Kooperativer Bibliotheksverbund

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Format: 1 online resource (0 p.)

Edition: 1st ed.

ISBN: 0-12-801072-X

Note: Description based upon print version of record. , Front Cover -- Essential Chemistry for Formulators of Semisolid and Liquid Dosages -- Copyright -- CONTENTS -- PREFACE -- 1 - Introduction -- 2 - Surfactants, Lipids, and Surface Chemistry -- 2.1 INTRODUCTION -- 2.2 TYPES OF SURFACTANTS -- 2.2.1 Surfactant Micelles -- 2.2.2 Anionic Surfactants -- 2.2.3 Cationic Surfactants -- 2.2.4 Nonionic Surfactants -- 2.3 NATURAL SURFACTANTS -- 2.3.1 Lipids -- 2.4 THE ROLE OF SURFACTANTS IN PHARMACEUTICAL FORMULATIONS -- 2.4.1 Skin Penetration Enhancers -- 2.4.2 Emulsifying Agents -- 2.4.2.1 Hydrophile-Lipophile Balance (HLB) System -- 2.4.3 Aerosol Formulations -- 2.4.4 Surfactant Gels -- 2.5 SURFACE CHEMISTRY FOR PHARMACEUTICAL FORMULATIONS -- 2.5.1 Surface and Interfacial Tension -- 2.5.2 Contact Angle -- 2.6 CONCLUSION -- REFERENCES -- 3 - Drug Delivery Vehicles -- 3.1 INTRODUCTION -- 3.2 EMULSION DRUG DELIVERY SYSTEMS -- 3.3 LIPOSOME DRUG DELIVERY SYSTEMS -- 3.3.1 Methods of Making Liposomes -- 3.4 OTHER NANODRUG DELIVERY SYSTEMS -- 3.5 CONCLUSION -- REFERENCES -- 4 - Formulating Creams, Gels, Lotions, and Suspensions -- 4.1 INTRODUCTION -- 4.2 CREAMS AND LOTIONS -- 4.3 GELS, OINTMENTS, AND SUSPENSIONS -- 4.4 FORMULATING WITH LIPOSOMES -- 4.5 EXCIPIENTS -- 4.6 CONCLUSION -- REFERENCES -- 5 - Use of Polymers and Thickeners in Semisolid and Liquid Formulations -- BACKGROUND -- 5.1 POLYMERS AS STYLING AGENTS -- 5.2 POLYMERS AS CONDITIONING AGENTS -- 5.2.1 Cationic Polymers -- 5.2.2 Silicones -- 5.2.3 Proteins -- 5.3 POLYMERS AS PRESERVATIVES [3,4] -- 5.4 POLYMERS AS PENETRATION ENHANCERS -- 5.5 POLYMERS AS THICKENING AND SUSPENDING AGENTS [11] -- 5.5.1 Emulsions -- 5.5.2 Gels -- 5.5.2.1 Examples of Gelling Agents -- 5.5.3 Suspensions -- 5.5.3.1 Examples of Suspending Agents -- 5.6 CHARACTERISTICS OF COMMONLY USED THICKENING, GELLING, AND SUSPENDING AGENTS -- 5.6.1 Natural Hydrocolloids -- 5.6.1.1 Agar. , 5.6.1.2 Alginates -- 5.6.1.3 Carrageenan -- 5.6.1.4 Chitin and chitosan -- 5.6.1.5 Gelatin -- 5.6.1.6 Guar gum -- 5.6.1.7 Gum acacia/gum arabic -- 5.6.1.8 Locust bean gum -- 5.6.1.9 Pectin -- 5.6.1.10 Starch -- 5.6.1.11 Tragacanth -- 5.6.1.12 Xanthan Gum -- 5.6.2 Cellulose and Derivatives -- 5.6.2.1 Cellulose/Microcrystalline Cellulose (MCC) -- 5.6.3 Synthetic Polymers -- 5.6.4 Clays -- REFERENCES -- 6 - Aerosols and Nasal Sprays -- 6.1 AEROSOLS -- 6.1.1 Types of Formulation -- 6.1.2 Typical Aerosol Excipients -- 6.1.2.1 Examples of Uses and Effects of Aerosol Formulation Excipients -- 6.1.3 Propellants -- 6.1.3.1 Numerical Designations for Fluorinated Hydrocarbon Propellants -- 6.1.3.2 Chlorofluorocarbon (CFC) Propellants -- 6.1.3.3 Hydrochlorofluorocarbon (HCFC) and Hydrofluorocarbon (HFC) Propellants -- 6.1.3.4 Hydrocarbon Propellants -- 6.1.3.5 Compressed Gases -- 6.1.4 Particle Engineering and pMDIs -- 6.1.5 Manufacturing Process -- 6.2 NASAL