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Pharmaceutical Formulation: The Science and Technology of Dosage Forms [Hardback]

Edited by (King's College London and Geoff Tovey Associates, UK)
  • Formāts: Hardback, 431 pages, height x width: 234x156 mm, weight: 793 g, No
  • Sērija : Drug Discovery Series Volume 64
  • Izdošanas datums: 25-Jun-2018
  • Izdevniecība: Royal Society of Chemistry
  • ISBN-10: 1849739412
  • ISBN-13: 9781849739412
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Pharmaceutical Formulation: The Science and Technology of Dosage FormsPalielināt
  • Formāts: Hardback, 431 pages, height x width: 234x156 mm, weight: 793 g, No
  • Sērija : Drug Discovery Series Volume 64
  • Izdošanas datums: 25-Jun-2018
  • Izdevniecība: Royal Society of Chemistry
  • ISBN-10: 1849739412
  • ISBN-13: 9781849739412
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9781849739412.html
Keywords:
Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field.



Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development.



Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
Chapter 1 Performulation Studies
1(20)
Trevor M. Jones
1.1 Introduction
1(2)
1.2 Solubility
3(2)
1.2.1 Absolute (Intrinsic) Solubility
3(1)
1.2.2 Molecular Dissociation pKa
4(1)
1.2.3 Solubility in Various Solvents
4(1)
1.2.4 Solubility Rate (Dissolution)
5(1)
1.3 Diffusion
5(1)
1.4 Partition Coefficient
6(1)
1.5 Permeability
7(1)
1.6 The Biopharmaceutical Classification System
8(1)
1.7 Moisture Uptake/Sorption
9(3)
1.7.1 Classification of Hygroscopicity
10(2)
1.8 Polymorphism and Crystallinity
12(2)
1.8.1 Differential Scanning Calorimetry (DSC)
13(1)
1.8.2 Thermogravimetric Analysis (TGA)
13(1)
1.8.3 Powder X-ray Diffraction
13(1)
1.8.4 Crystallinity
14(1)
1.9 Stability
14(4)
1.9.1 Chemical Degradation in Solution
15(1)
1.9.2 Hydrolytic Degradation
16(1)
1.9.3 Stability in Solvents Used in Formulation and/or Manufacture
16(1)
1.9.4 Dimerization and Polymerisation
16(1)
1.9.5 Photostability
16(1)
1.9.6 pH-dependent Stability
17(1)
1.9.7 Oxidative Stability
17(1)
1.9.8 Stability--Compatibility
18(1)
1.10 Solid-state Physico-Technical Properties
18(3)
Further Reading
19(1)
References
19(2)
Chapter 2 Hard Capsules in Modern Drug Delivery
21(31)
S. Stegemann
W. Tian
M. Morgen
S. Brown
2.1 Introduction
21(1)
2.2 Hard Capsules---Types, Characteristics and Applications
22(7)
2.2.1 Hard Capsules as a Pharmaceutical Excipient
22(3)
2.2.2 Hard Capsules for Special Applications
25(4)
2.3 Selection of Capsules in Formulation Development
29(1)
2.4 Hard Capsule Drug Delivery Addressing Pharmaceutical Needs
29(10)
2.4.1 Hard Capsule Powder Blend Formulation and Processing
29(3)
2.4.2 Highly Potent and Low-dose Drug Formulations
32(1)
2.4.3 Enhancing Bioavailability of Poorly Aqueous Soluble Drugs
33(1)
2.4.4 Physical Modification of the Drug Substance
34(5)
2.5 Targeted Drug Delivery
39(4)
2.5.1 Capsules with Solid Formulation
39(3)
2.5.2 Abuse Deterrent
42(1)
2.6 Manufacture of Commercial Hard Capsules Products
43(1)
2.6.1 Powder and Granule Blends
43(2)
2.6.2 Multiparticulates and Mini-tablets
45(2)
2.6.3 Tablet Filling
47(1)
2.6.4 Liquid and Semi-solid Formulation
47(1)
2.6.5 Powder Micro-dosing
48(1)
2.7 Conclusions
48(4)
Acknowledgements
50(1)
References
50(2)
Chapter 3 Soft Capsules
52(26)
Stephen Tindal
3.1 Introduction
52(1)
3.2 Background
53(1)
3.3 Technology Strengths/Limitations
54(1)
3.4 Description
55(2)
3.5 Equipment and Facilities
57(1)
3.6 Shell Components
58(1)
3.7 Fill Formulation
59(3)
3.8 Product Development
62(4)
3.8.1 Fill Formulation Development Processes
62(1)
3.8.2 Shell Compatibility
63(1)
3.8.3 Prototype Manufacture
64(1)
3.8.4 Process Development
65(1)
3.9 Clinical Supply
66(1)
3.10 Analytical Considerations
67(1)
3.11 Excipient Considerations
67(2)
3.11.1 Gelatin
68(1)
3.11.2 Plasticizers
68(1)
3.11.3 Water
69(1)
3.11.4 Colors, Opacifiers etc.
69(1)
3.11.5 Ingredient Specifications
69(1)
3.12 Packaging and Stability Considerations
69(1)
3.13 Manufacturing Process
70(2)
3.14 Key Process and Product Parameters
72(3)
3.14.1 In-process Testing
72(1)
3.14.2 Setup (Pre-start)
73(1)
3.14.3 During Encapsulation
73(1)
3.14.4 During Drying
74(1)
3.14.5 Finished Product
74(1)
3.15 Recent Technology Advances
75(1)
3.15.1 Film Coating
75(1)
3.15.2 Non-gelatin Shell and Controlled Release Fill
75(1)
3.15.3 Vaginal Dosage Forms
75(1)
3.16 Trends in Patent Activity
75(1)
3.17 Conclusions
76(2)
References
76(2)
Chapter 4 Tablet Formulation
78(27)
K. G. Pitt
4.1 Tablet Formulation
78(6)
4.1.1 Free Flowing
82(1)
4.1.2 Good Compression Properties
82(1)
4.1.3 Low Ejection Shear Stress
82(1)
4.1.4 Good Content Uniformity and Low Segregation Potential
83(1)
4.1.5 Rapid Disintegration and Dissolution
83(1)
4.1.6 Low Friability
83(1)
4.2 Impurity
84(1)
4.3 Types and Uses of Tablets
84(1)
4.3.1 Controlled-release Tablets
84(1)
4.3.2 Enteric Coated Tablets
85(1)
4.3.3 Buccal and Sublingual
85(1)
4.3.4 Soluble Tablets
85(1)
4.3.5 Chewable Tablets
85(1)
4.3.6 Vaginal Tablets
85(1)
4.4 Formulation Components
85(1)
4.5 Tabletting Material Preparation
86(3)
4.5.1 Wet Granulation
86(1)
4.5.2 Roller Compaction (Dry Compression) or Slugging
87(1)
4.5.3 Direct Compression
88(1)
4.6 Components of Tablet Formulations
89(6)
4.6.1 Compression Aids and Fillers
89(2)
4.6.2 Binders
91(1)
4.6.3 Disintegrants
92(1)
4.6.4 Lubricants
93(1)
4.6.5 Glidants
94(1)
4.6.6 Wetting Agents
95(1)
4.6.7 Flavours
95(1)
4.6.8 Colouring Agents
95(1)
4.6.9 Stability Enhancers
95(1)
4.7 Tabletting Problems and Solutions
95(6)
4.7.1 Cracking
96(2)
4.7.2 Low Tensile Strength
98(1)
4.7.3 Picking and Sticking
98(1)
4.7.4 Pitted or Fissured Surface
99(1)
4.7.5 Chipping
99(1)
4.7.6 Binding in the Die
99(1)
4.7.7 Uneven Weight Control
99(1)
4.7.8 Disintegration and Dissolution
100(1)
4.7.9 Mottled Appearance
101(1)
4.8 Formulation Considerations for Specific Tablet Dosage Forms and Processes
101(4)
4.8.1 Multilayer Tablet Formulation
101(1)
4.8.2 Minitablets
101(1)
4.8.3 Continuous Processing Formulation Considerations
102(1)
References
103(2)
Chapter 5 Suspension Quality by Design
105(21)
Brian A. C. Carlin
5.1 Introduction
105(1)
5.2 Suspension Quality by Design (QbD)
106(1)
5.3 Suspension Types
106(3)
5.4 Suspension Formulation Strategies
109(1)
5.5 Suspending Agents
109(2)
5.5.1 Clays
109(1)
5.5.2 Water-soluble Polymers
110(1)
5.5.3 Dispersible Cellulose
111(1)
5.6 Suspension Rheology and Rheometry
111(6)
5.6.1 Suspension Rheology
112(2)
5.6.2 Suspension Rheometry
114(3)
5.7 Suspension Formulation
117(4)
5.7.1 Chemical Stability
117(1)
5.7.2 Physical Stability
118(1)
5.7.3 Microbiological Considerations
118(1)
5.7.4 Formulation
119(2)
5.8 Manufacture
121(2)
5.9 Specification
123(1)
5.10 Conclusions
124(2)
References
124(2)
Chapter 6 Excipients: Kano Analysis and Quality by Design
126(23)
Brian A. C. Carlin
C. G. Wilson
6.1 Excipients
126(5)
6.2 Quality by Design (QbD)
131(5)
6.2.1 Criticality
132(2)
6.2.2 Complexity
134(1)
6.2.3 Special Cause Variation
135(1)
6.2.4 "Critical" vs. "Non-critical" Excipients
136(1)
6.3 Kano Analysis
136(4)
6.3.1 Kano Basic
137(1)
6.3.2 Kano Exciters
138(1)
6.3.3 Kano Performance
138(2)
6.4 Factoring Excipients into QbD During Development
140(1)
6.5 Kxcipient Samples for QbD
141(2)
6.6 All Excipients Are Critical
143(1)
6.7 Control Strategy and Changes in Excipient Criticality During the Lifecycle
144(2)
6.8 Conclusions
146(3)
References
146(3)
Chapter 7 Film Coating of Tablets
149(24)
Marshall Whiteman
7.1 Introduction
149(1)
7.2 Sugar Coating
150(1)
7.3 Film Coating Formulation and Materials
151(8)
7.3.1 Tablet Cores
151(1)
7.3.2 Polymers
152(4)
7.3.3 Plasticisers
156(1)
7.3.4 Colours
157(2)
7.3.5 Solvent or Continuous Phase
159(1)
7.3.6 Other Components
159(1)
7.4 The Coating Process
159(6)
7.4.1 Film Coating Equipment
159(1)
7.4.2 Preparation of the Coating Liquid
160(1)
7.4.3 Application of the Coating Liquid
161(3)
7.4.4 Distribution and Mixing
164(1)
7.4.5 Drying
165(1)
7.4.6 Control
165(1)
7.4.7 Effects of Process Parameters on Product Quality
165(1)
7.5 Evaluating Film Coats
165(5)
7.5.1 Appearance
167(1)
7.5.2 Colour
167(1)
7.5.3 Gloss
167(1)
7.5.4 Roughness
168(1)
7.5.5 Tensile Strength
168(1)
7.5.6 Adhesion
168(1)
7.5.7 Moisture Vapour Transmission Rate (MVTR)
169(1)
7.5.8 Glass Transition Temperature
169(1)
7.5.9 Minimum Film Forming Temperature (MFFT)
169(1)
7.5.10 Enteric Tests
170(1)
7.6 Conclusions
170(3)
References
170(3)
Chapter 8 Oral Controlled Release Technology and Development Strategy
173(59)
Christian Seiler
8.1 Introduction
173(3)
8.2 Key Considerations for Oral Controlled Release Development
176(3)
8.2.1 Gastrointestinal Environment
176(1)
8.2.2 API Attributes
177(2)
8.2.3 Manufacturability and Quality-by-Design (QbD)
179(1)
8.3 Process Technologies Utilised for Controlled Release Dosage Forms
179(6)
8.3.1 Conventional Manufacturing Technology
179(1)
8.3.2 Rotary Granulation Technology
179(1)
8.3.3 Extrusion--Spheronisation (E--S) Technology
180(2)
8.3.4 Hot-Melt Extrusion (HMEJ/Hot-Melt Pelletisation (HMP)
182(2)
8.3.5 Wurster-based Coating of Controlled Release Pellets or Multiparticulates
184(1)
8.4 Key Oral Controlled Release Technologies
185(37)
8.4.1 Hydrophilic Matrix Tablets
185(9)
8.4.2 Inert Matrix Tablets
194(1)
8.4.3 Controlled Release Pellets/Multiparticulates
195(18)
8.4.4 Osmotic Drug Delivery Systems
213(5)
8.4.5 Proprietary and Other Controlled Release Technologies
218(4)
8.5 Evaluation of Controlled Release Dosage Form Performance
222(10)
8.5.1 Invitro Evaluation
222(2)
8.5.2 Pre-clinical Species
224(1)
8.5.3 Clinical Evaluation
225(3)
Acknowledgements
228(1)
References
228(4)
Chapter 9 Less Common Dosage Forms
232(26)
Stephen Wicks
9.1 Introduction
232(1)
