Excipient development for pharmaceutical, biotechnology, and drug delivery systems:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Informa Healthcare
2006
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| Subjects: | |
| Online Access: | Publisher description Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XVII, 452 S. Ill., graph. Darst. 27 cm |
| ISBN: | 0849327067 9780849327063 |
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MARC
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| 245 | 1 | 0 | |a Excipient development for pharmaceutical, biotechnology, and drug delivery systems |c ed. by Ashok Katdare ; Mahesh V. Chaubal |
| 264 | 1 | |a New York [u.a.] |b Informa Healthcare |c 2006 | |
| 300 | |a XVII, 452 S. |b Ill., graph. Darst. |c 27 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Excipients | |
| 650 | 4 | |a Drug Approval | |
| 650 | 4 | |a Drug Evaluation | |
| 650 | 4 | |a Excipients | |
| 650 | 4 | |a Excipients |x chemistry | |
| 650 | 4 | |a Excipients |x pharmacokinetics | |
| 700 | 1 | |a Katdare, Ashok |e Sonstige |0 (DE-588)133943895 |4 oth | |
| 700 | 1 | |a Chaubal, Mahesh Vijay |d 1971- |e Sonstige |0 (DE-588)159809134 |4 oth | |
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| adam_text | EXCIPIENT DEVELOPMENT FOR PHARMACEUTICAL, BIOTECHNOLOGY, AND DRUG
DELIVERY SYSTEMS EDITED BY ASHOKKATDARE NEUROMOLECULAR PHARMACEUTICALS,
INC. EMERYVILLE, CALIFORNIA, U.S.A. MAHESHV. CHAUBAL BAXTER HEALTHCARE
ROUND LAKE, ILLINOIS, U.S.A. INFORMA HEALTHCARE NEW YORK LONDON CONTENTS
PREFACE .... HI CONTRIBUTORS .... XV 1. EXCIPIENTS:
BACKGROUND/INTRODUCTION / LOKESH BHATTACHARYYA, STEFAN SCHUBER,
CATHERINE SHEEHAN, AND ROGER WILLIAM 2. FOOD AND DRUG ADMINISTRATION
PERSPECTIVE ON REGULATION OF PHARMACEUTICAL EXCIPIENTS 3 HAROLD DAVIS
REFERENCES .... 12 3. PHARMACEUTICAL EXCIPIENT DEVELOPMENT*A PRECLINICAL
CHALLENGE 75 PAUL BALDRICK INTRODUCTION .... 15 PRECLINICAL TESTING
RECOMMENDED BY REGULATORY SITUATION .... 15 PRECLINICAL TESTING FOR A N
E W EXCIPIENT .... 16 PRECLINICAL TESTING FOR AN ESSENTIALLY N E W
EXCIPIENT .... 30 PRECLINICAL TESTING FOR AN ESTABLISHED EXCIPIENT ....
30 THE CHALLENGE .... 31 CONCLUSION .... 31 REFERENCES .... 32 4.
REGULATION OF PHARMACEUTICAL EXCIPIENTS 37 ROBERT G. PINCO AND THEODORE
M. SULLIVAN INTRODUCTION .... 37 N O INDEPENDENT STATUS FOR EXCIPIENTS
.... 38 EXCIPIENTS FOR OVER-THE-COUNTER DRUGS .... 39 EXCIPIENTS IN N E
W DRUGS .... 43 INFORMAL MECHANISMS TO PROMOTE EXCIPIENT ACCEPTANCE ....
45 GENERALLY RECOGNIZED AS SAFE NOTIFICATION .... 46 WORLDWIDE FOOD
ADDITIVE STATUS .... 47 EXCIPIENT DEVELOPMENT STAGNATION .... 47 VII
VIII CONTENTS INDUSTRY INITIATIVES .... 48 FOOD AND DRUG ADMINISTRATION
EXCIPIENT GUIDANCE .... 49 CONCLUSION .... 49 REFERENCES .... 50 5.
CYCLODEXTRINS*ENABLING EXCIPIENTS: A CASE STUDY OF THE DEVELOPMENT OF A
NEW EXCIPIENT*SULFOBUTYLETHER P-CYCLODEXTRIN (CAPTISOL ) 51 DIANE O.
THOMPSON CYCLODEXTRINS PROVIDE CASE STUDIES OF NEW EXCIPIENT DEVELOPMENT
.... 51 PARENT CDS .... 55 MODIFIED CDS .... 57 A CASE STUDY OF THE
DEVELOPMENT OF A NEW ENABLING EXCIPIENT*SBE-P-CD (CAPTISOL*) .... 60
CGMP MANUFACTURING*ANALYSIS, STABILITY, AND QUALITY .... 63 PRECLINICAL
SAFETY PACKAGE .... 65 THE COST TO DEVELOP A NEW EXCIPIENT .... 65
REFERENCES .... 65 6. THE USE OF FOOD ADDITIVE SAFETY EVALUATION
PROCEDURES AS A BASIS FOR EVALUATING THE SAFETY OF NEW PHARMACEUTICAL
EXCIPIENTS 69 CHRISTOPHER C. DEMERLIS AND JULIA C. HOWELL INTRODUCTION
.... 69 SAFETY EVALUATION PROCEDURES FOR THE REVIEW OF FOOD ADDITIVES
.... 70 CONCLUSION .... 80 REFERENCES .... 81 7. PHARMACOPEIA!
