Pharmaceutical Manufacturing Handbook: Production and

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PHARMACEUTICAL MANUFACTURING HANDBOOK <strong>Production</strong> <strong>and</strong> Processes SHAYNE COX GAD, PH.D., D.A.B.T. Gad Consulting Services Cary, North Carolina A JOHN WILEY & SONS, INC., PUBLICATION
Page 1: PHARMACEUTICAL MANUFACTURING HANDBO
Page 6 and 7: Copyright © 2008 by John Wiley & S
Page 8 and 9: vi CONTRIBUTORS Robert D. Arnold, T
Page 10 and 11: viii CONTRIBUTORS Iv á n Pe ñ uel
Page 12 and 13: x CONTENTS 3.2 Packaging and Labeli
Page 15: PREFACE This Handbook of Manufactur
Page 19 and 20: 1.1 BIOTECHNOLOGY - DERIVED DRUG PR
Page 21 and 22: INTRODUCTION 5 provide a suffi cien
Page 23 and 24: therapeutic potency, specifi city,
Page 25 and 26: Diffi culties in peroral delivery h
Page 27 and 28: tial. Therefore, the indication and
Page 29 and 30: TABLE 2 Continued Parameter Assesse
Page 31 and 32: ceutical stability program should a
Page 33 and 34: FORMULATION DEVELOPMENT 17 see when
Page 35 and 36: FORMULATION DEVELOPMENT 19 heat ter
Page 37 and 38: organisms, stability (shelf life),
Page 39 and 40: TABLE 3 Potential Degradative Mecha
Page 41 and 42: QUALITY BY DESIGN AND SCALE-UP 25 w
Page 43 and 44: QUALITY BY DESIGN AND SCALE-UP 27 p
Page 45 and 46: ACKNOWLEDGMENTS The authors would l
Page 47 and 48: REFERENCES 31 37. Berglund , M. , B
Page 49 and 50: 1.2 REGULATORY CONSIDERATIONS IN AP
Page 51 and 52: HISTORY OF BIOLOGICS REGULATION IN
Page 53 and 54: HISTORY OF BIOLOGICS REGULATION IN
Page 55 and 56:
HISTORY OF BIOLOGICS REGULATION IN
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TABLE 4 FDA Center Regulatory Respo
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approved via a BLA under the PHSA a
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LEGAL ARGUMENTS RELATED TO FOLLOW-O
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SCIENTIFIC ISSUES RELATED TO FOLLOW
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SCIENTIFIC ISSUES RELATED TO FOLLOW
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albumin with polysorbate 80 and gly
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PROPOSED REGULATORY PARADIGM: CASE
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effi cacy for Genotropin. These dat
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REFERENCES 57 21. Webber , K. ( 200
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60 RADIOPHARMACEUTICAL MANUFACTURIN
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2.1 STERILE PRODUCT MANUFACTURING J
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(FDA) in its 2004 Guideline on Ster
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PROCESS SELECTION AND DESIGN 103 di
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FACILITY DESIGN 105 is transfer int
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FACILITY DESIGN 107 The formulation
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FACILITY DESIGN 109 In large operat
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FACILITY DESIGN 111 universal expec
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FACILITY DESIGN 113 facilities equi
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from manual compounding of small ba
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2.1.5.4 Other Utilities The operati
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STERILIZATION AND DEPYROGENATION 11
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ENVIRONMENTAL CONTROL AND MONITORIN
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ENVIRONMENTAL CONTROL AND MONITORIN
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PRODUCTION ACTIVITIES 125 It is inc
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PRODUCTION ACTIVITIES 127 Filling o
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assembly/technique) using a growth
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culminate in the incubation of the
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REFERENCES REFERENCES 133 1. U.S. F
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ADDITIONAL READINGS 135 Ljungvist ,
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3.1 FROM PILOT PLANT TO MANUFACTURI
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BACKGROUND 141 Pisano [3] discusses
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T amb F3 F2 F1 Scale Scale Scale Ad
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LABORATORY VESSELS AND REACTION CAL
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LABORATORY VESSELS AND REACTION CAL
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Drive nozzle face D FIGURE 4 C E 10
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Overall U, English units 80 70 60 5
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mCp/UA, min 28 27 26 25 24 23 22 21
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control valve was on the inlet stre
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3.1.6 SUMMARY In this chapter we ha
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3.2 PACKAGING AND LABELING Maria In
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PACKAGING MATERIALS 161 For these r
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PACKAGING MATERIALS 163 3.2.2.2 Gla
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PACKAGING MATERIALS 165 Rubber clos
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PACKAGING MATERIALS 167 of the USP
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PACKAGING MATERIALS 169 Topical del
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PACKAGING MATERIALS 171 based topic
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QUALITY CONTROL OF PACKAGING MATERI
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TABLE 5 Chapter U.S. Pharmacopeia G
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Topical Drug Products Topical dosag
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IMPORTANCE OF PROPER PACKAGING AND
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4. Require that vials containing me
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8. A description of the scientifi c
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The only warning that is necessary,
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REGULATORY ASPECTS 191 Section 1451
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include any term qualifying a unit
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for the promulgation of any such re
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Label Issuance and Control • Acce
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REFERENCES 199 9. Aspinall , J. A.
