Industrial Pharmacy Unit 1 B Pharmacy 5th Semester Study Material

B.Pharm 5th Semester Industrial Pharmacy Unit 1 notes on preformulation studies covering drug physical and chemical properties, solubility, stability, and drug–excipient compatibility. Preformulation studies are the first step in dosage form development.

Bachelor of Pharmacy
Semester		5th Semester		Subject		Industrial Pharmacy
Syllabus
Unit 2nd	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 BCS classification of drugs & its significant Application of preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.

• Develop stable and effective dosage forms
• Generate data for formulation design
• Minimize formulation problems
• Ensure quality, safety, and efficacy of the drug

Physical Properties of Drug Substances

1. Particle Size and Shape
   • Affects dissolution rate, bioavailability, and flow properties
   • Measured by microscopy, sieving, sedimentation
2. Crystalline Properties and Polymorphism
   • Polymorphism: ability of a drug to exist in more than one crystalline form
   • Different forms have different solubility and stability
3. Solubility Analysis
   • Determines suitable dosage form
   • Influenced by pH, temperature, particle size
4. Hygroscopicity
   • Ability to absorb moisture
   • Important for storage and packaging

Chemical Properties

1. Stability Studies
   • Hydrolysis, oxidation, photolysis
   • Helps select excipients and packaging
2. Drug-Excipient Compatibility Studies
   • Identify incompatibilities between drug and excipients
   • Conducted using DSC, IR spectroscopy

Preformulation Parameters

• pKa determination
• Partition coefficient
• Dissolution studies

• First of all visit the website carewellpharma.shop
• After that select semester in B.Pharma
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