Global and India pharma  need to enhance research and the science base to develop validated methods for determining Bioequivalence (BE) of complex dosage forms  which covers  semisolids, aerosols and orally administered non-absorbed drug products.

The new FDA  Bioavailability and Bioequivalence Regulations will now form a critical basis for generic drug approval and help to  bridge the gap  between clinical formulations and marketed product. Companies will need to use the Biowaiver concept and in vitro dissolution as a surrogate. It will also need to adopt the BCS concept  to  lower the  regulatory burden without lowering drug product quality. Further, they will need to constantly and frequently refer to t regulatory guidances, said, Dr Vinod P Shah, pharmaceutical consultant, in a presentation on the Impact of pharmaceutical sciences on global healthcare regulations at the 63rd Indian Pharmaceutical Congress held in Bengaluru.

The presentation was part of the  scientific session. Dr Shah went on to add that it was an age for pharma majors to look at different options to comply with the healthcare regulations. These include the  application of nanotechnology to new medical products have the potential to be an anticancer agent and the development of individualized medicine.

The impact of pharmaceutical sciences will help drive innovations to bring in novel medicines to the market place and creating therapies that did not exist before. There is also the advent of generic drugs which have enabled the effective treatment of the disease at a reduced cost. In fact safe and effective generic medicines play a pivotal role in enabling a resourceful environment for drug development, pointed out Dr Shah.

“Along with scientists from other fields, pharmaceutical scientists have contributed significantly to the discovery and development of new drugs and drug preparations, and to improving the efficacy and safety of existing drugs and drug preparations. In particular, the scientists have been key players in facilitating the translation of these discoveries and developments into better healthcare,” he said.

 Stating that the evolution of pharmaceutical science, in a very broad sense, could  be viewed as ‘science of medicine’, Dr Shah’s presentation outline comprised of pharmaceutical sciences  and the impact of regulations.

“Pharmaceutical science is a broad scientific discipline which encompasses the scientific disciplines of drug discovery, formulation development, drug disposition, manufacturing and marketing of safe medicines. The later part also include drug approval process,” he said.

The impact of pharmaceutical sciences would be in the areas of drug discovery, dosage form development , formulation science, route of drug administration, drug disposition in the body, pharmacokinetics and pharmacodynamics .

Formulation science  of drug development will cover the dosage form development . The formulation factors can influence the outcome of drug therapy. There would also be the need for advanced equipment for the production of high quality classical pharmaceutical formulations in addition to the improved process design and development

The area of biopharmaceutics which deal with the biological factors will include routes of drug administration and targeted drug delivery. Under formulations comes the  importance of drug dissolution, improved PK characteristics of the API, improved patient compliance, OROS  or osmotic release oral system, liposomes, nanomedicines parenteral , transdermal and pulmonary routes.

Therefore, new FDA  Bioavailability and Bioequivalence Regulations  will now form a critical basis for generic drug approval, said Dr Shah.