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3.3 CLEAN - FACILITY DESIGN, CONSTR
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PLANNING FOR PROJECT SUCCESS 203 im
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PLANNING FOR PROJECT SUCCESS 205 of
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DESIGN OPTIONS 207 with clean - roo
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TABLE 1 Room Grade f A g B C D E An
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Clean Garment Storage Bench Air loc
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DESIGN OPTIONS 213 FIGURE 4 Furnish
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DESIGN OPTIONS 215 FIGURE 6 A CMU w
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DESIGN OPTIONS 217 spaces to suppor
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DESIGN OPTIONS 219 FIGURE 12 The wa
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DESIGN OPTIONS 221 FIGURE 15 Severa
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to the facility. IEST - RP - CC006
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CONSTRUCTION PHASE: CLEAN BUILD PRO
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APPENDIX A 227 and storage space fo
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APPENDIX A 229 closed at the neck,
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I. The HEPA fi lter protective fi l
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SECTION 4 NORMAL DOSAGE FORMS
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236 SOLID DOSAGE FORMS 4.1.9 Chewab
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238 SOLID DOSAGE FORMS A dose solub
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240 SOLID DOSAGE FORMS TABLE 3 Exci
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242 SOLID DOSAGE FORMS Antiadherent
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244 SOLID DOSAGE FORMS Despite the
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246 SOLID DOSAGE FORMS TABLE 4 Poly
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248 SOLID DOSAGE FORMS TABLE 5 Caps
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250 SOLID DOSAGE FORMS of both. Sof
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252 SOLID DOSAGE FORMS reaction in
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254 SOLID DOSAGE FORMS to a rapid o
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256 SOLID DOSAGE FORMS TABLE 8 Typi
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258 SOLID DOSAGE FORMS Piston Base
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260 SOLID DOSAGE FORMS TABLE 10 Exa
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262 SOLID DOSAGE FORMS pressures du
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264 SOLID DOSAGE FORMS 12. The Unit
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4.2 SEMISOLID DOSAGES: OINTMENTS, C
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OINTMENTS AND CREAMS 269 bases), ab
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OINTMENTS AND CREAMS 271 compendial
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TABLE 2 Properties of Different Gra
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OINTMENTS AND CREAMS 275 Preparatio
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OINTMENTS AND CREAMS 277 TABLE 3 Cr
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OINTMENTS AND CREAMS 279 FIGURE 1 S
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TABLE 4 Drug Acyclovir Alclometason
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OINTMENTS AND CREAMS 283 Packaging
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OINTMENTS AND CREAMS 285 presence o
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OINTMENTS AND CREAMS 287 side and s
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TABLE 6 a Drug Acyclovir Atropine s
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TABLE 7 Continued Commercial Produc
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GELS 293 (e.g., carbomers) that con
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GELS 295 molecular weight, gelling
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GELS 297 Ethylcellulose Ethylcellul
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GELS 299 practically insoluble in w
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GELS 301 out takes place. The visco
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GELS 303 FIGURE 3 Vacuum processing
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GELS 305 chramatograph for quantita
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TABLE 10 a Drug Benzocaine Benzoyl
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TABLE 11 Continued Type of Change C
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REFERENCES 311 8. Fisher , A. A. (
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4.3 LIQUID DOSAGE FORMS Maria V. Ru
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are both challenges and opportuniti
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GENERALITIES 317 that are more deci
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APPROACHES 319 To apply QbD as a sy
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CRITICAL ASPECTS OF LIQUIDS MANUFAC
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Dosing Pumps Collector Tank Continu
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LIQUID DOSAGE FORMS 339 For Solutio
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Suspension, Extended Release A liqu
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REFERENCES 343 26. Guides to inspec
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SECTION 5 SPECIAL/NEW DOSAGE FORMS
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348 CONTROLLED-RELEASE DOSAGE FORMS
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394 BIODEGRADABLE POLYMER-BASED MIC
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5.3 LIPOSOMES AND DRUG DELIVERY Sop
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LIPOSOME STRUCTURE AND CHARACTERIST
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H 2 C O O O - O - - O P O - O P O O
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In the second approach (probe sonic
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O R1 SH + N R2 N R2 R 1 Anchor R 2
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IN VIVO DISTRIBUTION 467 marrow (du
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IN VIVO DISTRIBUTION 469 absorption
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% injected dose/g % injected dose/g
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IN VIVO DISTRIBUTION 473 combinatio
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IN VIVO DISTRIBUTION 475 delivery i
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IN VIVO DISTRIBUTION 477 increases
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IN VIVO DISTRIBUTION 479 TABLE 3 Ex
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IN VIVO DISTRIBUTION 481 As mention
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TABLE 4 Currently Marketed Liposome
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addition to those existing already,
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Survival (%) 100 75 50 25 APPLICATI
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APPLICATIONS OF LIPOSOMES IN THERAP
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μg C 6 / MI Blood Ng C 6 / mg Tumo
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DXR plasma concentration (μg/mL) 1
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REFERENCES 507 6. Allen , T. M. , a
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REFERENCES 509 42. LeNeveu , D. M.
