Pharmaceutical Manufacturing Handbook: Production and

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5.8 AEROSOL DRUG DELIVERY Michael Hindle Virginia Commonwealth University, Richmond, Virginia Contents 5.8.1 5.8.2 5.8.3 5.8.4 5.8.5 5.8.6 5.8.7 Introduction Human Respiratory Tract and Aerosol Particle Deposition 5.8.2.1 Human Respiratory Tract 5.8.2.2 Mechanisms of Particle Deposition 5.8.2.3 Pharmacokinetics Therapeutic Indications for Aerosol Delivery 5.8.3.1 Current Applications 5.8.3.2 Future Applications Aerosol Drug Delivery Devices 5.8.4.1 Introduction 5.8.4.2 Characteristics of Ideal Delivery Device Metered Dose Inhalers 5.8.5.1 Introduction 5.8.5.2 Metered Dose Inhaler and HFA Reformulation 5.8.5.3 Propellants 5.8.5.4 Excipients 5.8.5.5 Valves 5.8.5.6 Actuators 5.8.5.7 Canisters 5.8.5.8 Breath Actuation 5.8.5.9 Spacers 5.8.5.10 Dose Counters Dry Powder Inhalers 5.8.6.1 Introduction 5.8.6.2 Size Reduction and Particle Formation Technologies 5.8.6.3 Drug – Lactose Formulations 5.8.6.4 Dry Powder Inhaler Design 5.8.6.5 Exubera Nebulizers Pharmaceutical Manufacturing Handbook: Production and Processes, edited by Shayne Cox Gad Copyright © 2008 John Wiley & Sons, Inc. 683
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PHARMACEUTICAL MANUFACTURING HANDBO
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PHARMACEUTICAL MANUFACTURING HANDBO
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CONTRIBUTORS Susanna Abrahms é n -
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CONTRIBUTORS vii Eddy Castellanos G
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CONTENTS PREFACE xiii SECTION 1 MAN
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CONTENTS xi 5.11 Transdermal Drug D
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SECTION 1 MANUFACTURING SPECIALTIES
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4 BIOTECHNOLOGY-DERIVED DRUG PRODUC
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10 BIOTECHNOLOGY-DERIVED DRUG PRODU
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34 REGULATORY CONSIDERATIONS IN APP
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1.3 RADIOPHARMACEUTICAL MANUFACTURI
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The terms tracer, radiotracer , and
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number of atoms that disintegrate d
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images that can also give quantitat
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PRODUCT DEVELOPMENT 67 Product Stab
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MANUFACTURING ASPECTS 69 stations s
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In general, the manufacturing of mo
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MANUFACTURING ASPECTS 73 Production
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PRODUCT MANUFACTURING 75 tainer. Th
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PRODUCT MANUFACTURING 77 practical
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PRODUCT MANUFACTURING 79 these radi
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PRODUCT MANUFACTURING 81 Most of th
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PRODUCT MANUFACTURING 83 PET Radiop
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PRODUCT MANUFACTURING 85 FIGURE 5 S
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PRODUCT MANUFACTURING 87 tions in t
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QUALITY CONSIDERATIONS 89 regulatio
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L1 L2 TC-MDP + Hydr. Tc TC-MDP + Tc
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EXTEMPORANEOUS PREPARATION OF RADIO
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Independent of which regulation app
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SECTION 2 ASEPTIC PROCESSING
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100 STERILE PRODUCT MANUFACTURING 2
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102 STERILE PRODUCT MANUFACTURING A
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104 STERILE PRODUCT MANUFACTURING T
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106 STERILE PRODUCT MANUFACTURING E
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108 STERILE PRODUCT MANUFACTURING I
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112 STERILE PRODUCT MANUFACTURING c
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118 STERILE PRODUCT MANUFACTURING i
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120 STERILE PRODUCT MANUFACTURING o
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122 STERILE PRODUCT MANUFACTURING a
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124 STERILE PRODUCT MANUFACTURING a
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126 STERILE PRODUCT MANUFACTURING e
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128 STERILE PRODUCT MANUFACTURING A
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132 STERILE PRODUCT MANUFACTURING p
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SECTION 3 FACILITY
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140 EFFECT OF SCALE-UP ON OPERATION
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160 PACKAGING AND LABELING 3.2.1 3.
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162 PACKAGING AND LABELING signifi
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164 PACKAGING AND LABELING Although
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166 PACKAGING AND LABELING componen
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168 PACKAGING AND LABELING sions. T
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170 PACKAGING AND LABELING TABLE 1
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172 PACKAGING AND LABELING the stab
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174 PACKAGING AND LABELING and accu
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176 PACKAGING AND LABELING The safe
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178 PACKAGING AND LABELING If the p
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180 PACKAGING AND LABELING exposure
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182 PACKAGING AND LABELING In many
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184 PACKAGING AND LABELING Nonpharm
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186 PACKAGING AND LABELING In 1906,
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188 PACKAGING AND LABELING A medica
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190 PACKAGING AND LABELING The inst
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192 PACKAGING AND LABELING the poun
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194 PACKAGING AND LABELING • (4)
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196 PACKAGING AND LABELING In the c
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198 PACKAGING AND LABELING • Inte
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200 PACKAGING AND LABELING 27. U.S.
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202 CLEAN-FACILITY DESIGN, CONSTRUC
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4.1 SOLID DOSAGE FORMS Barbara R. C
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TABLE 2 Types of Solid Dosage Form
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(GI) tract or for systemic effects.
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EXCIPIENTS IN SOLID DOSE FORMULATIO
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EXCIPIENTS IN SOLID DOSE FORMULATIO
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HARD AND SOFT GELATIN CAPSULES 245
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participants from the FDA, industry
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in the mouth. Compressed lozenges (
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ittle fi lm, have no unpleasant tas
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CHEWING GUMS 257 4.1.10.2 Manufactu
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already dissolved in the saliva pri
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ORALLY DISINTEGRATING TABLETS 261 a
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tions. Some buccal formulations hav
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REFERENCES 265 32. Habib , W. , Kha
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268 SEMISOLID DOSAGES: OINTMENTS, C
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314 LIQUID DOSAGE FORMS 4.3.1 INTRO
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316 LIQUID DOSAGE FORMS 4.3.2 GENER
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318 LIQUID DOSAGE FORMS design, bui
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320 LIQUID DOSAGE FORMS tions with
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322 LIQUID DOSAGE FORMS Dosing Pump
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324 LIQUID DOSAGE FORMS However, th
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326 LIQUID DOSAGE FORMS Location of
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328 LIQUID DOSAGE FORMS Solid drugs
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330 LIQUID DOSAGE FORMS TABLE 3 Emu
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332 LIQUID DOSAGE FORMS Temperature
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334 LIQUID DOSAGE FORMS for viscosi
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336 LIQUID DOSAGE FORMS spectrum, s
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338 LIQUID DOSAGE FORMS Product Spe
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340 LIQUID DOSAGE FORMS Liquid, Ext
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342 LIQUID DOSAGE FORMS 7. Kourouna
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344 LIQUID DOSAGE FORMS 46. Miller
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5.1 CONTROLLED - RELEASE DOSAGE FOR
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CONTROLLED-RELEASE DRUG DELIVERY SY
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CONTROLLED-RELEASE FORMULATIONS 351
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dosage forms [12] . For example, or
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Degradation Liver Hydrolytic Enzyma
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CONTROLLED-RELEASE ORAL DOSAGE FORM
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DESIGN AND FABRICATION OF CONTROLLE
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TECHNOLOGIES FOR DEVELOPING TRANSDE
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TECHNOLOGIES FOR DEVELOPING TRANSDE
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RELEASE OF DRUGS FROM CONTROLLED-RE
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REFERENCES 387 16. Anal , A. K. ( 2
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REFERENCES 389 57. M ü ller , R. H
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REFERENCES 391 96. Sungthongjeen ,
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5.2 PROGRESS IN DESIGN OF BIODEGRAD
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INTRODUCTION 395 sequences. In addi
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TABLE 2 Injectable Peptide/Proteins
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PEPTIDE/PROTEIN-LOADED MICROSPHERE
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ANALYTICAL CHARACTERIZATION 405 imm
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IMMUNE SYSTEM INTERACTION WITH INJE
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INJECTABLE PEPTIDE/PROTEIN-LOADED M
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PEPTIDE/PROTEIN ENCAPSULATED INTO B
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REFERENCES 427 novel ways to reduce
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REFERENCES 429 31. Morlock , M. , K
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REFERENCES 431 63. Lam , X. M. , Du
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REFERENCES 433 95. van de Weert , M
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REFERENCES 435 130. Bilati , U. , A
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REFERENCES 437 166. Means , G. E. ,
