TEXT BOOK OF PHARMACEUTICAL FORMULATION DEVELOPMENT(Paperback, Mr. Ankur Agrawal)
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Preformulation studies lay the groundwork for successful drug formulation by optimizing molecular properties, evaluating crystal morphology, and assessing powder flow. Understanding drug-excipient compatibility and employing methods like structure modification ensure the efficacy and stability of pharmaceutical products. In parallel, advances in formulation additives and excipient science facilitate innovative approaches to drug development, supported by techniques such as factorial design experiments for robust product and process optimization. Solubility and dissolution studies delve into crucial aspects of drug delivery, elucidating techniques like salt formation and solid dispersion to enhance bioavailability. Meanwhile, product stability assessments, including degradation kinetics and stability testing, adhere to stringent protocols and ICH guidelines to ensure quality and efficacy throughout a product's lifecycle.