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Performulation studies

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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.

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Performulation studies

  1. 1. CH- Preformulation Subject: Formulative Pharmacy BP-502 T By: Ms. Uditi Handa (Asst. Prof.) M.Pharma (Ph.D) GGSCOP, Yamunanagar
  2. 2. “Formulation” means API is to be dispensed into any suitable dosage form. “Pre” means before any formulation.
  3. 3. 4 Stability Studies Bulk Characterization Solubility Analysis Organoleptic Properties
  4. 4. 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 Thank You

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