A Review on Preformulation Studies

A Review on Preformulation Studies

Author Name : Shubhangi M. Dhore, Santosh A. Waghmare, Hemant V. Kamble

ABSTRACT

Performulation studies determine the characteristics of active substance, and focus on the physicochemical properties of the new drug. Which could affect the drug performance, and development of dosage from this could provide important information for formulation and development of the new dosage from every drug molecule has it's unique and intrinsic physical and chemical properties, Objectives of preformulation study is to develop stable, safe and effective dosage form by establishing kinetic rate profile. Compatibility of the drug with other ingredients or excipients and establish physicochemical parameter of new drug substance. Among these properties drug solubility, partition coefficient, polymorphism, dissolution rate and stability play an important role in the preformulation studies. Polymorphism is having ability of the substance to exist in two or more crystalline phases Crysatl amorphous forms shows different physical, chemical and therapeutic effect of the drug molecule. Preformulation studies are performed to give all necessary data especially physicochemical. physicomechanical and biopharmaceutical properties of the drug. This may influence formulation design method of manufacture of API and drug product and pharmacokinetic properties of the resulting product. This article explains some techniques and properties for preformulation evaluation parameter and product of new drug and its dosage form.