منو
رکورد قبلیرکورد بعدی

" Specialised pharmaceutical formulation "


Book No : E4872
Record identifier : 1630877
Originating Source : University of Tehran. Library of College of Science
Title and statement of responsibility and : Specialised pharmaceutical formulation [Electronic book] : the science and technology of dosage forms/ edited by Geoffrey D. Tovey.
Publication, Distribution,Etc. : London: Royal Society of Chemistry, 2022
Physical Description : 1 online resource
Series : Drug discovery and pharmaceutical science
International Standard Book Number (ISBN) : 9781839165603 (eISBN)
Language of the Item : eng
Internal Bibliographies/Indexes Note : Includes bibliographical references and index.
Contents Note : Cover -- Dedication -- Preface -- Editor Biography -- Contents -- Chapter 1 Ophthalmic Formulation -- 1.1 Introduction -- 1.2 The Tear Film -- 1.3 Delivery Volume and the Dosing Device -- 1.4 Topical Ophthalmic Formulation Ingredients -- 1.4.1 Tonicity -- 1.4.2 Salts -- 1.4.3 Buffers -- 1.4.4 Preservatives -- 1.4.5 Hydrotropes -- 1.4.6 Polymers -- 1.4.7 Lipid- based Emulsions -- 1.4.8 Ointments -- 1.4.9 Non-aqueous, Non-lipid Vehicles -- 1.4.10 Suspensions -- 1.4.11 Nanotechnology -- 1.5 Manufacture of Ophthalmic Products -- 1.5.1 Finished Product Specifications -- 1.6 Topical Delivery -- 1.6.1 Getting In: Epithelial PermeabilityBarriers and Other Physical Barriers in the External Eye -- 1.6.2 The Cornea -- 1.6.3 Conjunctiva and Sclera -- 1.7 Eye Structure and Strategies for Targeting -- 1.7.1 Use of Punctal Plugs -- 1.8 Targeting: Exterior to Interior -- 1.9 The Mid Eye Zone: The Intraocular Lens (IOL) as a Delivery System -- 1.10 Dosing the Internal Eye: Posterior segment Delivery -- 1.10.1 The Ageing Vitreous -- 1.11 Posterior Segment Delivery Approaches -- 1.11.1 Photodynamic Therapy -- 1.11.2 Direct Intravitreal Therapy -- 1.11.3 Crossing the Retina from the Inside -- 1.12 Concluding Remarks -- References -- Chapter 2 Parenteral Products -- 2.1 Parenteral Formulations and Products -- 2.1.1 Dosage Forms Used for Parenteral Administration -- 2.1.2 Powders for Reconstitution -- 2.2 Fundamental Requirements for a Parenteral Product -- 2.2.1 Sterility -- 2.2.2 Free from Pyrogens -- 2.2.3 Free from Particulate Matter -- 2.3 Formulation Considerations -- 2.3.1 Vehicles -- 2.3.2 Solubility and Solubilisation in Aqueous Media -- 2.3.3 Buffers -- 2.3.4 Preservative Agents -- 2.3.5 Antioxidants -- 2.3.6 Protein Stabilisers -- 2.3.7 Tonicity -- 2.3.8 Other Ingredients -- 2.4 Stability -- 2.5 Packaging of Parenteral Products.2.6 Manufacturing Considerations -- 2.7 Storage of Parenteral Products -- Abbreviations -- References -- Chapter 3 Dermal Formulations for Local Treatment -- 3.1 Introduction -- 3.2 Structure and Function of Human Skin -- 3.2.1 Epidermis -- 3.2.2 Dermis -- 3.2.3 Hypodermis -- 3.2.4 Skin Appendages -- 3.3 Pathways of Percutaneous Absorption and the Transport Process for Drugs -- 3.4 Physicochemical Properties, Topical Delivery and Formulation Development -- 3.5 Permeation Enhancement Strategies for Dermal Formulations -- 3.6 Topical Therapeutic Systems -- 3.6.1 Ointments, Creams and Lotions -- 3.6.2 Gels and Emulgels -- 3.6.3 Foams and Sprays -- 3.6.4 Topical Therapeutic Patches -- 3.6.5 Ungual Formulations -- 3.7 Dermal Formulations of the Future -- References -- Chapter 4 Transdermal Drug Delivery -- 4.1 Transdermal Drug Delivery -- 4.2 Anatomy and Physiology of the Skin -- 