Raw Materials

An International Guideline for the Preparation, Care and Use of Medicinal Products

See the new book, edited by Paul Le Brun, Sylvie Crauste-Manciet, Irene Krämer, Julian Smith, Herman Woerdenbag:

Description: Practical Pharmaceutics contains essential knowledge on the preparation, quality control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists and scientists working in hospitals, academia and industry throughout Europe, including practical examples as well as information on current GMP and GMP-based guidelines and EU-legislation. In this second edition all chapters have been updated with numerous new as well as didactically revised illustrations and tables. A completely new chapter about therapeutic proteins and Advanced Therapy Medicinal Products was added.

From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers, students as well as professionals. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the required medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information for patients as well as caregivers about product care and how to maintain the quality of the product. The basic knowledge presented in the book will also be valuable for industrial pharmacists to remind and focus them on the application of the medicines manufactured.

The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and in industry. Undergraduate as well as graduate pharmacy students will find knowledge presented in a coherent way and fully supported with relevant examples.

Practical Pharmaceutics has become a reliable and recognised source for the acquisition of pharmaceutical-technological knowledge. The book is used in the curriculum of a number of international universities and schools of Pharmacy.

Chapter 7

Raw materials for pharmaceutical preparations are either active substances (or active pharmaceutical ingredients (APIs)) or excipients. The choice of excipients and the quality of all raw materials determine the quality of a medicinal product. In addition to purity and content, physical properties such as particle size can influence the manufacturing process and the therapeutic effectiveness. Changes in quality can have unforeseen consequences.

The source of the raw materials, as well as their suppliers, should be assessed and qualified adequately. Active substances have to be manufactured according to EU GMP. When manufactured outside the European Union, various countries excepted, they need a ‘written confirmation’ from the manufacturing country’s authorities that active substances are manufactured in compliance with the EU GMP.

The general properties of raw materials will be discussed: identity, physical, chemical and microbiological quality, nomenclature, labelling, stability and shelf life. Main excipients and groups are discussed, for their quality properties as well as their applications: solvents such as water, ethanol, glycols, fatty oils, filling agents for capsules and tablets, surfactants, viscosity enhancers, preservatives, anti Learning oxidants, complexing agents and herbal raw materials.

See the chapter

Lantink, R., Hörnig, M. (2023). Raw Materials. In: Le Brun, P., Crauste-Manciet, S., Krämer, I., Smith, J., Woerdenbag, H. (eds) Practical Pharmaceutics. Springer, Cham. https://doi.org/10.1007/978-3-031-20298-8_7

See the full book here

Practical Pharmaceutics, Springer International Publishing, Le Brun, Paul, Crauste-Manciet, Sylvie, Krämer, Irene, Smith, Julian, Woerdenbag, Herman, April 2023, DOI: 10.1007/978-3-031-20298-8, ISBN: 978-3-03-120297-1, 978-3-03-120298-8

There will be to addtional articles here soon with the remaining book chapter contents: