Pharmaceutical Manufacturing Handbook: Production and

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988 TABLET DESIGN Drug release (%) 120 100 80 60 40 20 FIGURE 8 Enteric fi lm coating of tablets, acetylsalicylic acid (organic solution): paddle 100 rpm, 37 ° C; 0 – 2 h: 0.08 M HCl, 2 h+: phosphate buffer Ph 6.8. Component Kollicoat MAE 100 P Triethyl citrate Ethanol Isopropanol/Wasser (70/30) Total Polymer applied Content of polymer Parts by Weight [g] No. 1 No. 2 344.52 344.52 34.45 34.45 4214.60 — — 4214.60 4593.57 4593.57 10.0 mg/cm 2 7.5% Preparation of Spray Suspension Kollicoat MAE 100P and triethyl citrate were stirred into the solvent until complete dissolution. Process Parameters Ethanol Isopropanol/wasser (70/30) 0 0 50 100 Time (min) 150 200 Coating pan 24 Accela Cota Size of batch 5 kg Inlet air temperature 50 ° C Outlet air temperature 35 – 38 ° C Product temperature 30 – 35 ° C Inlet air rate 70 m Outlet air rate 140 m Spraying pressure 2.0 bars Nozzle diameter 1.0 mm Rate of spraying 30 g/min Time of spraying 2.5 h Preheating 3 min Final drying 5 min Dissolution: (See Figure 8 ). Dissolution was done according to USP monograph “ Aspirin Delayed - Release Tablets. ”
Beta Carotene Tablets (15 mg ) Formulation Beta carotene dry powder 10% Ludipress Dicalcium phosphate, granulated with 5% Kollidon 30 Avicel PH 101 Kollidon CL Aerosil 200 Talc Calcium arachinate Magnesium stearate LIMITATIONS FOR DIRECT COMPRESSION 989 Formulation 1 160.0 g 240.0 g — — 6.0 g — — — 2.0 g Formulation 2 150.0 g — 175.0 g 100.0 g 5.0 g 2.5 g 20.0 g 2.5 g — Manufacturing (Direct Compression) All components were mixed, passed through a 0.8 - mm sieve, and pressed with a medium compression force. Tablet Properties Weight Diameter Form Hardness Disintegration Friability Chemical and Physical Stability (20 – 25 ° C) Formulation 1 Loss of beta carotene Hardness Disintegration Friability Formulation 2 Loss of beta carotene Diclofenac Na – Dispersion – Tablet (50 mg ) Formulation Formulation 1 Formulation 2 400 mg 502 mg 12 mm 12 mm Biplanar Biplanar 59 N 57 N 12 min 1 min 0.1% 0% 6 Months 3% 60 N 9 min 0.15% 8% Diclofenac Na 50.0 mg Avicel PH 102 143.8 mg Kollidon CL 50.0 mg Aerosil 200 5.0 mg Magnesium stearate 1.0 mg 12 Months 4% 59 N 7 min 0.16% 9%
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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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OPTION FOR DELIVERY OF DRUGS TO CEN
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pseudostratifi ed epithelium compri
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NASAL DELIVERY OF VACCINES 635 Howe
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TABLE 5 Continued Delivery System/A
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REFERENCES 639 23. Hardy , J. G. ,
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REFERENCES 641 60. Collens , W. S.
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REFERENCES 643 97. Eden , S. ( 1979
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REFERENCES 645 comparison with oral
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REFERENCES 647 172. Sakane , T. , A
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REFERENCES 649 213. McCluskie , M.
