CA2335566A1 - Effervescent drug delivery system for oral administration - Google Patents

Effervescent drug delivery system for oral administration Download PDF

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Publication number
CA2335566A1
CA2335566A1 CA002335566A CA2335566A CA2335566A1 CA 2335566 A1 CA2335566 A1 CA 2335566A1 CA 002335566 A CA002335566 A CA 002335566A CA 2335566 A CA2335566 A CA 2335566A CA 2335566 A1 CA2335566 A1 CA 2335566A1
Authority
CA
Canada
Prior art keywords
dosage form
drug
amount
penetration enhancer
effervescent
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
CA002335566A
Other languages
French (fr)
Other versions
CA2335566C (en
Inventor
S. Indiran Pather
Joseph R. R0Binson
Jonathan D. Eichman
Rajendra K. Khankari
John Hontz
Sangeeta V. Gupte
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.)
Cima Labs 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
Application filed by Individual filed Critical Individual
Publication of CA2335566A1 publication Critical patent/CA2335566A1/en
Application granted granted Critical
Publication of CA2335566C publication Critical patent/CA2335566C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/20—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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/50—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

The pharmaceutical compositions of the present invention comprise orally administerable dosage forms that use effervescence as a penetration enhancer for drugs known, or suspected, of having poor bioavailability. Effervescence can occur in the stomach, once the tablet or other dosage form is ingested. In addition to effervescence in the stomach, or as alternative technique, by th e use of appropriate coatings and other techniques, the effervescence can occu r in other parts of the gastrointestinal tract, including, but not limited to, the esophagus, duodenum, and colon. The site of effervescence and drug relea se is chosen to correspond with the segment of the gastrointestinal tract displaying maximal absorption of the formulated drug, or to gain some other therapeutic advantage.

Claims (25)

1. A dosage form for delivery of a therapeutically effective amount of a drug to a target area in the gastrointestinal tract of a mammal; comprising:
(a) a therapeutically effective amount of a drug;
(b) at least one effervescent penetration enhancer;
wherein said at least one effervescent penetration enhancer is present in an amount sufficient to increases the penetration of said drug across said target area of said gastrointestinal tract to permit delivery of a therapeutically effective amount of said drug; and (c) an enteric coating maintained over said drug and said at least one effervescent penetration enhancer; wherein said enteric coating prevents the release of said drug and said at least one effervescent penetration enhancer until a time at which said dosage form reaches said target area in said gastrointestinal tract.
2. The dosage form of claim 1, wherein said amount of said at least one effervescent penetration enhancer is equal to about two times the amount of said drug.
3. The dosage form of claim 1, wherein said amount of said at least one effervescent penetration enhancer is equal to about three times the amount of said drug.
4 The dosage form of any one of claims 1-3, further comprising a pH adjusting substance.
5. The dosage form of any one of claims 1-3, further comprising a bioadhesive, wherein said bioadhesive increases contact time between said drug and a mucosa layer of said target area.
6. The dosage form of clams 5, wherein said bioadhesive is contained in a portion of said dosage form external to said drug.
7. The dosage form of any one of claims 1-3, further comprising at least one noneffervescent penetration enhancer.
8. The dosage form of any one of claims 1-3 further comprising at least one disintegration agent, wherein said disintegration agent causes the rapid dispersion of said drug to said target area of said gastrointestinal tract.
9. The dosage form of any one of claims 1-3, wherein said protective coating comprises a material that reacts with an enzyme present in said target area of the gastrointestinal tract to release said drug and said effervescent penetration enhancer.
10. The dosage form of any one of claims 1-3, wherein said dosage form is a tablet.
11. The dosage form of any one of claims 1-3, wherein said dosage form is a capsule.
12. The dosage form of any one of claims 1-3, wherein said dosage form is in the form of granules.
13. The dosage form of any one of claims 1-3, wherein said dosage from is in the form of pellets.
14. The dosage from of claim to wherein said tablet contains a biconcave zone central to two outer zones; wherein said drug and said effervescent penetration enhancer are located in said biconcave zone.
15. The dosage form of claim 14, wherein said two outer zones contain a bioadhesive.
16. The dosage form of claim 1, wherein said effervescent penetration enhancer comprises a pharmaceutically acceptable effervescent couple; said effervescent couple comprising an acid or equivalent thereof and a base or equivalent thereof.
17. The dosage form of claim 16 wherein said base is sodium bicarbonate.
18. The dosage form of claim 16 wherein said base or equivalent thereof is present in an amount equal to about two times the amount of said drug; and said acid is present in an amount approximately equimolar to said base.
19. The dosage form of claim 16 wherein said base or equivalent thereof is present in an amount equal to about three times the amount of said drug; and said acid is present in an amount approximately equimolar to said base.
20. The dosage form of claim 1 wherein said drug is a drug that displays poor bioavailability in said gastrointestinal tract.
21. A method for delivering a drug to a target area in the gastrointestinal tract of a mammal; comprising the steps of (a) orally administering a dosage form comprising a therapeutically effective amount of a drug and at least one effervescent penetration enhancer, (b) causing said drug and said effervescent penetration enhancer to release from said dosage form at said target area in said gastrointestinal tract and to provide effervescent action at said target area; so that said effervescent action promotes the absorption of a therapeutically effective amount of said drug across said target area.
22. The method of claim 21 wherein said amount of said at least one effervescent penetration enhancer is about two times the amount of said drug.
23. The method of claim 22 wherein said amount of said at least one effervescent penetration enhancer is about three times the amount of said drug.
24. The method as claimed in claim 21 wherein said target area is selected from the group consisting of the stomach, duodenum, intestines, and the colon of the mammal.
25. The method of any one of claims 21-24, further comprising the step of administering a suitable pH adjusting substance in said dosage form.
CA2335566A 1999-04-29 2000-04-25 Effervescent drug delivery system for oral administration Expired - Fee Related CA2335566C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/302,105 US6350470B1 (en) 1998-04-29 1999-04-29 Effervescent drug delivery system for oral administration
US09/302,105 1999-04-29
PCT/US2000/011053 WO2000066089A1 (en) 1999-04-29 2000-04-25 Effervescent drug delivery system for oral administration

Publications (2)

Publication Number Publication Date
CA2335566A1 true CA2335566A1 (en) 2000-11-09
CA2335566C CA2335566C (en) 2010-07-06

Family

ID=23166279

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2335566A Expired - Fee Related CA2335566C (en) 1999-04-29 2000-04-25 Effervescent drug delivery system for oral administration

Country Status (6)

Country Link
US (5) US6350470B1 (en)
EP (1) EP1091732A4 (en)
JP (1) JP2002543109A (en)
AU (1) AU4488700A (en)
CA (1) CA2335566C (en)
WO (1) WO2000066089A1 (en)

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WO2000066089A1 (en) 2000-11-09
US20020071809A1 (en) 2002-06-13
US20020076439A1 (en) 2002-06-20
US6764696B2 (en) 2004-07-20
US6391335B1 (en) 2002-05-21
JP2002543109A (en) 2002-12-17
US6509036B2 (en) 2003-01-21
EP1091732A1 (en) 2001-04-18
US6641838B2 (en) 2003-11-04
US20030133976A1 (en) 2003-07-17
AU4488700A (en) 2000-11-17
US6350470B1 (en) 2002-02-26

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