Specialised Pharmaceutical Formulation : The Science and Technology of Dosage Forms / edited by Geoffrey D. Tovey.

Format:

Book

Contributor:

Tovey, Geoffrey D., editor.

Series:

ISSO (Series)

Issn Series

Language:

English

Subjects (All):

Drug development.

Pharmaceutical chemistry.

Physical Description:

1 online resource (368 pages)

Edition:

First edition.

Place of Publication:

Cambridge, England : The Royal Society of Chemistry, [2022]

Summary:

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 patients.

Contents:

Intro

Title

Copyright

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 Permeability Barriers 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

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

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

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

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

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 and Clinically 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

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

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

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

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.

11.3 Appearance.

Notes:

Description based on publisher supplied metadata and other sources.

Description based on print version record.

Includes bibliographical references.

Other Format:

Print version: Tovey, Geoffrey D Specialised Pharmaceutical Formulation

ISBN:

9781839165603

183916560X

9781839165610

1839165618