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5.7 NASAL POWDER DRUG DELIVERY Jele
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NASAL DRY POWDER FORMULATIONS 653 t
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POLYMERS IN NASAL POWDER DELIVERY S
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POLYMERS IN NASAL POWDER DELIVERY S
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MICROSPHERES AS NASAL DRUG DELIVERY
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TOXICOLOGICAL CONSIDERATIONS 667 et
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Summary of Research Work on Nasal D
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Powder Formulation Preparation Meth
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Powder Formulation Preparation Meth
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REFERENCES 675 19. Van der Lubben ,
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REFERENCES 677 54. Witschi , C. , a
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REFERENCES 679 91. Varshosaz , J. ,
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REFERENCES 681 126. Jorissen , M. ,
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684 AEROSOL DRUG DELIVERY 5.8.8 5.8
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686 AEROSOL DRUG DELIVERY other sig
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688 AEROSOL DRUG DELIVERY are a num
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690 AEROSOL DRUG DELIVERY 5.8.5 MET
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692 AEROSOL DRUG DELIVERY TABLE 1 S
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694 AEROSOL DRUG DELIVERY valve siz
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696 AEROSOL DRUG DELIVERY Ferrule U
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698 AEROSOL DRUG DELIVERY 5.8.5.6 A
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700 AEROSOL DRUG DELIVERY 5.8.5.10
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702 AEROSOL DRUG DELIVERY low inter
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704 AEROSOL DRUG DELIVERY Transpare
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706 AEROSOL DRUG DELIVERY of the cl
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708 AEROSOL DRUG DELIVERY is achiev
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710 AEROSOL DRUG DELIVERY Aerosol g
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712 AEROSOL DRUG DELIVERY REFERENCE
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714 AEROSOL DRUG DELIVERY 42. Witek
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716 AEROSOL DRUG DELIVERY 81. Ohmor
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718 AEROSOL DRUG DELIVERY 119. Lewi
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720 AEROSOL DRUG DELIVERY 153. Terz
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722 AEROSOL DRUG DELIVERY 189. Sham
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724 AEROSOL DRUG DELIVERY 225. Newh
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726 AEROSOL DRUG DELIVERY 263. Dolo
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5.9 OCULAR DRUG DELIVERY Ilva D. Ru
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CHALLENGES IN OCULAR DRUG DELIVERY
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FORMULATION APPROACHES TO IMPROVE O
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Drug Fluorescein FORMULATION APPROA
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is characterized by a transient ove
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REFERENCES 755 11. Klyce , S. D. ,
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REFERENCES 757 53. Saettone , M. F.
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REFERENCES 759 87. Lin , H. R. , an
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REFERENCES 761 122. Durrani , A. M.
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REFERENCES 763 158. Weyenberg , W.
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REFERENCES 765 of various ophthalmi
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REFERENCES 767 233. Grass , G. M. ,
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770 MICROEMULSIONS AS DRUG DELIVERY
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794 TRANSDERMAL DRUG DELIVERY 5.11.
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796 TRANSDERMAL DRUG DELIVERY conta
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798 TRANSDERMAL DRUG DELIVERY 5.11.
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800 TRANSDERMAL DRUG DELIVERY FIGUR
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802 TRANSDERMAL DRUG DELIVERY a rat
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804 TRANSDERMAL DRUG DELIVERY passi
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806 TRANSDERMAL DRUG DELIVERY 19. E
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5.12 VAGINAL DRUG DELIVERY Jos é d
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Therefore, this chapter discusses t
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THE HUMAN VAGINA 813 thetic innerva
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THE HUMAN VAGINA 815 the upper repr
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THE HUMAN VAGINA 817 tant in the re
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GENERAL FEATURES OF VAGINAL DRUG DE
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Although this strategy may enhance
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VAGINAL DRUG DELIVERY SYSTEMS 823 a
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VAGINAL DRUG DELIVERY SYSTEMS 825 f
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VAGINAL DRUG DELIVERY SYSTEMS 827 f
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Amount released, μg/day 800 700 60
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VAGINAL DRUG DELIVERY SYSTEMS 831 5
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TABLE 4 Examples of Mucoadhesive Po
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VAGINAL DRUG DELIVERY SYSTEMS 835 i
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PHARMACEUTICAL EVALUATION OF VAGINA
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CLINICAL USAGE AND POTENTIAL OF VAG
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TABLE 6 Selected Drugs Administered
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Selected Veterinary Vaginal Drug De
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REFERENCES 857 Much work remains to
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REFERENCES 859 33. Hocini , H. , Ba
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REFERENCES 861 70. Kristmundsdottir
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REFERENCES 863 105. McClelland , R.
