Handbook of pharmaceutical manufacturing formulations: 4 Semisolid products
Gespeichert in:
| 1. Verfasser: | |
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| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton [u.a.]
CRC Press
2004
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| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | 263 S. 29 cm |
| ISBN: | 0849317495 |
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| 100 | 1 | |a Niazi, Sarfaraz K. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Handbook of pharmaceutical manufacturing formulations |n 4 |p Semisolid products |c Sarfaraz K. Niazi |
| 264 | 1 | |a Boca Raton [u.a.] |b CRC Press |c 2004 | |
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Datensatz im Suchindex
| _version_ | 1804135012323295232 |
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| adam_text | H A N D B O O K OF PHARMACEUTICAL MANUFACTURING FORMULATIONS SEMISOLID
PRODUCTS VOLUME 4 SARFARAZ K. NIAZI CRC PRESS BOCA RATON LONDON NEW YORK
WASHINGTON, D.C CONTENTS PARTI REGULATORY AND MANUFACTURING GUIDANCE.
CHAPTER 1 CHANGES TO APPROVED NEW DRUG APPLICATIONS OR ABBREVIATED NEW
DRUG APPLICATIONS 3 I. INTRODUCTION 3 II. REPORTING CATEGORIES 3 III.
GENERAL REQUIREMENTS 4 IV. ASSESSING THE EFFECT OF MANUFACTURING CHANGES
4 A. ASSESSMENT OF THE EFFECTS OF THE CHANGE 4 B. EQUIVALENCE 5 C.
ADVERSE EFFECT 5 V. COMPONENTS AND COMPOSITION 5 VI. MANUFACTURING SITES
5 A. GENERAL CONSIDERATIONS 5 B. MAJOR CHANGES (PRIOR APPROVAL
SUPPLEMENT) 6 C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 6
D. MINOR CHANGES (ANNUAL REPORT) 7 VII. MANUFACTURING PROCESS 7 A.
GENERAL CONSIDERATIONS 7 B. MAJOR CHANGES (PRIOR APPROVAL SUPPLEMENT) 7
C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 8 D. MINOR
CHANGES (ANNUAL REPORT) 9 VIII. SPECIFICATIONS 9 A. GENERAL
CONSIDERATIONS 9 B. MAJOR CHANGES (PRIOR APPROVAL SUPPLEMENT) 9 C.
MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 10 D. MINOR CHANGES
(ANNUAL REPORT) 10 IX. PACKAGE A. GENERAL CONSIDERATIONS B. MAJOR
CHANGES (PRIOR APPROVAL SUPPLEMENT) C. MODERATE CHANGES
(SUPPLEMENT*CHANGES BEING EFFECTED) D. MINOR CHANGES (ANNUAL REPORT) X.
LABELING A. GENERAL CONSIDERATIONS B. MAJOR CHANGES (PRIOR APPROVAL
SUPPLEMENT) C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) D.
MINOR CHANGES (ANNUAL REPORT) XI. MISCELLANEOUS CHANGES A. MAJOR CHANGES
(PRIOR APPROVAL SUPPLEMENT) B. MODERATE CHANGES (SUPPLEMENT*CHANGES
BEING EFFECTED) C. MINOR CHANGES (ANNUAL REPORT) 14 XII. MULTIPLE
RELATED CHANGES 14 GLOSSARY 1? CHAPTER 2 POSTAPPROVAL CHANGES TO
SEMISOLID DRUGS 17 I. PRESERVATIVE IK II. MANUFACTURING CHANGES IS III.
PROCESS 18 IV. MANUFACTURING SITE 18 CHAPTER 3 SCALE-UP AND POSTAPPROVAL
CHANGES FOR NONSTERILE SEMISOLID DOSAGE FORMS: MANUFACTURING EQUIPMENT
21 I. INTRODUCTION 21 II. PARTICLE SIZE REDUCTION AND SEPARATION 21 A.
DEFINITIONS 21 B. EQUIPMENT CLASSIFICATIONS 22 III. MIXING 22 A.
DEFINITIONS 22 B. EQUIPMENT CLASSIFICATION 23 IV TRANSFER 23 A.
DEFINITIONS 23 B. EQUIPMENT CLASSIFICATION 23 V. PACKAGING 24 A.
DEFINITIONS 24 B. EQUIPMENT CLASSIFICATION 24 CHAPTER 4 STABILITY
TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS 25 I. INTRODUCTION 25 II.
STABILITY TESTING FOR NEW DRUG APPLICATIONS 25 A. DRUG SUBSTANCE 25 B.
DRUG PRODUCT 27 C. NEW DOSAGE FORMS [ICH QIC] 34 D. OTHER NDAS 34 III.
STABILITY TESTING FOR ABBREVIATED NDAS 34 A. DRUG SUBSTANCE STABILITY
DATA SUBMISSION 34 B. DRUG SUBSTANCE TESTING 34 C. DRUG PRODUCT 35 D.
ANDA DATA PACKAGE RECOMMENDATIONS 35 E. EXCEPTIONS TO THE ANDA DATA
PACKAGE RECOMMENDATIONS 35 F. DATA PACKAGE FOR APPROVAL 35 G. STABILITY
STUDY ACCEPTANCE 35 IV. STABILITY TESTING FOR INVESTIGATIONAL NDAS 36 A.
