ABSTRACT
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
The anti-motility properties of the leaves of African mistletoe; Loranthus micranthus (Linn); Loranthaceae harvested from Kola acuminatahost tree was studied by the charcoal meal test in mice. The intraperitoneal LD50 of the methanol extract was determined in mice by the Locke's method. The phytochemical constituents of the leaf extract were also determined. An attempt was also made to resolve the extracts into its components using thin layer chromatography (TLC). The leaves of L. micranthus were found to contain alkaloids; cyanogenetic glycosides; saponins; flavonoids; tannins; proteins and resins. The intraperitoneal LD50 of the methanol extract of the leaves in mice was calculated to be 5916 mg/kg. Among the chromatographic solvent systems tested; toluene: diethylamine (19:1) gave the best resolution in all the extracts. The highest number of spots was obtained with the ethanol extract. Result of the charcoal meal test revealed that the methanol extract had a significant dose-dependent anti-motility effect. At a dose of 200 mg/kg; the methanol extract produced a decrease in gastric transit time; which was significantly (P 0.05) higher than that of atropine (10 mg/kg)