HARMONIZATION 83 J. LANE AND CATHERINE SHEEHAN INTRODUCTION .... 83
STAGE 1: IDENTIFICATION .... 85 STAGE 2: INVESTIGATION .... 85 STAGE 3:
PROPOSAL FOR EXPERT COMMITTEE REVIEW .... 88 STAGE 4: OFFICIAL INQUIRY
.... 88 STAGE 5: CONSENSUS .... 89 STAGE 6: REGIONAL ADOPTION AND
IMPLEMENTATION .... 89 STAGE 7: INTERREGIONAL IMPLEMENTATION .... 90 8.
EXCIPIENT INTERACTIONS 93 R. CHRISTIAN MORETON INTRODUCTION .... 93
EXCIPIENT INTERACTIONS .... 95 EXCIPIENT COMPATIBILITY STUDIES .... 101
PHYSIOLOGICAL/BIOPHARMACEUTICAL INTERACTIONS .... 104 CONTENTS IX
SUMMARY .... 106 REFERENCES .... 107 9. IMPROVED EXCIPIENT FUNCTIONALITY
BY COPROCESSING 109 PIYUSH GUPTA, SATISH K. NACHAEGARI, AND ARVIND K.
BANSAL INTRODUCTION .... 109 MANUFACTURING PROBLEMS IN SOLID DOSAGE
FORMS .... 110 SHIFT TOWARD DIRECT COMPRESSION .... 110 DEVELOPMENT OF
NEW EXCIPIENTS .... ILL SOURCES OF NEW EXCIPIENTS .... 112 PARTICLE
ENGINEERING FOR DEVELOPING NEW EXCIPIENTS .... 113 ROLE OF MATERIAL
CHARACTERISTICS IN COPROCESSING .... 116 MATERIAL CHARACTERISTICS AND
COMPRESSION .... 116 MATERIAL CHARACTERISTICS AND FLOW PROPERTIES ....
117 PROPERTIES OF COPROCESSED EXCIPIENTS .... 117 REGULATORY PERSPECTIVE
.... 120 COMMERCIAL STATUS .... 123 FUTURE TRENDS .... 123 CONCLUSIONS
.... 123 REFERENCES .... 124 BIBLIOGRAPHY .... 124 10. A COMPARISON OF
PHYSICAL AND MECHANICAL PROPERTIES OF COMMON TABLETING DILUENTS 127
GLENN T, CARLSON AND BRUNO C. HANCOCK INTRODUCTION .... 127 BACKGROUND
.... 129 EXPERIMENTAL .... 133 RESULTS AND DISCUSSION .... 136 SUMMARY
.... 150 REFERENCES .... 151 BIBLIOGRAPHY .... 151 11. EXCIPIENTS FOR
ORAL LIQUID FORMULATIONS 155 MEAGAN ANDERSON, F. OPAWALE, M. RAO, D.
DELMARRE, AND GOPAL ANYARAMBHATLA INTRODUCTION .... 155 IS THE ORAL
LIQUIDS MARKET REALLY A NICHE ? .... 155 IMPORTANCE OF EXCIPIENT
SELECTION IN THE PROCESS OF ORAL LIQUID FORMULATION DEVELOPMENT .... 156
EXCIPIENTS USED IN ORAL LIQUID FORMULATIONS .... 158 SUSPENDING AGENTS
AND VISCOSITY-MODIFYING AGENTS .... 167 PH MODIFIERS AND BUFFERING
AGENTS .... 167 PRESERVATIVES .... 169 ANTIOXIDANTS, CHELATING AGENTS,
AND SEQUESTRANTS .... 172 COLORING AGENTS .... 174 FLAVORS .... 175 X
CONTENTS MANUFACTURING CHALLENGES TO CONSIDER WHEN CHOOSING EXCIPIENTS
.... 176 POLYMORPHIC CHANGES IN ORAL LIQUID DOSAGE FORMS .... 179
REGULATORY ISSUES OF PHARMACEUTICAL EXCIPIENTS .... 180 REFERENCES ....
180 12. USE OF NONACTIVE PHARMACEUTICAL EXCIPIENTS IN ORAL DRUG
FORMULATIONS: BIOPHARMACEUTICAL CLASSIFICATION SYSTEM CONSIDERATIONS 181
JANE P. F. BAI, JIAN-HWA GUO, AND MAHESH V. CHAUBAL INTRODUCTION ....
