Chapter 1. Status of Implantable and Long-acting Injectable Technologies
Chapter 2. Developing Complex Dosage Forms of Long-acting Biologics for the Eye: Current State, Challenges, and Opportunities
Chapter 3. Monolithic Devices for Sustained Delivery of Protein Therapeutics for Ocular Disease
Chapter 4. Sustained Delivery of Ocular Protein Therapeutics
Chapter 5. Development of Risperidone Implant Formulations (DLP-114) for Long-term Maintenance Treatment of Schizophrenia
Chapter 6. In-line Extrusion Process and Product Evaluation of ProNeura® by Near-infrared Spectroscopy
Chapter 7. Addressing Immunogenicity for Implantable Drug-delivery Devices and Long-acting Injectables, Including Pharmacokinetic and Pharmacodynamic Correlations
Chapter 8. Characterization Methods for Parenteral Peptide Controlled Release Drug Delivery Systems
Chapter 9. Parenteral Delivery of Therapeutic Proteins, Peptides and Small Molecules Using Biodegradable Silica
Chapter 10. Development of User-initiated Vaginal Dosage Forms
Chapter 11. Three-dimensional Printed Implantable Products.

Intro
Half Title
Series Title
Title
Copyright
Foreword
Preface
Editor Biography
Contents
Chapter 1 Status of Implantable and Long-acting Injectable Technologies 1
1.1 Introduction
1.2 Implantable Minipumps for Research and Preclinical Studies
1.2.1 The Alzet® Pump
1.2.2 iPRECIO® Microinfusion Pump
1.3 Implantable Minipump Devices in Commercial Application
1.4 Implantable Technologies Under Clinical Studies and Development
1.4.1 Medici Drug Delivery System™
1.4.2 Microneedles Array Technology
1.4.3 Microchip Drug Delivery Devices

1.4.4 Biodegradable Injectable Drug Delivery System
1.5 Challenges with Implantable and Long-acting Injectable Technologies
1.6 Conclusion
Acknowledgements
References
Chapter 2 Developing Complex Dosage Forms of Long-acting Biologics for the Eye: Current State, Challenges, and Opportunities 14
2.1 Unmet Medical Needs for Long-acting Biologic Products for the Eye
2.1.1 Eye Diseases, Epidemiology, and Unmet Need for Long-acting Biologic Therapies
2.1.2 Ocular Drug-delivery Considerations

2.2 Success Criteria for Long-acting Ocular Biologic Products and Scientific Challenges
2.3 Complex Dosage Forms for the Eye: Current State and Trend
2.3.1 Introduction
2.3.2 Erodible Polymers
2.3.3 Implants
2.3.4 Nano- and Microparticles
2.3.5 In Situ-forming and Injectable Depots
2.3.6 Conjugation Approaches
2.3.7 Non-erodible Implantable Devices
2.4 Conclusions and Outlook
Acknowledgements
References
Chapter 3 Monolithic Devices for Sustained Delivery of Protein Therapeutics for Ocular Disease 54
3.1 Introduction

3.1.1 Posterior Segment Eye Diseases of Interest
3.1.2 Protein Therapeutics for Posterior Segment Eye Disease
3.2 Considerations for Sustained Delivery of Proteins and Biologics
3.2.1 Challenges in Ocular Drug Delivery
3.2.2 Animal Models for Preclinical Research
3.2.3 Non-biodegradable and Biodegradable Materials
3.3 Current Drug-delivery Implant Technology for Ocular Disease
3.3.1 Commercial Development
3.3.2 Ocular Drug-Delivery Implantable Technology in the Clinical Pipeline
3.3.3 Ocular Drug-delivery Implantable Technology in Preclinical Stages

3.4 Concluding Remarks
Acknowledgements
References
Chapter 4 Sustained Delivery of Ocular Protein Therapeutics 76
4.1 Introduction
4.2 Physicochemical Characteristics of the Vitreous Humour
4.3 Current Challenges in the Sustained Delivery of Ocular Therapeutics
4.3.1 Long-term Stability of Therapeutics
4.3.2 Limitations with Surrogate Vitreous Systems
4.4 Anti-VEGF Therapies
4.4.1 In Vitro Long-term Stability of Anti-VEGF Therapies
4.5 Development of the PDS
4.5.1 Overview
4.5.2 Preclinical Studies of the PDS
4.5.3 Clinical Studies on the PDS