The "Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume Four - Semisolid Products" is a comprehensive guide that provides detailed information on the manufacturing processes and formulations of semisolid dosage forms in the pharmaceutical industry. This handbook is an essential reference for pharmaceutical scientists, engineers, and researchers involved in the development, production, and quality control of semisolid dosage forms.
The guidebook discusses creams, ointments, gels, pastes, and lotions as semisolid dosage forms. It begins with a review of general concepts and semisolid product production methods, such as formulation, mixing, and processing procedures. It also covers the regulatory elements of semisolid product production, such as Good Production Practice (GMP) standards compliance.
The guide then digs into the intricacies of each type of semisolid dosage form's production process, including thorough information on the formulation, equipment, and processing procedures. It encompasses, for example, the use of emulsifiers and stabilizers in cream and lotion formulation, as well as the equipment and processing techniques used for emulsion preparation, homogenization, and particle size reduction.
The handbook also provides detailed information on the excipients and active ingredients used in semisolid product formulations, as well as their physicochemical properties and compatibility. It covers the various types of emollients, moisturizers, and penetration enhancers used in semisolid formulations, as well as the selection and use of preservatives, antioxidants, and other additives.
The manual also covers quality control components of semisolid product production, such as analytical procedures for product testing and release, stability testing, and specification formulation for raw materials and completed products. It also includes a section on semisolid product packaging and labeling standards.
Overall, the "Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume Four - Semisolid Products" is a thorough handbook that explains the production procedures and formulations of semisolid dosage forms in depth. It addresses all areas of semisolid product manufacturing, from formulation through packaging and labeling, as well as regulatory compliance and quality control. This guide is a must-have for pharmaceutical scientists, engineers, and researchers involved in the development, manufacturing, and quality control of semisolid dosage forms.
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting.
A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Features:
- The largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions
- Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing
- Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements
- Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
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