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Drug Stability & Drug development: Course Outline (P2, P-III)

pharmaceutical chemistry is the study and development of new drugs. It involves cures and remedies for diseases, analytical techniques, pharmacology, metabolism, quality assurance, and drug chemistry.

Course Outline

Introduction to drug design and discovery

  • Terms used
  • Brief discussion of research phases of drug discovery
  • Rational drug
  • Designing including biological phase
  • Chemical phase
  • Pre-clincial and clinical phases
  • Approval phase

Development of new drugs

  • Sources of drugs including serendipity
  • Natural source
  • Soil
  • Shemical libraries
  • Brief discussion of drug development pathways

Concept of Pro-drug and application in drug designing

  • Application in the formulation development for example I/V
  • Oral drugs

Drug designing through studies of metabolites of drugs

  • Phase I and phase II reactions
  • Role of cytochrome P450
  • Oxidative
  • Reductive and hydrolytic reaction

Receptor theories

  • Concept of agonists and antagonists
  • Clark’s theories
  • Occupational theory
  • Macromolecular perturbation theory
  • Brief discussion of drug receptor interaction with special reference to with the
  • Mechanism of action of the drug molecule

Introduction and objectives of drug stability studies significance of stability

  • Stability testing during development stages of pharmaceutical products
  • Types of stability testing
  • GMP requirements regarding stability
  • Compendial requirements FDA
  • Guidelines and stability protocols
  • Introduction to product stability of different pharmaceutical dosage form
  • Tablets
  • Capsule
  • Suspensions
  • Solutions
  • Emulsions
  • Ointments

Mode of degradation of drugs kinetic principles in drug stability

  • Chemical degradation rates
  • Pharmaceutical compatibilities
  • Physical degradation
  • Kinetics of degradation
  • The arhenius equation and calculated stability testing

Physical and photo-stability of pharmaceutical substances in solid and liquid


  • Physical degradation
  • Factors affecting physical stability
  • Kinetics of solid-phase transitions

Chemical factors affecting the stability of drugs

  • The role of molecular structure
  • Temperature pH and pH rate profiles buffer
  • General and acid base
  • Nucleophilic and electrophilic catalysis dielectric constant

Stereochemistry of drug molecules and pharmacological activity

  • Conformational isomers
  • Geometrical isomerism
  • Optical isomers and analysis of stereochemistry of the drugs in terms of pharmacological activity

Relevant Books