Introduction to Pharmaceutical Analysis

Introduction to Pharmaceutical Analysis

• Pharmaceutical research and development often takes 12 years and costs around £500 million.

• A drug's journey from research and development to market launch involves numerous stages:

  • Library screening
  • Hit to lead stage
  • Lead to candidate stage
  • Candidate selection
  • Clinical trials (Phase I to III)
  • File and launch

Research & Development

• Analytical techniques are critical in each stage of pharmaceutical research and development.

• Analytical techniques evaluate the structure, purity, stability and properties of compounds:

  • Are the structures correctly identified?
  • How stable are the compounds over time?
  • Analysis of degradation products to understand mechanisms of degradation

Obtaining a Marketing Authorization

• A product license is required for all drugs, and it is a comprehensive documentation containing:
  • Clinical evidence demonstrating the drug's effectiveness and safety
  • Description of the manufacturing process
  • Data from studies supporting the quality, purity and shelf life of the drug

Manufacture Authorization

• All pharmaceutical companies require manufacture authorization.
• This ensures only authorized manufacturers produce licensed products.
• Authorities conduct regular inspections to ensure compliance with good manufacturing practices (GMP), quality assurance (QA), good laboratory practices (GLP), and quality control (QC).

Pharmacopoeias

• Published standards (monographs) for pharmaceutical products and raw materials.
• Examples:
  • European Pharmacopoeia (Ph.Eur.)
  • United States Pharmacopoeia (USP)
  • British Pharmacopoeia (BP)

Pharmacopoeia Guidelines

• Outline requirements for:
  • Purity of raw materials (standards)
  • Methods for controlling raw materials
  • Pharmaceutical formulations (dosage forms)
  • Finished preparations (e.g., vaccines)

Questions regarding Marketed Drugs

• Analytical techniques evaluate:
  • Quality of each batch
  • Continuity of supply
  • Patent protection
  • Counterfeiting
  • Customer complaints regarding quality or effectiveness
  • Patient safety concerns

Counterfeiting – Key facts

• Counterfeit medicine is deliberately mislabeled with respect to identity or source.
• Counterfeiting can lead:
  • Treatment failure
  • Death
  • Erosion of public confidence in healthcare systems
• Both generic and branded medicines are subject to counterfeiting.
• All kinds of drugs have been counterfeited.

Counterfeiting – Mislabeling

• Counterfeiting can involve:
  • Use of correct ingredients, wrong ingredients, or no active ingredients
  • Insufficient or excessive active ingredients
  • Fake packaging

Counterfeit Drug Examples

• Avastin (cancer treatment):

  • Counterfeit batches lacked the active ingredient

• Alli (weight-loss medicine):

  • Counterfeit batches were smuggled and contained undeclared active ingredients
  • These undeclared ingredients posed serious health risks to consumers

Identifying Counterfeit Drugs

• Package and appearance help to identify counterfeit drugs:
  • Misspelling or missing LOT codes
  • Irregular expiration dates
  • Incorrect pill color or markings
  • Presence of powder instead of pellets in capsules

Analysis Techniques for Counterfeiting

• Visual Inspection: Analyzing packaging and tablets with microscopes.

• Chemical Analysis:

  • Identifies the presence/absence of active pharmaceutical ingredients using:
    • Mass spectrometry (MS)
    • Nuclear magnetic resonance (NMR)
    • Infrared spectroscopy (IR)
  • Identifies excipients in formulations using:
    • MS, NMR, IR
  • Elemental mapping on tablet surfaces

• Physical Analysis:

  • Measures particle size.

This quiz covers the essential aspects of pharmaceutical analysis in drug development. Delve into the stages of research and development and understand the analytical techniques critical for ensuring drug efficacy and safety. Learn about the importance of marketing authorization in bringing drugs to market.