4.3 Percutaneous Absorption and Penetration Route -- 4.4 Skin Delivery Enhancement -- 4.4.1 Passive Techniques -- 4.4.2 Active Techniques -- 4.5 Characteristics and Development -- 4.6 Advantages of Microneedle Arrays -- 4.7 Classification of Microneedle Arrays -- 4.8 Fabrication and Material Selection -- 4.9 Microneedle Array Commercialisation and Future Prospects -- 4.10 Conclusion -- References -- Chapter 5 Oral Suspensions -- 5.1 Introduction -- 5.2 Types of Oral Suspensions -- 5.3 Critical Quality Attributes of an Oral Suspension -- 5.4 Milling of the Active Pharmaceutical Ingredient -- 5.5 Manufacturing of Oral Suspensions -- 5.6 Ingredients of an Oral Suspension -- 5.6.1 Suspending Agents -- 5.6.2 Preservatives -- 5.6.3 pH Buffering Agents -- 5.6.4 Sweetening Agents -- 5.6.5 Wetting Agents -- 5.6.6 Antioxidants and Chelating Agents -- 5.6.7 Colouring Agents -- 5.6.8 Flavouring Agents -- 5.7 Challenges in Formulating and Manufacturing Oral Suspensions.5.7.1 Changes in Particle Size Distribution -- 5.7.2 Gas Entrainment and Foaming -- 5.7.3 Discoloration and Browning -- 5.7.4 Taste and Texture Optimisation -- 5.8 Conclusions -- References -- Chapter 6 Oral Films -- 6.1 Introduction -- 6.2 Manufacturing Technology -- 6.2.1 Solvent Casting -- 6.2.2 Hot Melt Extrusion -- 6.2.3 Solid Dispersion Extrusion -- 6.2.4 Semisolid Casting -- 6.2.5 Flexographic Printing -- 6.2.6 Inkjet Printing -- 6.2.7 3-D Printing -- 6.3 Formulation -- 6.3.1 API -- 6.3.2 Polymers -- 6.3.3 Plasticisers -- 6.3.4 Taste Masking -- 6.3.5 Stabilizing and Thickening Agents -- 6.3.6 Saliva- Stimulating Agents -- 6.3.7 Other Components -- 6.4 Oral Films in Peptide and Protein Delivery -- 6.4.1 Buccal Absorption -- 6.4.2 Formulation Approaches for Protein Peptide Delivery -- 6.5 Characterisation and Assessment -- 6.5.1 Standard Oral Solid Dosage Critical Quality Attributes (CQAs) -- 6.5.2 Common In-process Control Tests for Films -- 6.5.3 Tests Used in Development -- 6.5.4 Tests for Buccal Films -- 6.6 Conclusions -- Note -- References -- Chapter 7 Inhalation Devices and Formulations -- 7.1 Introduction -- 7.2 Drug Formulation, Manufacturing Processes and Delivery Devices -- 7.2.1 Particle Engineering -- 7.2.2 Inhaled Biopharmaceuticals -- 7.2.3 Pressurised Metered Dose Inhalers -- 7.2.4 Dry Powder Inhalers -- 7.2.5 Nebulisers -- 7.2.6 Continuous Processing -- 7.3 Analytical Testing -- 7.3.1 Aerosol Characterisation Methodologies -- 7.3.2 Data Analysis, Equivalence Testing andClinically Relevant Drug Product Specifications -- 7.3.3 Dissolution Testing of Inhaled Products -- 7.3.4 Assessment of Aerosol Performance Under Biorelevant Testing Conditions -- 7.3.5 Assessment of Formulation Microstructure -- 7.3.6 The Future of Analytical Testing -- 7.4 Predictive Tools -- 7.4.1 The Rise of Predictive Tools and Computational Modelling.7.4.2 Development of an Inhaled Biopharmaceutics Classification System -- 7.4.3 Product and Process Understanding: Particle Size Reduction -- 7.4.4 Product and Process Understanding: Formulation Design -- 7.4.5 Product and Process Understanding: Manufacturing Process Development -- 7.4.6 Predicting Drug Delivery Performance -- 7.4.7 Predicting Lung Deposition of Aerosols -- 7.5 Future Perspectives -- 7.6 Concluding Remarks -- Notes -- References -- Chapter 8 Advanced Therapy Medicinal Products (ATMPs) -- 8.1 Introduction -- 8.1.1 Gene Therapy Medicinal Products (GTMPs) -- 8.1.2 Somatic-cell Therapy Medicinal