In this research work biowaiver studies of newly developed and optimized Meloxicam 7.5mg and 15mg water dispersible formulations were carried out at different dissolution media i.e. 0.1N HCl, phosphate buffer pH 4.5, pH 6.8, and pH 7.5 at 50 rpm. For this purpose reference (MA and MB) and tests (MA, MA, MA, MA and MA (15 mg) and MB2, MB4, MB6, MB7and MB8 (7.5 mg) formulations were compared. In vitro patterns were analyzed by using model-independent and model-dependent methods. Results indicated that all formulation at pH 0.1N HCl and phosphate buffer pH 4.5 followed Weibull model, while at pH 6.8 and pH 7.5 all formulations followed Hixson-Crowell model. Similarly results of model independent methods demonstrated that all the reference formulations were found to be similar with the tests formulations. Results indicated that Biowaiver could be granted to all the optimized water dispersible meloxicam formulations of both batches, so waiver for bioequivalence study can be allowed.
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Mol Pharm
January 2025
Institute of Chinese Medical Sciences (ICMS), State Key Laboratory of Quality Research in Chinese Medicine, University of Macau, Macau 999078, China.
The Biopharmaceutics Classification System (BCS) has facilitated biowaivers and played a significant role in enhancing drug regulation and development efficiency. However, the productivity of measuring the key discriminative properties of BCS, solubility and permeability, still requires improvement, limiting high-throughput applications of BCS, which is essential for evaluating drug candidate developability and guiding formulation decisions in the early stages of drug development. In recent years, advancements in machine learning (ML) and molecular characterization have revealed the potential of quantitative structure-performance relationships (QSPR) for rapid and accurate BCS classification.
View Article and Find Full Text PDFJ Pharm Sci
November 2024
Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany. Electronic address:
According to the ICH M9 Guideline, the triazole antifungal voriconazole is a Biopharmaceutics Classification System (BCS) class II drug, being highly soluble at the highest dose strength but not at the highest single dose. Although the ICH M9 allows for consideration of BCS-based biowaivers in such cases, voriconazole does not meet the additional requirement of dose proportional pharmacokinetics (PK) over the therapeutic dose range. By contrast, if the classification were based on the FDA solubility criteria that were in place prior to ICH M9 (based on the highest dose strength), voriconazole would belong to BCS class I and thus qualify for the BCS-based biowaiver.
View Article and Find Full Text PDFJ Pharm Sci
October 2024
Fraunhofer Institute for Translational Medicine and Pharmacology, Frankfurt am Main, Germany. Electronic address:
Lemborexant is a dual orexin receptor antagonist assigned to class II of the Biopharmaceutics Classification System (BCS). Thus, the ICH M9 Guideline excludes immediate-release (IR) solid oral dosage forms containing lemborexant from BCS-based biowaivers, irrespective of their in vitro dissolution behavior. By contrast, classification of lemborexant according to the refined Developability Classification System (rDCS) falls into class I, indicating few biopharmaceutics risks.
View Article and Find Full Text PDFAnal Chim Acta
November 2024
Laser Chemistry Research Group, Department of Analytical Chemistry, Faculty of Chemistry. Complutense University, 28040, Madrid, Spain. Electronic address:
Eur J Clin Pharmacol
December 2024
Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090, Telangana, India.
Purpose: In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development. Virtual bioequivalence leverages these computation tools to predict bioequivalence between reference and test formulations thereby demonstrating possibilities to reduce human studies. A pre-requisite for virtual bioequivalence is development of validated virtual population that depicts the same variability as that of observed in clinic.
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