PROCESS FOR PREPARATION OF PHARMACEUTICAL COMPOSITION CONTAINING ANTIRETROVIRAL PROTEASE INHIBITOR WITH IMPROVED BIOAVAILABILITY
Application 325/MUM/2002 published 2006-08-04, filed 2002-04-04
The present invention relates to a process for manufacturing pharmaceutical compositions containing antiretroviral protease inhibitor with improved bioavailability. According to present invention it is possible to improve biovailability of protease inhibitors like Saquinavir, Indinavir, Nelfinavir, Lopinavir, Amprenavir but it is not possible to improve bioavilability of Ritanovir. The incorporation of Piperine, its metabolites or structural analogues or isomers thereof with antiretroviral protease inhibitor/s results in a synergistic composition having unexpected increased bioavailability of antiretroviral protease inhibitor/s. It is also to be noted that Piperine or its metabolites or structural analogues or isomers thereof has no pharmacological properties. The quantity of Piperine typically required for this purpose ranges up to 30 mgm per dosage form to be administered. Increasing the amount of piperine beyond this does not improve the bioavailability of the drug further. Like excipients used in pharmaceutical composition, Piperine is not found to have any therapeutic effect in management of HIV when used in this amount. It is also not found to affect chemical composition of a drug when combined with it in a single pharmaceutical composition. The pharmaceutical compositions incorporating piperine may be prepared in the form of liquid, powder, capsule or tablet or any other desired dosage form. The improved bioavilability of the drug is helpful in reducing the amount of the drug to be consumed as well as no. and or frequency of dosage form to be consumed. This is a much desired effect and helps in improving compliance of patient. Drawing: 1 Sheet Total Pages: 18 Fig. Nil
Applicant
CADILA PHARMACEUTICALS LTD.
“CADILA CORPORATE CAMPUS”, SARKHEJ-DHOLKA ROAD, BHAT, AHMEDABAD, 382210, GUJARAT, INDIA
Inventor
1. MR. INDRAVADAN A. MODI 2. DR. BAKULESH MAFATLAL KHAMAR
International Info
Classification: A61K 31/522, A61K 31/551