Pharmaceutical Technology - Concepts and Applications

Description

Cover Contents Preface Contributors Chapter 1 : Preformulation Introduction Goals of Preformulation Preliminary Evaluation Major Areas of Preformulation Research Organoleptic Properties Color Odor and Taste Purity Particle Size, Shape and Surface Area Drawbacks of Grinding Methods for Determining Particle Size Preformulation Testing Solubilization Factors Affecting Solubilization Applications of Solubilization Methods of Solubilization Solid Dispersion System Types of Solid Dispersions Compound or Complex Formations Combinations and Miscellaneous Mechanisms Methods of Preparation Methods of Determination of Types of Solid Dispersion Systems Pharmaceutical Applications Dissolution Beta-Cyclodextrin Drug Dispersion System Applications Chemistry of Cyclodextrins Pharmaceutically Useful Beta-cyclodextrin Derivatives Advantages of Beta-cyclodextrins Methods of Preparation of Beta-cyclodextrin Complex Preformulation Stability Studies Types of Stability Studies Types of Stability Crystallinity and Polymorphism Techniques for Investigation of the Solid State Physico-chemical Properties of Drug Molecule of Different Dosage Forms Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 2 : Polymer Science Historical Background Clasification of Polymers Homopolymers and Copolymers Random Copolymers, Graft Copolymers and Block Copolymers Linear, Branched and Cross-linked Polymers Thermoplastics, Thermosets and Elastomers Natural, Semisynthetic and Synthetic Polymers Plastics, Elastomers, Fibers and Liquid Resins Biodegradable and Nonbiodegradable Polymers Polymer Synthesis Addition Polymerization Condensation Polymerization Cross-linking of Polymers Polymer Degradation — Steps and Types Types of Polymer Degradation Polymer Characterization and Techniques Used Molecular Weight Determination Thermal Analysis Mechanical Properties Morphology Polymers for Drug Delivery Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 3 : Packaging Technology Classification of Packaging Materials Paper and Board-based Packaging Materials (Ancillary Materials) Cartons Corrugated Boards Glass Containers Plastic Containers Drug–Plastic Considerations Metal Containers Closures and Closure Systems Rubber Plastic Metal Cork Glass Types of Closures Tamper-Resistant Packaging Labeling Pharmaceutical Labels Evaluation of Containers Testing of Glass Containers Testing of Plastic Containers Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 4 : Production Management Introduction Pharmaceutical Manufacturing Facilities Chemical Weighing Tablet Department Tablet Granulation Tablet Compression Tablet Presses Tablet Coating Liquid Department Manufacturing of Liquids Packaging Warehousing Shipping and Receiving Productivity Reasons to Increase Productivity Methods to Increase Productivity Economic Growth and Productivity Processes that Create and Distribute Productivity Production Systems International Organization for Standardization ISO 9000 Series Advantages of ISO 9000 Series Limitations of the ISO System Elements of ISO 9000 Series Types of ISO 9000 Series Types of ISO 14000 Series Benefits of ISO 14000 Series Total Quality Management Total Quality Management (TQM) Quality Assurance Principles of Quality Assurance Quality Assurance System Organization Functions of Quality Assurance Department Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 5 : Pilot Plant Scale-up Techniques Introduction Focus of Pilot Plant Scale-up Studies Requirements for Pilot Plant Scale-up Technique Personnel Requirements Space Requirements Responsibility of Pilot Plant Group Validation of Raw Materials Review of the Formula Selection of Relevant Processing Equipments Process Evaluation Production Rates Preparation of Master Manufacturing Procedures Analytical Method Development Pilot Plant Scale-up of Solid Dosage Forms Material Handling Dry Blending/Mixing Granulation Drying Reduction of Particle Size Blending Granulation Handling and Feed System Compression Pilot Plant Scale-up of Liquid Dosage Forms Solutions Suspensions Emulsions Pilot Plant Scale-up of Semisolid Dosage Forms Semisolid Dosage Form Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 6 : Novel Drug Delivery Systems I — Oral Controlled Drug Delivery System Introduction Advantages of Conventional Oral Route Disadvantages of Conventional Oral Route Design of Oral Controlled-Release Drug Delivery Systems Applications of Controlled-Release Dosage Forms Limitations of Controlled-Release Dosage Forms Terminologies Factors to be Considered in the Design of Controlled-Release Factors Affecting the Design of Controlled-Release Dosage Forms Physicochemical Properties Biological Properties Polymers in Controlled Drug Delivery Factors Affecting the Selection of Polymers Models of Oral Controlled Drug Delivery Systems Dissolution Controlled-Release Systems Diffusion Controlled-Release Systems Dissolution and Diffusion Controlled-Release Systems Osmotic Controlled Drug Delivery Systems Gastroretentive Drug Delivery Systems Ion Exchange Resins as