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Does Direct Transfer from A High Shear Granulator To a Fluidized Bed Dryer Improve Finished Tablet Quality Attributes?

2022; Linguagem: Inglês

10.20935/al1252

2771-9359

Fred Rowley,

Drug Solubulity and Delivery Systems

Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. There are many chemicals with pharmacological properties, but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Pharmaceutics helps relate the formulation of drugs to their delivery and disposition in the body. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Branches of pharmaceutics include: Pharmaceutical formulation Pharmaceutical manufacturing Dispensing pharmacy Pharmaceutical technology Physical pharmacy Bio-Pharmaceutics Pharmaceutical jurisprudence Pure drug substances are usually white crystalline or amorphous powders. Before the advent of medicine as a science, it was common for pharmacists to dispense drugs as is. Most drugs today are administered as parts of a dosage form. The clinical performance of drugs depends on their form of presentation to the patient. Though the subject Pharmaceutics is only studied or in the educational curricula of the College of Pharmacy in different universities across the globe, but its use and at least some knowledge is needed or essential for the other technical disciplines personnel in the pharmaceutical industry as a formulator, analyst, process engineer and regulatory affairs. It is also very important for a reviewer in the regulatory agency, going through the section P.3 Drug Product and Process Development of the application, to understand the basics of pharmaceutics for authentic endorsement or approval of an application from quality perspective. This Hand book of Pharmaceutics is a reference work containing a compilation of information collected and edited by the initiator and made it easy by using his education in pharmaceutics and 45 years of professional experience; with over 10 years in the public service as USFDA/CDER CMC reviewer and 35+ years in the private sector (Pharmaceutical Industry) as Product Development Scientist, writing and collecting many scientific articles and giving many presentations to the audience at the scientific seminars of ISPE and AAPs and for the training as a mentor of the FDA CMC reviewers . For this task of compilation, the editor has utilized his own education, exposure and experience in the field by covering multiple subjects and technologies in a way that would not be merely a review of the literature but in-depth review and interpretation. Each chapter begins by assuming either the reader is not very familiar with the subject or would be a refresher. P.S: This version of the Handbook of Pharmaceutics is only for the use of academic and scientific purpose and only its electronic or printed copies may be distributed among the user but not to be published by anybody for their financial benefit without the permission of the editor.