CA 002359812A CA 2359812 A CA2359812 A CA 2359812A CA 2359812 A1 CA2359812 A1 CA 2359812A1
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
CA002359812A
Other languages
French (fr)
Other versions
CA2359812C (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
Procter and Gamble Co
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=22954700&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2359812(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Procter and Gamble Co filed Critical Procter and Gamble Co
Priority to CA002444814A priority Critical patent/CA2444814C/en
Publication of CA2359812A1 publication Critical patent/CA2359812A1/en
Application granted granted Critical
Publication of CA2359812C publication Critical patent/CA2359812C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61K9/28—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
    • 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
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • 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
    • 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

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.
CA002359812A 2000-11-20 2001-10-24 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Expired - Lifetime CA2359812C (en)

Priority Applications (1)

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

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25212200P 2000-11-20 2000-11-20
US60/252,122 2000-11-20

Related Child Applications (1)

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

Publications (2)

Publication Number Publication Date
CA2359812A1 true CA2359812A1 (en) 2002-05-20
CA2359812C CA2359812C (en) 2004-02-10

Family

ID=22954700

Family Applications (1)

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

Country Status (3)

Country Link
US (4) US6893662B2 (en)
CA (1) CA2359812C (en)
PE (1) PE20020529A1 (en)

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US20050169996A1 (en) 2005-08-04
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US20140093576A1 (en) 2014-04-03

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