tailieunhanh - HPLC for Pharmaceutical Scientists 2007 (Part 15)

What is the definition of a formulation? Why is it needed? What is the importance of a formulation? These are some important questions that need to be addressed during the development of a potential drug product. The strict definition of the word is to specify a formula or to express a formula in systematic terms or concepts. The formula, in the current case, is a pharmaceutical dosage form. A formulation is needed to deliver the drug or the active pharmaceutical ingredient (API) to its targeted site. In order to overcome some of the physiochemical limitations of an API,. | 15 ROLE OF HPLC DURING FORMULATION DEVELOPMENT Tarun S. Patel and Rosario LoBrutto INTRODUCTION What is the definition of a formulation Why is it needed What is the importance of a formulation These are some important questions that need to be addressed during the development of a potential drug product. The strict definition of the word is to specify a formula or to express a formula in systematic terms or concepts. The formula in the current case is a pharmaceutical dosage form. A formulation is needed to deliver the drug or the active pharmaceutical ingredient API to its targeted site. In order to overcome some of the physiochemical limitations of an API it must be combined with inert ingredients excipients to safely and reproducibly deliver the API by the selected route of administration. Whether the delivery of a drug is oral capsules tablets suspensions by injection intravenous and intramuscular injections transdermal patches or by inhalation metered dose inhaler dry powder inhalation nebulizer the drug active pharmaceutical ingredient cannot be delivered by itself. Formulation development is a complex process involving the physiochemical characterization of the API identifying compatible excipients developing a reliable manufacturing process and thorough analytical characterization of the dosage form. The entire process starts early in the preformulation stage covered in Chapter 12 and continues until the final market image is developed and launched after approval from health authorities . The goal of any HPLC for Pharmaceutical Scientists Edited by Yuri Kazakevich and Rosario LoBrutto Copyright 2007 by John Wiley Sons Inc. 679 680 ROLE OF HPLC DURING FORMULATION DEVELOPMENT formulation development is to ensure that each batch manufactured meets the specifications for identity strength quality and purity. Formulation development has four generic phases that are somewhat aligned to the clinical phases preclinical clinical registration and commercial. .