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The Art and Science of Dermal Formulation Development.

Author: Marc B Brown; Adrian C Williams
Publisher: Milton : Chapman and Hall/CRC, 2019. ©2019.
Series: Drugs and the Pharmaceutical Sciences Ser.
Edition/Format:   eBook : Document : English
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Genre/Form: Electronic books
Additional Physical Format: Print version
Brown, Marc B.
The Art and Science of Dermal Formulation Development
Milton : Chapman and Hall/CRC,c2019
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Marc B Brown; Adrian C Williams
ISBN: 9780429596063 0429596065
OCLC Number: 1099923079
Accession No: 991009642140704001
Description: 1 online resource (241 pages).
Contents: Cover --
Half Title --
Series Page --
Title Page --
Copyright Page --
Dedication --
Contents --
Preface --
Acknowledgements --
About the Authors --
Chapter 1: Structure and Function of Human Skin --
1.1#Introduction --
1.2#Healthy Skin Structure and Function --
1.2.1#The Subcutaneous Fat Layer --
1.2.2#The Dermis --
1.2.2.1#Pilosebaceous Unit --
1.2.2.2#Eccrine (Sweat) Glands --
1.2.2.3#Apocrine Glands --
1.2.3#The Epidermis --
1.2.3.1#Basement Membrane --
1.2.3.2#The Stratum Basale (Stratum Germinativum or, More Commonly, Basal Layer) --
1.2.3.3#The Stratum Spinosum (Spinous Layer/Prickle Cell Layer) --
1.2.3.4#The Stratum Granulosum (Granular Layer) --
1.2.3.5#The Stratum Lucidum --
1.2.3.6#The Stratum Corneum (Horny Layer) --
1.2.4#Epidermal Enzyme Systems --
1.3#Physiological Factors Affecting Transdermal and Topical Drug Delivery --
1.3.1#Gender --
1.3.2#Skin Age --
1.3.3#Body Site --
1.3.4#Race --
1.3.5#Other Factors --
1.4#Skin Microbiome --
1.5#Damaged Skin --
References --
Chapter 2: Theoretical Aspects of Transdermal and Topical Drug Delivery --
2.1#Terminology --
2.2#The Transdermal Permeation Process --
2.3#Permeation Pathways through the Stratum Corneum --
2.3.1#Transappendageal Transport (Shunt Route Transport) --
2.3.2#Transcellular Route --
2.3.3#Intercellular Pathway --
2.4#Influence of Permeant Physicochemical Properties on Route of Absorption --
2.4.1#Partition Coefficient --
2.4.2#Molecular Size --
2.4.3#Solubility/Melting Point --
2.4.4#Ionisation --
2.4.5#Other Factors --
2.4.6#Biomacromolecules --
2.5#Mathematics of Skin Permeation --
2.5.1#Pseudo Steady-State Permeation (Infinite Dosing) --
2.5.2#Concentration Gradient or Thermodynamic Activity? --
2.5.3#Transient Permeation (Finite Dosing) --
References --
Chapter 3: Chemical Modulation of Topical and Transdermal Permeation --
3.1#Introduction. 3.2#Chemical Modulation of Drug Flux --
3.2.1#Mechanisms of Chemical Penetration Enhancement --
3.2.1.1#Interaction (Disordering) of Intercellular Lipids --
3.2.1.2#Interactions within Corneocytes --
3.2.1.3#Alteration of Partitioning --
3.2.1.4#Other Mechanisms of Chemical Penetration Enhancement --
3.2.2#Common Chemical Penetration Enhancers --
3.2.2.1#Water --
3.2.2.2#Sulphoxides and Similar Chemicals --
3.2.2.3#Pyrrolidones --
3.2.2.4#Azone --
3.2.2.5#Fatty Acids --
3.2.2.6#Alcohols, Fatty Alcohols, and Glycols --
3.2.2.7#Surfactants --
3.2.2.8#Urea --
3.2.2.9#Terpenes --
3.2.2.10#Phospholipids --
3.2.2.11#Amino Acid-Based Enhancers --
3.2.2.12#Peptides --
3.2.3#Synergy between Chemical Penetration Enhancers --
3.2.4#General Comments on Penetration Enhancers --
3.3#Permeation Retardation --
3.4#Drug and Formulation Manipulation Strategies --
3.4.1#Prodrugs --
3.4.2#Ion-Pairing --
3.4.3#Eutectic Systems/Depression of Permeant Melting Point --
3.4.4#Supersaturation --
References --
Chapter 4: Physical and Technological Modulation of Topical and Transdermal Drug Delivery --
4.1#Introduction --
4.2#Vesicles --
4.2.1#Liposomes --
4.2.2#Non-Ionic Surfactant Vesicles (Niosomes) --
4.2.3#Highly Deformable (or Elastic) Liposomes-Transfersomes® --
4.2.4#Ethosomes --
4.2.5#Applicability --
4.3#Nanosystems --
4.4#Needleless Injection --
4.5#Physical Avoidance of the Stratum Corneum --
4.5.1#Laser Ablation --
4.5.2#Other Ablation Methods --
4.5.3#Microneedles --
4.6#Ultrasound --
4.7#Electrical Methods --
4.7.1#Iontophoresis --
4.7.2#Electroporation --
4.8#Heat (Thermophoresis) --
4.9#Combined Enhancement Strategies --
4.10#Summary --
Bibliography --
