Pharmaceutical Formulations for Older Patients (AAPS Advances in the Pharmaceutical Sciences Series, 51)

✍ Scribed by Mine Orlu (editor), Fang Liu (editor)

• Publisher: Springer
• Year: 2023
• Tongue: English
• Leaves: 294
• Category: Library

✦ Synopsis

Pharmaceutical formulation design affects patient acceptability/adherence and pharmacokinetics of the drug. This is particularly important for older patients because of the physiological changes due to ageing and clinical/social circumstances related to medicine taking.

This book provides a comprehensive review in the design of formulations to meet the needs of older patients. An overview of the key clinical, social and pharmaceutical factors affecting medication optimization, safety and acceptability in older adults is included, followed by patient-centric considerations including regulatory requirements, dosage form design and human factor studies.

Advanced pharmaceutical technologies are discussed for their potential use in older adults such as 3D printing, long-acting oral formulations and novel vaccine technologies. The unique focus of the book will be of interest to pharmaceutical scientists in both industryand academia in searching for better formulations for older patients.

✦ Table of Contents

Preface
Contents
About the Editors
Medication Optimisation in Older People
1 Introduction
2 Key Clinical and Social Issues in Older People and Related Medication Optimisation Challenges
2.1 Frailty
2.2 Falls
2.3 Evidence-Based Medicine in Older People
2.4 Polypharmacy and Overprescribing
2.5 Anticholinergic Burden
2.6 Deprescribing
2.7 Dementia
2.8 Social Issues
3 Importance of Formulation in Medication Optimisation
3.1 Formulation Considerations for People with Swallowing Difficulties
3.2 Other Factors
3.3 Personalised Medication for Older People
4 Conclusion
References
Medication Safety in Older People
1 Background
1.1 Medication Safety Considerations in Older People
1.2 General Support Strategies for Safer Use of Medicines
2 Medication Safety Concerns in Older People
2.1 Impact of Pharmacokinetic and Pharmacodynamics Changes
2.2 Switching and Bioequivalence
2.3 Provision and Monitoring Concerns
2.4 Accessibility
2.5 Monitoring by Patient, Carer and Healthcare Professionals
3 Medication Safety Support Strategies
4 Risk-Benefit Considerations in Initiating and Deprescribing Medication
4.1 Use of Guidelines
4.2 Shared Decision-Making and Patient Empowerment
5 Case Study
6 Conclusion
References
Medicine Acceptability: A Key Aspect in the Older Population
1 Why Medicine Acceptability Is Essential in the Elderly?
2 How Medicine Acceptability Assessment Can Be Standardized?
2.1 Identifying Relevant Data
2.2 Evaluating Product Use
2.3 Developing a Reference Framework
2.4 Confirming Adequacy
2.5 Scoring Acceptability
3 Exploring Medicine Acceptability Drivers in the Elderly
3.1 Medicine Acceptability in the Elderly with Swallowing Disorders
3.2 Palatability Issues in the Elderly
4 Improving Knowledge on Acceptability Drivers
References
The Design of Patient-centric Dosage Forms for Older Adults
1 Introduction
1.1 Regulatory Framework for Drug Development in Vulnerable Populations
1.2 Defining a Target Product Profile for a Specific Indication and Patient Population
1.3 Defining the Drug Product Quality Profiles
2 Intended Product Performance: Development of Safe and Efficacious Medicines
2.1 Physiological Changes in the GI Tract Due to Age and Disease
2.2 Impact of Co-medication on the Safety and Efficacy of Drugs
3 Patient-centric Pharmaceutical Drug Product Design
3.1 Age and Condition Appropriateness of Dosage Forms
3.1.1 Classical Oral Dosage Forms: Liquids, Granules, Tablets, and Capsules
3.1.2 Modern Oral Dosage Forms
Oral Films
Orally Disintegrating Tablets
Multiparticulates Including Minitablets
3D-Printed Dosage Forms
3.2 Medication Adherence
3.2.1 Reduction in Dosing Frequency
3.2.2 Polypharmacy
3.2.3 Visual Impairment
3.3 From Clinical Studies to Real-Life Administration
3.3.1 Usability/Human Factors Engineering
3.3.2 Older Patient Population as Users
3.3.3 Potential Use Risks and Design Considerations
3.3.4 Usability Testing with Older Adult Patients
4 Conclusion and Future Opportunities
References
Development of Appropriate Medicines for Older Patients: An Industrial Perspective
1 Introduction
1.1 Paediatric Population
1.2 Older Adult Population
1.2.1 Patient Capability and Acceptability
1.2.2 Swallowability
1.2.3 Disease State
1.3 The EMA Strategy
1.4 The FDA Strategy
2 The Principle of Patient Centricity
2.1 Definitions
