Preformulation parameters of formulation and development of new dosage form

Author: 
Hareesh Reddy, M. and Dr. Samalbasivarao, A.

This review article focus on the various preformulation parameters which effect the development of new dosage form like drug solubility, dissolution rate, partition coefficient, polymorphic forms and stability. Every drug has intrinsic physical and chemical properties which have been consider before development of pharmaceutical formulation. This property provides the framework for drug’s combination with pharmaceutical ingredients. Preformulation studies carried out by various researchers and scientists are reviewed. Preformulation studies conduct for newly synthesized compounds or extracted compound and it gives the information regarding the degradation process, any side effects relevant to the drug, bioavailability, pharmacokinetics and formulation of similar compound and toxicity. Preformulation studies strengthen the scientific foundation of the guide lines, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality in the manufacturing of dosage form. Objective of preformulation study is to develop the elegant, comfort, stable, effective and safe dosage form by establishing kinetic rate profile, compatibility with the other ingredients and establish Physico- chemical factors of new drug substances.

Paper No: 
1679