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REFERENCES 439 bic poly(lactide -co
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REFERENCES 441 237. Singh , M. , Li
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444 LIPOSOMES AND DRUG DELIVERY (sm
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446 LIPOSOMES AND DRUG DELIVERY Con
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448 LIPOSOMES AND DRUG DELIVERY and
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450 LIPOSOMES AND DRUG DELIVERY tec
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452 LIPOSOMES AND DRUG DELIVERY 250
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454 LIPOSOMES AND DRUG DELIVERY a s
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456 LIPOSOMES AND DRUG DELIVERY For
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458 LIPOSOMES AND DRUG DELIVERY con
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460 LIPOSOMES AND DRUG DELIVERY The
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462 LIPOSOMES AND DRUG DELIVERY in
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464 LIPOSOMES AND DRUG DELIVERY c a
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466 LIPOSOMES AND DRUG DELIVERY Eve
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468 LIPOSOMES AND DRUG DELIVERY inc
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470 LIPOSOMES AND DRUG DELIVERY wit
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472 LIPOSOMES AND DRUG DELIVERY i.v
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474 LIPOSOMES AND DRUG DELIVERY for
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476 LIPOSOMES AND DRUG DELIVERY bet
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478 LIPOSOMES AND DRUG DELIVERY cli
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480 LIPOSOMES AND DRUG DELIVERY lea
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482 LIPOSOMES AND DRUG DELIVERY Vag
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484 LIPOSOMES AND DRUG DELIVERY TAB
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486 LIPOSOMES AND DRUG DELIVERY thr
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488 LIPOSOMES AND DRUG DELIVERY TAB
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490 LIPOSOMES AND DRUG DELIVERY tar
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492 LIPOSOMES AND DRUG DELIVERY tha
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494 LIPOSOMES AND DRUG DELIVERY wit
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496 LIPOSOMES AND DRUG DELIVERY Pul
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498 LIPOSOMES AND DRUG DELIVERY whi
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500 LIPOSOMES AND DRUG DELIVERY Inc
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502 LIPOSOMES AND DRUG DELIVERY Per
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504 LIPOSOMES AND DRUG DELIVERY can
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506 LIPOSOMES AND DRUG DELIVERY Tum
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508 LIPOSOMES AND DRUG DELIVERY 25.
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5.4 BIODEGRADABLE NANOPARTICLES Sud
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NATURAL BIODEGRADABLE POLYMERIC NAN
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and drug loading of gliadin nanopar
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SYNTHETIC BIODEGRADABLE POLYMERIC N
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APPLICATIONS OF BIODEGRADABLE NANOP
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PHYSICOCHEMICAL CHARACTERIZATION OF
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TARGETING NANOPARTICLES BY SURFACE
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5.4.9 CONCLUSIONS Biodegradable nan
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REFERENCES 555 of a model protein (
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REFERENCES 557 65. Kaul , G. , and
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REFERENCES 559 99. Carino , G. P. ,
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REFERENCES 561 133. Na , K. , Lee ,
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REFERENCES 563 168. Freitas , C. ,
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5.5 RECOMBINANT SACCHAROMYCES CEREV
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Potential Medical Applications of B
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BIODRUG CONCEPT USING YEAST AS VECT
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BIODRUG CONCEPT USING YEAST AS VECT
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Cumulative ileal delivery of viable
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tine [30] . No signal was detectabl
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ORAL FORMULATION OF RECOMBINANT YEA
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Cumulative ileal delivery of viable
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ORAL FORMULATION OF RECOMBINANT YEA
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Viable yeasts released (% of initia
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Steidler et al. [47] have already d
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REFERENCES 587 23. Steidler , L. (
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REFERENCES 589 nant yeasts as novel
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5.6 NASAL DELIVERY OF PEPTIDE AND N
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fi rst - pass metabolism and gut -
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[6] . The nasal blood vessels can b
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FACTORS INFLUENCING NASAL DRUG ABSO
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5.6.3.6 Type of Delivery Device FAC
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FACTORS INFLUENCING NASAL DRUG ABSO
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FIGURE 4 ( a ) Optinose multidose l
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Dogs, sheep, and monkeys can be kep
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NASAL DELIVERY OF PEPTIDE AND HIGH-
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in solutions containing different c
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Morphine plasma concentration (nmol
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Concentration (μg/L) 1000 100 10 1
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NASAL DELIVERY OF NONPEPTIDE MOLECU
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NASAL DELIVERY OF NONPEPTIDE MOLECU
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Page 649 and 650: pseudostratifi ed epithelium compri
Page 651 and 652: NASAL DELIVERY OF VACCINES 635 Howe
Page 653 and 654: TABLE 5 Continued Delivery System/A
Page 655 and 656: REFERENCES 639 23. Hardy , J. G. ,
Page 657 and 658: REFERENCES 641 60. Collens , W. S.