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REFERENCES 511 78. Frederik , P. M.
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REFERENCES 513 115. Grit , M. , de
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REFERENCES 515 154. Maruyama , K. ,
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REFERENCES 517 185. Schnyder , A. ,
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REFERENCES 519 220. Gregoriadis , G
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REFERENCES 521 254. Shek , P. N. ,
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REFERENCES 523 290. Weiner , N. , W
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REFERENCES 525 328. Torres , P. F.
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REFERENCES 527 A. ( 2004 ), Human i
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REFERENCES 529 393. Fiorillo , A. ,
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REFERENCES 531 423. Paridaens , R.
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REFERENCES 533 455. Seiden , M. V.
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536 BIODEGRADABLE NANOPARTICLES 5.4
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538 BIODEGRADABLE NANOPARTICLES Som
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540 BIODEGRADABLE NANOPARTICLES for
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542 BIODEGRADABLE NANOPARTICLES ami
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544 BIODEGRADABLE NANOPARTICLES bot
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546 BIODEGRADABLE NANOPARTICLES Pol
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548 BIODEGRADABLE NANOPARTICLES 99m
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550 BIODEGRADABLE NANOPARTICLES ext
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552 BIODEGRADABLE NANOPARTICLES 5.4
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554 BIODEGRADABLE NANOPARTICLES 14.
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556 BIODEGRADABLE NANOPARTICLES 48.
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558 BIODEGRADABLE NANOPARTICLES Cal
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560 BIODEGRADABLE NANOPARTICLES cop
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562 BIODEGRADABLE NANOPARTICLES 150
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564 BIODEGRADABLE NANOPARTICLES of
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566 IN VITRO VALIDATION AND ORAL FO
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592 NASAL DELIVERY OF PEPTIDE AND N
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652 NASAL POWDER DRUG DELIVERY clea
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654 NASAL POWDER DRUG DELIVERY cohe
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656 NASAL POWDER DRUG DELIVERY comb
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658 NASAL POWDER DRUG DELIVERY Its
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660 NASAL POWDER DRUG DELIVERY stud
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662 NASAL POWDER DRUG DELIVERY Chit
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664 NASAL POWDER DRUG DELIVERY PLGA
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666 NASAL POWDER DRUG DELIVERY ties
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668 NASAL POWDER DRUG DELIVERY [124
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TABLE 1 Continued Powder Formulatio
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TABLE 1 Continued Powder Formulatio
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674 NASAL POWDER DRUG DELIVERY REFE
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676 NASAL POWDER DRUG DELIVERY Drug
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678 NASAL POWDER DRUG DELIVERY 72.
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680 NASAL POWDER DRUG DELIVERY 109.