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REFERENCES 865 141. Kuyoh , M. A. ,
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REFERENCES 867 178. Ondracek , J. ,
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REFERENCES 869 212. Bagga , R. , Ra
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REFERENCES 871 244. International W
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REFERENCES 873 276. Mor , E. , Saad
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REFERENCES 875 310. Saltzman , W. M
Page 893 and 894:
REFERENCES 877 vaginal microbicides
Page 895:
SECTION 6 TABLET PRODUCTION
Page 898 and 899:
882 PHARMACEUTICAL PREFORMULATION 6
Page 900 and 901:
884 PHARMACEUTICAL PREFORMULATION E
Page 902 and 903:
886 PHARMACEUTICAL PREFORMULATION T
Page 904 and 905:
Page 906 and 907:
Page 908 and 909:
892 PHARMACEUTICAL PREFORMULATION p
Page 910 and 911:
Page 912 and 913:
Page 914 and 915:
898 PHARMACEUTICAL PREFORMULATION l
Page 916 and 917:
Page 918 and 919:
902 PHARMACEUTICAL PREFORMULATION s
Page 920 and 921:
904 PHARMACEUTICAL PREFORMULATION C
Page 922 and 923:
906 PHARMACEUTICAL PREFORMULATION p
Page 924 and 925:
Page 926 and 927:
Page 928 and 929:
912 PHARMACEUTICAL PREFORMULATION D
Page 930 and 931:
Page 932 and 933:
916 PHARMACEUTICAL PREFORMULATION u
Page 934 and 935:
918 PHARMACEUTICAL PREFORMULATION d
Page 936 and 937:
920 PHARMACEUTICAL PREFORMULATION q
Page 938 and 939:
922 PHARMACEUTICAL PREFORMULATION w
Page 940 and 941:
Page 942 and 943:
Page 944 and 945:
928 PHARMACEUTICAL PREFORMULATION a
Page 946 and 947:
930 PHARMACEUTICAL PREFORMULATION a
Page 949 and 950:
6.2 ROLE OF PREFORMULATION IN DEVEL
Page 951 and 952:
maceutics ” documentation forms a
Page 953 and 954: e altered without any change in the
Page 955 and 956: Solubility Heat flow II I T m,II Ts
Page 957 and 958: TABLE 2 Techniques to Characterize
Page 959 and 960: Percent weight loss Heat flow (a) (
Page 961 and 962: Heat flow Intensity 100 50 Endother
Page 963 and 964: Change in mass (%) PHYSICAL/BULK CH
Page 965 and 966: 6.2.2.6 Powder Flow and Compressibi
Page 967 and 968: Solvent required for 1 gm of solid
Page 969 and 970: ⎧ 100 ⎪ Ka 1+10 Percent ionized
Page 971 and 972: Percent Ionization Percent Ionizati
Page 973 and 974: SOLUBILITY CHARACTERISTICS 957 para
Page 975 and 976: SOLUBILITY CHARACTERISTICS 959 of p
Page 977 and 978: Dissolution studies pH solubility p
Page 979 and 980: High Permeability Low SOLUBILITY CH
Page 981 and 982: is evident form the fact [51] that
Page 983 and 984: independent of initial drug concent
Page 985 and 986: STABILITY CHARACTERISTICS 969 drug
Page 987 and 988: 6.2.5 CONCLUSIONS Preformulation te
Page 989 and 990: REFERENCES 973 16. Huang , L. , and
Page 991: 54. 55. 56. REFERENCES 975 IFAMA (
Page 994 and 995: 978 TABLET DESIGN 6.3.9.3 Case Stud
Page 996 and 997: 980 TABLET DESIGN Another reason, t
Page 998 and 999: 982 TABLET DESIGN E: This ensures t
Page 1000 and 1001: 984 TABLET DESIGN substance would b
Page 1002 and 1003: 986 TABLET DESIGN Plasticity 1.0 0.