Page 659 and 660: REFERENCES 643 97. Eden , S. ( 1979
Page 661 and 662: REFERENCES 645 comparison with oral
Page 663 and 664: REFERENCES 647 172. Sakane , T. , A
Page 665 and 666: REFERENCES 649 213. McCluskie , M.
Page 667 and 668: 5.7 NASAL POWDER DRUG DELIVERY Jele
Page 669 and 670: NASAL DRY POWDER FORMULATIONS 653 t
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Page 675 and 676: MICROSPHERES AS NASAL DRUG DELIVERY
Page 683 and 684: TOXICOLOGICAL CONSIDERATIONS 667 et
Page 685 and 686: Summary of Research Work on Nasal D
Page 687 and 688: Powder Formulation Preparation Meth
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Page 691 and 692: REFERENCES 675 19. Van der Lubben ,
Page 693 and 694: REFERENCES 677 54. Witschi , C. , a
Page 695 and 696: REFERENCES 679 91. Varshosaz , J. ,
Page 697: REFERENCES 681 126. Jorissen , M. ,
Page 701 and 702: HUMAN RESPIRATORY TRACT AND AEROSOL
Page 703 and 704: 5.8.3 THERAPEUTIC INDICATIONS FOR A
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Page 707 and 708: FIGURE 1 Schematic of MDI. METERED
Page 709 and 710: TABLE 2 Property METERED DOSE INHAL
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Page 717 and 718: 5.8.6.2 Size Reduction and Particle
Page 719 and 720: DRY POWDER INHALERS 703 recognized
Page 721 and 722: DRY POWDER INHALERS 705 Spinhaler f
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Page 725 and 726: EMERGING TECHNOLOGIES 709 Mouthpiec
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Page 729 and 730: REFERENCES 713 22. Kim , C. S. , an
Page 731 and 732: REFERENCES 715 61. Blanchard , J. D
Page 733 and 734: REFERENCES 717 100. Dolovich , M. B
Page 735 and 736: REFERENCES 719 136. Anonymous ( 200
Page 737 and 738: REFERENCES 721 170. Ward , G. H. ,
Page 739 and 740: REFERENCES 723 206. Young , P. M. ,
Page 741 and 742: REFERENCES 725 244. DeFronzo , R. A
Page 743: REFERENCES 727 280. Schurmann , W.
Page 746 and 747: 730 OCULAR DRUG DELIVERY tissues. T
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732 OCULAR DRUG DELIVERY FIGURE 3 S
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734 OCULAR DRUG DELIVERY melanocyte
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736 OCULAR DRUG DELIVERY represents
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738 OCULAR DRUG DELIVERY TABLE 1 Su
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740 OCULAR DRUG DELIVERY TABLE 1 Co
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742 OCULAR DRUG DELIVERY TABLE 2 Ma
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744 OCULAR DRUG DELIVERY shear - th
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746 OCULAR DRUG DELIVERY 5.9.3.3 Co
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748 OCULAR DRUG DELIVERY tigated in
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750 OCULAR DRUG DELIVERY that w/o M
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752 OCULAR DRUG DELIVERY [138, 232]
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754 OCULAR DRUG DELIVERY Only a few
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756 OCULAR DRUG DELIVERY 32. Schoen
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758 OCULAR DRUG DELIVERY 70. Shibuy
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760 OCULAR DRUG DELIVERY 105. Diepo
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762 OCULAR DRUG DELIVERY 139. Maest
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764 OCULAR DRUG DELIVERY 175. Davie
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766 OCULAR DRUG DELIVERY 213. Law ,
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5.10 MICROEMULSIONS AS DRUG DELIVER
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STRUCTURE AND FORMATION OF MICROEMU
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oily phase, and the interfacial lay
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CHARACTERIZE MICROEMULSIONS AND REL
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CHARACTERIZE MICROEMULSIONS AND REL
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study was conducted on systems comp
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5.10.6.1 Oral Drug Delivery MICROEM
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MICROEMULSIONS AS DRUG DELIVERY SYS
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REFERENCES 785 stability of incorpo
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REFERENCES 787 22. Saint - Ruth , H
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REFERENCES 789 58. Ktistis , G. ( 1
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REFERENCES 791 94. Rhee , Y. S. , C
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5.11 TRANSDERMAL DRUG DELIVERY C. S
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Drug plasma concentration FIGURE 1
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PHYSIOLOGY AND CHARACTERISTICS OF H
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Another important parameter when se
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COMMERCIALLY AVAILABLE PATCHES 801
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5.11.8.1 Chemical Penetration Enhan
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corneum much like the microneedle t
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REFERENCES 807 40. Mitragotri , S.