SPRAYS -- 6.2.1 Types of Formulation -- 6.2.2 Typical Nasal Spray Excipients -- 6.2.2.1 Examples of Uses and Effects of Nasal Spray Formulation Excipients -- 6.2.3 Nasal Spray Devices -- 6.2.4 Manufacturing Process -- REFERENCES -- 7 - Preparation and Stability Testing -- 7.1 HOW FORMULATIONS ARE PUT TOGETHER -- 7.1.1 General Comments -- 7.1.2 Solutions -- 7.1.3 Suspensions -- 7.1.4 Ointments -- 7.1.5 Gels -- 7.1.6 Emulsions -- 7.2 MIXING SYSTEMS -- 7.3 QUALITY BY DESIGN (QBD) FOR FORMULATION AND PROCESS DEVELOPMENT -- 7.3.1 Example of QbD Formulation Development [3] -- 7.3.1.1 Preformulation -- 7.3.1.2 Formulation Development -- 7.3.1.3 Preliminary Risk Assessment -- 7.3.1.4 Stress Testing Assessment -- 7.3.1.5 Formulation Modifications -- 7.3.1.6 Informal Stability Testing -- 7.4 STABILITY TESTING -- 7.4.1 Examples of Physical Instability -- 7.4.2 Examples of Chemical Instability. , 7.4.3 Examples of Biological Instability -- 7.4.4 Examples of Microbiological Instability -- 7.4.5 Stress Testing -- 7.4.5.1 Stress Conditions -- 7.4.6 Informal Stability Testing -- 7.4.7 Formal Stability Testing-ICH Guidelines -- 7.4.7.1 Testing Frequency (ICH Q1A(R2) [1]) -- 7.4.7.2 Storage Conditions (ICH Q1A(R2) [1]) -- 7.4.7.3 Short-term Excursions Outside the Label Storage Condition -- REFERENCES -- 8 - Particle Size Analysis: An Overview of Commonly Applied Methods for Drug Materials and Products -- 8.1 INTRODUCTION -- 8.2 LASER DIFFRACTION -- 8.2.1 Development and Validation of Laser Diffraction Particle-Size Methods -- 8.2.2 Method Development and Validation -- 8.2.3 Concerns about Laser Diffraction Technique -- 8.3 PARTICLE SIZE EVALUATION BY MICROSCOPY -- 8.4 CONCLUSION -- REFERENCES -- 9 - Rheological Studies -- 9.1 GENERAL TERMS AND DEFINITIONS [3] -- 9.2 INSTRUMENTS AND MEASURING GEOMETRIES -- 9.2.1 Glass Capillary Viscometers -- 9.2.2 Rotational Instruments [3] -- 9.2.2.1 Rotational Viscometers [5] -- 9.2.2.2 Rotational Rheometers -- 9.2.3 Measuring Geometries [5] -- 9.3 MATERIAL BEHAVIOR -- 9.3.1 Newtonian Fluids -- 9.3.2 Non-Newtonian Fluids -- 9.3.3 Zero-Shear Viscosity -- 9.3.4 Yield Stress Testing [9] -- 9.3.5 Factors Affecting Rheological Measurements -- 9.3.6 Characteristics of Dispersions and Emulsions [5] -- 9.4 RHEOLOGICAL STUDIES -- 9.4.1 Viscosity -- 9.4.2 Flow -- 9.4.3 Creep [11,12] -- 9.4.4 Oscillation -- 9.5 PRACTICAL APPLICATION OF RHEOLOGICAL DATA -- 9.5.1 Reported Examples -- REFERENCES -- 10 - Microscopy Techniques -- 10.1 INTRODUCTION -- 10.2 OPTICAL MICROSCOPY -- 10.2.1 Particle Size Testing -- 10.2.2 Morphology -- 10.2.3 Thermal or Hot-Stage Microscopy -- 10.2.4 Evaluation of Particulate Matter -- 10.2.5 Evaluation of Foreign Particulate Matter -- 10.2.6 Evaluation of Material Compatibility. , 10.2.7 Testing of Tablets -- 10.2.8 Ingredient-Specific Particle Sizing -- 10.2.9 Fourier-Transform Infrared Microscopy -- 10.3 SCANNING ELECTRON MICROSCOPY -- 10.4 TRANSMISSION ELECTRON MICROSCOPY -- 10.5 ATOMIC FORCE MICROSCOPY -- 10.6 CONCLUSION -- REFERENCES -- 11 - Miscellaneous