02121nam a22002057a 4500001001300000003000400013005001700017008004100034245010800075520140200183580006201585650001301647650002801660700002301688700002901711700002901740942000701769999001501776952012401791D0001J000030DOH20210211151459.0210211b           ||||| |||| 00| 0 eng d00aComparative bioavailability of three rifampicin preparations /cGodofreda V. Dalmacion [and two others]3 aSetting: Because of its lower cost, the use of generic drug products is aggressively encouraged in the Philippines. However,
local physicians are not confident about their quality and remain unsure of their therapeutic interchangeability with the branded preparations.

Objective: The objective of the study is to determine the bioavailability of generic -Rifampicin and Rifampicin in fixed dose combination (FDC) with INH against the innovator Rifampicin (Rifinah).

Methodology: Dissolution test using the basket stirring apparatus was done prior to the randomized cross- over, three period, six sequence clinical trial using three preparations of rifampicin among 12 normal volunteers. Plasma drug concentration was measured by HPLC.

Results: Only the branded preparation passed the basket stirring test whereby 95 percent of its weight was recovered in 45 minutes. Standard Rifampicin has a Tmax of 1.9 hrs (SD= 0.5), Cmax = 14.08 ng/ml (SD=6 ), and AUC= 60.45 ng/ml (SD=24.65). The Tmax of the Generic preparation is 2.75 hrs (SD=1.14), Cmax= 9.2 ng/ml (SD= 4.09) and AUC=51.37 ng/ml (SD= 24.53) while that of Rifinah is 2.50 hrs. (SD= 1.17), 9.52 ng/ml (SD=3.98) and 45.66 ng/ml (SD=19.9) respectively.

Conclusion: Both generic rifampicin and rifampicin in FDC were not bioequivalent with the branded preparation.There was statistically significant difference in Cmax and AUC for sequence.  aIn: Acta Medica Philippina, 2006 vol. 40 (2) pages: 28-32 2aRifampin 2aBiological Availability1 aAmarillo, Lourdes 1 aDe Ocampo, Esperanza J. 1 aDalmacion, Godofreda V.   cJA  c2816d2816  00102nlm4070aDOHCLbDOHCLcElectronicResd2021-02-11l0oJ000030pD0001J000030r2021-02-11 00:00:00w2021-02-11yJA