Quantitative and Qualitative Determination Technologies of Counterfeit Drugs

Description

Drugs are often counterfeited to reduce manufacture costs, while still marketing it at as an authentic product. Increased incidence of drug counterfeiting is most noticeable in developing countries, which may not have the resources to supply counterfeit detection devices on a large scale. It is important to consider the problems caused and to propose options for controlling and reducing the prevalence of counterfeit medications. Various technologies are needed to identify the chemical properties of a questioned medicinal product, which can then be used to determine its authenticity. This volume focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. Features • Focuses on current technological approaches that are able to detect counterfeited pharmaceuticals. • Assesses the chemical methods of identifying counterfeit medicinal products and explains the theoretical underpinnings of the methods. • Provides case study type examples of the application for analysis of suspected counterfeit pharmaceuticals. • Discusses the detection and analysis of counterfeit drugs, and appropriate tools for combating this issue. • The editor draws on his experience as a respected chemist and prolific author in the field to provide this unique text on drug counterfeiting detection. Cover Half Title Series Information Title Page Copyright Page Table of Contents Preface Editor List of Contributors 1 Screening for Bad-Quality Pharmaceuticals in Field Settings 1.1 Introduction 1.1.1 Scope and Scale of the Problem 1.1.2 Who Defines Quality? 1.1.3 What Do Regulators in LMICs Do to Help Catch SFPs? 1.1.4 What Is Field Screening? 1.1.5 How Does Field Screening Help Solve the Problem of SFPs? 1.2 What Can Go Wrong With Pharmaceuticals? 1.2.1 Pharmaceuticals Can Be Badly Made 1.2.2 Pharmaceuticals Can Be Badly Packaged Or Transported and Stored in Ways That Cause Degradation of Quality 1.2.3 Pharmaceuticals Can Be Dispensed Badly 1.2.4 The Manufacturer Can Be Unresponsive 1.3 Instrument-Free Field Screening Technologies 1.3.1 What Analytical Metrics Are Appropriate for Field Screening Technologies? 1.3.2 Packaging Inspection 1.3.3 Glassware-Based Field Color Tests 1.3.4 Thin-Layer Chromatography 1.3.5 Merck-GPHF MinilabTM 1.3.6 Disintegration/Dissolution Testing 1.3.7 Lateral Flow Immunoassay Strips 1.3.8 Paper Microfluidics: the Paper Analytical Device (PAD) 1.3.8.1 How the PAD Works 1.3.8.2 Test Development 1.3.8.3 Making PADs 1.3.8.4 Data Analytics for the PAD 1.4 An Implementation Case Study: Paper Analytical Device (PAD) 1.5 Who Tests the Tests? 1.5.1 LOMWRU Multiphase Review 1.5.2 USP Technology Review Program 1.6 Conclusion References 2 HPLC for Analysis of Substandard and Falsified Medicinal Products 2.1 Introduction 2.2 Falsified Medicines 2.2.1 Illegal Preparations Containing Small Molecules 2.2.1.1 Characterization of Suspected APIs 2.2.1.2 Characterization of Suspected Finished Products 2.2.2 Illegal Preparations Containing Macromolecules 2.2.2.1 Protein Or Peptide 2.2.2.2 Use of LC-MS for the Identification of Illegal Peptide Drugs 2.2.2.3 Use of LC-MS in the Identification of Illegal Protein Drugs 2.2.2.4 Quantification of Polypeptide Drugs By Means of Chromatography 2.3 Regulated and Toxic Plants in Traditional Medicinal Products and Plant Food Supplements 2.4 Conclusion References 3 Tackling a Global Crisis: A Review of