The pre-formulation is the very first and most important step of any formulation development. It decides the stability, integrity and quality of any dosage from and also the success of any of the product development process. Pre-formulation studies from the route stop like solubility testing, bulk density, polymorphism, angle of repose to the endorsement of bio-pharmaceutical information so as to decide appropriate formulation compositions, excipients, polymers, dosage form, process methods, evaluation techniques and finally packaging standards and marketing. It reduces the chance of mistakes and material wastage while formulation. The process of pre-formulation and optimization has become easier by the exploration of novel software techniques. The whole range of steps involved from pre-formulation studies to manufacturing and evaluation of dosage form is called formulation development.
- Drug-Excipient Compatibility Studies
- Crystalinity and Polymorphism