Pharmaceutical pre formulation for product development and analytical techniques use in new dosage form

Abstract

Fundamentals to preformulation studies are analytical techniques. Evaluation of the quality of materials, precursors of products or final product is not possible without them. Measuring pharmacological and biological response in the clinical and preclinical stages are also not possible without them. Analytical techniques should be selected based on several categories such as specificity, accuracy, precision, sensitivity, and speed of a test must be verified for selection of the method. Several analytical techniques like Spectroscopic, Chromatographic, Thermal methods and some specific detection methods like Capillary electrophoresis are very convenient method for generating preformulation data. The intrinsic chemical data and physical properties of every drug are distinctively considered before development of pharmaceutical formulation. This property of drug act as the basic structure that is responsible for the binding of drug with other pharmaceutical ingredients. Several research scientist carries out these preformulation studies and they are again reviewed later. When a preformulation study is executed on a newly synthesized compounds or extracted compound, several crucial information such as the degradation process, any adverse conditions relevant to the drug, bioavailability, pharmacokinetics and formulation of similar compound and toxicity can be obtained. Preformulation studies strengthen the scientific foundation of the steerage, give restrictive relief and conserve resources within the drug development and analysis method, improve public safety standards, enhance product quality within the fabrication of indefinite quantity type. Objective of preformulation study is to develop the exquisite, stable, effective and safe indefinite quantity kind by establishing kinetic rate profile, compatibility with the opposite ingredients and establish physicochemical parameter of new drug substances. Polymorphic substances who have both amorphous and crystal forms shows totally different chemical, physical and therapeutic description of the drug molecule. The main purpose of this review article focuses on the various preformulation factors which distinctly impacts the development of new dosage form like drug solubility, partition coefficient, dissolution rate, polymorphic forms and stability. The present article is framed with the target to produce an in-depth insight the appliance of Analytical Techniques in Preformulation Study