Chapter 5: Topical and Transdermal Formulation Development --
5.1#Introduction --
5.2#A Target Product Profile --
5.3#The Pharmaceutical Development Process --
5.4#Quality by Design. 5.4.1#The Principles of Quality by Design in Product Development --
5.4.2#Quality Target Product Profile and Critical Quality Attributes --
5.4.3#Risk Assessment (ICH Q9) --
5.4.4#Design Space (DS) and Development of the Design of Experiment --
5.5#Topical (Dermal) Formulation Options --
5.5.1#Liquid Formulations --
5.5.2#Semi-Solid Formulations --
5.5.2.1#Ointments --
5.5.2.2#Creams --
5.5.2.3#Gels --
5.5.3#Solid Formulations --
5.6#Transdermal Patch Options --
5.6.1#Transdermal Systems --
5.6.2#Transdermal Patches --
5.6.2.1#Types of Transdermal Patches --
5.6.2.2#Transdermal Patch Components --
5.7#PreFormulation Studies --
5.7.1#Overview --
5.7.2#Initial Considerations of the Drug --
5.7.2.1#Drug Physicochemical Properties --
5.7.2.2#Drug Pharmacology (Target) and Efficacy --
5.7.3#Preformulation --
5.7.3.1#Solubility --
5.7.3.2#Compatibility --
5.8#Formulation Development --
5.9#Some General Formulation Rules and Risk Mitigation --
5.9.1#Select a Good Drug Candidate --
5.9.2#Selection of Excipients for the Formulation of Choice --
5.9.2.1#Regulatory Perspective --
5.9.2.2#Role of Excipients --
5.9.3#Product "In Use" Considerations --
5.9.4#Thermodynamic Activity --
5.9.5#Be Realistic with Regard to Drug Enhancement and Localisation --
5.9.6#Alcohol Can Help --
5.9.7#Use an Appropriate Analytical Method --
5.9.8#Solution or Suspension --
5.9.9#Developing to Proof of Concept (PoC) or a Commercial Formulation --
5.9.10#Systemic Toxicity of a Topically Applied Drug --
5.10#Formulation Optimisation and Selection --
5.10.1#Formulation Optimisation --
5.10.2#Formulation Selection --
5.11#Formulation Characterisation and ICH Stability --
5.11.1#Formulation Characterisation --
5.11.1.1#Macroscopic/Microscopic Appearance and Odour --
5.11.1.2#Drug Content and Uniformity, Related Substances, and Degradation Products --
5.11.1.3#Preservative Content. 5.11.1.4#pH --
5.11.1.5#Rheology and Viscosity --
5.11.1.6#Microbial Quality or Microbial Limit Test (MLT) and Preservative Efficacy Test (PET) --
5.11.1.7#Sterility --
5.11.2#ICH Stability --
5.12#Case Studies --
Bibliography --
Chapter 6: Performance Testing --
6.1#Introduction --
6.2#In Vitro Drug Release Testing --
6.2.1#IVRT Method Design --
6.3#In Vitro (Ex Vivo) Drug Permeation and Penetration Testing (IVPT) --
6.3.1#The Choice of Membrane --
6.3.2#The Choice of Membrane Layer and Its Preparation --
6.3.3#The Choice of Diffusion Cell --
6.3.4#Formulation Application Considerations --
6.3.5#Permeant Detection --
6.3.6#Donor Solution Concentration --
6.3.7#Receptor Solution --
6.3.8#Integrity Checks --
6.3.9#Temperature --
6.3.10#Experimental Duration --
6.3.11#In Vitro Experiment Replicates --
6.3.12#Mass Balance --
6.3.13#Expression of Results --
6.3.14#Pivotal IVPT Methodological Design --
6.4#Activity/Disease Models --
6.4.1#Reconstituted Human Epithelium Activity/Disease Models --
6.4.2#Ex Vivo Human Skin Activity/Disease Models --
6.5#Summary --
Bibliography --
Chapter 7: Process Development Considerations for Topical and Transdermal Formulations --
7.1#Introduction --
7.2#Basic Principles of the Manufacture of Semi-Solids and Transdermal Patches --
7.2.1#Ointments --
7.2.2#Creams --
7.2.3#Gels --
7.2.4#Transdermal Patches --
7.3#Process Development and Scale-Up --
7.3.1#Process Risk Assessment --
7.3.2#Manufacturing Process --
7.3.2.1#Manufacturing Equipment Considerations --
7.3.2.2#Process Dynamics Involved in Manufacturing Topical Formulations --
7.3.2.3#Process Designing --
7.3.2.4#Process Optimisation --
7.3.2.5#Process Confidence --
7.3.3#Stability Studies --
7.3.3.1#Hold Time Studies --
7.3.3.2#ICH Stability --
7.3.4#Filling and Packaging Considerations --
7.3.5#Scale-Up Considerations --
7.4#Technology Transfer and Validation. 7.4.1#Technology Transfer --
7.4.1.1#Elements of Technology Transfer --
7.4.1.2#Process Development, QbD, and Robustness --
7.4.2#Process Validation --
7.5#Cost Improvement Programmes --
7.6#SUPAC --
7.7#Case Study --
Bibliography --
Index.
Series Title: Drugs and the Pharmaceutical Sciences Ser.

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