05984pam a2200613 i 4500 AALScienceDirectebook000003 BD-DhAAL 20191205133250.0 m o d cr cnu|||unuuu 180730s2018 enk ob 001 0 eng d 41948 41948 GBB8C0857 bnb 018922633 Uk 0128144246 9780128144244 0128144238 9780128144237 (OCoLC)1046633728 (OCoLC)1047806807 BD-DhAAL RS200 MED 071000 bisacsh 615.19 23 Dosage form design considerations. Volume 1 / edited by Rakesh K. Tekade. [electronic resource] London, United Kingdom : Elsevier, [2018] 1 online resource. Advances in pharmaceutical product development and research series <strong>Off-Campus Access:</strong> Athens ID and Password Required <strong>On-Campus Access:</strong> No User ID or Password Required Includes bibliographical references and index. Front Cover; Dosage Form Design Considerations; Copyright Page; Dedication; Contents; List of Contributors; About the Editor; 1 Preformulation in Drug Research and Pharmaceutical Product Development; 1.1 Introduction; 1.1.1 An Overview of Formulation Life Cycle and Management; 1.1.2 Need of Preformulation: First Stage of Formulation Development; 1.1.3 Major Hurdles Impeding Successful Product Development; 1.1.4 Role of Preformulation During Product Development; 1.2 Parameters of preformulation studies; 1.2.1 Solubility; 1.2.2 The Permeability of the Drug 1.2.3 Bulk Characterization: Physical, Analytical, and Physicochemical1.2.4 Inherent Properties: pH, pKa, Log P, Log D, and Intrinsic Dissolution; 1.2.5 Stability: The Solution, Solid State, & ICH Photostability; 1.2.6 Drug-Excipient Compatibility; 1.2.7 Particle Size and Distribution; 1.2.8 Thermal Properties; 1.2.9 Hygroscopicity; 1.2.10 Bulk Properties; 1.2.11 Mechanical Properties and Compatibility; 1.2.12 Crystallinity and Polymorphism; 1.3 Role of preformulation in drug discovery; 1.3.1 Material Properties in Lead Selection, High Throughput Preformulation Studies 1.3.2 "Drugability" of New Chemical Entities1.3.3 Tools to Assist in Lead Selection; 1.4 Role of preformulation in drug development; 1.4.1 Identification of Challenges During Formulation Development: Pre-Assumptions; 1.4.2 The Dosage Form Specific Studies; 1.5 Preformulation studies of proteins and peptides; 1.6 Preformulation in vaccine development: Critical views; 1.7 Preformulation studies of packaging components; 1.8 Preformulation in 21st century: technological advancements; 1.8.1 Computerization and Aid of Software in the Preformulation Studies 1.8.2 Artificial Neural Network Tool Used in the Factorial Design: An Optimization Approach1.9 Case studies on preformulation of dosage forms; 1.10 Pharmacokinetics and preformulation: Point to note; 1.11 Rules and regulations in preformulation studies: Role of regulatory bodies; 1.12 Future remarks and conclusion; Acknowledgment; Abbreviations; References; Further Reading; 2 Physicochemical Aspects to Be Considered in Pharmaceutical Product Development; 2.1 Introduction; 2.2 Physical Characteristics of Solid Substances Used in Pharmaceutical Product Development 2.2.1 Crystalline Solid-State Substances2.2.1.1 Polymorphism; 2.2.1.2 Hydrates; 2.2.1.3 Solvates; 2.2.1.4 Cocrystals; 2.2.2 Amorphous Solids; 2.2.3 Particle Size; 2.2.4 Wettability; 2.2.5 Hygroscopicity; 2.3 Chemical Characteristics to be Considered in Pharmaceutical Product Development; 2.3.1 Degradation Reactions of Drugs; 2.3.1.1 Hydrolysis; 2.3.1.2 Dehydration; 2.3.1.3 Oxidation; 2.3.1.4 Photochemical Degradation; 2.3.1.5 Isomerization; 2.3.1.6 Polymerization; 2.3.1.7 Other Reactions; 2.4 Solubility Aspects in Pharmaceutical Products Development; 2.4.1 Aqueous Solubility Electronic access restricted to authorized BRAC University faculty, staff and students Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Mode of access: Internet Drug delivery systems. 37984 Drug development. 37985 Drugs Design. 37986 Drugs Dosage forms. 37987 Drug delivery systems. fast 37984 Drug development. fast 37985 Drugs Design. fast 37986 Drugs Dosage forms. fast 37987 MEDICAL / Pharmacology. bisacsh 37988 Electronic books. 37989 Tekade, Rakesh K., editor. 37990 Original 0128144238 9780128144237 (OCoLC)1007038271 Advances in pharmaceutical product development and research series. 37991 Full text available on ScienceDirect https://www.sciencedirect.com/science/book/9780128144237 ddc EBK 0 0 ddc 0 615_190000000000000_DOS 0 67371 BRACUL BRACUL 2019-12-05 0 615.19 DOS 2019-12-05 2019-12-05 EBK