9.2 Why Are Alternative Dosage Forms Important?
232(1)
9.3 Alternative Dosage Form Formulation Design and Control
233(6)
9.3.1 Drug Delivery in and via the Skin
233(6)
9.4 Ophthalmic Drug Delivery
239(3)
9.4.1 Formulation Design and Controls for Ophthalmic Drug Delivery
239(2)
9.4.2 Derivatised Cyclodextrins and Ophthalmic Dosage Forms
241(1)
9.5 Drugs Given by Inhalation
242(16)
9.5.1 Inhalation Drug Delivery Devices
243(11)
References
254(4)
Chapter 10 Paediatric Pharmaceutics---The Science of Formulating Medicines for Children
258(30)
Mine Orlu
Smita Salunke
Catherine Tuleu
10.1 Introduction
258(6)
10.1.1 Children and Their Specific Needs
258(1)
10.1.2 Children and Their Medicines
259(5)
10.2 Paediatric Drug Development: Key Attributes
264(16)
10.2.1 Dosage Form Design
264(2)
10.2.2 Excipients
266(13)
10.2.3 Administration
279(1)
10.3 Patient Centric Pharmaceutical Drug Product Design and Future Visions
280(8)
References
281(7)
Chapter 11 The Formulation of Biological Molecules
288(29)
Tudor Arvinte
Amelia Cudd
Caroline Palais
Emilie Poirier
11.1 Definitions: Biologies and Their Formulations
288(2)
11.2 Formulation of Small Molecules VS. Biopharmaceutics
290(4)
11.3 The Importance of Formulation
294(2)
11.4 The Importance of Analytical Methods
296(1)
11.5 Potential for Particle Formation In vivo: Studies of Aggregates Formation After Mixing of Biopharmaceutics with Human Plasma and Human Blood
297(6)
11.5.1 Aggregation in Plasma
297(2)
11.5.2 Aggregation in Blood
299(4)
11.6 New Formulation Strategy: High-throughput Analysis and High-throughput Formulation
303(8)
11.6.1 HTF Methods
303(6)
11.6.2 HTA Methods
309(2)
11.7 The Biopharmaceutical Industry Today
311(6)
References
314(3)
Chapter 12 Intellectual Property
317(26)
Dominic Adair
Chloe Dickson
12.1 Introduction to Intellectual Property
317(1)
12.2 Patents
318(10)
12.2.1 The Patent System
320(2)
12.2.2 Challenges to the Validity of a Patent
322(1)
12.2.3 Prior Disclosure
322(1)
12.2.4 Clinical Trials
322(1)
12.2.5 Life Cycle Management
323(1)
12.2.6 Case Law on Formulation Patents
324(4)
12.2.7 Conclusion
328(1)
12.3 Protecting a Product's Appearance
328(15)
12.3.1 Trade Marks
328(7)
12.3.2 Design Rights
335(2)
12.3.3 Other Rights and Protection
337(4)
References
341(2)
Chapter 13 User-friendly Medicines
343(36)
Clive Wilson
Martin Koeberle
13.1 The Concept of User-friendly Medicine
343(1)
13.2 The Relevance of User-friendly Medicine to the Patient
344(9)
13.2.1 The Issue of Swallowing
345(1)
13.2.2 Organoleptic Assessments and Presentation
346(1)
13.2.3 The Issue of Taste
347(2)
13.2.4 Assessing Taste
349(4)
13.2.5 The Interplay Between Taste, Texture and Smell
353(1)
13.3 Palatability of Medicines: an Issue for Children
353(3)
13.3.1 Dosing Issues in Paediatric Medicines
354(1)
13.3.2 The Design of Paediatric Medicines
355(1)
13.4 The Elderly: Living Longer
356(2)
13.4.1 The Elderly and Flavour Preferences
357(1)
13.4.2 Community Homes Practice and Geriatric Medicine
357(1)
13.5 Mothers and Potential Mothers
358(1)
13.6 Maximizing the Innovative Value of Pharmaceutical Products
359(6)
13.6.1 Innovation Through User-friendly Formulations
360(4)
13.6.2 Enabling High-dose APIs and Combined Dosage Forms
364(1)
13.6.3 Packaging
365(1)
13.7 Challenges in Developing and Manufacturing User-friendly Dosage Forms
365(12)
13.7.1 Product Design and Formulation Development: Defining API Characteristics and Matching the Right Dosage Form
365(1)
13.7.2 Taste-masking in Oral Pharmaceuticals
366(3)
13.7.3 Manufacturing
369(8)
13.8 Concluding Remarks
377(2)
References 379(7)
Subject Index 386