Preformulation Studies of Pharmaceutical New Drug Molecule & Products: An Overview.
Kailash Vilegave1*, Gali Vidyasagar2, Pratibha Chandankar3,
1.School of Pharmaceutical sciences JJT University Chudela Jhunjhunu Rajsthan.
2. Veerayatan Institute Jhakhaniya Bhuj Gujrat 370460
3. S.S.Jondhle College of Polytechnic Ambarnath M.S - 421501.
ABSTRACT
Every drug has intrinsic chemical and physical properties which has been consider before development of pharmaceutical formulation. This property provides the framework for drug’s combination with pharmaceutical ingredients in the fabrication of dosage form. Objective of Preformulation study is to develop the elegant (stable, effective, and safe ) dosage form by establishing kinetic rate profile, compatibility with the other ingredients & establish Physico-Chemical parameter of new drug substance. Among these properties, drug solubility, partition coefficient, dissolution rate, polymorphic forms and stability are plays important role in Preformulation study. Polymorphism having crystal and amorphous forms shows different chemical physical and therapeutic description of the drug molecule. So the for study of crystal properties some techniques are mentioned in this article. And also stability of drug and product how they affected and prevention is mentioned. Preformulation study is a step in time saves nine that is disastrous effect after formulation is prevented in advance.
Keywords: Preformulation, Stability testing, Physic-Chemical properties, Polymorphism.