Aulton's Pharmaceutics
The Design and Manufacture of Medicines
Edited by
M i c h a e l E . AultOriBPharmPhDFAAPSFRPharmS
THIRD EDITION
CHURCHILL LIVINGSTONE
11 si \ 1 1
EDINBURGH LONDON NEW YORK OXFORD PHILADELPHIA ST LOUIS SYDNEY TORONTO 2007
Contents
What is "pharmaceutics'? 1 Design of dosage forms 4
12 13
Mixing 152
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Powder flow 168
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PART1 Scientific principles of dosage form design 15 2 3 4 5 6 7 Dissolution and solubility 16
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PART 3 Pharmaceutical microbiology and sterilization 181 14 15 Fundamentals of microbiology 182
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Properties of solutions 33
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Rheology 42
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Pharmaceutical applications of microbiological techniques 205
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Surface and interracial phenomena 59 ./. / I'll Disperse systems 70
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16
Action of physical and chemical agents on microorganisms 225
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17 18
Principles of sterilization 242 V A. Wuhh. ./>: Maillanl Sterilization in practice 251
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Kinetics of product stability 99
PART 2 Particle science and powder technology 109 8 9 10 Solid-state properties 1 0 1
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PART 4 Biopharmaceutical principles of drug delivery 265 19 20 Introduction to biopharmaceutics 266
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Particle size analysis 121
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Particle size reduction 137
./. ,V. Stdiiifurth, M. E. Altitun
Gastrointestinal tract - physiology and drug absorption 270 M. Ashfoni Bioavailability - physicochemical and dosage form factors 286 M. Ashfoni
21
11 Particle size separation 145 ./. N. Staniforth. M. E. Aulton
CONTENTS
22
Assessment of biopharmaceutical properties 304
34
Hard gelatin capsules II /.'. Junes
515
M. Ashtonl 35 23 Dosage regimens ./. //. (ulleti 324 36 Soft gelatin capsules 527 K. (i. Hutchison, J. lerdiiidinlu Pulmonary drug delivery A. M (i. Taylor Nasal drug delivery /' M Idxlur 555 539
PART 5 Dosage form design and manufacture 335
24 Pharmaceutical preformulation
./. /. Wells. M /;. Altitun
37
38 336 39 25 26 27 Solutions 361 M. K. Billanv 40 Clarification 374 A. M. Iw it, hell 41 Suspensions and emulsions M. R HilldiiY Powders and granules M I' Summers 406 43 29 Granulation 410 M. I' Summers, M. E. Aiilton Drying 425 M. /.. Aultnn Tablets and compaction (/'. Alderhuni 441 44 383 42 28
Transdermal drug delivery B. W. Barrx Wound dressings (7. M. Ea lestun 598
565
Rectal and vaginal drug delivery ./. ./. Tukker
606
Delivery of pharmaceutical proteins 616 I). ./. A. Cruinmelln, E. van Wiiuicn. A. Mckkinti Packs and packaging /' M. Taylor 626
Microbial contamination, spoilage and preservation of medicines 640 A'. A. HudKe\ Product stability and stability testing
A. R. Barnes
30 31 32
650
45
Pharmaceutical plant design M. /;. Aulton, A. M. Twitehell
666
Modified-release peroral dosage forms 483 ./. H. Collclt. R. ('. Moreton Coating of tablets and multiparticulates 500 S. C. Porter
46
H e a t transfer and the properties and use
of steam 679 /\. M. Twitehell Index 691
33