Controlled release formulations for poorly soluble drugs

Details Controlled release formulations for poorly soluble drugs Controlled release formulations for poorly soluble drugs

A - Human Necessities

61

K

A61K 9/32 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/28 (2006.01) A61K 9/48 (2006.01) A61K 31/19 (2006.01) A61K 31/405 (2006.01) A61K 31/44 (2006.01) A61K 31/445 (2006.01) A61K 31/455 (2006.01) A61K 31/52 (2006.01) A61K 38/13 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2226008

A controlled release formulation for oral administration comprises a solid dispersion of a poorly soluble active ingredient in a hydrophilic poloxamer, the solid dispersion being a component of a core and the core as such or following coating of the core with a polymeric coating being effective to achieve therapeutic levels of the active ingredient over extended periods of time (24 hours or longer) following oral administration. The formulation can be in a multi-particulate form such as pellets or mini-tablets or in the form of tablets. Examples of active ingredients whose solubility and therapeutic effectiveness can be improved with the formulation are cisapride, cyclosporin, diclofenac, felodipine, ibuprofen, indomethacin, nicardipine, nifedipine, terfenadine and theophylline.

Formulation à libération lente pouvant être administrée par voie orale et comportant une dispersion solide d'un ingrédient actif faiblement soluble dans un poloxamère hydrophile, cette dispersion solide étant un constituant d'un noyau, et ce noyau, tel quel ou enrobé d'une couche de polymère, étant susceptible de libérer des quantités thérapeutiques de l'ingrédient actif pendant des durées prolongées (24 heures ou plus), après son administration par voie orale. Ladite formulation peut se présenter sous une forme multiparticulaire (pastilles ou mini-comprimés) ou sous la forme de comprimés. Les ingrédients actifs dont la solubilité et l'efficacité thérapeutique peuvent être améliorées par cette formulation sont, par exemple, le cisapride, la cyclosporine, le diclofénac, la félodipine, l'ibuprofène, l'indométhacine, la nicardipine, la nifédipine, la terfénadine et la théophylline.

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