Controlled-Release Systems pH Independent Systems Latest Technologies Related to Sustained or Controlled Dosage Forms Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences II — Transdermal Drug Delivery System Introduction Advantages of Transdermal Drug Delivery Systems Disadvantages of Transdermal Drug Delivery Systems Physiology of the Skin Components of the Stratum Corneum Concepts of Skin Permeation and Drug Absorption Drug Absorption across Human Skin Kinetics of Transdermal Permeation Factors Affecting Transdermal Permeability Biological Factors Physiological and Pathological Conditions of Skin Physicochemical Nature of the Drug Physicochemical Property of Drug Delivery System Formulation Considerations in the Development of Transdermal Drug Delivery Systems Drug Polymer Matrix Permeation Enhancers Other Excipients Manufacture of Transdermal Patches Circular Teflon Mold Method Mercury Substrate Method Using ‘EVAC Membranes’ Method Aluminum-backed Adhesive Film Method Using Proliposomes Approaches to Transdermal Therapeutic Systems Adhesive Dispersion Controlled System Matrix Dispersion-type System Microreservoir System Evaluation Studies of Transdermal Therapeutic Systems Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences III — Buccal Drug Delivery System Introduction Advantages of Buccal Drug Delivery System Limitations of Buccal Drug Administration Mucosal Membrane Model Epithelium Basement Membrane Connective Tissues Types of Oral Mucosa Pathways of Drug Absorption Mucoadhesive Materials Factors Affecting Mucoadhesion Formulation Consideration of Buccal Drug Delivery System Physiological Aspects Pathological Aspects Pharmacological Aspects Pharmaceutical Aspects Current Technology of Buccal Drug Delivery Buccal Tablets Lozenges Liquid Dosage Forms Buccal Films or Strips Buccal Gels and Ointments Buccal Patches Evaluation of Buccal Drug Delivery System Moisture Absorption Studies for Buccal Patches Swelling and Erosion Studies for Buccal Tablets Study of the Surface pH Measurement of Mechanical Properties In Vitro Bioadhesion Measurement Ex Vivo Residence Time In Vitro Drug Permeation Studies Buccal Absorption Test Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences IV — Nasal Drug Delivery System Introduction Divisions and Histological Characteristics of Nasal Cavity Vestibular Region Respiratory Region Olfactory Region Mechanism of Drug Absorption from the Nasal Cavity Factors Affecting Nasal Bioavailability Physiological Factors Physicochemical Factors Pharmaceutical Factors Nasal Drug Delivery Formulations Liquid Nasal Formulations Powder Dosage Forms Pressurized Multidose Inhalers Nasal Gels New Technologies in Nasal Formulations Microspheres Nanoparticles Liposomes Controlled Particle Dispersion™ Advanced Nasal Spray Medications MAD Nasal–Mucosal Atomizer Preservative-free Systems Evaluation of Nasal Drug Delivery Systems Nasal Drops Metered-dose Inhalers Powder Dosage Forms Gel Dosage Forms Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences V — Ocular Drug Delivery System Introduction Anatomy and Physiology of the Eye Basic Structure Mechanism of Ocular Drug Absorption Factors Influencing Corneal Absorption of Drugs Ocular Drug Release Mechanism Diffusion Osmosis Bioerosion Novel Ocular Delivery Systems Controlled Ocular Delivery Systems Ocular Drug Delivery Devices Formulation and Manufacturing Considerations of Ocular Drug Delivery Systems Evaluation of Ocular Controlled Drug Delivery Systems Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences VI — Vaginal Drug Delivery System Introduction Advantages of Vaginal Drug Administration Limitations of Vaginal Drug Administration Applications of Vaginal Drug Delivery System Anatomy and Physiology of the Vagina Factors Affecting Drug Absorption Methods to Improve Vaginal Absorption Formulation of Vaginal Drug Delivery Systems Classification of Intravaginal Drug Delivery Systems Vaginal Rings Vaginal Tablets Vaginal Powders Vaginal Capsules Vaginal Creams Vaginal Creams and Gels Vaginal Suppositories (Pessaries) Current Approaches in Vaginal Drug Delivery Bioadhesive Delivery Systems Mucoadhesive Delivery Systems Other Novel Delivery Systems Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences VII — Microspheres Introduction Types of Microspheres Bioadhesive Microspheres Magnetic Microspheres Floating Microspheres Radioactive Microspheres Mucoadhesive Microspheres Polymeric Microspheres Formulation Considerations and Microencapsulation Techniques Methods of Microspheres Manufacture Characterization of Microspheres Applications Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences VIII — Nanoparticles Introduction Methods of Formation of Nanoparticles Cross-linking of Amphiphilic Macromolecules Polymerization-based Methods Polymer Precipitation Methods Characterization of Nanoparticles Novel Nanoparticulate Systems Applications of Nanoparticles Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences IX — Liposomes Introduction Target-specific Liposomes Structure of Liposomes Classification of Liposomes Methods of