Biopharmaceutics Applications in Drug Development

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1 Biopharmaceutics Applications in Drug Development Edited by Rajesh Krishna Merck & Co., Inc. Rahwav, NJ. USA and Lawrence Yu Center for Drug Evaluation & Research Rockville, MD, USA 4y Springer

2 Contents Contributors xxi 1 Introduction to Biopharmaceutics and its Role in Drug Development Introduction to Biopharmaceutics What is Biopharmaceutics? Physical Pharmacy: Physical-Chemical Principles Solubility Hydrophilicity/Lipophilicity Salt Forms and Polymorphs Stability Particle and Powder Properties Ionization and pata Formulation Principles Physiological/Biological Principles Pharmacokinetics Biopharmaceutics: Integration of Physical/Chemical and Biological/Pharmacokinetic Principles and Impact on Clinical Efficacy Introduction to the Biopharmaceutics Classification System Impact of Physical/Chemical Properties on Absorption and Transport Strategies to Achieve Target Pharmacokinetic Profile Role of Biopharmaceutics in Drug Development Importance of Biopharmaceutics in the Overall Development Process Discovery and Preclinical Development: Candidate Selection Preclinical Development: Preparation for Phase I Clinical Studies Early Clinical Development Advanced Clinical Development Postapproval Considerations 20

3 xii Contents Regulatory Considerations Summary 21 2 Molecular and Physicochemical Properties Impacting Oral Absorption of Drugs Introduction Molecular and Physicochemical Properties Impacting Oral Absorption Molecular Weight, Log P, the Number of H-Bond Donors and Acceptors, Polar Surface Area, and the Number of Rotatable Bonds Chirality Dissolution Solubility Definition of Solubility Factors Contributing to Poor Aqueous Solubility ph-solubility Profile Effect of Temperature on Solubility Solubility in Gastric and Intestinal Fluids Solubility as a Limiting Factor to Absorption Solubility Determination Solubility Prediction Chemical Stability Solid State Properties Polymorphism Amorphous Material Particle Size Physicochemical Properties and Drug Delivery Systems Summary 43 3 Dissolution Testing Introduction Significance of Dissolution in Drug Absorption Theories of Dissolution Factors Affecting Dissolution Factors Related to the Physicochemical Properties of the Drug Substance Solubility Particle Size Solid Phase Characteristics Salt Effects Factors Related to Drug Product Formulation Factors Related to Manufacturing Processes Factors Related to Dissolution Testing Conditions Roles of Dissolution Testing 55

4 Contents xiii 3.6 In Vitro Dissolution Testing as a Quality Control Tool Dissolution Method for Quality Control of Immediate-Release Dosage Forms Dissolution Media Apparatus and Test Conditions Dissolution Method for Quality Control of Modified-Release Dosage Forms Dissolution Media Apparatus and Test Conditions Limitations of Quality Control Dissolution Tests Biorelevant Dissolution Testing In Vivo-In Vitro Correlations The Importance of BCS on Biorelevant Dissolution Testing Biorelevant Dissolution Methods Biorelevant Dissolution Media for Gastric Conditions Apparatus and Test Conditions for Simulating the Stomach Biorelevant Dissolution Media for Intestinal Conditions Apparatus and Test Conditions for Simulating Small Intestine Biorelevant Methods for Extended-Release Dosage Forms Remaining Challenges Conclusions 70 Drug Absorption Principles Drug Absorption and Bioavailability Types of Intestinal Membrane Transport Passive Diffusion Carrier-Mediated Transport Facilitated Diffusion Active Transport Paracellular Transport Endocytosis Which Absorption Path Dominates Drug Absorption? Three Primary Factors Influence Drug Absorption Membrane Permeability Effective Permeability Fraction of Drug Absorbed Permeability and Absorption Rate Constant Solubility Dissolution of Solid Dosage Forms 83

