Comparative bioavailability of three rifampicin preparations / (Record no. 2816)

000 -LEADER
fixed length control field 01994nam a22001937a 4500
003 - CONTROL NUMBER IDENTIFIER
control field DOH
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20210211151459.0
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fixed length control field 210211b ||||| |||| 00| 0 eng d
245 00 - TITLE STATEMENT
Title Comparative bioavailability of three rifampicin preparations /
Statement of responsibility, etc. Godofreda V. Dalmacion [and two others]
520 3# - SUMMARY, ETC.
Summary, etc. Setting: Because of its lower cost, the use of generic drug products is aggressively encouraged in the Philippines. However,<br/>local physicians are not confident about their quality and remain unsure of their therapeutic interchangeability with the branded preparations.<br/><br/>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).<br/><br/>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.<br/><br/>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.<br/><br/>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.
580 ## - LINKING ENTRY COMPLEXITY NOTE
Linking entry complexity note In: Acta Medica Philippina, 2006 vol. 40 (2) pages: 28-32
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Rifampin
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biological Availability
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Amarillo, Lourdes
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name De Ocampo, Esperanza J.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Dalmacion, Godofreda V.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
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-- 2816
-- 2816
Holdings
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    National Library of Medicine     DOH Central Library DOH Central Library Electronic Resource Section 02/11/2021   J000030 D0001J000030 02/11/2021 02/11/2021 Journal Article