ABSTRACT
Purpose: In everyday practice clinicians are overwhelmed by claims from the pharmaceutical industry and, due to marketing efforts, they often view generic multisource products with scepticism despite proof and registration by regulatory authorities of bioequivalence. The primary aim of this study was exploratory and aimed to compare the acceptability of generic cefpodoxime (Cepodem®) versus the innovator brand product (Orelox®) in terms of effectiveness, safety and tolerability in a general private setting in South Africa in the treatment of upper and lower respiratory tract infections.Methods and patients: Ninety patients were recruited and randomised to receive either product for 10 days after clinical diagnoses of either tonsillo-pharyngitis or rhino-sinusitis or pneumonia.Results: It was demonstrated that both products resulted in similar clinical and bacteriological cure rates with also no difference in tolerability profiles. Conclusion: These findings support the bioequivalence data as submitted for regulatory approval, of the generic Cepodem® translating into clinical effectiveness and argues against the need for a clinical non-inferiority study to demonstrate sameness
Subject(s)
Cephalosporins , Therapeutic EquivalencyABSTRACT
Background: Studies have shown an increase in the usage of generic drug products from multiple sources. These generic drugs are expected to satisfy similar established standards as the original or innovator brands. Aim: To assess the standards and interchangeability of six common brands of paracetamol (acetaminophen) tablet generics marketed in Nigeria. Methods: The biopharmaceutical parameters; weight uniformity and assay of active ingredients were carried out according to established methods. The dissolution rates and disintegration times were determined in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) without enzymes. A variation of the concept of dissolution efficiency (DE); known as predicted availability equivalent (PAE); was used to predict the likely in vivo bioavailability. Results: All the brands complied with specifications for the weight uniformity; friability; disintegration time and assay of active ingredient tests. In the dissolution efficiency determination; all the brands released more in SGF than SIF. Conclusion: The study showed that all the six brands of paracetamol tablet tested are interchangeable with one another and thus could be prescribed one in place of the other. This would lead to the reduction in the cost of treatment; increased drug availability and an enhanced patients compliance in the use of acetaminophen tablets
Subject(s)
Acetaminophen , In Vitro Techniques , Tablets , Therapeutic EquivalencyABSTRACT
Les auteurs rapportent les resultats d'une enquete aupres de 318 adiltes; sur les differents signes ou equivalents semiologiques conduisant a la prise d'antipaludiques. 50 pour cent des sujets interroges sont des adultes jeunes de 15 a 29 ans. La symptomatologie est riche : 21 signes; 25 equivalents semiologiques. La fievre est le symptome dominant. Par ailleurs; dans 10 pour cent des cas; le traitement presomptif est entrepris sur des signes originaux