Preformulation Studies (IP:- 1) Handwritten Notes
Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical characteristics of drug substances. a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization BCS classification of drugs & its significance. Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
Detailed Explanation
Preformulation studies are an essential part of the drug development process, focusing on the characterization of a drug's physicochemical properties. The goals and objectives of preformulation include understanding the drug's physical and chemical properties to ensure its stability, solubility, and bioavailability.
This section covers various physical properties such as the physical form (crystal and amorphous), particle size, shape, flow properties, and solubility profile (including pKa, pH, and partition coefficient). Polymorphism, which refers to the existence of different crystalline forms of a drug, is also discussed.
Chemical properties such as hydrolysis, oxidation, reduction, racemisation, and polymerization are explored, along with the Biopharmaceutics Classification System (BCS) classification of drugs and its significance. This classification helps in understanding the solubility and permeability characteristics of drugs, which are crucial for designing effective drug delivery systems.
The application of preformulation considerations in the development of solid, liquid oral, and parenteral dosage forms is examined, highlighting their impact on the stability of dosage forms. These studies provide a foundation for formulating stable and effective pharmaceutical products, ultimately enhancing patient care and treatment outcomes.
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