Extended Release Rates Technology for Injection Dosage Form

Extended Release Rates Technology for Injection Dosage Form

Extended-release injectable formulations are designed to release the active pharmaceutical ingredient (API) at a controlled rate over an extended period, from several hours to weeks. The primary goal of these formulations is to reduce the frequency of administration, minimize drug fluctuations, and maintain therapeutic drug levels, improving patient adherence and clinical efficacy. The development of…

Formulation Development Strategies for Biologics Product

Formulation Development Strategies for Biologics Product

The formulation of biologics presents unique challenges due to their structural complexity and sensitivity to environmental conditions. This review explores critical aspects of biologic formulation, including stability considerations, excipient selection, and delivery systems. Additionally, biopharmaceutical factors such as absorption, distribution, metabolism, and excretion (ADME) of biologics are discussed. Recent advancements in formulation strategies, including novel…

Osmotic Pump Extended-Release Technology for Oral Dosage Forms

Osmotic Pump Extended-Release Technology for Oral Dosage Forms

Oral drug delivery remains the most convenient and preferred route of administration. However, conventional oral dosage forms often face challenges such as fluctuating drug plasma levels and poor patient compliance. Extended-release formulations, particularly osmotic pump systems, have been developed to overcome these limitations by providing a consistent and controlled release of the drug. Osmotic pump…

Understanding the Tablet Dissolution

Understanding the Tablet Dissolution

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…

Factors Affecting Bioequivalence (BE) Results

Factors Affecting Bioequivalence (BE) Results

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…

Deviations and Nonconformities in Pharmaceutical Industry

Deviations and Nonconformities in Pharmaceutical Industry

“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…

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