Biopharmaceutics. Группа авторов

13.6 The Implication of Disease States on Gastrointestinal Physiology and Its Effect on Oral Drug Performance 13.7 Diseases that Affect the Gastrointestinal Tract 13.8 Infections in the Gastrointestinal Tract 13.9 Systemic Diseases that Alter GI Physiology and Function 13.10 Age‐related Influences on Gastrointestinal Tract Physiology and Function 13.11 Conclusion References

      20  14 Inhalation Biopharmaceutics 14.1 Introduction 14.2 Structure of the Lungs 14.3 Molecules, Inhalation Devices, Formulations 14.4 Inhaled Drug Delivery and Models for Studying Inhalation Biopharmaceutics 14.5 Bioequivalence and an Inhalation Bioclassification System 14.6 Conclusion References

      21  15 Biopharmaceutics of Injectable Formulations 15.1 Introduction 15.2 Subcutaneous Physiology and Absorption Mechanisms 15.3 Intramuscular Physiology and Absorption Mechanisms 15.4 In Vitro Performance and IVIVC 15.5 Bioequivalence of Injectable Formulations 15.6 Summary References

      22  16 Biopharmaceutics of Topical and Transdermal Formulations 16.1 Introduction 16.2 Skin Structure 16.3 Active Pharmaceutical Ingredient Properties 16.4 Topical and Transdermal Dosage Forms 16.5 Measurement of In Vitro Drug Release 16.6 Measurement of Skin Permeation 16.7 Bioequivalence Testing of Topical/Transdermal Products 16.8 Conclusions References

      23  17 Impact of the Microbiome on Oral Biopharmaceutics 17.1 Introduction 17.2 Microbiome Distribution in the GI Tract 17.3 Key Causes of Microbiome Variability 17.4 Microbiome Influence on Key GI Parameters 17.5 Enzymatic Degradation of Drugs by GI Microbiota 17.6 Exploitation of the GI Microbiome for Drug Delivery 17.7 Models of the GI Microbiome 17.8 Conclusion References

      24  Index

      25  End User License Agreement

      List of Tables

      1 Chapter 3Table 3.1 Solubility criteria as listed in the BP and USP.

      2 Chapter 4Table 4.1 Impact of dose and permeability on the target solubility for a candidat...Table 4.2 An overview of the four levels of biorelevant media that can simulate t...Table 4.3 Composition of commonly used simulated intestinal media: fasted state s...

      3 Chapter 5Table 5.1 Human intestinal transporters shown to be involved in the transport of ...

      4 Chapter 6Table 6.1 Example experimental setup within USP3 apparatus to mimic fasted state.Table 6.2 Overview of USP dissolution apparatus (ER = extended release; IR = imme...Table 6.3 Summary of USP compendial dissolution media.Table 6.4 Composition and physicochemical characteristics of FaSSGF.Table 6.5 Composition and physicochemical characteristics of three versions of F...Table 6.6 Composition and physicochemical characteristics of FeSSGF.Table 6.7 Composition and physicochemical characteristics of FeSSIF media publis...Table 6.8 Composition and physicochemical characteristics of simulated colonic f...

      5 Chapter 7Table 7.1 Summary of oral drug product design considerations during early develo...Table 7.2 Summary of the enabling technologies that can be applied to a compound...

      6 Chapter 8Table 8.1 Biopharmaceutics parameters and their cut‐off values guiding the devel...Table 8.2 Formulation strategies to improve oral drug absorption.

      7 Chapter 10Table 10.1 Potential relationships between dissolution and clinical performance, ...

      8 Chapter 11Table 11.1 The relative anatomical lengths and surface areas of various regions ...Table 11.2 Gastric fluid volumes reported in healthy subjects as determined by m...

      9 Chapter 12Table 12.1 Summary of key parameters within the DLM and the equations that relat...

      10 Chapter 13Table 13.1 Physiological changes during pregnancy and its effects on drug perfor...Table 13.2 Diabetes‐mellitus‐induced physiological, motor and sensory alteration...

      11 Chapter 15Table 15.1 Typical characteristics of common parenteral injection types.Table 15.2 IM and SC injection volumes in preclinical species.Table 15.3 Composition of ISF.

      12 Chapter 17Table 17.1 Changes in pharmacokinetics mediated