Research & Reviews: A Journal of Drug Formulation, Development and Production
Volume 3, Issue 2 (2016)
Published
Table of contents
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An Overview of GMP Requirements for Drug Product in China
Abstract: Good manufacturing practice (GMP) is a tool which facilitates the innovation and continual improvement throughout the lifecycle of products and strengthens the link between pharmaceutical development and manufacturing activities. It also helps in increasing the process efficiency and product quality by adopting the current, risk-based manufacturing approach and in turn optimizes manufacturing process and improves quality of the end product which improves the health of the individual patient and the …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 1–6 Read article
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Pastillation—Towards Next Generation Particle Engineering
Abstract: Particle engineering is quiet essential nowadays in order to get desired qualities for generating stable formulation with improved therapeutic credentials. The current pharmaceutical technology has already realized the tremendous potential of controlled release multiparticulate system in terms of its flexibility in product development and therapeutic benefits to the patients in comparison to the conventional single unit dosage form. Pastillation provides an efficient, cost-effective process for the continuous converting of molten …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 36–43 Read article
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Validation and Forced Degradation Studies for the Determination of Erlotinib in Bulk and Pharmaceutical Dosage Forms by RP-HPLC
Abstract: A new reverse phase-high performance liquid chromatography (RP-HPLC) have been developed and validated for the determination of Erlotinib in bulk drug and pharmaceutical dosage form. The developed method is rapid, accurate, precise, simple and economical. The separation was carried out using column Hypersil ODS C-18 (150 mm x 4.6 mm 5 μm particle size) in isocratic mode, using mobile phase composition of 0.1% orthophosphoric acid: Acetonitrile in the ratio of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 44–53 Read article
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An Overview of GMP Requirements for Generics in Brazil and Russia
Abstract: Implementation of good manufacturing practice (GMP) is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the key GMP requirements for manufacturing of generics in Brazil and …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 3, Issue 2, 2016 · pp. 7–14 Read article