Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Patent
1996-08-07
1998-08-11
Jordan, Kimberly
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
514963, A61K 3120
Patent
active
057927952
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/EP96/02038, filed May 13, 1996.
The present invention relates to the oral administration of omega-3 polyunsaturated acids especially, but not exclusively, eicosapenta-5,8,11,14,17-enoic acid ("EPA") and/or docosahexa-4,7,10,13,16,19-enioc acid ("DHA"). In particular, it provides enteric dosage forms of omega-3 polyunsaturated acids for the treatment of inflammatory bowel disease especially, but not exclusively, Crohn's disease and ulcerative colitis.
It is known that DHA, EPA and other omega-3 polyunsaturated acids are of use in the treatment of inflammatory bowel disease (see, for example, EP-A-0244832, EP-A-0289204, EP-A-0311091 & WO-A-93/21912).
EP-A-0244832 discloses pharmaceutical compositions containing certain unsaturated fatty acids with certain specified stimulators. The compositions are of use for treating disorders associated with prostaglandin deficiency, especially gastrointestinal ulcers. The unsaturated fatty acids are those which have 3 to 5 isolated double bonds and 18 to 22 carbon atoms arranged in a straight chain and are capable of being methylated or ethylated at one or two carbon atoms in positions 2, 3, 4, 16, 17, 18, 19 or 20. EPA is amongst the exemplified acids. Reference is made to pH dependent delayed release formulations containing polystyrene or polyacrylic derivatives and to enteric coated products.
EP-A-0289204 discloses disinfectant and pharmaceutical compositions comprising the lithium salt of a C.sub.18 -C.sub.22 polyunsaturated fatty acid. Specified polyunsaturated fatty acids include DHA and EPA. The pharmaceutical compositions can be for enteral, parenteral and topical administration and are for use in the treatment of conditions responsive to lithium and/or polyunsaturated fatty acid therapy. Specified conditions responsive to polyunsaturated fatty acid therapy include Crohn's disease and ulcerative colitis. Reference is made to providing an enteric coat of, for example, an acrylate or cellulose acetate phthalate to delay release of the salt until the intestine.
EP-A-0311091 discloses physiologically acceptable isotonic fat emulsions containing an omega-3-fatty acid or ester, a medium-chain length triglyceride, and an emulsifier. The fatty acid or ester component can be present as a pure compound or in the form of a fish oil and preferably is EPA. The emulsion is administered parenterally for, inter alia, treatment of chronic inflammatory bowel disease.
WO-A-93/21912 discloses the use of emulsions containing a polyunsaturated long-chain omega-3-fatty acid or ester for parenterally administration to treat inflammatory disorders including inflammatory bowel disease. The fatty acid or ester can be present as fish oil and preferred fatty acids include DHA and EPA.
Enteric coated products containing DHA or EPA have been reported for use in the treatment of other conditions (see EP-A-0336662, GB-A-2090529, JP-A-62201823, & WO-A-90/04391)
EP-A-0336662 discloses the micro encapsulation of fish oil acids within an enteric coating to provide a stable, odorless and tasteless composition for incorporation into a food product to reduce plasma triglyceride, low density lipoprotein and cholesterol levels . The specified coating materials are ethyl cellulose, cellulose acetate phthalate and cellulose acetate trimelitate. Reference is made to release of the active below the pylorus in the upper portion of the intestine but there is no specific reference to targeting release to the ileum.
GB-A-2090529 discloses the prophylaxis and treatment of thrombosis using DHA or esters or amides thereof. Reference is made in general terms to intestine soluble coated tablets and to film coated tablets.
JP-A-62201823 discloses enterically coated capsules for treating enteral abnormal fermentation or diarrhoea which contain bacteria in an oil. The oil can be EPA and a number of enteric materials are specified including shellac, carboxymethyl cellulose, cellulose acetate phthalate, hydroxymethyl propylcellulose phthalate, and polyvinyl alcohol phthalate.
WO-A-90/04391
REFERENCES:
patent: 5252333 (1993-10-01), Horrobin
patent: 5411988 (1995-05-01), Bockow et al.
patent: 5422115 (1995-06-01), Horrobin
patent: 5603953 (1997-02-01), Herbig et al.
Rohm Pharma Gmbh brochure titled "Sustained-release coatings with Eudragit.RTM. NE 30D from aqueous dispersions" (1995).
Belluzzi, A., et al, abstract titled "New Fish Oil Derivative for Preventing Clinical Relapses in Crohn's Disease: A Double Blind Placebo Controlled Randomized Trail", published Digestive Disease Weekly 14 May 1995.
Buser Thomas
Camporesi Emilio P.
Jordan Kimberly
Tillotts Pharma AG
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