Physical, Chemical, and Microbiological Test Methods -- 11.1 GENERAL PHYSICAL TESTS -- 11.1.1 Description/Appearance -- 11.1.2 Color -- 11.1.3 pH (US Pharmacopeia [USP]< -- 791> -- ) -- 11.1.4 Osmolality (USP< -- 785> -- ) -- 11.1.5 Viscosity (USP< -- 911> -- , < -- 912> -- , < -- 913> -- ) -- 11.1.6 Rheology (USP< -- 912> -- ) -- 11.1.7 Specific Gravity (USP< -- 841> -- ) -- 11.1.8 Net Content/Minimum Fill (USP< -- 755> -- ) -- 11.1.9 Particle Size Distribution -- 11.1.10 Particulate Matter (USP< -- 788> -- , < -- 789> -- ) -- 11.1.11 Weight Loss -- 11.1.12 Container Closure Integrity -- 11.1.13 Temperature Cycling and Freeze/Thaw -- 11.1.14 Photostability -- 11.1.15 Conductivity -- 11.1.16 Microscopy -- 11.1.17 In Vitro Release Testing -- 11.1.18 Transit Trials -- 11.1.19 Differential Scanning Calorimetry/Thermal Analysis (USP< -- 891> -- ) -- 11.2 GENERAL CHEMICAL TESTS -- 11.2.1 Identification Test -- 11.2.2 Assays for Active Ingredient, Degradants, and Impurities -- 11.2.3 Preservative and Other Chemical Assays -- 11.2.4 Content Uniformity -- 11.2.5 Extractables/Leachables -- 11.3 GENERAL MICROBIOLOGICAL TESTS -- 11.3.1 Microbial-Limits Testing -- 11.3.2 Antimicrobial Effectiveness Testing -- 11.3.3 Sterility Testing -- 11.3.4 Endotoxin Testing (USP< -- 85> -- ) -- 11.4 PRODUCT-SPECIFIC TESTS -- 11.4.1 Tests Performed on Metered Dose Nasal Sprays and Pressurized Aerosols (e.g., pMDIs) -- Sublingual Sprays [17] -- 11.4.1.1 Spray Pattern -- 11.4.1.2 Plume Geometry. , 11.4.1.3 Spray Content Uniformity/Delivered Dose Uniformity (USP< -- 601> -- ) -- 11.4.1.4 Droplet Size Distribution -- 11.4.1.5 Dose Weight -- 11.4.1.6 Priming/Repriming -- 11.4.1.7 Number of Doses -- 11.4.1.8 Tail-Off Characteristics -- 11.4.2 Tests Performed on Pressurized Aerosols Fitted with Continuous Valves (e.g., Topical Aerosols) (USP< -- 601> -- ) -- 11.4.2.1 Container Pressure -- 11.4.2.2 Delivery Rate/Delivered Amount -- 11.4.2.3 Leakage Test -- 11.4.3 Aerodynamic Size Distribution -- 11.4.4 Stress Tests (Section 7.4.5.1) -- 11.4.4.1 Centrifugation -- 11.4.4.2 Wick Test -- 11.4.5 Drop Weight -- 11.4.6 Resuspendability -- 11.4.7 Penetration -- 11.4.8 Drop Point/Congealing Temperature -- 11.4.9 Metal Particles -- REFERENCES -- 12 - An Overview of Regulatory Aspects for Pharmaceutical Semisolid Dosages -- 12.1 QUALITY DATA [1] -- 12.1.1 Stability -- 12.1.2 Analytical Validation -- 12.1.3 Impurities -- 12.1.4 Biotechnological Products -- 12.1.5 Specifications -- 12.1.6 Pharmaceutical Development -- 12.1.7 Quality Risk Management -- 12.2 TYPES OF REGULATORY SUBMISSIONS -- 12.3 RESOURCES-ICH -- 12.3.1 Quality Guidelines Relating to Drug Products -- 12.3.2 Other Quality Guidelines -- 12.3.3 Safety Guidelines -- 12.3.4 Efficacy Guidelines -- 12.3.5 Multidisciplinary Guidelines -- 12.4 RESOURCES-FDA -- 12.5 RESOURCES-WHO -- REFERENCES -- INDEX -- A -- B -- C -- D -- E -- F -- G -- H -- I -- J -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W -- X -- Z -- Back Cover. , English

Additional Edition: ISBN 0-12-801024-X

Language: English