181 BIOPHARMACEUTICAL CLASSIFICATION SYSTEM .... 182 EXCIPIENTS USED IN
SITE-SPECIFIC-RELEASE FORMULATIONS .... 184 EXCIPIENTS USED IN
SUSTAINED-RELEASE FORMULATIONS .... 185 EXCIPIENTS USED TO ENHANCE
DISSOLUTION OF BIOPHARMACEUTICAL CLASSIFICATION SYSTEM CLASS II AND IV
DRUGS .... 187 PERMEABILITY-ENHANCING EXCIPIENTS .... 191 CONCLUSION
.... 193 REFERENCES .... 193 13. EXCIPIENTS FOR SEMISOLID FORMULATIONS
197 PRASHANT SRIVASTAVA INTRODUCTION .... 197 CREAMS .... 198 OINTMENTS
.... 203 PASTES .... 203 GELS .... 204 SUPPOSITORIES .... 208 REFERENCES
.... 212 APPENDIX I .... 215 APPENDIX II .... 219 APPENDIX III .... 221
APPENDIX IV .... 222 APPENDIX V .... 223 14. EXCIPIENTS FOR PULMONARY
FORMULATIONS 225 HUGH SMYTH INTRODUCTION .... 225 OVERVIEW OF PULMONARY
FORMULATIONS AND DELIVERY SYSTEMS .... 226 GENERAL CONSIDERATIONS FOR
EXCIPIENT SELECTION FOR PULMONARY DOSAGE FORMS: EXCIPIENT USE DETERMINED
VIA PRINCIPLES OF DELIVERY .... 229 PHYSICAL AND CHEMICAL PROPERTIES
REQUIRED .... 235 CONTENTS XI FUTURE CHALLENGES AND OPPORTUNITIES ....
243 SUMMARY .... 244 REFERENCES .... 244 15. SYNERGISTIC COMBINATIONS OF
PENETRATION ENHANCERS AND THEIR DISCOVERY BY HIGH-THROUGHPUT SCREENING
251 PANKAJ KARANDE, AMIT JAIN, AND SAMIR MITRAGOTRI INTRODUCTION ....
251 BACKGROUND .... 252 CHALLENGES IN DESIGNING MULTICOMPONENT CHEMICAL
PENETRATION ENHANCER FORMULATIONS .... 253 DESIGNING MULTICOMPONENT
FORMULATIONS .... 253 DESIGNING A HIGH-THROUGHPUT SCREENING ASSAY FOR
TESTING TRANSDERMAL FORMULATIONS .... 257 IN VITRO SKIN IMPEDANCE GUIDED
HIGH-THROUGHPUT SCREENING .... 259 VALIDATION OF IN VITRO SKIN IMPEDANCE
GUIDED HIGH-THROUGHPUT SCREENING WITH FRANZ DIFFUSION CELLS .... 261
APPLICATIONS OF IN VITRO SKIN IMPEDANCE GUIDED HIGH-THROUGHPUT SCREENING
.... 261 DISCOVERY OF RARE ENHANCER COMBINATIONS .... 262 EXPLORING
SYNERGIES BETWEEN CHEMICAL ENHANCERS .... 264 GENERATING DATABASE FOR
STRUCTURE-ACTIVITY CORRELATIONS .... 265 REFERENCES .... 266 16.
EXCIPIENT SELECTION AND CRITERIA FOR INJECTABLE DOSAGE FORMS .... 271
MAHESH V. CHAUBAL, JAMES KIPP, AND BARRETT RABINOW INTRODUCTION .... 271
IMPACT OF INJECTABLE ROUTE OF ADMINISTRATION UPON SELECTION OF
EXCIPIENTS .... 272 EXCIPIENTS FOR INJECTABLE FORMULATIONS .... 278
EXCIPIENTS FOR DELIVERY OF WATER-INSOLUBLE AGENTS .... 282
CONTAINER-EXCIPIENT INTERACTIONS IN INJECTABLE DOSAGE FORMS .... 286
SUMMARY .... 287 REFERENCES .... 287 17. EXCIPIENTS FOR PROTEIN DRUGS
291 YATIN R. GOKARN, ANDREW KOSKY, EVA KRAS, ARNOLD MCAULEY, AND RICHARD
L. REMMELE, JR. INTRODUCTION .... 291 DEGRADATION PATHWAYS OF PROTEINS
.... 292 COMPONENTS OF LIQUID AND LYOPHILIZED PROTEIN FORMULATIONS ....
294 EXCIPIENTS .... 295 XII CONTENTS REFERENCES .... 303 APPENDIX ....
307 18. EXCIPIENTS USED IN VACCINES 333 MANMOHAN SINGH AND DEREK O HAGAN
INTRODUCTION .... 333 ADJUVANTS .... 333 PRESERVATIVES .... 335
ADDITIVES .... 336 SALTS .... 337 RESIDUALS FROM THE MANUFACTURING
PROCESS .... 337 EXCIPIENTS USED TO IMPROVE STABILITY OF VACCINES ....