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810 VAGINAL DRUG DELIVERY 5.12.5.6
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812 VAGINAL DRUG DELIVERY The vagin
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814 VAGINAL DRUG DELIVERY have mucu
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816 VAGINAL DRUG DELIVERY TABLE 1 C
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818 VAGINAL DRUG DELIVERY Menopausa
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820 VAGINAL DRUG DELIVERY 500 400 3
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822 VAGINAL DRUG DELIVERY spreadabi
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824 VAGINAL DRUG DELIVERY distribut
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826 VAGINAL DRUG DELIVERY improved
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828 VAGINAL DRUG DELIVERY FIGURE 4
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834 VAGINAL DRUG DELIVERY availabil
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838 VAGINAL DRUG DELIVERY results.
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842 VAGINAL DRUG DELIVERY studies t
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844 VAGINAL DRUG DELIVERY subject i
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846 VAGINAL DRUG DELIVERY formulati
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850 VAGINAL DRUG DELIVERY shown to
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852 VAGINAL DRUG DELIVERY poloxamer
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854 VAGINAL DRUG DELIVERY made. Ide
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858 VAGINAL DRUG DELIVERY 13. Wagne
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860 VAGINAL DRUG DELIVERY 54. Corbo
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862 VAGINAL DRUG DELIVERY supposito
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864 VAGINAL DRUG DELIVERY 123. van
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866 VAGINAL DRUG DELIVERY nanospher
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868 VAGINAL DRUG DELIVERY 196. Jone
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870 VAGINAL DRUG DELIVERY Irritatio
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872 VAGINAL DRUG DELIVERY 261. Czei
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874 VAGINAL DRUG DELIVERY 293. Fowl
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876 VAGINAL DRUG DELIVERY 327. O
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878 VAGINAL DRUG DELIVERY 359. Rath
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6.1 PHARMACEUTICAL PREFORMULATION:
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tion. According to global Internati
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SELECTION OF PHARMACEUTICAL EXCIPIE
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TABLE 4 Disintegrant Starch Commonl
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Page 911 and 912:
Page 913 and 914:
DRUG-EXCIPIENT COMPATIBILITY 897 ap
Page 915 and 916:
DRUG-EXCIPIENT COMPATIBILITY 899 in
Page 917 and 918:
POWDER CHARACTERISTICS 901 their im
Page 919 and 920:
POWDER CHARACTERISTICS 903 TABLE 13
Page 921 and 922:
POWDER CHARACTERISTICS 905 Microsco
Page 923 and 924:
Powder flow rate FIGURE 6 No flow b
Page 925 and 926:
POWDER CHARACTERISTICS 909 Measurem
Page 927 and 928:
V − V ε= V b p b V = 1− V POWD
Page 929 and 930:
POWDER CHARACTERISTICS 913 The mois
Page 931 and 932:
Tensile strength (Pa) 14 12 10 8 6