PHASE 1 36 B. PHASE 2 36 C. PHASE 3 36 V. APPROVED STABILITY PROTOCOL 37
A. STABILITY PROTOCOL 37 B. STABILITY COMMITMENT 37 VI. REPORTING
STABILITY DATA 38 A. GENERAL 38 B. CONTENT OF STABILITY REPORTS 38 C.
FORMATTING STABILITY REPORTS 39 VII. SPECIFIC STABILITY TOPICS 39 A.
MEAN KINETIC TEMPERATURE 39 B. CONTAINER AND CLOSURE 39 C.
MICROBIOLOGICAL CONTROL AND QUALITY 40 D. STABILITY SAMPLING
CONSIDERATIONS 41 E. STATISTICAL CONSIDERATIONS AND EVALUATION 43 F.
EXPIRATION DATING PERIOD AND RETEST PERIOD 44 G. BRACKETING 46 H.
MATRIXING 47 I. SITE-SPECIFIC STABILITY DATA FOR DRUG AND BIOLOGIC
APPLICATIONS 48 J. PHOTOSTABILITY 49 K. DEGRADATION PRODUCTS 53 L.
THERMAL CYCLING 54 M. STABILITY TESTING IN FOREIGN LABORATORY FACILITIES
54 N. STABILITY TESTING OF BIOTECHNOLOGY DRUG PRODUCTS 54 VIII.
CONSIDERATIONS FOR SPECIFIC DOSAGE FORMS 59 A. TABLETS 59 B. CAPSULES 59
C. EMULSIONS 59 D. ORAL SOLUTIONS AND SUSPENSIONS 59 E. ORAL POWDERS FOR
RECONSTITUTION 59 F. METERED-DOSE INHALATIONS AND NASAL AEROSOLS 59 G.
INHALATION SOLUTIONS AND POWDERS 59 H. NASAL SPRAYS: SOLUTIONS AND
SUSPENSIONS 60 I. TOPICAL, OPHTHALMIC, AND OTIC PREPARATIONS 60 J.
TRANSDERMALS 60 K. SUPPOSITORIES 60 L. SVPS 60 M. LVPS 61 N. DRUG
ADDITIVES 61 O. IMPLANTABLE SUBDERMAL, VAGINAL, AND INTRAUTERINE DEVICES
THAT DELIVER DRUG PRODUCTS 61 IX. STABILITY TESTING FOR POSTAPPROVAL
CHANGES 61 A. GENERAL 61 B. CHANGE IN MANUFACTURING PROCESS OF THE DRUG
SUBSTANCE 62 C. CHANGE IN MANUFACTURING SITE 62 D. CHANGE IN
MANUFACTURING PROCESS OR EQUIPMENT FOR THE DRUG PRODUCT 63 E. CHANGE IN
BATCH SIZE OF THE DRUG PRODUCT 63 F. REPROCESSING OF A DRUG PRODUCT 63
G. CHANGE IN CONTAINER AND CLOSURE OF THE DRUG PRODUCT 63 H. CHANGES IN
THE STABILITY PROTOCOL 63 REFERENCES 64 GLOSSARY 64 CHAPTER 5 GUIDELINES
FOR EVALUATION OF STABILITY DATA IN RETEST PERIODS 69 I. INTRODUCTION 69
A. BACKGROUND 69 B. SCOPE OF THE GUIDELINE 69 II. GUIDELINES 69 A.
GENERAL PRINCIPLES 69 B. DATA PRESENTATION 70 C. EXTRAPOLATION 70 D.
DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR DRUG
SUBSTANCES OR PRODUCTS INTENDED FOR ROOM TEMPERATURE STORAGE 70 E.
DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR DRUG
SUBSTANCES OR PRODUCTS INTENDED FOR STORAGE BELOW ROOM TEMPERATURE 71
F. GENERAL STATISTICAL APPROACHES 72 REFERENCES 72 APPENDIX A: DECISION
TREE FOR DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR
DRUG SUBSTANCES OR PRODUCTS (EXCLUDING FROZEN PRODUCTS) 73 CHAPTER 6
SKIN IRRITATION AND SENSITIZATION TESTING OF GENERIC TRANSDERMAL DRUG
PRODUCTS 75 I. STUDY DESIGNS 75 A. RECOMMENDATIONS FOR A CUMULATIVE SKIN
IRRITATION STUDY 75 B. RECOMMENDATIONS FOR A SKIN SENSITIZATION STUDY
(MODIFIED DRAIZE TEST) 76 C. COMBINED STUDIES 76 APPENDIX A 76 SKIN
IRRITATION SCORING SYSTEMS 76 APPENDIX B 77 ADHESION SCORE 77 APPENDIX C
77 REFERENCES 77 CHAPTER 7 PHOTOSAFETY TESTING 79 I. INTRODUCTION 79 II.
BACKGROUND 79 A. PHOTOIRRITATION AND PHOTOCOCARCINOGENICITY 79 B.
