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Preface Introductiono Definition of a Drug * General Aspects of Drug Packaging: Containment, Protection, Other Essential FunctionsDrug Packaging vs. Food Packaging Major Trends in Drugs That Affect Packaging: Over-the-Counter Distribution, Liquids to Solids, Unit Dose Packaging, Administration Aids, Aging PopulationSize of the Drug Business in the U.S.: Overall Sales, Sales by Product Category, Relationship to Other Industries Drug Packaging Business: Materials, Packaging Types, Participants-Drug Manufacturers, Contract Manufacturers, Drug RepackagersManufacturers of Drug Packages and Packaging Materials: Flexible Packaging Converter, Rigid Packaging Converter Distributors of Packaged Drugs Drugs and Pharmaceuticals and Their Various Dosage Formso Stability: Moisture, Oxygen, Light, Prediction of Shelf Life, Packaging Needs Purity and Sterility: Packaging Needs Drug Physiology: Injection Route, Gastrointestinal Route, Transdermal Route, Inhalation and Nasal Routes, Rectal Route, Packaging Needs Dosage Forms: Solids, Liquids, Ointments, Transdermal Systems, Aerosols, SummaryRegulatory Environmento Food and Drug Administration: History Drug Approval Process-General Packaging Guidelines Current Good Manufacturing Practices (CGMP): Introduction, Summary of CGMP Applied to PackagingOther Packaging-Related Regulations in CFR: Packaging Antibiotics ValidationU.S. Pharmacopoeia: Introduction Drug Packaging in USP: Test Procedures and Requirements, Individual Drug MonographsDrug Packaging Materialso Glass: Composition and Manufacture, Types, Glass as a Drug Packaging Material Metal: Tinplate, Metals as DrugPackaging Materials Plastics: Plastics as DrugPackaging Materials, Plastics Materials-Their Nature and Manufacture Manufacture of Plastic Films: Overview, Film Manufacture, Composite Films, Permeability of Plastics Elastomeric Materials: Overview, General Description, Chemical Structure, Manufacture Future TrendsFabrication and Filling of Pharmaceutical Containerso Container Fabrication: Fabrication of Glass Containers, Blown Glass Containers, Annealing and Finishing, Fabrication of Metal Containers, Fabrication of Plastic Containers, Bottles and Vials, Blister and Strip Packages, Plastic Pouches, Bottles and Make-Fill-Seal Technology, Collapsible Plastic Tubes Container Filling and Sterilization: Container Filling, Filling Bottles and Jars, Filling with Solids, Filling with Liquids and Semisolids, Filling with Sterile Liquids, Filling Aerosol Containers, Sterile Packaging, Terminal Sterilization, Aseptic Packaging, Sterilization ValidationClosures for Pharmaceutical Packageso Closure by Adhesives or Heat Sealing Closure by Separate Devices: Closure Functions, Types of Separate Device Closures: Cans, Bottles and Jars, Closures for Tubes, Closure MaterialsClosure Liners: Structure and Materials Child-Resistant Closures: Poison-Prevention Packaging Act, Test Procedures, Designs, Recent Developments Tamper Evidence: FDA Regulations, Ease of OpeningLabels and Labellingo Legal Requirements: Prescription Drugs, Repackaging and Relabeling by Pharmacists and Physicians, Parenteral Preparations, OTC Drugs National Drug Code and Bar Coding Labels and the Labelling Process: Label Types, Self-Adhesive Labels, Heat Seal LabelsNoncontact Coding: Ink-Jet Printing, Laser Coding Inserts and Outserts Labelling Errors Drug Product Problem Reporting Program Label Legibility and UnderstandabilityPackages Used for Pharmaceuticalso Determinants in Selection or Design: Product Protection, USP Recommendations, Methods for Evaluating Package Protection, Results of Package Evaluations, Importance of Product Protection, Compatibility, Sorption, Leaching, Modification of Container, Importance of Compatibility, Regulations, Product Information, Product Image, Cost, Summary Packages for Solids: Bulk Packaging, Consumer and Pharmacy Packages Packages for Liquids: Bulk Packaging, Consumer and Pharmacy Packages Packages for Semisolids: Bulk Packages, Consumer/Pharmacy Packages Packages for Transdermal SystemsIssues in Modern Drug Packagingo Unit Dose Packaging: In Hospitals, In Retail Drug Distribution, Consumer, Pharmacist, Healthcare Providers, Drug Companies Green Packaging: Source Reduction, Recycling, Landfilling and Degradability GlossaryIndex<br/> |