European Journal of Biomedical and Pharmaceutical Sciences

IMPORTANCE OF PHARMACEUTICAL PREFORMULATION IN PHARMACEUTICAL TECHNOLOGY

Ch.Taraka Ramarao*, K.Girish Kumar, G .Sandeep Kumar, D.Tejeswi, B. Prasanna, N.Y.Reddy, P.Keerthi, V.Appalanaidu and V.Sravani

ABSTRACT

In recent years, there has been a significant increase in pressure on pharmaceutical companies to discover and develop new medicines ever faster to replace those coming off patent and to counter generic manufacturer competition. It is important that the reader is aware of the nature of pharmaceutical research and development (R&D) to appreciate the importance of preformulation and formulation in the overall process. After first-time-in-human (FTIH) studies in early development, if the compound progresses into full development, a more complete physicochemical characterization of the chosen compound, with particular emphasis on the dosage form, should be carried out, thus allowing a rational, stable, and bioavailable formulation to be progressed through to launch. Generally, drug absorption from the GI tract requires that the drug is brought into solution in the GI fluids and that it is capable of crossing the intestinal membrane into the systemic circulation. It has therefore been suggested that the drug must be in its molecular form before it can be absorbed. Approaches to lead generation during exploratory research often depend on how much is already known about the therapeutic target under consideration. The objective of the review is prior to the development of tablets, capsules and injectables dosage forms, it is essential that certain fundamental physical and chemical properties of the drug molecule and other derived properties of the drug powder are determined. This information dictates many of the subsequent events and approaches in formulation development. This first learning phase is known as preformulation.

Keywords: Solubility, Dissolution rate, melting point, flow properties, stability studies.