An empirical assessment of the possibility of interchangeability between multisource ciprofloxacin hydrochloride tablets marketed in Nigeria.
A critical quality control of seven brands of ciprofloxacin hydrochloride tablets marketed in Nigeria [Cifran (Ranbaxy, Nigeria), Ciproxin (Bayer, Nigeria), Cenox (Micro labs, India), Ciprotab (Fidson Drugs, India), Ciprofloxacin MS1 and MS2 (Sintacrus Medical stores] were carried out with the aim of selecting brands that are interchangeable. The weight uniformity, disintegration time, absolute drug content and in vitro dissolution profile of the various brands of the tablets were evaluated in simulated intestinal fluid (SIF) and simulated gastric fluid (SGF) without enzymes. The concept of dissolution efficiency (DE) was used to predict the likely in vivo availability. The weight uniformity and the disintegration time of most of the tablets were within the acceptable official ranges. The DE varies widely in the two media. Based on the DE in SGF, Cifran, Ciproxin, Cenox and Ciproflox are bioequivalent and therefore interchangeable. In SIF, however only Ciproflox and Ciprofloxacin MS1 (blue label) were bioequivalent with the innovator brand (Ciproxin, Bayer). In vitro dissolution studies using the concept of dissolution efficiency could serve as a rapid means of selecting probable therapeutically effective brands of ciprofloxacin HCl marketed in Nigeria. Using this concept, four brands (Cifran, Ciproflox, Cenox and Ciproxin) have been shown to be bioequivalent.
Osadebe
P O
PO
Department of Pharmaceutical Chemistry, University of Nigeria, Nsukka, Nigeria.
Esimone
O C
OC
Akabogu
I C
IC
D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000737:chemistry*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000737:chemistry*; D007700:Kinetics; D009549:Nigeria; D012995:Solubility; D013607:Tablets
D000890:Anti-Infective Agents; D013607:Tablets; D002939:Ciprofloxacin