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5.8 AEROSOL DRUG DELIVERY Michael H
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HUMAN RESPIRATORY TRACT AND AEROSOL
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5.8.3 THERAPEUTIC INDICATIONS FOR A
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AEROSOL DRUG DELIVERY DEVICES 689 n
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FIGURE 1 Schematic of MDI. METERED
Page 709 and 710:
TABLE 2 Property METERED DOSE INHAL
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METERED DOSE INHALERS 695 is then c
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METERED DOSE INHALERS 697 the other
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METERED DOSE INHALERS 699 the Easib
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5.8.6.2 Size Reduction and Particle
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DRY POWDER INHALERS 703 recognized
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DRY POWDER INHALERS 705 Spinhaler f
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oken up into droplets by the jet to
Page 725 and 726:
EMERGING TECHNOLOGIES 709 Mouthpiec
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capillary, the formulation is rapid
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REFERENCES 713 22. Kim , C. S. , an
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REFERENCES 715 61. Blanchard , J. D
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REFERENCES 717 100. Dolovich , M. B
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REFERENCES 719 136. Anonymous ( 200
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REFERENCES 721 170. Ward , G. H. ,
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REFERENCES 723 206. Young , P. M. ,
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REFERENCES 725 244. DeFronzo , R. A
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REFERENCES 727 280. Schurmann , W.
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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
Page 793 and 794:
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
Page 805 and 806:
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
Page 813 and 814:
PHYSIOLOGY AND CHARACTERISTICS OF H
Page 815 and 816:
Another important parameter when se
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COMMERCIALLY AVAILABLE PATCHES 801
Page 819 and 820:
5.11.8.1 Chemical Penetration Enhan
Page 821 and 822:
corneum much like the microneedle t
Page 823:
REFERENCES 807 40. Mitragotri , S.
Page 826 and 827:
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
Page 836 and 837:
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
Page 897 and 898:
6.1 PHARMACEUTICAL PREFORMULATION:
Page 899 and 900:
tion. According to global Internati
Page 901 and 902:
SELECTION OF PHARMACEUTICAL EXCIPIE
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Page 905 and 906:
TABLE 4 Disintegrant Starch Commonl
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DRUG-EXCIPIENT COMPATIBILITY 897 ap
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DRUG-EXCIPIENT COMPATIBILITY 899 in
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POWDER CHARACTERISTICS 901 their im
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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
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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
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934 ROLE OF PREFORMULATION IN DEVEL
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6.3 TABLET DESIGN Eddy Castellanos
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TABLETING CYCLE 979 The eccentric p
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FIGURE 4 (a) (b) (c) TABLETING CYCL
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TABLE 1 mm 3 4 5 6 7 8 9 10 11 12 1
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LIMITATIONS FOR DIRECT COMPRESSION
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Drug release (%) 120 100 80 60 40 2
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Beta Carotene Tablets (15 mg ) Form
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Lisinopril release (%) FIGURE 10 BI
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that do not compress well after wet
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Calcium phosphate, dibasic offers h
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FIGURE 11 Theophylline release (%)
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TABLET DESIGN WITH NATURAL PRODUCTS
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TABLE 7 Two Formulations for mangif
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TABLE 8 Weight Assay Disintegration
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TABLET DESIGN WITH NATURAL PRODUCTS
Page 1023 and 1024:
has a regulatory effect upon the an
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DESIGN TOOLS OF TABLET FORMULATION
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Amount released PPL (%) 110 100 90
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DESIGN TOOLS OF TABLET FORMULATION
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Percolation threshold (ε c) FIGURE
Page 1033 and 1034:
6.3.8 COATING SYSTEMS COATING SYSTE
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COATING SYSTEMS 1019 ences between
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Water absorption, % 8 7 6 5 4 3 2 1
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FIGURE 28 white. mg/h·m 0.9 0.8 0.
Page 1041 and 1042:
(a) (b) FIGURE 31 ( a ) Tablet coat
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TABLE 18 Solid content Batch size,
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Percent released FIGURE 35 Tablet b
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PHARMACEUTICAL TABLETS USING PERCOL
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TABLE 23 Calculation of Tablet Prop
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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
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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
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1058 TABLET PRODUCTION SYSTEMS and
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1060 TABLET PRODUCTION SYSTEMS FIGU
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Page 1080 and 1081:
Page 1082 and 1083:
1066 TABLET PRODUCTION SYSTEMS when
Page 1084 and 1085:
1068 TABLET PRODUCTION SYSTEMS die
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1072 TABLET PRODUCTION SYSTEMS TABL
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1074 TABLET PRODUCTION SYSTEMS Pres
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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.
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Page 1110 and 1111:
Page 1112 and 1113:
Page 1114 and 1115:
Page 1116 and 1117:
1100 CONTROLLED RELEASE OF DRUGS FR
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Page 1120 and 1121:
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Page 1150 and 1151:
1134 TABLET COMPRESSION stages invo
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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
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Page 1254 and 1255:
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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
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Page 1283 and 1284:
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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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1368 INDEX Cholera toxin, 637 Cilio
Page 1386:
1370 INDEX Production of radiopharm
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