A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/229
A61K 31/455 (2006.01) A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 31/44 (2006.01)
Patent
CA 2012194
The present invention relates to a process for the preparation of regulated release solid pharmaceutical compositions comprising 4-(2'-nitro-phenyl)-2,6-dimethyl- -3,5-dimethoxycarbonyl-l,4-dihydro-pyridine (referred to further on as "nifedipine") as active ingredient which comprises admixing a solution or solutions of 1 part by weight of nifedipine, 0.1-1.5 parts by weight of one or more hydrophilising agent(s) and 0.05-1.5 parts by weight of one or more retarding agent(s) formed with one or more identical or different solvent(s) completely or partly and applying the solution(s) thus obtained simultaneously or in succession onto an inert carrier, drying and sieving the product thus obtained and subsequently admixing the same with suitable conventional auxiliary agents and compressing the mixture thus obtained to tablets in a known manner and coating the tablets or filling the mixture into capsules. The process of the present invention is suitable for the preparation of both relatively quick and sustained release pharmaceutical compositions. The process is readily feasible on industrial scale, the absorption of the active ingredient is independent of the particle size distribution of the - 2 - bulk material used as starting material and no segrega- tion takes place during tabletting and encapsulation.
Barczay Erzsebet
Csorgo Margit
Erdos Sandor
Fekete Marton
Gorgenyi Frigyes
Egis Gyogyszergyar Rt.
G. Ronald Bell & Associates
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