Page 933 and 934:
POWDER CHARACTERISTICS 917 and poor
Page 935 and 936:
infl uence the physicochemical prop
Page 937 and 938:
Tablet disintegration is the import
Page 939 and 940:
ability studies and from human stud
Page 941 and 942:
Variables Affecting Dissolution In
Page 943 and 944:
TABLET CHARACTERIZATION 927 The dif
Page 945 and 946:
The requirements for content unifor
Page 947:
REFERENCES 931 15. Simon , P. , Vev
Page 950 and 951:
934 ROLE OF PREFORMULATION IN DEVEL
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Page 954 and 955:
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Page 993 and 994:
6.3 TABLET DESIGN Eddy Castellanos
Page 995 and 996:
TABLETING CYCLE 979 The eccentric p
Page 997 and 998:
FIGURE 4 (a) (b) (c) TABLETING CYCL
Page 999 and 1000:
TABLE 1 mm 3 4 5 6 7 8 9 10 11 12 1
Page 1001 and 1002:
LIMITATIONS FOR DIRECT COMPRESSION
Page 1003 and 1004:
Drug release (%) 120 100 80 60 40 2
Page 1005 and 1006:
Beta Carotene Tablets (15 mg ) Form
Page 1007 and 1008:
Lisinopril release (%) FIGURE 10 BI
Page 1009 and 1010:
that do not compress well after wet
Page 1011 and 1012:
Calcium phosphate, dibasic offers h
Page 1013 and 1014:
FIGURE 11 Theophylline release (%)
Page 1015 and 1016:
TABLET DESIGN WITH NATURAL PRODUCTS
Page 1017 and 1018:
TABLE 7 Two Formulations for mangif
Page 1019 and 1020:
TABLE 8 Weight Assay Disintegration
Page 1021 and 1022:
TABLET DESIGN WITH NATURAL PRODUCTS
Page 1023 and 1024:
has a regulatory effect upon the an
Page 1025 and 1026:
DESIGN TOOLS OF TABLET FORMULATION
Page 1027 and 1028:
Amount released PPL (%) 110 100 90
Page 1029 and 1030:
DESIGN TOOLS OF TABLET FORMULATION
Page 1031 and 1032:
Percolation threshold (ε c) FIGURE
Page 1033 and 1034:
6.3.8 COATING SYSTEMS COATING SYSTE
Page 1035 and 1036:
COATING SYSTEMS 1019 ences between
Page 1037 and 1038:
Water absorption, % 8 7 6 5 4 3 2 1
Page 1039 and 1040:
FIGURE 28 white. mg/h·m 0.9 0.8 0.
Page 1041 and 1042:
(a) (b) FIGURE 31 ( a ) Tablet coat
Page 1043 and 1044:
TABLE 18 Solid content Batch size,
Page 1045 and 1046:
Percent released FIGURE 35 Tablet b
Page 1047 and 1048:
PHARMACEUTICAL TABLETS USING PERCOL
Page 1049 and 1050:
TABLE 23 Calculation of Tablet Prop
Page 1051 and 1052:
Page 1053 and 1054:
Page 1055 and 1056:
TABLE 25 Aspect Ratios and Exponent
Page 1057 and 1058:
K H (%min - 1/2)/% v/v excipient pl
Page 1059 and 1060:
6.3.10 ULTRASOUND-ASSISTED TABLETIN
Page 1061 and 1062:
ULTRASOUND-ASSISTED TABLETING (A NE
Page 1063 and 1064:
REFERENCES 1047 18. S á nchez , G.
Page 1065 and 1066:
REFERENCES 1049 54. Hess , H. , and
Page 1067:
92. Mill á n , M. , and Caraballo
Page 1070 and 1071:
1054 TABLET PRODUCTION SYSTEMS 6.4.
Page 1072 and 1073:
1056 TABLET PRODUCTION SYSTEMS comp
Page 1074 and 1075:
1058 TABLET PRODUCTION SYSTEMS and
Page 1076 and 1077:
1060 TABLET PRODUCTION SYSTEMS FIGU
Page 1078 and 1079:
Page 1080 and 1081:
Page 1082 and 1083:
1066 TABLET PRODUCTION SYSTEMS when
Page 1084 and 1085:
1068 TABLET PRODUCTION SYSTEMS die
Page 1086 and 1087:
Page 1088 and 1089:
1072 TABLET PRODUCTION SYSTEMS TABL
Page 1090 and 1091:
1074 TABLET PRODUCTION SYSTEMS Pres
Page 1092 and 1093:
1076 TABLET PRODUCTION SYSTEMS Forc
Page 1094 and 1095:
1078 TABLET PRODUCTION SYSTEMS In(1
Page 1096 and 1097:
1080 TABLET PRODUCTION SYSTEMS In[1
Page 1098 and 1099:
1082 TABLET PRODUCTION SYSTEMS [78,
Page 1100 and 1101:
Page 1102 and 1103:
1086 TABLET PRODUCTION SYSTEMS When
Page 1104 and 1105:
1088 TABLET PRODUCTION SYSTEMS 3. P
Page 1106 and 1107:
