Pharmaceutical Preformulation Studies

Preformulation commences once a fresh synthesized drug shows sufficient pharmacological promise in animal models to warrant analysis in man. These studies should focus on those physicochemical properties of the new compound that could affect drug performance and development of an efficacious dosage form. A thorough understanding of these properties may ultimately provide a rational for formulation design or support the need for molecular modification. This review article focus on the various Preformulation factors which effect the development of new dosage form like drug solubility, partition coefficient, dissolution rate, polymorphic forms and stability

Every drug has intrinsic chemical and physical properties that has been contemplate before development of pharmaceutical formulation. This property provides the framework for drug’s combination with pharmaceutical ingredients. Preformulation studies applied by varied analysis scientists are reviewed. Preformulation studies conduct for fresh synthesized compounds or extracted compound and it offers the knowledge relating to the degradation method, any adverse conditions relevant to the drug, bioavailability, pharmacokinetics and formulation of similar compound and toxicity

Preformulation studies strengthen the scientific foundation of the guidance, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality 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 and establish Physio-chemical parameter of new drug substances.

Polymorphism having crystal and amorphous forms shows totally different chemical physical and therapeutic description of the drug molecule.

 

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