337 EXCIPIENTS USED IN VACCINE FORMULATIONS CURRENTLY IN CLINICAL TRIALS
.... 337 ANALYTICAL ASSAYS AND QUALITY CONTROL OF EXCIPIENTS FOR VACCINE
FORMULATIONS .... 338 SELECTION OF EXCIPIENTS FOR NEXT GENERATION
VACCINES .... 339 SUMMARY .... 339 REFERENCES .... 339 19. POLYMERIC
EXCIPIENTS FOR CONTROLLED RELEASE APPLICATIONS 341 MAHESH V. CHAUBAL
INTRODUCTION .... 341 ORAL DRUG DELIVERY .... 342 PARENTERAL DRUG
DELIVERY .... 344 NOVEL POLYMERS FOR DRUG DELIVERY .... 347 SUMMARY ....
354 REFERENCES .... 354 20. EMERGING EXCIPIENTS IN PARENTERAL
MEDICATIONS: THE NEW PARADIGM 357 SHIREESH P. APTE AND SYDNEY O. UGWU
INTRODUCTION .... 357 CONCENTRATION OF THE CHEMICAL ENTITY .... 358
INDICATION FOR WHICH THE CHEMICAL ENTITY IS ADMINISTERED .... 359
ELICITATION OF A PHARMACOLOGICAL RESPONSE .... 362 EXCIPIENT DRUG
CONJUGATES .... 364 NATURAL PRODUCTS INCLUDING NATURALLY OCCURRING
POLYMERS AND DERIVATIVES .... 365 CONCLUSIONS .... 368 REFERENCES ....
368 21. EXCIPIENT MANUFACTURING AND GOOD MANUFACTURING PRACTICES 373
IRWIN SILVERSTEIN INTRODUCTION .... 373 CONTENTS XIII SUMMARY .... 387
REFERENCES .... 388 22. EXCIPIENT QUALITY ASSURANCE: HANDLING, SAMPLING,
AND REGULATORY ISSUES 389 RAAFAT FAHMY AND STEPHEN W. HOAG INTRODUCTION
.... 389 REGULATORY ASPECTS OF EXCIPIENT QUALITY ASSURANCE .... 390
CERTIFICATE OF ANALYSIS .... 390 ADDITIONAL GUIDELINES .... 392 RECEIPT,
SAMPLING, TESTING, AND APPROVAL OF RAW MATERIALS .... 392 EXPIRATION OR
RETEST DATING .... 393 RECORDS .... 394 TRACEABILITY .... 394 ANALYTICAL
PROCEDURES .... 395 LABORATORY CONTROLS .... 395 EXCIPIENTS OF HUMAN OR
ANIMAL ORIGIN .... 396 SAMPLE COLLECTION .... 396 DEVELOPING A SAMPLING
PLAN .... 397 SAMPLING EQUIPMENT AND INFRASTRUCTURE .... 401
SPECTROSCOPIC TECHNIQUES FOR SAMPLE QUALIFICATION .... 402 DATA ANALYSIS
.... 404 PRINCIPAL COMPONENTS ANALYSIS .... 407 REFERENCES . . .
APPENDIX I: . . APPENDIX II: . APPENDIX III: . APPENDIX IV: . . 410 . .
411 . . . 412 ... 415 ... 417 23. EXCIPIENT DISTRIBUTION 421 VICTORIA M.
SHAHEEN INTRODUCTION .... 421 THE EVOLUTION AND SPECIALIZED ROLE OF THE
PHARMACEUTICAL DISTRIBUTOR IN THE PHARMACEUTICAL INDUSTRY .... 422
SPECIALIZED MODEL OF THE PHARMACEUTICAL DISTRIBUTOR .... 425
PHARMACEUTICAL-ORIENTED CUSTOMER SERVICE .... 427 TECHNICALLY
TRAINED/PROFICIENT SALES STAFF .... 427 WAREHOUSING, LOGISTICS, AND
MATERIALS MANAGEMENT .... 428 PHARMACEUTICAL EXCIPIENT DISTRIBUTOR
STRENGTHS .... 428 PHARMACEUTICAL EXCIPIENT DISTRIBUTOR CHALLENGES ....