1090 TABLET PRODUCTION SYSTEMS 44.
Page 1108 and 1109:
Page 1110 and 1111:
Page 1112 and 1113:
Page 1114 and 1115:
Page 1116 and 1117:
1100 CONTROLLED RELEASE OF DRUGS FR
Page 1118 and 1119:
Page 1120 and 1121:
Page 1122 and 1123:
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Page 1126 and 1127:
Page 1128 and 1129:
Page 1130 and 1131:
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Page 1146 and 1147:
Page 1148 and 1149:
Page 1150 and 1151:
1134 TABLET COMPRESSION stages invo
Page 1152 and 1153:
1136 TABLET COMPRESSION although on
Page 1154 and 1155:
1138 TABLET COMPRESSION P P = + C a
Page 1156 and 1157:
1140 TABLET COMPRESSION 4. Estimati
Page 1158 and 1159:
1142 TABLET COMPRESSION from a hopp
Page 1160 and 1161:
1144 TABLET COMPRESSION speed of th
Page 1162 and 1163:
1146 TABLET COMPRESSION FIGURE 4 Co
Page 1164 and 1165:
1148 TABLET COMPRESSION FIGURE 5 Id
Page 1166 and 1167:
1150 TABLET COMPRESSION its low tou
Page 1168 and 1169:
1152 TABLET COMPRESSION Standard TS
Page 1170 and 1171:
1154 TABLET COMPRESSION A B C D E F
Page 1172 and 1173:
1156 TABLET COMPRESSION Top view Pr
Page 1174 and 1175:
1158 TABLET COMPRESSION particle si
Page 1176 and 1177:
1160 TABLET COMPRESSION 6.6.10.3 Mo
Page 1178 and 1179:
1162 TABLET COMPRESSION 7. Masteau
Page 1181 and 1182:
6.7 EFFECTS OF GRINDING IN PHARMACE
Page 1183 and 1184:
MILLING EQUIPMENT 1167 whereas smal
Page 1185 and 1186:
Screen Product FIGURE 3 Hammers Ham
Page 1187 and 1188:
inders, disintegrants, glidants, lu
Page 1189 and 1190:
Airflow Press POWDER CHARACTERIZATI
Page 1191 and 1192:
Powder flow Sample Process stream (
Page 1193 and 1194:
Container 1 Container 1 Discard (a)
Page 1195 and 1196:
Porous particles in container POWDE
Page 1197 and 1198:
POWDER CHARACTERIZATION TECHNIQUES
Page 1199 and 1200:
expansions or fractal dimensions);
Page 1201 and 1202:
EFFECT OF PARTICLE SIZE REDUCTION O
Page 1203 and 1204:
EFFECT OF PARTICLE SIZE REDUCTION O
Page 1205 and 1206:
REFERENCES 1189 19. British Standar
Page 1207 and 1208:
6.8 ORAL EXTENDED - RELEASE FORMULA
Page 1209 and 1210:
INTRODUCTION 1193 line) together wi
Page 1211 and 1212:
INTRODUCTION 1195 substance) instea
Page 1213 and 1214:
of the drug particles/formulation a
Page 1215 and 1216:
M A DCt t = ⎡ ε s ( 2C − C )
Page 1217 and 1218:
method for insoluble matrix tablets
Page 1219 and 1220:
MEMBRANE-COATED ORAL EXTENDED RELEA
Page 1221 and 1222:
MEMBRANE-COATED ORAL EXTENDED RELEA
Page 1223 and 1224:
Swelling front Diffusion front Eros
Page 1225 and 1226:
dM Q = ∫ dt = kt 0 dt HYDROPHILIC
Page 1227 and 1228:
TABLE 2 FDA Registered Oral ER Form
Page 1229 and 1230:
6.8.6 OTHER ORAL ER FORMULATIONS OT
Page 1231 and 1232:
REFERENCES 1215 15. Neau , S. H. ,
Page 1233 and 1234:
REFERENCES 1217 54. Sousa , J. J. ,
Page 1235 and 1236:
REFERENCES 1219 89. Ford , J. L. ,
Page 1237 and 1238:
REFERENCES 1221 122. Talukdar , M.
