New self emulsifying drug delivery system

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/113 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 31/21 (2006.01) A61K 31/216 (2006.01) A61K 31/407 (2006.01) A61K 45/06 (2006.01) A61K 9/107 (2006.01)

Patent

CA 2401498

The present invention claims and discloses a pharmaceutical composition suitable for oral administration, in form of an emulsion pre-concentrate, comprising: (i) one or more NO-releasing NSAID(s); (ii) one or more surfactants; (iii) optionally an additional oil or semi-solid fat; said composition forming an in-situ oil-in-water emulsion upon contact with gastrointestinal fluids. The composition may optionally also comprise one or more short-chain alcohols. Also within the scope of the invention is a combination with a proton pump inhibitor. The pharmaceutical composition is useful in the treatment of pain and inflammation. Further within the scope of the invention is kit comprising a pharmaceutical composition according to the invention in a unit dosage form, in combination with a proton pump inhibitor, and said proton pump inhibitor is enteric coated.

La présente invention concerne une composition pharmaceutique adaptée à une administration orale et se présentant sous la forme d'un pré-concentré d'émulsion. Cette composition contient (i) au moins un NSAID libérant du NO; (ii) au moins un tensio-actif ; (iii) éventuellement une huile ou une graisse semi-solide additionnelle. Au contact avec les fluides gastro-intestinaux, cette composition forme in-situ une émulsion huile-eau. Eventuellement, la composition peut également contenir au moins un alcool à courte chaîne. L'invention concerne également une association avec un inhibiteur de la pompe à protons. La composition pharmaceutique est utile dans le traitement de douleurs et d'inflammations. Enfin, l'invention concerne un kit comprenant une composition pharmaceutique selon l'invention se présentant sous la forme de doses, en association avec un inhibiteur de pompe à protons. Cet inhibiteur de pompe à protons a un revêtement gastro-résistant.

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