HISTORICAL APPROACH TO PHOTOSAFETY TESTING 80 III. TESTING
CONSIDERATIONS 80 A. GENERAL CONSIDERATIONS FOR TESTING A DRUG PRODUCT
OR DRUG SUBSTANCE 80 B. TESTING FOR PHOTOCHEMICAL IRRITATION 81 IV.
TESTING FOR ENHANCEMENT OF UV-ASSOCIATED SKIN CARCINOGENESIS (DIRECT
PHOTOCHEMICAL CARCINOGENICITY OR INDIRECT EFFECTS IN SKIN) 82 A.
CONSIDERATIONS AND DECISION TREE FOR TESTING PHOTOSENSITIZING DRUGS FOR
LONG-TERM PHOTOSAFETY 82 B. DECISION TREE FOR TESTING NONPHOTOREACTIVE
DRUGS FOR LONG-TERM PHOTOSAFETY 83 C. MECHANISTICALLY BASED AND OTHER
ASSAYS 84 REFERENCES 84 GLOSSARY 86 CHAPTER 8 GUIDANCE ON FORMULATING
SEMISOLID DRUGS 87 I. POTENCY UNIFORMITY 87 II. EQUIPMENT AND PRODUCTION
CONTROL 87 A. MIXERS 87 B. FILLING AND PACKAGING 87 C. PROCESS
TEMPERATURE CONTROL 88 III. CLEANING VALIDATION 88 A. DETAILED CLEANING
PROCEDURES 88 B. SAMPLING PLAN FOR CONTAMINANTS 88 C. EQUIPMENT RESIDUE
LIMITS 88 IV. MICROBIOLOGICAL 89 A. CONTROLS (NONSTERILE TOPICALS) 89 B.
PRESERVATIVE ACTIVITY 90 V. CHANGE CONTROL 90 VI. TRANSDERMAL TOPICAL
PRODUCTS 90 A. FORMULATIONS OF SEMISOLID DRUGS 90 B. THE ROLE OF IN
VITRO RELEASE TESTING 91 C. IN VIVO BIOEQUIVALENCE STUDIES 91 REFERENCES
92 GLOSSARY 92 PART II FORMULATIONS OF SEMISOLID DRUGS 95 ACECLOFENAC
GEL-CREAM 97 ACETAMINOPHEN SUPPOSITORIES 97 ACETAMINOPHEN SUPPOSITORIES
98 ACETYLSALICYLIC ACID SUPPOSITORIES 98 ALCLOMETASONE DIPROPIONATE
CREAM AND OINTMENT 99 ACYCLOVIR CREAM 99 ACYCLOVIR OINTMENT 100
ADAPALENE CREAM 100 ALOE VERA GEL 100 ALUM CREAM 101 AMINACRINE
HYDROCHLORIDE CREAM 101 AMOXACILLIN LOTION 102 AMPICILLIN LOTION 102
ANTHRALIN CREAM 102 ANTIFUNGAL TOPICAL CREAM 103 ARGININE AND OLEORESIN
CAPSICUM CREAM 103 ARGININE CREAM 103 ARGININE-ASPARTATE CREAM 104
ATROPINE OPTHALMIC OINTMENT 104 AZELAIC ACID CREAM AND GEL 105 BABY
LOTION 105 BACITRACIN ZINC AND POLYMYXIN B SULFATE OPTHALMIC OINTMENT
105 BASE OINTMENT 106 BASE OINTMENT 107 BASE CREAM FOR EXTEMPORANEOUS
PREPARATIONS 107 BASE OINTMENT FOR THERAPEUTIC DELIVERY 108 BECAPLERMIN
GEL 0.01% 108 BENZALKONIUM CHLORIDE AND ZINC OXIDE CREAM 109
BENZALKONIUM CHLORIDE CONTRACEPTIVE GEL.. BENZOCAINE CREAM BENZOYL
PEROXIDE AND ALPHA-BISABOLOL GEL. BENZOYL PEROXIDE CREAM BENZOYL
PEROXIDE GEL BENZOYL PEROXIDE LOTION 10 10 12 13 BETAMETHASONE AND
CINCHOCAINE SUPPOSITORIES 113 BETAMETHASONE AND NEOMYCIN GEL-CREAM 114
BETAMETHASONE AND SALICYLIC ACID LOTION 114 BETAMETHASONE CREAM 115
BETAMETHASONE DIPROPIONATE CREAM, LOTION, AND OINTMENT 115 BETAMETHASONE
DIPROPIONATE OINTMENT 116 BETAMETHASONE GEL 116 BETAMETHASONE OPTHALMIC
OINTMENT 117 BETAMETHASONE VALERATE AND CINCHOCAINE OINTMENT 117
BETAMETHASONE VALERATE CREAM 118 BETAMETHASONE VALERATE FOAM 118
BETAMETHASONE VALERATE OINTMENT 119 BISACODYL SUPPOSITORIES 120
BISCARBOXYCHROMONYLOXY PROPANOL OINTMENT 121 BREAST CARE CREAM 121
BUDESONIDE CREAM 122 BUDESONIDE OINTMENT 122 BURN CREAM 123 BUTENAFINE
HYDROCHLORIDE CREAM 124 BUTESIN PICRATE AND METAPHEN OINTMENT 124
BUTESIN PICRATE OINTMENT 125 BUTOCONAZOLE NITRATE VAGINAL CREAM 126
CALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDE LOTION 126 CALAMINE CREAM 127
CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION 127 CALAMINE CREAM 128
CALAMINE LOTION 129 CALCIPOTRIENE CREAM 129 CAMPHOR, EUCALYPTUS OIL, AND
MENTHOL OINTMENT 129 CARBAMAZEPINE GEL 130 CARBAMAZEPINE CREAM 130
CARBAMAZEPINE OINTMENT 130 CASTOR OIL OINTMENT 131 CEFACLOR AND BENZOYL
PEROXIDE GEL 131 CEFACLOR AND BENZOYL PEROXIDE LOTION 132 CETRIMONIUM
BROMIDE CREAM 132 CHLORHEXIDINE AND CETRIMONIUM BROMIDE CREAM 133
CHLORHEXIDINE GEL 133 CHLORAMPHENICOL OPTHALMIC OINTMENT 133
CHLORPROMAZINE SUPPOSITORIES 133 CICLOPIROX CREAM, LOTION, AND GEL 134
CICLOPIROX NAIL VARNISH 134 CIPROFLOXACIN HYDROCHLORIDE OPTHALMIC
OINTMENT 134 CLINDAMYCIN GEL 135 CLINDAMYCIN LOTION AND GEL 135
CLINDAMYCIN PHOSPHATE TOPICAL GEL 135 CLINDAMYCIN PHOSPHATE VAGINAL
CREAM 136 CLINDAMYCIN PHOSPHATE VAGINAL SUPPOSITORY 136 CLOBETASOL
PROPIONATE CREAM 136 CLOBETASOL PROPIONATE CREAM, OINTMENT, AND GEL 137
CLOBETASOL PROPIONATE OINTMENT 137 CLOTRIMAZOLE AND BETAMETHASONE CREAM
AND LOTION 137 CLOTRIMAZOLE CREAM 138 CLOTRIMAZOLE LOTION 139
CLOTRIMAZONE VAGINAL CREAM INSERTS 139 CLOTRIMAZONE VAGINAL CREAM 140
CLOTRIMAZOLE AND CLINDAMYCIN CREAM 141 CLOTRIMAZOLE AND CLINDAMYCIN
SUPPOSITORIES 141 CLOTRIMAZOLE AND CLINDAMYCIN SUPPOSITORIES 142 COAL
TAR AND ALLANTOIN CREAM 142 COAL TAR AND ALLANTOIN CREAM 143 COAL TAR
CREAM 143 COLLAGENASE OINTMENT 143 CONJUGATED ESTROGENS VAGINAL CREAM
143 CYANOCOBALAMIN GEL 144 DBCAMP OINTMENT 144 DESONIDE CREAM, OINTMENT,
AND LOTION 144 DESOXIMETASONE EMOLLIENT CREAM, GEL, AND OINTMENT 145
DEXAMETHASONE SODIUM PHOSPHATE OINTMENT 145 DEXPANTHENOL CREAM 145
DEXPANTHENOL GEL-CREAM 146 DICLOFENAC DIETHYLAMINE GEL 146 DICLOFENAC
DIETHYLAMMONIUM GEL 147 DICLOFENAC SODIUM SUPPOSITORIES 147 DICLOFENAC
SODIUM SUPPOSITORIES 148 DICLOFENAC SODIUM SUPPOSITORIES 149
DICHLOROBENZYL ALCOHOL TOOTH GEL 149 DIENESTROL VAGINAL CREAM 149
DIETHYLAMINE SALICYLATE CREAM 150 DIFLORASONE DIACETATE CREAM AND
OINTMENT 150 DIMETHICONE AND ZINC OXIDE OINTMENT 151 DINOPROSTONE
CERVICAL GEL 151 DINOPROSTONE VAGINAL INSERT AND SUPPOSITORIES 151
DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE OINTMENT 151 DOCOSANOL
LOTION 151 ECONAZOLE NITRATE AND BENZOYL PEROXIDE CREAM 152 ECONAZOLE
NITRATE AND BENZOYL PEROXIDE LOTION 152 EFLORNITHINE HYDROCHLORIDE CREAM
152 ENZYME EXTRACT OINTMENT 153 ERYTHROMYCIN OINTMENT 153 ERYTHROMYCIN
OINTMENT 154 ERYTHROMYCIN AND NEOMYCIN OINTMENT 154 ERYTHROMYCIN GEL 155
ESTRADIOL AND NORETHINDRONE ACETATE TRANSDERMAL SYSTEM 155 ESTRADIOL
TRANSDERMAL SYSTEM 155 ESTRADIOL VAGINAL CREAM 156 ETHYLENEDIAMINE
TETRACETATE OINTMENT 157 FLUOCINONIDE CREAM, OINTMENT, AND GEL 157
FLUOCINONIDE CREAM 158 FLUOROMETHOLONE OPTHALMIC OINTMENT 158
FLUOROURACIL CREAM 158 FLURANDRENOLIDE LOTION 158 FLURANDRENOLIDE
TOPICAL FILM 159 FLUTICASONE PROPIONATE OINTMENT 159 FLUTICASONE
OINTMENT 160 FLUTICASONE PROPIONATE CREAM 160 FOSCARNET CREAM 161 GAMMA
BENZENE HEXACHLORIDE LOTION 161 GENTAMICIN SULFATE OINTMENT 162
