PHARMACEUTICS AND PREFORMULATION: THE DYNAMIC DUO OF PHARMACEUTICAL DEVELOPMENT
Ranitha R.*, Alka Eldos, Rifna Sherin C. K., Safvana P., Dr. Deepu S., Deborah Evangeline, Kanaka V. S., Neenu Anna Thomas, Srathika K.
ABSTRACT
This article presents a comprehensive review of key foundational and advanced concepts in the pharmaceutical
sciences. It outlines the scope of pharmaceutics and its critical role in ensuring drug efficacy, safety, and stability.
A detailed exploration of the preformulation phase is provided, highlighting essential physicochemical
considerations such as drug-excipient interactions, solubility, pH, partition coefficient, buffer capacity, salt forms,
pKa, and lipophilicity. Patient-related factors like age and sex, which influence drug performance and safety, are
also discussed. The review further elaborates on the sequential steps involved in pharmaceutical research and
development, starting from drug discovery and preclinical research to clinical evaluation. Key preclinical
processes such as toxicology testing, Investigational New Drug (IND) applications and product characterization
are examined. It also discusses formulation and packaging development, labeling standards, and regulatory
considerations. Additionally, pharmacokinetics and drug disposition are analyzed to understand the body's
handling of pharmaceuticals. Finally, the stages of clinical research, including bio analytical testing and clinical
trials are reviewed to emphasize their significance in ensuring therapeutic success and regulatory approval. This
review serves as an essential resource for students, researchers, and professionals seeking a holistic understanding
of the pharmaceutical research continuum.
Keywords: Preformulation, Pharmaceutics, Pharmaceutical industry, Research, Evaluation.
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