Specialised Pharmaceutical Formulation : The Science and Technology of Dosage Forms.

Specialised Pharmaceutical Formulation is an essential, up to date resource and will equip readers with the ability to effectively and reliably produce products intended for less common and novel routes of administration which can be approved, manufactured and made available to administer to patient...

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书目详细资料
其他作者:	Tovey, Geoffrey D.
格式:	Licensed eBooks
语言:	英语
出版:	Cambridge : Royal Society of Chemistry, 2022.
丛编:	ISSN.
在线阅读:	https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=3282524

书本目录:

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.

Specialised Pharmaceutical Formulation : The Science and Technology of Dosage Forms.

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