Pharmaceutical Manufacturing Handbook Production and by Shayne Cox Gad

By Shayne Cox Gad

This guide good points contributions from a staff of professional authors representing the various disciplines inside of technological know-how, engineering, and know-how which are keen on pharmaceutical production. they supply the data and instruments you must layout, enforce, function, and troubleshoot a pharmaceutical production process. The editor, with greater than thirty years' adventure operating with pharmaceutical and biotechnology businesses, conscientiously reviewed the entire chapters to make sure that every one is thorough, exact, and transparent.

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Briefly, by comparing the relative kill efficiency of the formulation containing varying concentrations of the preservative, the formulator can determine the minimal concentration required for preservative efficacy and design the formulation accordingly. 1 DRUG PRODUCT STABILITY Defining Drug Product Storage Conditions From a regulatory standpoint, the primary objective of formulation development is to enable the delivery of a safe and efficacious drug product to treat and/or mitigate a disease state throughout its proposed shelf life.

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Preferential hydration refers to the hydration layers on the outer surface of the protein and can be utilized to thermodynamically explain both stability enhancement and denaturation. Typical excipients used in protein formulations include albumin, amino acids, carbohydrates, chelating and reducing agents, cyclodextrins, polyhydric alcohols, polyethylene glycol, salts, and surfactants. Several of these excipients increase the preferential hydration of the protein and thus enhance its stability.

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