Methodology of Preformulation Studies related to Pharmaceutical Sciences. Physio-chemical properties, Program of analytical preformulation. Preformulation Drug Characterization in a Structured Program. Benefits of Preformulation Studies. Bio-pharmaceutical Properties. Bulk Characterization, Solubility analysis, organoleptic properties. Stability studies Pharmaceutical studies objectives of preformulation Need of preformulation studies in Drug Characterization Solubility analysis Dissolution Electrostatic Charges method for Characterization such as UV Spectroscopy, HPLC, TLC, pH determination. Microscopy, Flow Properties Assay development, Lipophilicity pH effect Parentral Preparation Pharmacokinetic Ophthalmic Preparation Isotonicity Suspensions and emulsions Aspirin Pilocarpine penicillin Crystalline compound Amorphous Compound Bioavailability method to determine Partition Coefficient Log P Values Particle Size , Shape and Surface area. Color, taste , odour and physical appearances types of preformulation studies major area of preformulation research absorption metabolism duration of action shake flask method gas chromatography 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 Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.

1. CH- Preformulation
Subject: Formulative Pharmacy
BP-502 T
By: Ms. Uditi Handa (Asst. Prof.)
M.Pharma (Ph.D)
GGSCOP, Yamunanagar

2. “Formulation” means API is
to be dispensed into any
suitable dosage form.
“Pre” means before any
formulation.

8. 4 Stability
Studies
Bulk
Characterization
Solubility
Analysis
Organoleptic
Properties

33. References
1. CHAPTER 1 Preformulation Studies (RSC Publishing) DOI ...
pubs.rsc.org
2. Preformulation Studies in a Drug Development ...
www.jpharmsci.org
3. Preformulation Studies: An Integral Part of Formulation Design ...
www.intechopen.com
4. Preformulation studies - ResearchGate
www.researchgate.net › publication › 320373570
5. Preformulation Studies: A Foundation for Dosage Form ...
www.pharmapproach.com › preformulation-studies
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