431 ANTICIPATING, ESTIMATING, AND COMMUNICATING ACCURATE LEAD TIMES ....
435 REGULATING PHARMACEUTICAL DISTRIBUTORS .... 436 REFERENCES .... 436
INDEX .... 437
|
| adam_txt |
EXCIPIENT DEVELOPMENT FOR PHARMACEUTICAL, BIOTECHNOLOGY, AND DRUG
DELIVERY SYSTEMS EDITED BY ASHOKKATDARE NEUROMOLECULAR PHARMACEUTICALS,
INC. EMERYVILLE, CALIFORNIA, U.S.A. MAHESHV. CHAUBAL BAXTER HEALTHCARE
ROUND LAKE, ILLINOIS, U.S.A. INFORMA HEALTHCARE NEW YORK LONDON CONTENTS
PREFACE . HI CONTRIBUTORS . XV 1. EXCIPIENTS:
BACKGROUND/INTRODUCTION / LOKESH BHATTACHARYYA, STEFAN SCHUBER,
CATHERINE SHEEHAN, AND ROGER WILLIAM 2. FOOD AND DRUG ADMINISTRATION
PERSPECTIVE ON REGULATION OF PHARMACEUTICAL EXCIPIENTS 3 HAROLD DAVIS
REFERENCES . 12 3. PHARMACEUTICAL EXCIPIENT DEVELOPMENT*A PRECLINICAL
CHALLENGE 75 PAUL BALDRICK INTRODUCTION . 15 PRECLINICAL TESTING
RECOMMENDED BY REGULATORY SITUATION . 15 PRECLINICAL TESTING FOR A N
E W EXCIPIENT . 16 PRECLINICAL TESTING FOR AN ESSENTIALLY N E W
EXCIPIENT . 30 PRECLINICAL TESTING FOR AN ESTABLISHED EXCIPIENT .
30 THE CHALLENGE . 31 CONCLUSION . 31 REFERENCES . 32 4.
REGULATION OF PHARMACEUTICAL EXCIPIENTS 37 ROBERT G. PINCO AND THEODORE
M. SULLIVAN INTRODUCTION . 37 N O INDEPENDENT STATUS FOR EXCIPIENTS
. 38 EXCIPIENTS FOR OVER-THE-COUNTER DRUGS . 39 EXCIPIENTS IN N E
W DRUGS . 43 INFORMAL MECHANISMS TO PROMOTE EXCIPIENT ACCEPTANCE .
45 GENERALLY RECOGNIZED AS SAFE NOTIFICATION . 46 WORLDWIDE FOOD
ADDITIVE STATUS . 47 EXCIPIENT DEVELOPMENT STAGNATION . 47 VII
VIII CONTENTS INDUSTRY INITIATIVES . 48 FOOD AND DRUG ADMINISTRATION
EXCIPIENT GUIDANCE . 49 CONCLUSION . 49 REFERENCES . 50 5.
CYCLODEXTRINS*ENABLING EXCIPIENTS: A CASE STUDY OF THE DEVELOPMENT OF A
NEW EXCIPIENT*SULFOBUTYLETHER P-CYCLODEXTRIN (CAPTISOL ) 51 DIANE O.
THOMPSON CYCLODEXTRINS PROVIDE CASE STUDIES OF NEW EXCIPIENT DEVELOPMENT
. 51 PARENT CDS . 55 MODIFIED CDS . 57 A CASE STUDY OF THE
DEVELOPMENT OF A NEW ENABLING EXCIPIENT*SBE-P-CD (CAPTISOL*) . 60
CGMP MANUFACTURING*ANALYSIS, STABILITY, AND QUALITY . 63 PRECLINICAL
SAFETY PACKAGE . 65 THE COST TO DEVELOP A NEW EXCIPIENT . 65
REFERENCES . 65 6. THE USE OF FOOD ADDITIVE SAFETY EVALUATION
PROCEDURES AS A BASIS FOR EVALUATING THE SAFETY OF NEW PHARMACEUTICAL
EXCIPIENTS 69 CHRISTOPHER C. DEMERLIS AND JULIA C. HOWELL INTRODUCTION
. 69 SAFETY EVALUATION PROCEDURES FOR THE REVIEW OF FOOD ADDITIVES
. 70 CONCLUSION . 80 REFERENCES . 81 7. PHARMACOPEIA!
HARMONIZATION 83 J. LANE AND CATHERINE SHEEHAN INTRODUCTION . 83
STAGE 1: IDENTIFICATION . 85 STAGE 2: INVESTIGATION . 85 STAGE 3:
PROPOSAL FOR EXPERT COMMITTEE REVIEW . 88 STAGE 4: OFFICIAL INQUIRY
. 88 STAGE 5: CONSENSUS . 89 STAGE 6: REGIONAL ADOPTION AND
IMPLEMENTATION . 89 STAGE 7: INTERREGIONAL IMPLEMENTATION . 90 8.
EXCIPIENT INTERACTIONS 93 R. CHRISTIAN MORETON INTRODUCTION . 93
EXCIPIENT INTERACTIONS . 95 EXCIPIENT COMPATIBILITY STUDIES . 101
PHYSIOLOGICAL/BIOPHARMACEUTICAL INTERACTIONS . 104 CONTENTS IX
SUMMARY . 106 REFERENCES . 107 9. IMPROVED EXCIPIENT FUNCTIONALITY
BY COPROCESSING 109 PIYUSH GUPTA, SATISH K. NACHAEGARI, AND ARVIND K.
