Medicines 1 - Tools in Analysis of Drugs and Medicines (Basic ppt) (2)

Medicines Quality

  • Importance of Quality Control: Essential in modern industrial processes.

  • Types of Analysis:

    • Chemical

    • Physical

    • Microbiological

  • Key Point: Ensure the quality of the analysis meets required standards.

Applications of Analysis

  • Bioanalysis

  • Dosage Form Attribute Testing

  • Drug Isolation

  • Quality Testing

  • Drug Identification

  • Drug Characterization

  • Stability Testing

  • Compatibility Testing

Example of Scientific Tools in R&D

  • Techniques:

    • Microscopy

    • ELISA

    • Flow Cytometry

    • Electrophysiology

    • Bioassay

    • Molecular Diagnostics

    • Biospecific Interactions

    • Proteomics

    • Bacterial & Mammalian Cell Culture

    • Pre-Clinical Animal Models

Analysis of Drugs in Blood

  • Key Terms:

    • Cmax: Maximum concentration

    • Elimination Phase (T1/2)

    • AUC: Area Under Curve

Preformulation

  • Definition: Stage before formal formulation in drug development

  • Derived Properties and Techniques:

    • Melting Point: DSC

    • Solubility: UV

    • Physical Forms (Polymorphs): DSC, XRPD

    • pK: UV

    • Particle Size and Shape: Microscopy, Titration, BET

    • Density, Flow, and Compressibility Testing

Quality Testing

  • Quality Assurance (QA) and Quality Control (QC):

    • Follow standard procedures to ensure quality, safety, and effectiveness of drug products.

  • Specifications: List of tests and acceptance criteria for drug substance and product quality.

  • Example Tests: Stability, Impurities, Residual solvents

Dosage Form Testing (Examples)

  • Tablets:

    • Disintegration Testing

    • Friability

    • Hardness

    • Dissolution Testing

  • Creams: Rheology Testing

Summary of Analysis in Pharmaceutical Science

  • Key Questions Addressed by Pharmaceutical Analysis:

    • Identity of the drug?

    • Percentage of stated content?

    • Stability and shelf-life of the formulation?

    • Rate of drug release?

    • Purity of drug and excipients?

  • Concentration Measurements: In biological samples

Types of Analysis

  • Qualitative Analysis: Determines the nature of chemical constituents

  • Quantitative Analysis: Determines amounts and proportions of constituents

Validation of Analytical Procedures

  • Accuracy: Closeness to true value

  • Precision: Closeness of measurements to each other

  • Levels of Precision: Repeatability, Intermediate Precision, Reproducibility

Factors Leading to Inaccuracy and Imprecision

  • Incorrect weighing

  • Inefficient extraction

  • Poor volume measurement technique

  • Improperly calibrated instruments

  • Unregulated assay conditions

Case Study: Analysis of Paracetamol Tablets

  • Examples of Errors:

    • Random vs. Systematic

    • Different students show varying levels of accuracy and precision in testing

Common Terminologies

  • Analytical Blank

  • Calibration

  • Limit of Detection

  • Limit of Quantification

  • Linearity

  • Range

  • Robustness

  • Selectivity

  • Sensitivity

Titrimetric and Chemical Analysis Methods

  • Principle: Reaction with known concentration reagent

  • Applications: Drug assays, solvent testing

  • Strengths: High precision, cost-efficient

  • Limitations: Requires skilled operators

Spectroscopy

  • Definition: Study of interaction between electromagnetic radiation (EMR) and molecules

UV and Visible Spectroscopy

  • Principle: Radiation passed through a solution causing electron excitation

  • Applications: Quantification of various drug properties

  • Strengths: Easy, low-cost, robust

  • Limitations: Moderate selectivity

Instrumentation and Case Drug Example: Aspirin

  • Monitoring Hydrolysis: Absorbance measurements related to aspirin degradation

IR Spectrometry: Principles and Applications

  • Definition: Absorption of EMR by molecular bonds

  • Applications: Preliminary compound identification, impurity detection

  • Strengths and Limitations: Specific fingerprinting

Other Spectroscopic Techniques

  • Types:

    • Atomic Absorption

    • Fluorescence

    • Raman Spectroscopy

    • Nuclear Magnetic Resonance

Mass Spectrometry

  • Principle: Ionization of analytes and mass-to-charge ratio analysis

  • Applications: Drug identification and characterization

  • Limitations: High cost, requires skilled operators

Chromatography in Pharmaceutical Analysis

  • Definition: Separation technique based on partitioning between phases

  • Types of Chromatography:

    • Column

    • Thin Layer

    • Gas

    • High Pressure Liquid

High Performance Liquid Chromatography (HPLC)

  • Principle: Pumping liquid phase through stationary phase column

  • Applications: Reliable for drug quantification

  • Strengths and Limitations: High precision but key requirements for sample preparation

Chromatography in Drug Purification

  • Process Overview: Sequence of processes for isolating proteins

Other Tools in Drug Analysis

  • Gravimetric Analysis: Substance isolation via precipitation and weighing

  • Electroanalytical Techniques: Measurement of current or potential

Bioanalytical Techniques

  • Definition: Application of biological sciences for analysis

  • Industries: Forensics, Pharmaceutical R&D, Drug Monitoring, Food Science

Immunoassays

  • Definition: Uses antibody-antigen reactions for analysis of drugs and biomolecules

Molecular Diagnostics

  • Technology Platforms for pharmacogenomic diagnostic assays

Bioanalysis Overview

  • Focus: Quantitative measurement of drugs and metabolites in biological systems

Pretreatment in Analysis

  • Definition: Analyte removal from complex matrices prior to analysis

  • Common Methods: Solvent extraction, solid phase extraction