• Laxmi B. Dhotre
• Sangram G. Nagargoje
• Shubham S. Kshirsagar
• Ashok A. Muchandi
• Ashwini G. Chintale

Understanding the physicochemical features of chemicals or biological entities that can affect their development into final products is critical at various stages of development. Preformulation data is crucial for understanding the possible pharmacokinetics of medicine in humans and animals, as well as the opportunities and constraints for process change as the product is scaled up in production. Preformulation studies are also carried out to anticipate the formulation's stability during manufacturing, transportation, and storage, and therefore to establish the marketed product's shelf life. The measurement of solubility and dissolution rate, molecular dissociation, pKa, diffusion, partition, and permeability, as well as how these might be included in a biopharmaceutical classification system, are all discussed in this review. Absorption and absorption of moisture Differential scanning calorimetric (DSC), thermo gravimetric analysis (TGA), and powder X-ray diffraction are used to classify hygroscopicity and evaluate polymorphism and crystallinity. Stress testing is used to evaluate the stability of active components and excipients in isolation and in combination, taking into account the effects of pH, temperature, humidity, light, and oxidizing agents. Finally, the characterization of powders and particle systems is discussed through the measurement of their fundamental and derived properties.

Preformulation, Shelf life, Crystallinity, X-ray diffraction

"A PREFORMULATION STUDIES (New)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.9, Issue 3, page no.e346-e360, March-2022, Available :http://www.jetir.org/papers/JETIR2203445.pdf

"A PREFORMULATION STUDIES (New)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.9, Issue 3, page no. ppe346-e360, March-2022, Available at : http://www.jetir.org/papers/JETIR2203445.pdf