2.2 Patient and Drug Product Interactions
2.3 Considerations for Patient-Centric Drug Product Design
2.4 Human Factor Trials
3 Drug Product Design, Appearance and Identification
3.1 Size
3.1.1 Handling
3.2 Tablet Shape
3.2.1 Tablet Splitting
3.3 Colour
3.4 Film Coating
3.4.1 Taste or Odour Masking
3.4.2 Improved Stability
3.4.3 Tablet Crushing
3.5 Modified Release
3.6 Capsules
3.7 Excipient Selection
3.8 Other Dosage Forms
3.9 Polypharmacy
3.10 Packaging
4 Ideas for Future Consideration
5 Summary
References
Advanced Oral Sustained-Release Drug Delivery Systems for Older Patients
1 Introduction
2 Oral Sustained Release for Older Patients
3 Conventional Sustained-Release Formulations Suitable for Older Patients
3.1 Mini-Tablets
3.2 Orally Disintegrating Tablets
3.3 Chewable Tablets
4 Advanced Sustained-Release Technologies for Older Patients
4.1 Oral Sustained-Release Liquids
4.1.1 Solid Lipid Nanoparticles
4.1.2 In Situ Gelling
4.1.3 Emulsion-Based Systems
4.2 Sustained-Release Microparticles
4.2.1 Spray Drying
4.2.2 Ion Exchange Resins
4.2.3 Coacervation
4.2.4 Spray Congealing
4.2.5 Coating
4.3 Ultra-Long-Lasting Oral Formulations
5 Concluding Remarks
References
3D Printing: Advancements in the Development of Personalised Pharmaceuticals for Older Adults
1 Introduction
2 Overview of 3D Printing Technologies
2.1 Binder Jetting
2.2 Vat Photopolymerisation
2.3 Powder Bed Fusion
2.4 Material Jetting
2.5 Material Extrusion
2.5.1 Fused Deposition Modelling
2.5.2 Semi-Solid Extrusion
2.5.3 Direct Powder Extrusion
3 Applications of 3D Printing in Personalised Medicines for Older Patients
3.1 Multi-Drug Dosage Forms
3.2 Overcoming Swallowing Difficulties
3.2.1 Orally Disintegrating Formulations
3.2.2 Chewable Printlets
3.2.3 Multiparticulate Printlets
3.3 Meeting Special Physical Needs
3.3.1 Blindness and Visual Impairment
3.3.2 Picking and Handling
3.4 Drug-Laden Devices
4 Digital Healthcare and 3D Printing
5 Conclusion
References
The Ageing Microbiome, Pharmaceutical Considerations, and Therapeutic Opportunities
1 Unravelling the Intestinal Microbiota
1.1 Functions of the Gut Microbiota
1.2 Establishment of the Intestinal Microflora from Early Life to Old Age
1.2.1 Gestation and Parturition
1.2.2 Early Life and Infancy
1.2.3 Adulthood
1.2.4 Older People
1.2.5 Centenarians
2 The Medicine-Microbiome Relationship
2.1 Bugs Vs. Drugs: Microbiome Effects on Pharmacokinetics
2.1.1 Enzymatic Microbial Metabolism
2.1.2 Indirect Microbiome Effects on Pharmacokinetics
2.2 Drugs Vs. Bugs: Drug-Induced Microbiome Remodelling
3 Microbiome Medicine: Targeting the Ageing Microbiome
3.1 Delivering Microbiome Therapeutics with Smart Formulation
3.1.1 Single-Trigger Approaches
3.1.2 Advanced Colonic Targeting
3.2 Novel Microbiome Therapeutics
3.2.1 Probiotics
3.2.2 Prebiotics
3.2.3 Synbiotics
3.2.4 Faecal Microbiota Transplantation
4 Conclusion
References
Tailoring Vaccines for Older Individuals: Aging of the Immune System and the Impact on Vaccine Efficacy
1 Introduction
2 A Brief Overview of the Immune System
2.1 The Host Defence
2.2 The Innate Immune System
2.3 The Adaptive Immune System
3 The Effect of Aging on the Immune System
3.1 Immunosenescence and Inflammaging
3.2 Immunosenescence of the Innate Immune System
3.2.1 Toll-Like Receptors (TLRs)
3.2.2 Macrophages and Monocytes
3.2.3 Dendritic Cells
3.2.4 Neutrophils
3.2.5 Natural Killer (NK) Cells
3.2.6 Eosinophils and Basophils
3.2.7 Mast Cells
3.2.8 The Complement System
3.3 Immunosenescence of the Adaptive Immune System
3.3.1 T Cells
3.3.2 B Cells
3.3.3 The Bone Marrow
3.3.4 The Lymph Nodes
4 The Mucosal Immune System
4.1 An Overview of Mucosal Immunity
4.2 Immunosenescence of Mucosal Immunity
4.2.1 M Cells
4.2.2 Goblet Cells
4.2.3 Epithelial Cell Barrier Integrity
4.2.4 Mucosal T Lymphocytes
4.2.5 Effects on Secretory IgA Responses
4.3 Immunosenescence of the Microbiota
5 Inflammaging
6 Immunological Mechanisms of Vaccination
6.1 Vaccine Efficacy and Effectiveness
6.2 The Immunisation Process
7 Types of Vaccine
8 Vaccines Tailored to the Older Population
8.1 Influenza
8.2 Herpes Zoster
9 Tailored Approaches that can be Applied to Formulate Vaccines for the Elderly
9.1 Addition of Adjuvants
9.1.1 Anti-Inflammatory Adjuvants
9.1.2 Cytokine Adjuvants
9.1.3 Single-Stranded RNA-Based Adjuvant
9.1.4 Cationic Lipid/DNA Complex Adjuvant
9.1.5 Flagellin Adjuvant: The TLR5 Activator (TLR Agonist)
9.2 Other Approaches
9.2.1 Trained Immunity
9.2.2 Virus-Like Particles Acquired from Plants
10 Vaccination of Older Adults and Public Health
11 Conclusion
References
Index