Preformulation and Formulation Aspects

Pre-formulation studies are important for various phases of clinical trials. Pre- formulation studies act as the first step as well as the scientific foundation for formulation design and development. These studies provide guidance in selection of drug, excipients, to determine chemical composition, physical pattern and assist in adjustment of pharmacokinetic profiles. Improving public safety measures and intensifying product quality, safety, accuracy are the other characteristics.

The main purpose of pre-formulation studies is to improve compatibility with the other ingredients and develop stable, potent and safe dosage form. Physico-chemical parameters, drug solubility studies, partition coefficient, dissolution kinetics, polymorphism and stability profiles play a significant role in pre-formulation studies. These studies furnish the information regarding the degradation process, toxic effects and adverse conditions. So Pre-formulation is an interdisciplinary basis in drug development.

Formulation is defined as the process in which different chemical substances including the active ingredient are compounded to produce a final dosage form. Developed formulations should be stable, safe and acceptable to the patient.