5 xiv Contents 4.4 Secondary Factors Influencing Drug Absorption Biological Factors of Gastrio Intestinal Tract Gastric Emptying Time Surface Area GI Transit Time Intestinal Motility Components, Volume, and Properties of Gastrointestinal Fluids Food Blood Flow Age Dosage Factors Influencing Absorption Evaluation of Oral Drug Absorption in Humans Drug Absorption Assessment Using In Vivo Data Estimation of Fraction of Drug Absorbed Using Experimental Intestinal Permeability In Vivo Estimation of Maximum Absorbable Dose Using In Vivo Absorption Rate Constant and Drug Solubility Estimation of MAD from Drug In Vivo Permeability in Human and Drug Solubility Drug Absorption Assessment Using In Vitro Data In Vitro Testing Conditions for Determining Drug Permeability in Caco-2 Cells and In Vitro/In Vivo Permeability Correlation Estimation of Fraction of Drug Absorbed In Humans Using In Vitro Drug Permeability in Caco-2 Cells Estimation of MAD in Human Based on In Vitro Data Correlation of Oral Drug Bioavailability and Intestinal Permeability Between Rat and Human Summary 97 5 Evaluation of Permeability and P-glycoprotein Interactions: Industry Outlook Introduction Anatomy and Physiology of the Small Intestine Permeability Absorption Models Physicochemical Methods Lipophilicity (Log P/Log D) Absorption Potential Immobilized Artificial Membrane (IAM)

6 Contents xv In Vitro Methods Animal Tissue-Based Methods Cell-Based Methods In Situ Methods Ill In Vivo Methods In Silico Methods Comparison of PAMPA and Caco-2 Cells Parallel Artificial Membrane Permeability Assay PAMPA Study Protocol Caco-2 Cells Caco-2 Cell Culture Caco-2 cells Study Protocol PAMPA and Caco-2 Cell: Synergies PAMPA and Caco-2 Cell: Caveats Transporter- and Paracellular-Mediated Absorption Incomplete Mass-Balance Due to Nonspecific Binding Inadequate Aqueous Solubility Other Experimental Variability P-gp Studies Using Caco-2 Cells Experimental Factors Effecting Efflux Ratio Conclusions 132 Excipients as Absorption Enhancers Introduction Basic Mechanisms in Transcellular and Paracellular Transport Transcellular Transport Paracellular Transport Mechanisms of Action of Absorption Enhancers Action on the Mucus Layer Action on Membrane Components Mucoadhesive Polymers as Absorption Enhancers Theories of Mucoadhesion Material Properties of Mucoadhesives Classes of Mucoadhesive Polymers Polyacrylates Chitosan N,N,N,-Trimethyl Chitosan Hydrochloride (TMC) Monocarboxymethyl Chitosan Thiolated Polymers Solid Dosage Form Design Based on TMC and Thiolated Polymers and Their In Vivo Evaluation Conclusions 166

7 xvi Contents 7 Intestinal Transporters in Drug Absorption Introduction ' ATP Binding Cassette Transporters P-Glycoprotein(P-gp;ABCBl) The Expression of P-gp The Regulation of P-gp Expression P-gp Mediated Drug Transport The Substrate Specificity of P-gp Multidrug Resistance-Associated Protein Family (MRP;ABCC) The Expression of MRPs The Regulation of MRP Isoform Expression The Substrate Specificity of MRP's Breast Cancer Resistance Protein (BCRP; ABCG2) Solute Carrier Transporters Proton/Oligopeptide Transporters (POT; SLC15A) Peptide Transporter Mediated Transport The Substrate Specificity of Peptide Transporters The Regulation of Peptide Transporters Organic Anion Transporters (OAT, SLC22A; OATP, SLCO) OAT(SLC22A) OATP (SLCO) Organic Cation Transporters (OCT, OCTN; SLC22A) The Substrate Specificity of Organic Cation Transporters Organic Cation Transporter Mediated Transport The Expression of Organic Cation Transporters The Regulation of Organic Cation Transporters Nucleoside Transporters (CNT, SLC28A; ENT, SLC29A) The Molecular and Structural Characteristics of Nucleoside Transporters The Substrate Specificities of Nucleoside Transporters The Expression of Nucleoside Transporters The Regulation of Nucleoside Transporters Monocarboxylate Transporters (MCT; SLC16A) Molecular and Structural Characteristics of Monocarboxylate Transporters 222

8 Contents xvii The Substrate Specificity of Monocarboxylate Transporters The Expression of Monocarboxylate Transporters The Regulation of Monocarboxylate Transporters Impact of Intestinal Transporters on Bioavailability 225 Bioavailability and Bioequivalence Introduction Bioavailability and Bioequivalence Bioavailability and its Utility in Drug Development and Regulation Bioequivalence and its Utility in Drug Development and Regulation Bioavailability and Bioequivalence Studies: General Approaches Pharmacokinetic Bioavailability and Bioequivalence Studies Bioavailability Studies: General Guidelines and Recommendations Bioequivalence Studies: General Guidelines and Recommendations Study Design Dose Subjects Statistical Analysis of Bioequivalence Bioequivalence: Challenging Topics Drugs with Active Metabolites Enantiomers vs. Racemates Endogenous Substances Highly Variable Drugs Static Expansion of the BE Limits Expansion of Bioequivalence Limits Based on Fixed Sample Size Scaled Average Bioequivalence Biowaivers Solutions Lower Strength Biopharmaceutical Classification System Biowaivers for BCS Class 2 Drugs with ph Dependent Solubility Biowaivers for BCS Class 3 Drugs Locally Acting Drugs Topical Dermatological Products 281

