US 6,641,838 B2Granted

Effervescent drug delivery system for oral administration

AssigneeCima Labs Inc.

InventorsS. Indiran Pather, Joseph R. Robinson, Jonathan D. Eichman, Rajendra K. Khankari, John Hontz, Sangeeta V. Gupte

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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 the use of appropriate coatings and other techniques, the effervescence can occur in other parts of the gastrointestinal tract, including, but not limited to, the esophagus, duodenum, and colon. The site of effervescence and drug release 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.

Claims24

Dependent claims

A dosage form for delivery of a therapeutically effective amount of a drug to a target area in the gastrointestinal tract of a mammal, said dosage form comprising:

(a) a therapeutically effective amount of a drug;
(b) at least one effervescent penetration enhancer present in an amount sufficient to increase the penetration of said drug across said target area of said gastrointestinal tract to permit delivery of said therapeutically effective amount of said drug, wherein said amount of said at least one effervescent penetration enhancer is at least about two times the 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 more elements

Dependencies are inferred from the claim text.

Facts

Application: 10/021,109Filed 29 Oct 2001 · continuation
Priority: 29 Apr 1998
Published: US 2002/0076439 A120 Jun 2002
Granted: 4 Nov 2003
Term ends: Not estimatedThe source records don’t support an estimate.

Classification6 codes

A61K 9/2886
Dragees; Coated pills or tablets , e.g. with film or compression coating: having two or more different drug-free coatings; Tablets of the type…
A61K 9/0007
Galenical forms characterised by the drug release technique; Application systems commanded by energy: effervescent
A61K 9/2072
Pills, tablets, discs, rods: characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially…
A61K 9/2866
Polysaccharides, e.g. gums; Cyclodextrin: cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Family

Application60/083,391Us provisional application · filed 29 Apr 1998
Application09/302,105Parent of this division · filed 29 Apr 1999
Application09/613,270Parent of this continuation · filed 10 Jul 2000
US 2002/0076439 A1Pre-grant publication · published 20 Jun 2002
US 6,391,335 B1Parent of this continuation
Application09/613,270Parent of this division
US 6,350,470 B1Parent of this division
US 6,139,874 ARelated patent
US 6,641,838 B2This patent

From the US filing history. Foreign family members aren’t listed.