Page 1006 and 1007: 990 TABLET DESIGN FIGURE 9 Dissolut
Page 1008 and 1009: 992 TABLET DESIGN TABLE 2 Number 1
Page 1010 and 1011: 994 TABLET DESIGN Formulation Table
Page 1012 and 1013: 996 TABLET DESIGN TABLE 4 Theophyll
Page 1014 and 1015: 998 TABLET DESIGN often very fi ne,
Page 1016 and 1017: 1000 TABLE 6 Formulations by Wet Gr
Page 1018 and 1019: 1002 TABLET DESIGN 6.3.6.2 FIGURE 1
Page 1020 and 1021: 1004 TABLET DESIGN TABLE 9 Papaveri
Page 1022 and 1023: 1006 TABLET DESIGN TABLE 12 Weight
Page 1024 and 1025: 1008 TABLET DESIGN (3.179 and 4.500
Page 1026 and 1027: 1010 TABLET DESIGN TABLE 14 Run Ord
Page 1028 and 1029: 1012 TABLET DESIGN Regression coeff
Page 1030 and 1031: 1014 TABLET DESIGN to being the out
Page 1032 and 1033: 1016 TABLET DESIGN Mechanical Prope
Page 1034 and 1035: 1018 TABLET DESIGN drawbacks (unsaf
Page 1036 and 1037: 1020 TABLET DESIGN TABLE 16 Basic F
Page 1038 and 1039: 1022 TABLET DESIGN PEG (e.g., Macro
Page 1040 and 1041: 1024 TABLET DESIGN 0.45% 0.40% 0.35
Page 1042 and 1043: 1026 TABLET DESIGN FIGURE 34 Granul
Page 1044 and 1045: 1028 TABLET DESIGN TABLE 19 SEPIFIL
Page 1046 and 1047: 1030 TABLET DESIGN (c) Blistering D
Page 1048 and 1049: 1032 TABLET DESIGN % Dextromethorph
Page 1050 and 1051: 1034 TABLET DESIGN (a) (b) 500 μm
Page 1052 and 1053: 1036 TABLET DESIGN threshold p c1 a
Page 1054 and 1055:
1038 TABLET DESIGN TABLE 24 Composi
Page 1056 and 1057:
1040 TABLET DESIGN Korsmeyer - Pepp
Page 1058 and 1059:
1042 TABLET DESIGN % Water uptake/d
Page 1060 and 1061:
1044 TABLET DESIGN FIGURE 47 Temper
Page 1062 and 1063:
1046 TABLET DESIGN REFERENCES 1. Un
Page 1064 and 1065:
1048 TABLET DESIGN 34. Congreve , M
Page 1066 and 1067:
1050 TABLET DESIGN 73. Miranda , A.
Page 1069 and 1070:
6.4 TABLET PRODUCTION SYSTEMS Katha
Page 1071 and 1072:
PHYSICS OF TABLET FORMATION 1055 en
Page 1073 and 1074:
Tablet production systems can be op
Page 1075 and 1076:
TABLETING MACHINES 1059 Eccentric T
Page 1077 and 1078:
TABLETING MACHINES 1061 In Figure 4
Page 1079 and 1080:
TABLETING MACHINE SIMULATORS (COMPA
Page 1081 and 1082:
TABLETING MACHINE SIMULATORS (COMPA
Page 1083 and 1084:
However, for mechanical compaction
Page 1085 and 1086:
INSTRUMENTATION OF TABLETING MACHIN
Page 1087 and 1088:
Force (kN) FIGURE 13 ANALYSIS OF TA
Page 1089 and 1090:
TABLE 4 Source Emschermann [91] (Fi
Page 1091 and 1092:
TABLE 6 Parameters Directly Deduced
Page 1093 and 1094:
TABLE 7 Parameters Calculated from
Page 1095 and 1096:
ANALYSIS OF TABLETING PROCESS 1079
Page 1097 and 1098:
TABLE 8 Source 3D model [143, 144,
Page 1099 and 1100:
6.4.11 SPECIAL ACCESSORIES OF TABLE
Page 1101 and 1102:
usually tends to vary. However, the
Page 1103 and 1104:
ing at punches and dies. Low produc
Page 1105 and 1106:
REFERENCES 1089 24. Elamin , A. , S
Page 1107 and 1108:
REFERENCES 1091 64. Yeh , C. , Alta
Page 1109 and 1110:
REFERENCES 1093 100. Armstrong , N.
