Lecture 01, 2

• What are the modes of drug substance and product degradation?

  Chemical, physical, and microbiological
• How is drug stability assessed?

  By evaluating degradation and efficacy
• What is the link between drug stability and shelf life?

  Stability affects the drug's shelf life
• How can we identify drug degradation?

  By changes in smell and appearance
• Why does drug degradation matter?

  It affects drug stability and efficacy
• What are the moral, legal, and economic considerations in medicines?

  Ethics, regulations, and cost factors
• How do we measure the quality of a drug?

  By assessing active substance content and purity
• What are the key factors in measuring drug quality?

  • Content of active substance
  • Purity of active substance
  • Physico-chemical properties
  • Microbiological properties
  • Organoleptic and aesthetic properties
• What are the classes of degradation for drugs/products?

  Chemical, physical, and microbiological
• What is hydrolysis in drug degradation?

  Degradation caused by water interaction
• What types of drugs are susceptible to hydrolysis?

  Esters, amides, lactones, and lactams
• How can we prevent hydrolysis of drugs?

  Minimize moisture contact and adjust pH
• What is a major cause of drug degradation?

  Oxidation
• What functional groups are subject to oxidation?

  Phenols, catechols, and aldehydes
• What is auto-oxidation?

  Oxidation through atmospheric oxygen and radicals
• How can we prevent oxidation in drugs?

  Avoid heavy metals and use antioxidants
• What is photochemical degradation?

  Degradation caused by light exposure
• Which drugs are light sensitive?

  Corticosteroids and tetracyclines
• How can we prevent photochemical degradation?

  Store in amber bottles and darkness
• What is isomerisation in drug degradation?

  Conversion to optical or geometric isomers
• What is polymerisation in drug degradation?

  Formation of complexes from identical molecules
• What causes microbiological deterioration?

  Microbial flora from raw materials and environment
• How does temperature affect drug stability?

  Higher temperatures increase decay rates
• Why is stability testing important?

  It assesses drug quality over time
• What factors influence stability testing?

  Temperature, humidity, and light exposure
• What are the climatic zones for stability testing?

  I, II, III, and IV
• What is accelerated stability testing?

  Testing under exaggerated conditions to speed degradation
• What is stress testing in drug stability?

  Exploring extreme conditions for degradation prediction
• What are the limitations of predicting shelf life?

  Stability depends on multiple degradation reactions

  
• Why is empirical determination of shelf life necessary?

  Mixtures and physical stability complicate predictions