GENTAMICIN SULFATE CREAM 163 GENTAMICIN SULFATE OINTMENT 163 GLYCERIN
SUPPOSITORIES 164 GLYCOLIC ACID CREAM 165 GRAMICIDIN, NEOMYCIN,
NYSTATIN, AND TRIAMCINOLONE OINTMENT 165 HALOBETASOL PROPIONATE CREAM
AND OINTMENT 166 HEPARIN GEL-CREAM 166 HEXACHLOROPHEN CREAM 167
HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE CREAM AND LOTION 168
HYDROCORTISONE OINTMENT 168 HYDROCORTISONE ACETATE SUPPOSITORIES 168
HYDROCORTISONE AND NITROFURAZONE CREAM 169 HYDROCORTISONE BUTYRATE CREAM
AND OINTMENT 169 HYDROCORTISONE CREAM 170 HYDROCORTISONE CREAM 171
HYDROCORTISONE CREAM AND OINTMENT 172 HYDROCORTISONE GEL 172
HYDROCORTISONE GEL 173 HYDROCORTISONE OINTMENT 174 HYDROGEN PEROXIDE
OINTMENT 174 HYDROPHILIC OINTMENT USP 175 HYDROQUINONE CREAM AND GEL 175
HYDROQUINONE GEL 176 HYDROQUINONE CREAM 177 IBUPROFEN CREAM 178
IBUPROFEN GEL-CREAM 178 IBUPROFEN GEL-CREAM 179 IBUPROFEN GEL 180
IBUPROFEN GEL 181 IMIQUIMOD CREAM 181 INDOMETHACIN GEL 181 INDOMETHACIN
GEL 182 INDOMETHACIN SUPPOSITORIES 182 INDOMETHACIN SUPPOSITORIES 183
KOJIC DIPALMITATE CREAM 184 KETOCONAZOLE CREAM 184 LACTIC ACID CREAM 185
LANOLIN CREAM 186 LIDOCAINE AND PRILOCAINE TOPICAL ADHESIVE SYSTEM CREAM
186 LIDOCAINE ADHESIVE SYSTEM GEL 187 LIDOCAINE AND TRIBENOSIDE CREAM
187 LIDOCAINE AND TRIBENOSIDE OINTMENT 188 LIDOCAINE AND TRIBENOSIDE
SUPPOSITORIES 188 LIDOCAINE ANORECTAL CREAM 188 LIDOCAINE GELS 189
LIDOCAINE OINTMENT 190 LIDOCAINE, EUGENOL, AND MENTHOL DENTAL OINTMENT
191 LINDANE LOTION 191 MAFENIDE ACETATE CREAM 191 MALATHION LOTION 191
MANDELIC ACID CREAM 192 MENTHOL, METHYL SALICYLATE, AND MENTHOL CREAM
AND OINTMENT 192 MESALAMINE SUPPOSITORY 192 METHOTREXATE CATAPLASMS 193
METHOTREXATE GEL 193 METHOTREXATE CREAM 194 METHOTREXATE LOTION 194
METHOXSALEN LOTION 195 METHYL SALICYLATE AND MENTHOL GEL 195 METHYL
SALICYLATE AND MENTHOL OINTMENT 195 METHYL SALICYLATE CREAM 196 METHYL
SALICYLATE CREAM 197 METHYL SALICYLATE LOTION 197 METHYL SALICYLATE,
THYME, PINE, AND MENTHOL FOOT CREAM 198 METHYL SALICYLATE AND MENTHOL
CREAM 199 METHYL SALICYLATE AND MENTHOL LOTION 199 METHYL SALICYLATE
CLEAR GEL 200 METOCLOPRAMIDE SUPPOSITORIES 200 METOCLOPRAMIDE
SUPPOSITORIES 201 METOCLOPRAMIDE SUPPOSITORIES 202 METRONIDAZOL VAGINAL
GEL 203 METRONIDAZOLE CREAM 203 METRONIDAZOLE LOTION 203 METRONIDAZOLE
GEL SOLUTION 203 MICONAZOLE CREAM 204 MICONAZOLE MOUTH GEL 204
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES 205 MICONAZOLE NITRATE VAGINAL
SUPPOSITORIES 400 MG 206 MOMETASONE FUROATE LOTION 206 MOMETASONE
FUROATE CREAM 207 MONOBENZONE CREAM 207 MULTIVITAMIN ORAL GEL VETERINARY
208 MULTIVITAMIN ORAL GEL WITH LINOLEIC AND LINOLENIC ACID 209 MUPIROCIN
CALCIUM CREAM 209 MUPIROCIN OINTMENT 210 NAFTIFINE HYDROCHLORIDE CREAM
211 NANOXYNOL SUPPOSITORY WITH BACTERIAL CULTURE 212 NEOMYCIN AND
BACITRACIN OINTMENT 213 NEOMYCIN GEL 213 NEOMYCIN, POLYMYXIN B SULFATE,
AND BACITRACIN ZINC OPTHALMIC OINTMENT 214 NICOTINE POLYMER GEL 214
NITROFURAZONE CREAM 214 NYSTATIN OINTMENT 215 NYSTATIN, NEOMYCIN
SULFATE, GRAMICIDIN, AND TRIAMCINOLONE ACETONIDE CREAM 216 NYSTATIN,
