Divided into three clear sections, the text begins with Section A - Consideration for Product: Medicinal Formulation which includes a historical perspective, explanation of what is an emulsion, stability and instability, and manufacture. Section B - Forms, Use and Application follows, with chapters on creams and ointments, pastes and bases, colloids, transdermal, gels and implants. The final Section, Tests: Chemistry to control the quality, efficacy and fitness for purpose of the product includes chapters on physic-chemical properties, sizing and microscopy, rheology, QC and finally questions, calculations and dilemmas. Throughout the text there are numerous figures, diagrams and tables to engage the reader.
This is an invaluable reference for all students of pharmaceutical sciences, pharmacy industrial pharmaceutical sciences, physical pharmacy and pharmaceutical forms as well as industry professionals
Table of Contents
Mathematical symbols (with normal units) xiAcronyms and abbreviations xiii
Preface xv
Acknowledgements xvii
About the companion website xix
I Product considerations: medicinal formulations 1
1 Historical perspective 5
1.1 Landmarks 5
1.2 Significant discoveries 7
1.3 Difficulties 8
1.4 Traditional uses 10
1.5 Product regulation 13
2 What is an emulsion? 15
2.1 States of matter 24
2.2 Summary thermodynamics 34
2.3 Interfacial tension and wetting 36
2.4 Shear and size reduction 46
2.5 Raw materials 47
3 Stability, metastability and instability 49
3.1 Stokes’ law 51
3.2 Derjaguin–Landau–Verwey–Overbeek (DLVO) theory 52
3.3 Interfacial rheology 56
4 Manufacture 63
4.1 Premixing 63
4.2 High-shear mixers and size reduction 64
4.3 Multiple and microemulsions 65
4.4 Hot melt (steriles) 65
4.5 Filling 66
II Forms, uses and applications: biopharmaceutics 67
5 Creams and ointments 69
5.1 Nutraceuticals and cosmeceuticals 71
5.2 Medicinals 71
6 Pastes and bases 77
6.1 Emolliency 77
6.2 Suppositories 78
6.3 Pessaries 79
7 IV colloids 81
7.1 Needle free 86
7.2 Ocular therapy 87
7.3 Cancer 88
7.4 Antimicrobials 90
7.5 Temperature-sensitive matrices and release forms 93
7.6 Targeted endosomal use 94
7.7 Solid lipid nanoparticles 95
7.8 Diagnostic emulsions 98
8 Transdermal patches: semisolids 99
8.1 Hormones 104
8.2 Analgesia 104
8.3 Anaesthesia 104
8.4 Nicotine 105
8.5 Inserts: vaginal rings 105
9 Gels 107
9.1 Micro- and nanogels 107
9.2 Semisolids 107
10 Implants 109
10.1 Plastics and glasses 109
10.2 Thermoresponsive materials 110
11 De novo science, sustainable novel products and platform applications 111
11.1 Tablets 113
11.2 Metered-dose inhalers 113
11.3 Blood substitutes 114
III Tests: chemistry to control the quality, efficacy and fitness for purpose of a product 117
12 Physicochemical properties 119
12.1 Thermal evaluation (differential scanning calorimetry) and lipid polymorphs 124
12.2 Drug form, log P and Lipinski rules 129
12.3 Skin and epithelial models 133
12.4 Drug delivery routes 134
13 Sizing and microscopy 137
13.1 ζ -potential 137
13.2 Hydrodynamic diameter 139
14 Rheology, texture, consistency and spreadability 141
14.1 Bulk properties 141
14.2 Solid-state and nanorheological properties 144
14.3 Interfacial properties 144
15 Quality control, process analytical technology and accelerated testing 149
15.1 Preformulation, high-throughput screening 150
15.2 Industrial concerns 151
15.3 Rancimat and other methods 152
Questions 155
Guide for readers 155
Specimen 'test' questions 155
Answers 168
References 173
Index 181
