Lecture 05

• Why are drugs tested?

  To ensure safety and efficacy
• Why is analysis important in the manufacture of medicines?

  It ensures quality and safety of medicines
• Why do we need to test for impurities?

  To ensure the drug's safety and effectiveness
• What is the difference between qualitative and quantitative analysis?

  • Qualitative analysis: Identifies the presence of substances
  • Quantitative analysis: Measures the amount of substances
• What is the British Pharmacopoeia?

  A collection of standards for medicines
• Why do we need the British Pharmacopoeia?

  To ensure medicines meet quality standards
• What should medicines do for patients?

  Make people better without causing harm
• What is a major concern regarding side effects of medicines?

  They should not cause additional health issues
• What is identity testing in pharmaceuticals?

  Qualitative analysis to confirm drug identity
• What can cause major failures in drug production?

  Equipment failure and incorrect reagents
• What are the consequences of poor labeling in drug production?

  Potentially severe issues with drug safety
• What is an assay in pharmaceuticals?

  Quantitative analysis of active ingredients
• What happens if the amount of active pharmaceutical ingredient is too low?

  It may harm the patient due to ineffectiveness
• What could happen if the amount of active pharmaceutical ingredient is too high?

  It could lead to toxicity or overdose
• What is impurity testing in pharmaceuticals?

  Detecting small amounts of impurities in medicines
• Why is it important to know the origin of impurities?

  To understand their effects on drug function
• What does Active Pharmaceutical Ingredient (API) mean?

  Drug substance that is pharmacologically active
• What are excipients in pharmaceuticals?

  Substances other than the active ingredient
• What is the purpose of excipients?

  To aid in drug administration and absorption
• What is formulation in pharmaceuticals?

  Turning a drug substance into a medicine
• What is a Drug Product (DP)?

  Fully formulated medicine in its packaging
• What are pharmaceutical ingredients?

  All API and excipients in drug manufacture
• What is the journey of a medicine from API to DP?

  • API: Starting materials, solvents, reagents
  • DP: Excipients, manufacturing equipment, packaging
  • Storage: Conditions affecting stability
• What can happen during API manufacture?

  By-products may form and impurities may exist
• What issues can arise during drug product manufacture?

  Contamination from equipment and excipients
• Why do we need to test for impurities in medicines?

  To detect small amounts of impurities that could be toxic or affect the drug's function
• What is the difference between qualitative and quantitative analysis?

  Qualitative analysis identifies the presence or absence of a substance, while quantitative analysis measures the amount of a substance
• What does the British Pharmacopoeia contain?

  Standards and specifications for medicines
• Why do we need the British Pharmacopoeia?

  To ensure medicines meet quality, safety and efficacy standards
• What are the potential consequences of a major failure in the production of a medicine?

  Potentially severe, as it could lead to the medicine causing harm to patients
• Why is assay testing (quantitative analysis) important?

  To ensure the correct amount of active pharmaceutical ingredient is present to effectively treat the patient without causing toxicity
• What is the difference between an active pharmaceutical ingredient (API) and an excipient?

  API is the pharmacologically active compound, while excipients are pharmacologically inert substances that facilitate administration of the API
• What is the purpose of the formulation process?

  To turn the drug substance into a medicine that can be administered to patients in a suitable form (e.g. tablet, capsule, syrup)
• What are the main sources of impurities in medicines?

  Starting materials, solvents, reagents, manufacturing equipment, and containers
• Why is it important to test for impurities in medicines?

  Because we do not know what effect the impurities may have on the drug's function or patient safety
• What are the main types of criminal activities related to medicines?

  Counterfeit drugs, selling expired drugs, and selling drugs with the wrong active ingredient
• Why is it important to test pharmaceutical raw materials according to pharmacopoeial standards?

  To ensure they meet the required quality specifications before being used to manufacture the final drug product
• What is the purpose of using a C18 column and gradient elution in HPLC analysis of medicines?

  The C18 column allows separation of compounds based on polarity, and gradient elution improves resolution compared to isocratic elution
• How do the aims of testing medicines differ from the aims of manufacturing medicines?

  The aims of testing are to produce a high-quality product, treat patients effectively, protect patients from harm, and maintain trust in the healthcare system, while the aims of manufacturing are to turn the drug substance into a suitable dosage form
• What are the key steps in the journey of a medicine from active pharmaceutical ingredient (API) to final drug product (DP)?

  • API manufacture:
  • Starting materials, solvents, reagents, catalysts
  • Manufacturing equipment (vessels, pumps, mills)
  • Containers (storage, reaction vessels)
  • DP manufacture:
  • Excipients
  • Manufacturing equipment (blending, tableting, etc.)
  • Packaging materials, containers
  • Storage:
  • At manufacturing site, during transport, at pharmacies/hospitals/patients' homes
  • Conditions: temperature, light, humidity
  • Stability testing for degradation