9 xviii Contents Locally Acting Nasal and Oral Inhalation Drug Products Nasal Spray Products Oral Inhalation Products Conclusions A Biopharmaceutical Classification System Approach to Dissolution: Mechanisms and Strategies Introduction Biopharmaceutical Classification System Approach to Dissolution In Vitro-In Vivo Dissolution Correlation Recent Climate: Pharmaceutical Quality Assessment Discussion BCS Class I and III Case Studies Case Study 1: Fast Release (>85% Release in 15 min) with Disintegration Controlled Dissolution Case Study 2: <85% Release in 15 min with Disintegration/Erosion Controlled Dissolution Case Study 3: Dissolution Mechanism not Dependent on Disintegration/Erosion BCS Class II and IV Case Studies Case Study 4: Liquid Filled (True Solution) Capsules Case Studies 5, 6, and 7: Intrinsic Rate of Drug Solubilization Controlled Dissolution Case Studies 8 and 9: Mixed Contribution of Formulation Colligative Properties and Intrinsic Rate of Drug Solubilization Case Study 10: API with High Solubility at Gastric phs Controlled Release Dosage Form Case Study Pharmaceutical Quality Assessment Implications of Dissolution Conclusion Food Effects on Drug Bioavailability: Implications for New and Generic Drug Development Introduction Objectives Oral Bioavailability Defined How Food Can Affect Drug Bioavailability Food Interactions with Drug Substance 318

10 Contents xix Pharmacokinetic Parameters Used to Characterize Food Effects on Drug Bioavailability Prolonged Rate of Drug Absorption in the Presence offood Decreased Drug Absorption in the Presence of Food Overview Instability in Gastric Acids Physical or Chemical Binding with Food Components Increased First-Pass Metabolism and Clearance Increased Drug Absorption in the Presence of Food Inhibition of First-Pass Effect Physicochemical and Physiological Effects Effects of Bile Release Effects of Longer Gastric Residence Time Drug Absorption Unaffected by Food FDA Guidance for Industry on Characterizing Food Effects in Drug Development Objectives Recommended Designs for Food-Effect Bioavailability Studies Recommendations for Drug Product Labeling Food Interactions with Drug Product Introduction Issues with Modified-Release Drug Products: Potential for Dose-Dumping Issues with Modified-Release Drug Products: Formulation-Dependant Food Effects In Vitro Drug Release Predictive of Food Effects In Vitro Drug Release Profiles Not Predictive of Food Effects Implications for Development of Generic Modified-Release Drug Products Introduction Role of In Vivo Fed Bioequivalence Studies Implications for Development of Generic Immediate-Release Drug Products BCS Class I Drugs Label-Driven Criteria for Requesting Fed Bioequivalence Studies Recommendations for Designing Fed Bioequivalence Studies 330

11 xx Contents Food Effects and Generic Drug Product Labeling Sprinkle Studies in New and Generic Drug Product Development Sprinkle Studies in Development of New Modified-Release Capsules Sprinkle Studies in Development of Generic Modified-Release Capsules Example Summary and Conclusions In Vitro-In Vivo Correlation on Parenteral Dosage Forms IVIVC Definition Modified Release Parenteral Products Factors to Consider for Meaningful IVIVC Product Related Factors Factors Affecting In Vitro Release Accelerated In Vitro Release Testing Mathematical Models of In Vitro Drug Release Factors Affecting In Vivo Release In Vitro-In Vivo Correlation Microspheres Liposomes Emulsions Hydrogels, Implants Dendrimers In Vitro-In Vivo Correlation in Dosage Form Development: Case Studies Introduction IVIVC in Drug Product Development: A Four-Tier Approach Case Studies Tier 1 - Discovery and Early Preclinical Development: Assessing Developability and Formulation Principles Tier 2 - Preclinical Product Development: Selection of a Meaningful Dissolution Method Tier 3 - Full Development: Deconvolution of Human Pharmacokinetic Data and Comparison with In Vitro Dissolution Data Deconvolution and Convolution Tier 4: Application of IVIVC in LCM Conclusions 380 Index 383

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