Products (sCTMPs) -- 8.1.3 Tissue-engineered Products (TEPs) -- 8.1.4 Combined Advanced Therapy Medicinal Products -- 8.1.5 Differences Between ATMPs and Other Medicinal Products -- 8.2 Regulations -- 8.2.1 European Medicines Agency (EMA) -- 8.2.2 Committee for Medicinal Products of Human Use (CHMP) -- 8.2.3 Committee for Advanced Therapies (CAT) -- 8.3 ATMP Life Cycle -- 8.3.1 Research and Development -- 8.3.2 Clinical Trials -- 8.3.3 Manufacture -- 8.3.4 Intellectual Property (IP) -- 8.3.5 Marketing Authorisation -- 8.3.6 Hospital Exemption -- 8.3.7 Post- authorisation and Pharmacovigilance -- 8.4 Current Market -- 8.4.1 Challenges Associated with Clinical Translation -- 8.4.2 Ongoing Clinical Trials -- 8.5 Conclusions -- References -- Chapter 9 Geriatric Pharmaceutics -- 9.1 Introduction -- 9.2 Geriatric Oral Biopharmaceutics -- 9.3 Patient-centric Formulations for Ageing Populations -- 9.3.1 Oral Dosage Forms -- 9.3.2 Patient Acceptability -- 9.3.3 Medicine Management -- 9.4 Modification of Orally Administered Medicines -- 9.4.1 Swallowing Difficulties -- 9.5 Medical Devices Aiding the Oral Administration of Medicine -- 9.5.1 Packaging -- 9.5.2 Multi-compartment Compliance Aids and Multi-dose Dispensing systems -- 9.5.3 Dosing Devices.9.6 Digital Health for an Ageing Population -- 9.6.1 Personalised Medicine for Older People -- 9.6.2 Applying Artificial Intelligence to Geriatric Pharmacy -- 9.6.3 Ethical Considerations and Ease of Translation -- Acknowledgements -- References -- Chapter 10 Development Programs for Oral Fixed Dose Combination Products -- 10.1 Introduction -- 10.2 Regulatory Guidelines and Definitions -- 10.3 Drivers for Combination Products -- 10.3.1 Patient Adherence -- 10.3.2 Unit Size (Oral Dosage) -- 10.3.3 Therapeutic Efficacy -- 10.3.4 Side Effects -- 10.3.5 Repurposing -- 10.3.6 Cost of Goods -- 10.3.7 Societal Costs -- 10.4 Evaluation Programs -- 10.4.1 Regulatory Requirements -- 10.5 Category 1 Programs -- 10.5.1 Dosage Form Design for a Category 1 Program -- 10.6 Category 2 Programs -- 10.6.1 Dosage Forms for Category 2 Programs -- 10.7 Category 3 Programs -- 10.7.1 Dosage Forms for Category 3 Programs -- 10.7.2 Dosage Forms for Category 3 Clinical Trials -- 10.8 Category 4 Programs -- 10.8.1 Dosage Forms for Category 4 Programs -- 10.9 Quality by Design Programs for Combination Products -- 10.10 Opportunities for Combination Products -- 10.10.1 Life Cycle Management -- 10.10.2 Changed Treatment Paradigms -- 10.10.3 Improving Bioavailability -- 10.10.4 Combination Products for Treating HIV and Other Viral Infections -- 10.11 Future Perspectives -- 10.11.1 Antimalarial Medications -- 10.11.2 Anti-cancer Medications -- 10.11.3 Antiviral Combination Products -- 10.12 Summary and Conclusions -- Appendix -- References -- Chapter 11 Presentational and Organoleptic Aspects of Formulation -- 11.1 Introduction -- 11.1.1 The Importance of Acceptability -- 11.1.2 Aspects of Acceptability -- 11.2 Organoleptic Aspects -- 11.2.1 Taste -- 11.2.2 Modifying Taste -- 11.2.3 Taste Masking -- 11.2.4 Mouthfeel/Trigeminal Effects -- 11.2.5 Aroma -- 11.2.6 Non-oral Products.
Topical Name Used as Subject : Pharmaceutical chemistry
: Drug development
Personal name - Secondary Intellectual Responsibility : Tovey, Geoffrey D., editor.
publication status : e
Type of Electronic Resource : PDF file.
copyhttps://lib.ut.ac.ir/site/catalogue/1630877
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