CA2149152A1 - Pulsatile particles drug delivery system - Google Patents

Pulsatile particles drug delivery system

Info

Publication number
CA2149152A1
CA2149152A1 CA002149152A CA2149152A CA2149152A1 CA 2149152 A1 CA2149152 A1 CA 2149152A1 CA 002149152 A CA002149152 A CA 002149152A CA 2149152 A CA2149152 A CA 2149152A CA 2149152 A1 CA2149152 A1 CA 2149152A1
Authority
CA
Canada
Prior art keywords
water
coating
pellets
core
drugs
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
CA002149152A
Other languages
French (fr)
Other versions
CA2149152C (en
Inventor
Chih-Ming Chen
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.)
Andrx Pharmaceuticals LLC
Original Assignee
Chih-Ming Chen
Andrx Pharmaceuticals, Inc.
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 Chih-Ming Chen, Andrx Pharmaceuticals, Inc. filed Critical Chih-Ming Chen
Publication of CA2149152A1 publication Critical patent/CA2149152A1/en
Application granted granted Critical
Publication of CA2149152C publication Critical patent/CA2149152C/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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Abstract

Unit dosage form for delivering drugs into the body in a series of sequential, pulsatile releasing events employs conventional pharmaceutical equipment and processes for optimum economy, reliability, and bioavailability. The system can be used with drugs which cannot be released by diffusion through a porous coating, such as water insoluble drugs. A plurality of populations of pellets is provided within a unit dosage form such as a capsule (8) or tablet.
The pellets are composed of a core containing the drug (3) and a swelling agent (4) which expands in volume when exposed to water. The core is enclosed within a membrane or coating which is permeable to water. The membrane is composed of a water insoluble and permeable film forming polymer, a water soluble film forming polymer (11) and a permeability reducing agent (14). When the unit dose releases the pellets into the digestive tract, water diffuses through the coating and into the core. As water is taken up by the swelling agent, the core expands, exerting force on the coating until it bursts, releasing the drug. The permeability reducing agent reduces the rate at which water reaches the swelling agent, thereby delaying release time. The water soluble polymer dissolves, weakening the coating so that it bursts sooner. By varying the proportions of the three coating ingredients and/or coating thickness from one pellet population to another, the release timing of the pellets can be very effectively controlled.
CA002149152A 1992-11-27 1993-11-02 Pulsatile particles drug delivery system Expired - Lifetime CA2149152C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/982,761 US5260069A (en) 1992-11-27 1992-11-27 Pulsatile particles drug delivery system
US07/982,761 1992-11-27
PCT/US1993/010643 WO1994012160A1 (en) 1992-11-27 1993-11-02 Pulsatile particles drug delivery system

Publications (2)

Publication Number Publication Date
CA2149152A1 true CA2149152A1 (en) 1994-06-09
CA2149152C CA2149152C (en) 2003-09-30

Family

ID=25529482

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002149152A Expired - Lifetime CA2149152C (en) 1992-11-27 1993-11-02 Pulsatile particles drug delivery system

Country Status (10)

Country Link
US (2) US5260069A (en)
EP (1) EP0670718B1 (en)
JP (1) JPH08506802A (en)
AT (1) ATE206613T1 (en)
AU (1) AU680642B2 (en)
CA (1) CA2149152C (en)
DE (1) DE69330910T2 (en)
ES (1) ES2165869T3 (en)
NZ (1) NZ258012A (en)
WO (1) WO1994012160A1 (en)

Families Citing this family (266)

* Cited by examiner, † Cited by third party
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