Pharmaceutical

Author: Zhu Shengshan
Publisher:
Publish Date: 2002-08-01
Features: Pharmaceutical formulation engineering is a process that studies the practical aspects of formulation production using scientific theories and methods from pharmacy, formulation engineering, and related disciplines. Combining current formulation production practices, development trends, and the characteristics of pharmaceutical engineering and pharmaceutical formulation engineering, the content was developed through in-depth enterprise visits, extensive solicitation of opinions from faculty and students, and drafting. The first part introduces the basic knowledge related to formulation production, including excipients and the unit operations of main formulations. The second part discusses how to organize formulation production, monitor the production process, and ensure product quality. Building on this foundation, the third part explores the design of formulations and dosage forms, processes and non-process aspects, as well as plant and workshop design, emphasizing advanced and rational approaches. In accordance with the new drug review and approval procedures, it introduces the development and submission of new drug research and the pilot production after obtaining production approval. In line with GMP certification requirements, it covers engineering validation, which is a crucial aspect in ensuring the consistency and reproducibility of formulation production processes and product quality. This book can serve as a textbook for pharmacy education in pharmaceutical engineering, pharmaceutical formulation engineering, and related chemical engineering disciplines in pharmaceutical engineering, as well as a reference for production and research technicians.