NEOMYCIN SULFATE, GRAMICIDIN, AND TRIAMCINOLONE ACETONIDE OINTMENT 217
OCTYL METHOXYCINNAMATE, OCTYL SALICYLATE, AND OXYBENZONE GEL 217
OLIBANUM GUM CREAM 218 OXICONAZOLE CREAM AND LOTION 218 OXYMORPHONE
HYDROCHLORIDE SUPPOSITORIES 218 OXYTETRACYCLINE OINTMENT 219 PANTHENOL
AND CHLORHEXIDINE LOTION 219 PANTHENOL OINTMENT 220 PAPAIN OINTMENT 220
PENCICLOVIR CREAM 220 PEPPERMINT CREAM 221 PERMETHRIN CREAM AND LOTION
221 PETROLATUM AND LANOLIN OINTMENT 221 PHENYLEPHRINE OINTMENT, CREAM,
SUPPOSITORIES, AND GEL 221 PIROXICAM OINTMENT 222 PIROXICAM AND
DEXPANTHENOL GEL 222 POLYMYXIN, BACITRACIN, HYDROCORTISONE, AND ZINC
OINTMENT 223 POVIDONE-IODINE AND LIDOCAIN GEL 223 POVIDONE-IODINE CREAM
224 POVIDONE-IODINE GEL 225 POVIDONE-IODINE GEL 226 POVIDONE-IODINE
GLUCOSE OINTMENT 226 POVIDONE-IODINE VAGINAL OVULES 227 PRAMOXINE CREAM
228 PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION AND OINTMENT 228
PRAMOXINE SUPPOSITORIES 229 PRANOPROFEN OINTMENT 230 PREDNICARBATE
EMOLLIENT CREAM 230 PROCHLORPERAZINE SUPPOSITORIES 230 PROGESTERONE GEL
231 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES 231 PROMETHAZINE
SUPPOSITORY 231 RESORCINOL ACNE CREAM 231 SALICYLIC ACID CREAM 232
SALICYLIC ACID GEL 233 SCOPOLAMINE TRANSDERMAL THERAPEUTIC SYSTEM 233
SELENIUM SULFIDE DETERGENT LOTION 234 SELENIUM SULFIDE LOTION 234
SILICONE CREAM 235 SILVER SULFADIAZINE CREAM 235 SODIUM CHLORIDE
OINTMENT 236 SODIUM SULFACETAMIDE LOTION 236 SQUALENE CREAM 237 STARCH
OINTMENT 237 SUCRALAFATE OINTMENT 237 SUCRALAFATE AND HYALURONIC ACID
OINTMENT 238 SUCRALAFATE OPTHALMIC OINTMENT 238 SULFACETAMIDE OINTMENT
238 SULFACETAMIDE SODIUM AND PREDNISOLONE AETATE OPTHALMIC OINTMENT 238
SULFANILAMIDE SUPPOSITORIES 239 SULFATHIAZOLE CREAM 239 SULFUR OINTMENT
239 TACROLIMUS OINTMENT 239 TERCONAZOLE VAGINAL CREAM 240 TERCONAZOLE
VAGINAL SUPPOSITORIES 240 TESTOSTERONE GEL 240 TESTOSTERONE TRANSDERMAL
SYSTEM 240 TESTOSTERONE TRANSDERMAL SYSTEM CONTROLLED DELIVERY 241
TETRACAINE GEL AND CREAM 241 TETRACYCLINE HYDROCHLORIDE OINTMENT 241
TGF-OC OINTMENT 242 THERAPEUTIC SKIN LOTION 242 TOLNAFATE AND
UNDECYLANATE CREAM 243 TRETINOIN AND ALPHA BISABOLOL GEL 243 TRETINOIN
AND DEXPANTHENOL GEL 244 TRETINOIN CREAM 244 TRETINOIN GEL 245 TRETINOIN
GEL MICROSPHERE 245 TRIACONTANOL OINTMENT 245 TRICLOSAN FOOT CREAM 246
TRIDAX PROCUMBENS OINTMENT 246 TROLAMINE SALICYLATE CREAM 247 ULTRASONIC
ADHESIVE GEL 247 VITAMIN A SUPPOSITORIES 248 VITAMIN A OINTMENT 248
VITAMIN C VAGINAL OINTMENT 249 VITAMIN E GEL-CREAM 249 ZINC OXIDE AND
VITAMIN E CREAM 250 ZINC OXIDE LOTION 251 ZINC OXIDE OINTMENT 251 ZINC
OXIDE OINTMENT WITH VITAMIN E AND ALOE 252 ZINC PYRITHIONE DETERGENT
LOTION 252 ZINC UNDECYLENATE CREAM 252 ZIRCONIUM OXIDE LOTION 253 INDEX
255
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| adam_txt |
H A N D B O O K OF PHARMACEUTICAL MANUFACTURING FORMULATIONS SEMISOLID
PRODUCTS VOLUME 4 SARFARAZ K. NIAZI CRC PRESS BOCA RATON LONDON NEW YORK
WASHINGTON, D.C CONTENTS PARTI REGULATORY AND MANUFACTURING GUIDANCE.