Page 1111 and 1112:
REFERENCES 1095 140. Kuentz , M. ,
Page 1113 and 1114:
REFERENCES 1097 178. Hauschild , K.
Page 1115 and 1116:
6.5 CONTROLLED RELEASE OF DRUGS FRO
Page 1117 and 1118:
INTRODUCTION 1101 ings, and their e
Page 1119 and 1120:
needed to circulate them [57] . Typ
Page 1121 and 1122:
APPLICATIONS 1105 stream. During dr
Page 1123 and 1124:
APPLICATIONS 1107 TABLE 1 Theophyll
Page 1125 and 1126:
APPLICATIONS 1109 FIGURE 1 Release
Page 1127 and 1128:
(a) (b) APPLICATIONS 1111 FIGURE 3
Page 1129 and 1130:
APPLICATIONS 1113 FIGURE 5 Ternary
Page 1131 and 1132:
APPLICATIONS 1115 of the drug, dC/d
Page 1133 and 1134:
APPLICATIONS 1117 FIGURE 9 Ternary
Page 1135 and 1136:
Release rate (mg/min) 0.40 0.30 0.2
Page 1137 and 1138:
REFERENCES REFERENCES 1121 1. Lange
Page 1139 and 1140:
REFERENCES 1123 37. Lin , Y - K. ,
Page 1141 and 1142:
REFERENCES 1125 73. St - Onge , L.
Page 1143 and 1144:
REFERENCES 1127 107. Lai , J. - Y.
Page 1145 and 1146:
APPENDIX 1129 FIGURE A3 Release of
Page 1147 and 1148:
APPENDIX 1131 FIGURE A7 Release of
Page 1149 and 1150:
6.6 TABLET COMPRESSION Helton M. M.
Page 1151 and 1152:
during compression, which will also
Page 1153 and 1154:
of powder mixtures is usually chara
Page 1155 and 1156:
lose in combination with either tal
Page 1157 and 1158:
Due to the signifi cant nonlinearit
Page 1159 and 1160:
EQUIPMENT FOR TABLET COMPRESSION 11
Page 1161 and 1162:
Product Fill cam (mm) column height
Page 1163 and 1164:
TABLET PRESS TOOLING 1147 TABLE 1 T
Page 1165 and 1166:
TABLET PRESS TOOLING 1149 7. Tungst
Page 1167 and 1168:
FIGURE 6 Tooling standards confi gu
Page 1169 and 1170:
6.6.7 TABLE ENGRAVING Engraving is
Page 1171 and 1172:
Shallow and standard concave tablet
Page 1173 and 1174:
is the most popular bisect confi gu
Page 1175 and 1176:
PROBLEMS DURING TABLET MANUFACTURIN
Page 1177 and 1178:
thus reducing a potential variation
Page 1179:
REFERENCES 1163 27. Train , D. ( 19
Page 1182 and 1183:
1166 EFFECTS OF GRINDING IN PHARMAC
Page 1184 and 1185:
Page 1186 and 1187:
Page 1188 and 1189:
Page 1190 and 1191:
Page 1192 and 1193:
Page 1194 and 1195:
Page 1196 and 1197:
Page 1198 and 1199:
Page 1200 and 1201:
Page 1202 and 1203:
Page 1204 and 1205:
Page 1206 and 1207:
Page 1208 and 1209:
1192 ORAL EXTENDED-RELEASE FORMULAT
Page 1210 and 1211:
Page 1212 and 1213:
Page 1214 and 1215:
Page 1216 and 1217:
Page 1218 and 1219:
Page 1220 and 1221:
Page 1222 and 1223:
Page 1224 and 1225:
Page 1226 and 1227:
Page 1228 and 1229:
Page 1230 and 1231:
Page 1232 and 1233:
Page 1234 and 1235:
Page 1236 and 1237:
Page 1238 and 1239:
Page 1241 and 1242:
7.1 CYCLODEXTRIN - BASED NANOMATERI
Page 1243 and 1244:
OH (3) OH (2) HOCH 2 HOCH 2 O O OH
Page 1245 and 1246:
APPLICATIONS OF CYCLODEXTRINS IN NA
Page 1247 and 1248:
Percentage of release 100 90 80 70
Page 1249 and 1250:
Page 1251 and 1252:
Page 1253 and 1254:
Page 1255 and 1256:
O APPLICATIONS OF CYCLODEXTRINS IN
Page 1257 and 1258:
β - CDC6 loaded with the model dru
Page 1259 and 1260:
REFERENCES 1243 13. Stella , V. J.
