CA2290624A1 - Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs - Google Patents

Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs Download PDF

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Publication number
CA2290624A1
CA2290624A1 CA002290624A CA2290624A CA2290624A1 CA 2290624 A1 CA2290624 A1 CA 2290624A1 CA 002290624 A CA002290624 A CA 002290624A CA 2290624 A CA2290624 A CA 2290624A CA 2290624 A1 CA2290624 A1 CA 2290624A1
Authority
CA
Canada
Prior art keywords
gastric
drug
matrix
dosage forms
highly soluble
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
CA002290624A
Other languages
French (fr)
Other versions
CA2290624C (en
Inventor
John W. Shell
Jenny Louie-Helm
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.)
Assertio Therapeutics Inc
Original Assignee
Individual
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=25355537&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2290624(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2290624A1 publication Critical patent/CA2290624A1/en
Application granted granted Critical
Publication of CA2290624C publication Critical patent/CA2290624C/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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • 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

Abstract

Drugs that are freely or highly soluble in water are formulated as unit dosage forms by incorporating them into polymeric matrices comprised of high molecular weight hydrophilic polymers that swell upon imbibition of water. The dosage form can be a single compressed tablets, or two or three compressed tablets retained in a single gelatin capsule. The oral formulation is designed for gastric retention and controlled delivery of an incorporated drug into the gastric cavity, and thus administered, the drug is released from the matrix into the gastric fluid by solution diffusion. The swollen polymeric matrix, having achieved sufficient size, remains in the gastric cavity for several hours if administered while the patient is in the fed mode, and remains intact long enough for substantially all of the drug to be released before substantial erosion of the matrix occurs. The swelling matrix lowers the accessibility of the gastric fluid to the drug and thereby limits the drug release rate. This process, together with diffusion retardation by selection of specific polymers, polymer molecular weights, and other variables, results in a sustained and controlled delivery rate of the drug to the gastric environment.
CA002290624A 1997-06-06 1998-06-05 Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs Expired - Lifetime CA2290624C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US87050997A 1997-06-06 1997-06-06
US08/870,509 1997-06-06
PCT/US1998/011302 WO1998055107A1 (en) 1997-06-06 1998-06-05 Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs

Publications (2)

Publication Number Publication Date
CA2290624A1 true CA2290624A1 (en) 1998-12-10
CA2290624C CA2290624C (en) 2006-12-05

Family

ID=25355537

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002290624A Expired - Lifetime CA2290624C (en) 1997-06-06 1998-06-05 Gastric-retentive oral drug dosage forms for controlled release of highly soluble drugs

Country Status (11)

Country Link
US (2) US6340475B2 (en)
EP (1) EP0998271B3 (en)
JP (1) JP4083818B2 (en)
AT (1) ATE302597T1 (en)
AU (1) AU729529B2 (en)
CA (1) CA2290624C (en)
DE (1) DE69831335T3 (en)
ES (1) ES2248908T7 (en)
HK (1) HK1027298A1 (en)
PT (1) PT998271E (en)
WO (1) WO1998055107A1 (en)

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