Assessment of Pharmaceutical Quality of Furosemide Tablets from Multinational Markets

摘要: This report describes results of a collaborative study in which samples the 40-mg strength furosemide tablets were evaluated following common protocol based on British (BP), European (Ph. Eur.), and US Pharmacopoeial (USP) specifications. Several tests, including identification, uniformity mass, dissolution, performed. In total, excluding Lasix lots, for 162 lots obtained from 115 manufacturers or suppliers submitted. Also, 23 laboratories identified submitted data 34 products available their countries. There no reported abnormalities physical test requirements analyzed. The summaries (n, mean, 95% CI) assay "standard sample" (a sample), participating countries, all other products, respectively, are as follows: 30, 99.8%, 96-104; 33, 100.0%, 94-106; 162, 99.6, 94-105. About half (approximately 62%) mass tablet weights range 150-175 mg/tablet. However, there appears to be notable variability that would result significant differences ratios (0.14 0.40) active ingredient excipient. disintegration times ranged 0 (instantaneous) 18 min, with most less than 1 min. drug dissolution testing was conducted phosphate buffer at pH 5.8 (USP recommended). Another acetate 4.6 (noncompendial). remarkable similarity overall percentage release three types (standard sample, products). Although apparently is very wide spread characteristics tested, analyses variance did not detect among tested and, this extent, indicate bioavailability these products. It observed about 20-38% product related (i.e., it itself), while remaining 62-80% (manufacturing, formulation, etc). multinational showed different countries met required pharmaceutical quality standards, drug-release characteristics. Based an extensive statistical analysis, main concern high require tolerance standards (e.g., pharmacopoeial standards). may lack needed discriminating ability revealing impacts formulation manufacturing changes vitro, perhaps vivo,