Biopharmaceutics classification system (BCS)-based biowaiver for immediate release solid oral dosage forms of moxifloxacin hydrochloride (Moxiflox GPO) manufactured by the Government Pharmaceutical Organization (GPO)

摘要

Literature and experimental data relevant to the decision toallow a waiver of in vivo bioequivalence (BE) testing for approvalof immediate release (IR) solid dosage forms containingmoxifloxacin hydrochloride as the API manufactured by theGovernment Pharmaceutical Organization (GPO) are evaluated.The solubility of moxifloxacin hydrochloride determinedby the shake flask method in six different pH mediums (1.2,4.5, 5.4, 6.4, 6.8 and 7.5) was 4.988 ± 0.1962, 27.012 ± 0.4138,21.668 ± 0.5165, 47.200 ± 0.8095, 73.438 ± 1.7310 and196.475 ± 4.4624 mg/mL, respectively. The Dose/Solubility (D/S) Ratio of the highest strength (400 mg) available in the marketof moxifloxacin tablets was 80.192, 14.808, 18.460, 8.475, 5.447and 2.036 mL, respectively. Therefore, the moxifloxacin hydrochloridecan be classified as highly soluble drug since highestdose strength of drug can solute in 250 mL or less of aqueousmedium over the pH range of 1–7.5 [1].