Tablet dissolution is a critical process in pharmaceutical sciences, influencing drug bioavailability and therapeutic effectiveness. This review explores the principles of tablet dissolution, detailing the key stages from administration to absorption. It also discusses factors affecting dissolution, analytical methods, regulatory considerations, and emerging technologies shaping the future of drug release and bioavailability enhancement. Oral solid…
Bioequivalence (BE) studies are crucial in the pharmaceutical industry to ensure that generic formulations exhibit comparable bioavailability to their reference products. Several factors influence BE results, potentially impacting regulatory approval and market entry. This review highlights the key determinants affecting BE outcomes, including formulation characteristics, physiological variability, study design, and analytical considerations. Formulation Factors The…
“Deviation” terms used in the pharmaceutical industry, while the term “non-conformance” is classically used in the medical devices industry (ISO 13485:2016). Nonconformity Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements. ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” According to FDA…
The lifecycle approach to process validation has become the global standard, incorporated into guidelines by the US FDA, EU, and WHO (See TRS 1019, Annex 3, Appendix 7). Since WHO GMP guidelines apply to Bangladesh, this approach is equally relevant to our pharmaceutical industry. What does this mean for us? Process validation is no longer…
Is a process simulation testing, is a critical validation procedure in aseptic pharmaceutical manufacturing. It ensures the sterility of drug products by simulating the entire production process using sterile media in place of the actual product. The importance of media fill lies in its ability to verify that every step of the aseptic process maintains…
In the pharmaceutical industry, precision and innovation are everything. Among the many technologies shaping this field, the lyophilizer (freeze dryer) stands out as one of the most impactful. Lyophilization Lyophilization or freeze-drying removes water from a product by sublimation converting ice directly into vapor without passing through the liquid phase. It’s performed under low temperatures…