Page 1239:
SECTION 7 ROLE OF NANOTECHNOLOGY
Page 1242 and 1243:
1226 CYCLODEXTRIN-BASED NANOMATERIA
Page 1244 and 1245:
Page 1246 and 1247:
Page 1248 and 1249:
Page 1250 and 1251:
Page 1252 and 1253:
Page 1254 and 1255:
Page 1256 and 1257:
Page 1258 and 1259:
Page 1260 and 1261:
Page 1262 and 1263:
Page 1265 and 1266:
7.2 NANOTECHNOLOGY IN PHARMACEUTICA
Page 1267 and 1268:
NANOMATERIALS 1251 tists regard mat
Page 1269 and 1270:
NANOMATERIALS 1253 TABLE 1 Characte
Page 1271 and 1272:
NANOMATERIALS 1255 sor molecules/pa
Page 1273 and 1274:
TABLE 2 Continued Types of Nanomate
Page 1275 and 1276:
H 3 C CH 3 N + CH 3 O O O O - P O O
Page 1277 and 1278:
NANOTECHNOLOGY FOR DRUG DELIVERY 12
Page 1279 and 1280:
entrapped drugs releasing [90] . So
Page 1281 and 1282:
Page 1283 and 1284:
Page 1285 and 1286:
Page 1287 and 1288:
Page 1289 and 1290:
Page 1291 and 1292:
Page 1293 and 1294:
Page 1295 and 1296:
NANOMEDICINE 1279 prises) visibly p
Page 1297 and 1298:
REFERENCES 1281 16. http://www.whit
Page 1299 and 1300:
REFERENCES 1283 55. Kam , N. W. S.
Page 1301 and 1302:
REFERENCES 1285 92. Zhang , J. Q. ,
Page 1303 and 1304:
REFERENCES 1287 126. Smart , S. K.
Page 1305 and 1306:
7.3 PHARMACEUTICAL NANOSYSTEMS: MAN
Page 1307 and 1308:
7.3.2 TAXONOMY OF NANOMEDICINE TECH
Page 1309 and 1310:
TABLE 1 Continued Molecular medicin
Page 1311 and 1312:
Applications of quantum dots includ
Page 1313 and 1314:
7.3.5 MANUFACTURING TECHNOLOGIES Th
Page 1315 and 1316:
Ratio of hydrodynamic radius, R H ,
Page 1317 and 1318:
eplicated on the substrate, with na
Page 1319 and 1320:
MANUFACTURING TECHNOLOGIES 1303 bel
Page 1321 and 1322:
CHARACTERIZATION TECHNIQUES 1305 TA
Page 1323 and 1324:
CHARACTERIZATION TECHNIQUES 1307 TA
Page 1325 and 1326:
Limitations of AFM [255 - 257] Pote
Page 1327 and 1328:
REFERENCES 1311 thelial cells, the
Page 1329 and 1330:
REFERENCES 1313 34. Ostrander , K.
Page 1331 and 1332:
REFERENCES 1315 77. Muangsiri , W.
Page 1333 and 1334:
REFERENCES 1317 124. Caruso , F. ,
Page 1335 and 1336:
REFERENCES 1319 170. Rogers , J. A.
Page 1337 and 1338:
REFERENCES 1321 application: Synthe
Page 1339 and 1340:
252. Fontaine , P. A. , et al. ( 19
Page 1341:
Characterization Methods Binks , B.
Page 1344 and 1345:
1328 OIL-IN-WATER NANOSIZED EMULSIO
Page 1346 and 1347:
Page 1348 and 1349:
1332 Application TABLE 1 Selected M
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Page 1352 and 1353:
Page 1354 and 1355:
Page 1356 and 1357:
Page 1358 and 1359:
Page 1360 and 1361:
Page 1362 and 1363:
Page 1364 and 1365:
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Page 1382 and 1383:
Page 1384 and 1385:
1368 INDEX Cholera toxin, 637 Cilio
Page 1386:
1370 INDEX Production of radiopharm
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