the Efficacy of LC-MS 3.1 Introduction 3.2 Chromatography Coupled With Mass Spectrometry 3.3 Counterfeit Drugs for Pathogenic Diseases 3.4 Counterfeit Drugs for Erectile Dysfunction 3.5 Counterfeit Drugs for Steroids 3.6 Counterfeit Drugs for Obesity 3.7 Concerning Counterfeit Drugs With Detrimental Effects 3.8 Conclusion References 4 Analyzing Counterfeit and Falsified Herbal Products With GC/MS 4.1 Introduction 4.2 Adulteration of Herbal Drugs 4.2.1 Reasons for Adulteration 4.2.2 Various Methods of Adulteration of Herbal Drugs 4.3 Types of Analysis for Authentication Identification 4.3.1 Detection of Active Pharmaceutical Ingredients in Counterfeit Herbal Drugs 4.3.2 Sample Preparation Prior to Analytical Toxicology Process 4.3.2.1 Microextraction Techniques 4.3.2.2 Liquid Phase Extraction (LPE) 4.3.2.3 Pressurized Liquid Extraction (PLE) 4.3.2.4 Dispersive Liquid-Liquid Microextraction (DLLME) 4.3.2.5 Ultrasonic Assisted Extraction 4.3.2.6 Microwave Assisted Extraction (MAE) 4.3.2.7 Dispersive Liquid-Liquid Microextraction (DLLME) 4.3.2.8 Hollow Fiber-Based Liquid-Phase Microextraction 4.3.2.9 Solid Phase Extraction (SPE) 4.3.2.10 Solid Phase Microextraction (SPME) 4.3.2.11 Dispersive Solid-Phase Extraction (d-SPE) 4.3.2.12 QuEChERS 4.3.3 Instrumental Methods for Undeclared Drug Detection in Counterfeit Herbal Drugs 4.3.3.1 Spectrophotometric Techniques 4.3.3.2 Chromatographic Techniques 4.3.3.2.4 Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) 4.4 Gas Chromatography/Mass Spectrometry for Counterfeit Herbal Drugs Detection 4.5 Comparing GC/MS and HPLC in the Analysis of Counterfeit Herbal Drugs 4.6 Necessity for Method Validation in Counterfeit Drug Analysis 4.6.1 Method Validation 4.6.1.1 Selectivity 4.6.1.2 Accuracy 4.6.1.3 Precision 4.6.1.4 Limit of Detection (LOD) 4.6.1.5 Limit of Quantification (LOQ) 4.6.1.6 Linearity 4.6.1.7 Recovery of Extraction Efficiency 4.7 Conclusion References 5 Applications of UV-Vis Spectroscopy in Counterfeit Medications 5.1 Introduction 5.2 Ultraviolet Visible Spectroscopy 5.3 Quantitative UV-Vis 5.4 Qualitative UV-Vis 5.5 Conclusion References 6 IR Spectroscopic Analytical Tools in the Fight Against Counterfeit Medicines 6.1 Introduction 6.2 Fundamentals of Infrared Spectroscopy 6.2.1 Near-Infrared Spectroscopy 6.2.2 Mid-Infrared Spectroscopy 6.2.2.1 Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy 6.2.3 Comparison of NIR and ATR-FTIR Spectroscopy 6.3 Chemometric Approaches Used in Combination With IR Spectroscopy 6.3.1 Data Pre-Processing 6.3.2 Unsupervised Methods 6.3.2.1 Principal Component Analysis 6.3.3 Supervised Methods 6.3.3.1 Linear Discriminant Analysis 6.3.3.2 Soft Independent Modelling of Class Analogies 6.3.3.3 Data Driven-Soft Independent Modelling of Class Analogies 6.3.3.4 Partial Least Squares-Discriminant Analysis 6.3.3.5 K-Nearest Neighbour 6.3.3.6 Classification and Regression Tree 6.3.4 Regression Methods 6.3.4.1 Principal Component Regression 6.3.4.2 Partial Least Squares Regression 6.4 Applications of IR Techniques for the Detection of Counterfeit and Substandard Medicines 6.4.1 Near-Infrared Spectroscopy Applications 6.4.2 Mid-Infrared Spectroscopy Applications 6.5 Conclusion 6.6 In Memoriam: Dr Graham Lawson 6.7 Acknowledgments References 7 Using NMR Spectroscopy to Analyze Counterfeit Medications 7.1 Introduction 7.2 Nuclear Magnetic Resonance (NMR) 7.3 Quantitative NMR 7.4 Qualitative NMR 7.5 Conclusion References Index