BANSAL INTRODUCTION . 109 MANUFACTURING PROBLEMS IN SOLID DOSAGE
FORMS . 110 SHIFT TOWARD DIRECT COMPRESSION . 110 DEVELOPMENT OF
NEW EXCIPIENTS . ILL SOURCES OF NEW EXCIPIENTS . 112 PARTICLE
ENGINEERING FOR DEVELOPING NEW EXCIPIENTS . 113 ROLE OF MATERIAL
CHARACTERISTICS IN COPROCESSING . 116 MATERIAL CHARACTERISTICS AND
COMPRESSION . 116 MATERIAL CHARACTERISTICS AND FLOW PROPERTIES .
117 PROPERTIES OF COPROCESSED EXCIPIENTS . 117 REGULATORY PERSPECTIVE
. 120 COMMERCIAL STATUS . 123 FUTURE TRENDS . 123 CONCLUSIONS
. 123 REFERENCES . 124 BIBLIOGRAPHY . 124 10. A COMPARISON OF
PHYSICAL AND MECHANICAL PROPERTIES OF COMMON TABLETING DILUENTS 127
GLENN T, CARLSON AND BRUNO C. HANCOCK INTRODUCTION . 127 BACKGROUND
. 129 EXPERIMENTAL . 133 RESULTS AND DISCUSSION . 136 SUMMARY
. 150 REFERENCES . 151 BIBLIOGRAPHY . 151 11. EXCIPIENTS FOR
ORAL LIQUID FORMULATIONS 155 MEAGAN ANDERSON, F. OPAWALE, M. RAO, D.
DELMARRE, AND GOPAL ANYARAMBHATLA INTRODUCTION . 155 IS THE ORAL
LIQUIDS MARKET REALLY A "NICHE"? . 155 IMPORTANCE OF EXCIPIENT
SELECTION IN THE PROCESS OF ORAL LIQUID FORMULATION DEVELOPMENT . 156
EXCIPIENTS USED IN ORAL LIQUID FORMULATIONS . 158 SUSPENDING AGENTS
AND VISCOSITY-MODIFYING AGENTS . 167 PH MODIFIERS AND BUFFERING
AGENTS . 167 PRESERVATIVES . 169 ANTIOXIDANTS, CHELATING AGENTS,
AND SEQUESTRANTS . 172 COLORING AGENTS . 174 FLAVORS . 175 X
CONTENTS MANUFACTURING CHALLENGES TO CONSIDER WHEN CHOOSING EXCIPIENTS
. 176 POLYMORPHIC CHANGES IN ORAL LIQUID DOSAGE FORMS . 179
REGULATORY ISSUES OF PHARMACEUTICAL EXCIPIENTS . 180 REFERENCES .
180 12. USE OF NONACTIVE PHARMACEUTICAL EXCIPIENTS IN ORAL DRUG
FORMULATIONS: BIOPHARMACEUTICAL CLASSIFICATION SYSTEM CONSIDERATIONS 181
JANE P. F. BAI, JIAN-HWA GUO, AND MAHESH V. CHAUBAL INTRODUCTION .
181 BIOPHARMACEUTICAL CLASSIFICATION SYSTEM . 182 EXCIPIENTS USED IN
SITE-SPECIFIC-RELEASE FORMULATIONS . 184 EXCIPIENTS USED IN
SUSTAINED-RELEASE FORMULATIONS . 185 EXCIPIENTS USED TO ENHANCE
DISSOLUTION OF BIOPHARMACEUTICAL CLASSIFICATION SYSTEM CLASS II AND IV
DRUGS . 187 PERMEABILITY-ENHANCING EXCIPIENTS . 191 CONCLUSION
. 193 REFERENCES . 193 13. EXCIPIENTS FOR SEMISOLID FORMULATIONS
197 PRASHANT SRIVASTAVA INTRODUCTION . 197 CREAMS . 198 OINTMENTS
. 203 PASTES . 203 GELS . 204 SUPPOSITORIES . 208 REFERENCES
. 212 APPENDIX I . 215 APPENDIX II . 219 APPENDIX III . 221
APPENDIX IV . 222 APPENDIX V . 223 14. EXCIPIENTS FOR PULMONARY
FORMULATIONS 225 HUGH SMYTH INTRODUCTION . 225 OVERVIEW OF PULMONARY
FORMULATIONS AND DELIVERY SYSTEMS . 226 GENERAL CONSIDERATIONS FOR
EXCIPIENT SELECTION FOR PULMONARY DOSAGE FORMS: EXCIPIENT USE DETERMINED
VIA PRINCIPLES OF DELIVERY . 229 PHYSICAL AND CHEMICAL PROPERTIES
REQUIRED . 235 CONTENTS XI FUTURE CHALLENGES AND OPPORTUNITIES .