Liposomal Preparation Passive Loading Techniques Active (Remote) Loading Techniques Incorporation of Drugs into Liposomes Mechanism of Drug Release from Liposomes Characterization of Liposomes Physical Characterization Chemical Characterization Biological Characterization Stability of Liposomes Chemical Stability Physical Stability Advantages of Liposomes Disadvantages of Liposomes Applications of Liposomes Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences X — Niosomes Introduction Structure of Niosomes Methods of Preparation of Niosomes Ether Injection Method Hand Shaking Method (Thin Film Hydration Technique) Reverse Phase Evaporation Technique Transmembrane pH Gradient (Inside Acidic) Drug Uptake Process(Remote Loading) The “Bubble” Method Advantages of Niosomes Characterization Techniques Applications of Niosomes Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 7 : Stability Testing of Active Substances and Pharmaceutical Products What is ICH ICH Team ICH Guidelines Quality Guidelines Issued by ICH Climatic Zones Regulations and Guidelines Guidelines for the Conduct of Stability Studies Active Substance Drug Product Important Terminologies Used in Stability Studies Accelerated Testing Bracketing Commitment Batches Container Closure System Dosage Form Drug Product Drug Substance Excipient Expiration Date Formal Stability Studies Impermeable Containers Stress Testing Intermediate Testing Long-term Testing Mass Balance Matrixing Mean Kinetic Temperature New Molecular Entity Pilot Scale Batch Primary Batch Production Batch Re-test Date Re-test Period Semi-permeable Containers Shelf Life Specification—Release Specification—Shelf Life Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 8 : Intellectual Property Rights in Pharmaceuticals Advantages Disadvantages Types of Intellectual Property Rights 1. Copyrights and Related Rights 2. Industrial Property Rights Role of Intellectual Property Rights in Pharmaceutical Research Filing a Patent International Patents Commercialization of Patents Treaties and Agreements Related to Intellectual Property Rights Patent Cooperation Treaty Exclusive Marketing Rights Agreement on TRIPS Doha Declaration Compulsory Licensing Thoughts for Inventors Web Links Related to Intellectual Property Rights and Patents Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 9 : Regulatory Affairs Good Manufacturing Practices 1. General Requirements 2. Sterile Products 3. Working Space and Storage Area 4. Health, Clothing and Sanitation of the Workers 5. Medical Services 6. Sanitation in the Manufacturing Premises 7. Equipment 8. Raw Materials 9. Master Formula Records 10. Batch Manufacturing Records 11. Manufacturing Operation and Controls 12. Reprocessing and Recovery 13. Product Container and Closure 14. Label and Other Printed Materials 15. Distribution Records 16. Record of Complaints and Adverse Reactions 17. Quality Control System Quality Assurance (Qa) Quality Control (Qc) In-Process Quality Controls Content of Master Formula Records WHO GMP Guidelines US FDA Guidelines US FDA Drug Master Files Types and Contents of the DMF Registration Dossier Contents Volume I Volume II GMP for Active Pharmaceutical Ingredient/Bulk Drug Good Automated Manufacturing Practices ISO (14001:1996) Environment Management System Clause Technology Transfer Guidance Standard Classification, Testing and Monitoring Reports Clean-room Class Designation ISO 14644-2: Clean-room Testing for Compliance Periodic Monitoring and Requirements in Testing Reports Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 10 : Validation Introduction Definition Need for Validation Benefits of Validation Classification of Validation Methods Analytical Validation Process Validation Qualification Cleaning Validation Validation of Solid Dosage Forms Validation of Raw Materials Validation of Analytical Methods Validation Equipment and Facility Control of Process Variables Validation of Tablets Tablet Composition Process Evaluation and Selection Equipment Evaluation for Manufacturing of Tablets Validation of Parenterals Validation and Facility Design Validation Master Plan (VMP) Documentation in Validation Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Chapter 11 : Nutraceuticals and Cosmeceuticals Part I: Introduction to Nutraceuticals Introduction History Terminologies Mode of Action Classification of Nutraceuticals Nutrients Dietary Supplements Functional Foods Herbals Probiotics Safety and Efficacy Future Prospects Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Part II: Introduction to Cosmeceuticals Introduction Description of Cosmeceuticals Desirable Features of a Cosmeceutical Product Ingredients Used in Cosmeceuticals Safety and Efficacy Assessment Safety Assessment Efficacy Assessment Classification of Cosmeceuticals Hydroxy Acids or Polysaccharides Botanicals Skin Lightening Agents or Depigmenting Agents Exfoliants Moisturizers Topical Peptides Retinoids Sunscreens Antioxidants Growth Factors Future Scope Review Questions Answer in Detail Answer in Brief Answer in One or Two Sentences Bibliography Index