Oral pharmaceutical compositions of lipase-containing...

A - Human Necessities – 61 – K

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Details

A61K 38/48 (2006.01) A61K 31/22 (2006.01) A61K 31/745 (2006.01) A61P 1/18 (2006.01)

Patent

CA 2560613

The invention relates to novel pharmaceutical compositions of lipase- containing products for oral administration, in particular pancreatin and pancreatin-containing prod~ucts, or of enzyme products which contain at least one lipase of non-animal, especially microbial origin. These pharmaceutical compositions improve the lipolytic activity and in particular result in stabilisation of the lipase in the acidic pH range. These novel oral pharmaceutical compositions are characterized in that they contain a system which comprises at least one surfactant and one co-surfactant and optionally a lipophilic phase, and that they are self-emulsifiable on contact with a hydrophilic and a lipophilic phase. These novel pharmaceutical compositions are well suited for the treatment and/or prophylaxis of maldigestion, in particular maldigestion based on chronic exocrine pancreatic insufficiency, in mammals and humans.

L'invention concerne des compositions pharmaceutiques à administration per os, faites de produits contenant des lipases, en particulier de la pancréatine ou des produits pancréatiniques, ou bien des produits enzymatiques contenant au moins une lipase d'origine non animale, en particulier microbienne. Ces compositions pharmaceutiques améliorent l'activité lipolytique et apportent en particulier une stabilisation de la lipase dans la plage de pH acide. Ces nouvelles compositions pharmaceutiques à administration per os se caractérisent en ce qu'elles contiennent un système comprenant au moins un tensioactif et au moins un co-tensioactif et éventuellement une phase lipophile, et qu'elles sont auto-émulsifiables au contact d'une phase hydrophile et lipophile. Ces nouvelles compositions conviennent bien pour le traitement et/ou la prophylaxie des troubles digestifs chez les mammifères et les humains, en particulier lorsqu'ils sont dus à une insuffisante pancréatique exocrine chronique.

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