243 SUMMARY . 244 REFERENCES . 244 15. SYNERGISTIC COMBINATIONS OF
PENETRATION ENHANCERS AND THEIR DISCOVERY BY HIGH-THROUGHPUT SCREENING
251 PANKAJ KARANDE, AMIT JAIN, AND SAMIR MITRAGOTRI INTRODUCTION .
251 BACKGROUND . 252 CHALLENGES IN DESIGNING MULTICOMPONENT CHEMICAL
PENETRATION ENHANCER FORMULATIONS . 253 DESIGNING MULTICOMPONENT
FORMULATIONS . 253 DESIGNING A HIGH-THROUGHPUT SCREENING ASSAY FOR
TESTING TRANSDERMAL FORMULATIONS . 257 IN VITRO SKIN IMPEDANCE GUIDED
HIGH-THROUGHPUT SCREENING . 259 VALIDATION OF IN VITRO SKIN IMPEDANCE
GUIDED HIGH-THROUGHPUT SCREENING WITH FRANZ DIFFUSION CELLS . 261
APPLICATIONS OF IN VITRO SKIN IMPEDANCE GUIDED HIGH-THROUGHPUT SCREENING
. 261 DISCOVERY OF RARE ENHANCER COMBINATIONS . 262 EXPLORING
SYNERGIES BETWEEN CHEMICAL ENHANCERS . 264 GENERATING DATABASE FOR
STRUCTURE-ACTIVITY CORRELATIONS . 265 REFERENCES . 266 16.
EXCIPIENT SELECTION AND CRITERIA FOR INJECTABLE DOSAGE FORMS . 271
MAHESH V. CHAUBAL, JAMES KIPP, AND BARRETT RABINOW INTRODUCTION . 271
IMPACT OF INJECTABLE ROUTE OF ADMINISTRATION UPON SELECTION OF
EXCIPIENTS . 272 EXCIPIENTS FOR INJECTABLE FORMULATIONS . 278
EXCIPIENTS FOR DELIVERY OF WATER-INSOLUBLE AGENTS . 282
CONTAINER-EXCIPIENT INTERACTIONS IN INJECTABLE DOSAGE FORMS . 286
SUMMARY . 287 REFERENCES . 287 17. EXCIPIENTS FOR PROTEIN DRUGS
291 YATIN R. GOKARN, ANDREW KOSKY, EVA KRAS, ARNOLD MCAULEY, AND RICHARD
L. REMMELE, JR. INTRODUCTION . 291 DEGRADATION PATHWAYS OF PROTEINS
. 292 COMPONENTS OF LIQUID AND LYOPHILIZED PROTEIN FORMULATIONS .
294 EXCIPIENTS . 295 XII CONTENTS REFERENCES . 303 APPENDIX .
307 18. EXCIPIENTS USED IN VACCINES 333 MANMOHAN SINGH AND DEREK O'HAGAN
INTRODUCTION . 333 ADJUVANTS . 333 PRESERVATIVES . 335
ADDITIVES . 336 SALTS . 337 RESIDUALS FROM THE MANUFACTURING
PROCESS . 337 EXCIPIENTS USED TO IMPROVE STABILITY OF VACCINES .
337 EXCIPIENTS USED IN VACCINE FORMULATIONS CURRENTLY IN CLINICAL TRIALS
. 337 ANALYTICAL ASSAYS AND QUALITY CONTROL OF EXCIPIENTS FOR VACCINE
FORMULATIONS . 338 SELECTION OF EXCIPIENTS FOR NEXT GENERATION
VACCINES . 339 SUMMARY . 339 REFERENCES . 339 19. POLYMERIC
EXCIPIENTS FOR CONTROLLED RELEASE APPLICATIONS 341 MAHESH V. CHAUBAL
INTRODUCTION . 341 ORAL DRUG DELIVERY . 342 PARENTERAL DRUG
DELIVERY . 344 NOVEL POLYMERS FOR DRUG DELIVERY . 347 SUMMARY .
354 REFERENCES . 354 20. EMERGING EXCIPIENTS IN PARENTERAL
MEDICATIONS: THE NEW PARADIGM 357 SHIREESH P. APTE AND SYDNEY O. UGWU
INTRODUCTION . 357 CONCENTRATION OF THE CHEMICAL ENTITY . 358
INDICATION FOR WHICH THE CHEMICAL ENTITY IS ADMINISTERED . 359
ELICITATION OF A PHARMACOLOGICAL RESPONSE . 362 EXCIPIENT DRUG
CONJUGATES . 364 NATURAL PRODUCTS INCLUDING NATURALLY OCCURRING
POLYMERS AND DERIVATIVES . 365 CONCLUSIONS . 368 REFERENCES .
