Plasma pooling to expedite bioequivalence estimation of rifampicin in fixed dose combinations.
Rifampicin has been found to be one of the most important antitubercular drugs; however, variable bioavailability of rifampicin in some fixed dose combinations (FDCs) as well as separate formulations has been reported in the literature. This resulted in proper evaluation of FDCs with standard protocol for bioequivalence trials. Earlier, plasma pooling as a rapid method for bioequivalence assessment of rifampicin in FDCs was proposed from our laboratory. Results obtained after pooled plasma sample analysis were compared with those from the individual plasma sample analysis. Case studies from our laboratories further validate and support the use of plasma pooling method as a faster and cost effective tool for bioequivalence assessment of rifampicin in FDCs, which will be useful in order to speed up the registration and approval of good quality FDCs.
Panchagnula
R
R
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar (Mohali), Punjab, India. panchagnula@yahoo.com
Parmar
J
J
Kaur
J K
JK
Singh
I
I
Bhade
S R
SR
D000284:Administration, Oral; D000904:Antibiotics, Antitubercular / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002986:Clinical Trials as Topic / Q000379:methods; D006801:Humans; D012107:Research Design; D012293:Rifampin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D000904:Antibiotics, Antitubercular; D012293:Rifampin