CHAPTER 1 CHANGES TO APPROVED NEW DRUG APPLICATIONS OR ABBREVIATED NEW
DRUG APPLICATIONS 3 I. INTRODUCTION 3 II. REPORTING CATEGORIES 3 III.
GENERAL REQUIREMENTS 4 IV. ASSESSING THE EFFECT OF MANUFACTURING CHANGES
4 A. ASSESSMENT OF THE EFFECTS OF THE CHANGE 4 B. EQUIVALENCE 5 C.
ADVERSE EFFECT 5 V. COMPONENTS AND COMPOSITION 5 VI. MANUFACTURING SITES
5 A. GENERAL CONSIDERATIONS 5 B. MAJOR CHANGES (PRIOR APPROVAL
SUPPLEMENT) 6 C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 6
D. MINOR CHANGES (ANNUAL REPORT) 7 VII. MANUFACTURING PROCESS 7 A.
GENERAL CONSIDERATIONS 7 B. MAJOR CHANGES (PRIOR APPROVAL SUPPLEMENT) 7
C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 8 D. MINOR
CHANGES (ANNUAL REPORT) 9 VIII. SPECIFICATIONS 9 A. GENERAL
CONSIDERATIONS 9 B. MAJOR CHANGES (PRIOR APPROVAL SUPPLEMENT) 9 C.
MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) 10 D. MINOR CHANGES
(ANNUAL REPORT) 10 IX. PACKAGE A. GENERAL CONSIDERATIONS B. MAJOR
CHANGES (PRIOR APPROVAL SUPPLEMENT) C. MODERATE CHANGES
(SUPPLEMENT*CHANGES BEING EFFECTED) D. MINOR CHANGES (ANNUAL REPORT) X.
LABELING A. GENERAL CONSIDERATIONS B. MAJOR CHANGES (PRIOR APPROVAL
SUPPLEMENT) C. MODERATE CHANGES (SUPPLEMENT*CHANGES BEING EFFECTED) D.
MINOR CHANGES (ANNUAL REPORT) XI. MISCELLANEOUS CHANGES A. MAJOR CHANGES
(PRIOR APPROVAL SUPPLEMENT) B. MODERATE CHANGES (SUPPLEMENT*CHANGES
BEING EFFECTED) C. MINOR CHANGES (ANNUAL REPORT) 14 XII. MULTIPLE
RELATED CHANGES 14 GLOSSARY 1? CHAPTER 2 POSTAPPROVAL CHANGES TO
SEMISOLID DRUGS 17 I. PRESERVATIVE IK II. MANUFACTURING CHANGES IS III.
PROCESS 18 IV. MANUFACTURING SITE 18 CHAPTER 3 SCALE-UP AND POSTAPPROVAL
CHANGES FOR NONSTERILE SEMISOLID DOSAGE FORMS: MANUFACTURING EQUIPMENT
21 I. INTRODUCTION 21 II. PARTICLE SIZE REDUCTION AND SEPARATION 21 A.
DEFINITIONS 21 B. EQUIPMENT CLASSIFICATIONS 22 III. MIXING 22 A.
DEFINITIONS 22 B. EQUIPMENT CLASSIFICATION 23 IV TRANSFER 23 A.
DEFINITIONS 23 B. EQUIPMENT CLASSIFICATION 23 V. PACKAGING 24 A.
DEFINITIONS 24 B. EQUIPMENT CLASSIFICATION 24 CHAPTER 4 STABILITY
TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS 25 I. INTRODUCTION 25 II.
STABILITY TESTING FOR NEW DRUG APPLICATIONS 25 A. DRUG SUBSTANCE 25 B.
DRUG PRODUCT 27 C. NEW DOSAGE FORMS [ICH QIC] 34 D. OTHER NDAS 34 III.
STABILITY TESTING FOR ABBREVIATED NDAS 34 A. DRUG SUBSTANCE STABILITY
DATA SUBMISSION 34 B. DRUG SUBSTANCE TESTING 34 C. DRUG PRODUCT 35 D.
ANDA DATA PACKAGE RECOMMENDATIONS 35 E. EXCEPTIONS TO THE ANDA DATA
PACKAGE RECOMMENDATIONS 35 F. DATA PACKAGE FOR APPROVAL 35 G. STABILITY
STUDY ACCEPTANCE 35 IV. STABILITY TESTING FOR INVESTIGATIONAL NDAS 36 A.
PHASE 1 36 B. PHASE 2 36 C. PHASE 3 36 V. APPROVED STABILITY PROTOCOL 37
A. STABILITY PROTOCOL 37 B. STABILITY COMMITMENT 37 VI. REPORTING
STABILITY DATA 38 A. GENERAL 38 B. CONTENT OF STABILITY REPORTS 38 C.
FORMATTING STABILITY REPORTS 39 VII. SPECIFIC STABILITY TOPICS 39 A.
MEAN KINETIC TEMPERATURE 39 B. CONTAINER AND CLOSURE 39 C.