368 21. EXCIPIENT MANUFACTURING AND GOOD MANUFACTURING PRACTICES 373
IRWIN SILVERSTEIN INTRODUCTION . 373 CONTENTS XIII SUMMARY . 387
REFERENCES . 388 22. EXCIPIENT QUALITY ASSURANCE: HANDLING, SAMPLING,
AND REGULATORY ISSUES 389 RAAFAT FAHMY AND STEPHEN W. HOAG INTRODUCTION
. 389 REGULATORY ASPECTS OF EXCIPIENT QUALITY ASSURANCE . 390
CERTIFICATE OF ANALYSIS . 390 ADDITIONAL GUIDELINES . 392 RECEIPT,
SAMPLING, TESTING, AND APPROVAL OF RAW MATERIALS . 392 EXPIRATION OR
RETEST DATING . 393 RECORDS . 394 TRACEABILITY . 394 ANALYTICAL
PROCEDURES . 395 LABORATORY CONTROLS . 395 EXCIPIENTS OF HUMAN OR
ANIMAL ORIGIN . 396 SAMPLE COLLECTION . 396 DEVELOPING A SAMPLING
PLAN . 397 SAMPLING EQUIPMENT AND INFRASTRUCTURE . 401
SPECTROSCOPIC TECHNIQUES FOR SAMPLE QUALIFICATION . 402 DATA ANALYSIS
. 404 PRINCIPAL COMPONENTS ANALYSIS . 407 REFERENCES . . .
APPENDIX I: . . APPENDIX II: . APPENDIX III: . APPENDIX IV: . . 410 . .
411 . . . 412 . 415 . 417 23. EXCIPIENT DISTRIBUTION 421 VICTORIA M.
SHAHEEN INTRODUCTION . 421 THE EVOLUTION AND SPECIALIZED ROLE OF THE
PHARMACEUTICAL DISTRIBUTOR IN THE PHARMACEUTICAL INDUSTRY . 422
SPECIALIZED MODEL OF THE PHARMACEUTICAL DISTRIBUTOR . 425
PHARMACEUTICAL-ORIENTED CUSTOMER SERVICE . 427 TECHNICALLY
TRAINED/PROFICIENT SALES STAFF . 427 WAREHOUSING, LOGISTICS, AND
MATERIALS MANAGEMENT . 428 PHARMACEUTICAL EXCIPIENT DISTRIBUTOR
STRENGTHS . 428 PHARMACEUTICAL EXCIPIENT DISTRIBUTOR CHALLENGES .
431 ANTICIPATING, ESTIMATING, AND COMMUNICATING ACCURATE LEAD TIMES .
435 REGULATING PHARMACEUTICAL DISTRIBUTORS . 436 REFERENCES . 436
INDEX . 437 |
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| illustrated | Illustrated |
| index_date | 2024-07-02T18:51:31Z |
| indexdate | 2024-07-09T21:07:42Z |
| institution | BVB |
| isbn | 0849327067 9780849327063 |
| language | English |
| lccn | 006046565 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016089400 |
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| owner_facet | DE-19 DE-BY-UBM |
| physical | XVII, 452 S. Ill., graph. Darst. 27 cm |
| publishDate | 2006 |
| publishDateSearch | 2006 |
| publishDateSort | 2006 |
| publisher | Informa Healthcare |
| record_format | marc |
| spelling | Excipient development for pharmaceutical, biotechnology, and drug delivery systems ed. by Ashok Katdare ; Mahesh V. Chaubal New York [u.a.] Informa Healthcare 2006 XVII, 452 S. Ill., graph. Darst. 27 cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Excipients Drug Approval Drug Evaluation Excipients chemistry Excipients pharmacokinetics Katdare, Ashok Sonstige (DE-588)133943895 oth Chaubal, Mahesh Vijay 1971- Sonstige (DE-588)159809134 oth http://www.loc.gov/catdir/enhancements/fy0661/2006046565-d.html Publisher description lizenzfrei GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016089400&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Excipient development for pharmaceutical, biotechnology, and drug delivery systems Excipients Drug Approval Drug Evaluation Excipients chemistry Excipients pharmacokinetics |
| title | Excipient development for pharmaceutical, biotechnology, and drug delivery systems |
| title_auth | Excipient development for pharmaceutical, biotechnology, and drug delivery systems |
| title_exact_search | Excipient development for pharmaceutical, biotechnology, and drug delivery systems |
| title_exact_search_txtP | Excipient development for pharmaceutical, biotechnology, and drug delivery systems |
| title_full | Excipient development for pharmaceutical, biotechnology, and drug delivery systems ed. by Ashok Katdare ; Mahesh V. Chaubal |
| title_fullStr | Excipient development for pharmaceutical, biotechnology, and drug delivery systems ed. by Ashok Katdare ; Mahesh V. Chaubal |
| title_full_unstemmed | Excipient development for pharmaceutical, biotechnology, and drug delivery systems ed. by Ashok Katdare ; Mahesh V. Chaubal |
| title_short | Excipient development for pharmaceutical, biotechnology, and drug delivery systems |
| title_sort | excipient development for pharmaceutical biotechnology and drug delivery systems |
| topic | Excipients Drug Approval Drug Evaluation Excipients chemistry Excipients pharmacokinetics |
| topic_facet | Excipients Drug Approval Drug Evaluation Excipients chemistry Excipients pharmacokinetics |
| url | http://www.loc.gov/catdir/enhancements/fy0661/2006046565-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016089400&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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