Abu Serajuddin Ph. D
Executive Director Pharmaceutical Development Novartis Pharmaceuticals
East Hanover, New Jersey,
Dr. Abu Serajuddin
is Director of Pharmaceutical Development at Novartis Pharmaceuticals Corp., East Hanover, New Jersey, where he is responsible for dosage form development of new chemical entities, life cycle management of drug products, and novel drug delivery research. He received his Ph.D. in Industrial Pharmacy from St. John's University, New York and his M.S. in Pharmaceutics from Columbia University, New York. He also studied Industrial Pharmacy at the University of Pisa, Italy, with an International Scholarship from the Government of Italy. He authored or co-authored about 50 research papers and book chapters and made over 30 invited presentations in major national and international meetings. In recognition of his outstanding contribution to pharmaceutical sciences through systematic application of physicochemical principles in drug development, Dr. Serajuddin was elected Fellow of American Association of Pharmaceutical Scientists (AAPS) in 1998. He is a charter member of AAPS and served the organization in many different capacities. He was Vice-Chair, Chair-Elect and Chair of its Pharmaceutics and Drug Delivery (PDD) Section in 1999, 2000 and 2001, respectively. PDD is the largest section of AAPS with approximately 6000 primary and secondary members. As Chair of the PDD Section, Dr. Serajuddin organized and co-chaired the First AAPS Conference on Pharmaceutics and Drug Delivery that was held in Arlington, Virginia, in April, 2002. He also organized the AAPS workshop on Chemical and Physical Form Selection of Drug Candidates (2002) and the AAPS/FDA Workshop on Polymorphism of Drug Substances (1996). He served as Member, AAPS Task Force on Pharmaceutical Education (1999); Chair, AAPS Preformulation Focus Group (1994-96); Chair, AAPS Eastern Regional Meeting PDD Programming Committee (1994); Chair, AAPS National Meeting PT Paper Screening Committee (1994); Member, AAPS national and regional meeting programming committees (1992-98); and Member, Academy of Pharmaceutical Sciences Journal Evaluation Committee (1984). Dr. Serajuddin is also committed to strengthening the education in pharmaceutical sciences in the USA, and, following his publication of a highly influential commentary on pharmaceutical education in the journal Pharmaceutical Research (January 1998), he consulted with several pharmacy schools towards the development of pharmaceutical sciences programs.
Abstract
Because of the introduction of combinatorial chemistry and high throughput screening (HTS) during the past decade, the pharmaceutical industry is going through a revolutionary change in the way it has been discovering and developing drugs. In this presentation, challenges in the development of such compounds into acceptable pharmaceutical dosage forms will be discussed. Since some of the attributes of newer drug molecules are unfavorable to their development as dosage forms, the ‘developability' is becoming a critical consideration for the transition of a chemical entity from the discovery phase to the development phase. Various developability criteria such as solubility, dissolution rate, stability, permeability, and so forth, for the selection of optimal development candidates will be discussed. Strategies will be presented to overcome some of the unfavorable attributes of new drug candidates through appropriate selection of their physical and chemical forms (salts, polymorphs, etc.). After a candidate is identified for development, the primary objective in most cases is to initiate Phase I clinical studies at the earliest possible time so that safety, proof of concept, potential dose, pharmacokinetic parameters, etc., can be established.