Page 1261 and 1262:
REFERENCES 1245 49. Dodziuk , H. ,
Page 1263:
REFERENCES 1247 81. Memi şo ğlu -
Page 1266 and 1267:
1250 NANOTECHNOLOGY IN PHARMACEUTIC
Page 1268 and 1269:
Page 1270 and 1271:
Page 1272 and 1273:
Page 1274 and 1275:
Page 1276 and 1277:
Page 1278 and 1279:
Page 1280 and 1281:
Page 1282 and 1283:
Page 1284 and 1285:
Page 1286 and 1287:
Page 1288 and 1289:
Page 1290 and 1291:
Page 1292 and 1293:
Page 1294 and 1295:
Page 1296 and 1297:
Page 1298 and 1299:
Page 1300 and 1301:
Page 1302 and 1303:
Page 1304 and 1305:
Page 1306 and 1307:
1290 PHARMACEUTICAL NANOSYSTEMS 7.3
Page 1308 and 1309:
1292 PHARMACEUTICAL NANOSYSTEMS TAB
Page 1310 and 1311:
Page 1312 and 1313:
1296 PHARMACEUTICAL NANOSYSTEMS Lam
Page 1314 and 1315:
1298 PHARMACEUTICAL NANOSYSTEMS 7.3
Page 1316 and 1317:
1300 PHARMACEUTICAL NANOSYSTEMS sta
Page 1318 and 1319:
Page 1320 and 1321:
1304 PHARMACEUTICAL NANOSYSTEMS har
Page 1322 and 1323:
Page 1324 and 1325:
1308 PHARMACEUTICAL NANOSYSTEMS Sur
Page 1326 and 1327:
1310 PHARMACEUTICAL NANOSYSTEMS Aut
Page 1328 and 1329:
1312 PHARMACEUTICAL NANOSYSTEMS ®
Page 1330 and 1331:
1314 PHARMACEUTICAL NANOSYSTEMS 55.
Page 1332 and 1333:
1316 PHARMACEUTICAL NANOSYSTEMS 100
Page 1334 and 1335:
Page 1336 and 1337:
Page 1338 and 1339:
Page 1340 and 1341:
1324 PHARMACEUTICAL NANOSYSTEMS Nan
Page 1343 and 1344:
7.4 OIL - IN - WATER NANOSIZED EMUL
Page 1345 and 1346:
GENERATIONS OF OIL-IN-WATER NANOSIZ
Page 1347 and 1348:
Page 1349 and 1350:
Page 1351 and 1352:
Page 1353 and 1354:
Page 1355 and 1356:
Page 1357 and 1358:
DRUG-FREE/LOADED OIL-IN-WATER NANOS
Page 1359 and 1360:
EXCIPIENT INCLUSION: OIL-IN-WATER N
Page 1361 and 1362:
EXCIPIENT INCLUSION: OIL-IN-WATER N
Page 1363 and 1364:
MEDICAL APPLICATIONS OF OIL-IN-WATE
Page 1365 and 1366:
Page 1367 and 1368:
Page 1369 and 1370:
Page 1371 and 1372:
evaluation of the lipid hydroperoxi
Page 1373 and 1374:
REFERENCES 1357 21. Ott , G. , Sing
Page 1375 and 1376:
REFERENCES 1359 57. Harris , J. M.
Page 1377 and 1378:
REFERENCES 1361 94. Kim , Y. J. , K
Page 1379 and 1380:
REFERENCES 1363 131. Swietlikowska
Page 1381 and 1382:
REFERENCES 1365 167. Acheampong , A
Page 1383 and 1384:
INDEX Abortifacients, 850 Acyclovir
Page 1385 and 1386:
Lung cancer, 497-502 Lung toxicity,
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