Research & Reviews: A Journal of Drug Formulation, Development and Production
Volume 4, Issue 2 (2017)
Published
Table of contents
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Biological Classification System (BCS), its Significance on Dissolution Study and Application in Dosage Form Development
Abstract: Bioavailability (BA) has an important role in new drug discovery and product development in pharmaceutical field. The solubility and permeability are important parameters of biopharmaceutics and have central role in lead optimization by controlling the pharmacokinetic parameters to give better therapeutic activity. Biopharmaceutical classification system (BCS) is a drug development tool that is based on correlation of solubility and permeability with bioavailability of drug in human body. The principles of …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 1–16 Read article
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Overview of Regulatory Scenario on Switch Mechanism for Over The Counter class in European Countries, and Assessing its Effectiveness on Self-Care Management
Abstract: Short term self-medication has tremendous power in lowering the burden of medical practitioners. Responsible self-care allows everyone to maintain their healthcare status with limited involvement in obtaining guidance from other health care practitioners such as pharmacists, etc. Although most of the EU countries have adopted to formal procedure of switch to change the class from Rx to OTC category, still there are chances to harmonize the mechanism of switch process …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 17–23 Read article
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Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.
Abstract: The Rx-to-OTC switch was a phenomenal success in USA, which was based on risk/benefit ratio of all scientific evidences in collaboration with FDA, manufacturer and consumers. Different surveys speak about the success stories of Rx-to-OTC movement as consumers experience the benefit from self-care in terms of empowerment, convenience, savings of money and time, etc. OTC perspective of scientific and regulatory bodies is based upon a valid procedure and just not …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 24–31 Read article
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Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario
Abstract: The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 32–39 Read article
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Formulation And Evaluation of Domperidone Medicated Jelly Using Solvent Deposition Method For Solubility Enhancement
Abstract: Objective: The purpose of this study is to develop and characterize medicated jelly of Domperidone. Domperidone is associated with poor aqueous solubility and dissolution rate and thus exhibit a poor bioavailability. Solvent deposition is a promising method to improve the solubility of poor water soluble drugs.Methods: Solvent depositions were prepared for optimization and evaluated for percentage drug content, invitro dissolution, solubility analysis. Optimization of Domperidone solvent deposition was done using …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 4, Issue 2, 2017 · pp. 40–53 Read article