MICROBIOLOGICAL CONTROL AND QUALITY 40 D. STABILITY SAMPLING
CONSIDERATIONS 41 E. STATISTICAL CONSIDERATIONS AND EVALUATION 43 F.
EXPIRATION DATING PERIOD AND RETEST PERIOD 44 G. BRACKETING 46 H.
MATRIXING 47 I. SITE-SPECIFIC STABILITY DATA FOR DRUG AND BIOLOGIC
APPLICATIONS 48 J. PHOTOSTABILITY 49 K. DEGRADATION PRODUCTS 53 L.
THERMAL CYCLING 54 M. STABILITY TESTING IN FOREIGN LABORATORY FACILITIES
54 N. STABILITY TESTING OF BIOTECHNOLOGY DRUG PRODUCTS 54 VIII.
CONSIDERATIONS FOR SPECIFIC DOSAGE FORMS 59 A. TABLETS 59 B. CAPSULES 59
C. EMULSIONS 59 D. ORAL SOLUTIONS AND SUSPENSIONS 59 E. ORAL POWDERS FOR
RECONSTITUTION 59 F. METERED-DOSE INHALATIONS AND NASAL AEROSOLS 59 G.
INHALATION SOLUTIONS AND POWDERS 59 H. NASAL SPRAYS: SOLUTIONS AND
SUSPENSIONS 60 I. TOPICAL, OPHTHALMIC, AND OTIC PREPARATIONS 60 J.
TRANSDERMALS 60 K. SUPPOSITORIES 60 L. SVPS 60 M. LVPS 61 N. DRUG
ADDITIVES 61 O. IMPLANTABLE SUBDERMAL, VAGINAL, AND INTRAUTERINE DEVICES
THAT DELIVER DRUG PRODUCTS 61 IX. STABILITY TESTING FOR POSTAPPROVAL
CHANGES 61 A. GENERAL 61 B. CHANGE IN MANUFACTURING PROCESS OF THE DRUG
SUBSTANCE 62 C. CHANGE IN MANUFACTURING SITE 62 D. CHANGE IN
MANUFACTURING PROCESS OR EQUIPMENT FOR THE DRUG PRODUCT 63 E. CHANGE IN
BATCH SIZE OF THE DRUG PRODUCT 63 F. REPROCESSING OF A DRUG PRODUCT 63
G. CHANGE IN CONTAINER AND CLOSURE OF THE DRUG PRODUCT 63 H. CHANGES IN
THE STABILITY PROTOCOL 63 REFERENCES 64 GLOSSARY 64 CHAPTER 5 GUIDELINES
FOR EVALUATION OF STABILITY DATA IN RETEST PERIODS 69 I. INTRODUCTION 69
A. BACKGROUND 69 B. SCOPE OF THE GUIDELINE 69 II. GUIDELINES 69 A.
GENERAL PRINCIPLES 69 B. DATA PRESENTATION 70 C. EXTRAPOLATION 70 D.
DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR DRUG
SUBSTANCES OR PRODUCTS INTENDED FOR "ROOM TEMPERATURE" STORAGE 70 E.
DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR DRUG
SUBSTANCES OR PRODUCTS INTENDED FOR STORAGE BELOW "ROOM TEMPERATURE" 71
F. GENERAL STATISTICAL APPROACHES 72 REFERENCES 72 APPENDIX A: DECISION
TREE FOR DATA EVALUATION FOR RETEST PERIOD OR SHELF-LIFE ESTIMATION FOR
DRUG SUBSTANCES OR PRODUCTS (EXCLUDING FROZEN PRODUCTS) 73 CHAPTER 6
SKIN IRRITATION AND SENSITIZATION TESTING OF GENERIC TRANSDERMAL DRUG
PRODUCTS 75 I. STUDY DESIGNS 75 A. RECOMMENDATIONS FOR A CUMULATIVE SKIN
IRRITATION STUDY 75 B. RECOMMENDATIONS FOR A SKIN SENSITIZATION STUDY
(MODIFIED DRAIZE TEST) 76 C. COMBINED STUDIES 76 APPENDIX A 76 SKIN
IRRITATION SCORING SYSTEMS 76 APPENDIX B 77 ADHESION SCORE 77 APPENDIX C
77 REFERENCES 77 CHAPTER 7 PHOTOSAFETY TESTING 79 I. INTRODUCTION 79 II.
BACKGROUND 79 A. PHOTOIRRITATION AND PHOTOCOCARCINOGENICITY 79 B.
HISTORICAL APPROACH TO PHOTOSAFETY TESTING 80 III. TESTING
CONSIDERATIONS 80 A. GENERAL CONSIDERATIONS FOR TESTING A DRUG PRODUCT
OR DRUG SUBSTANCE 80 B. TESTING FOR PHOTOCHEMICAL IRRITATION 81 IV.
TESTING FOR ENHANCEMENT OF UV-ASSOCIATED SKIN CARCINOGENESIS (DIRECT
PHOTOCHEMICAL CARCINOGENICITY OR INDIRECT EFFECTS IN SKIN) 82 A.
CONSIDERATIONS AND DECISION TREE FOR TESTING PHOTOSENSITIZING DRUGS FOR
LONG-TERM PHOTOSAFETY 82 B. DECISION TREE FOR TESTING NONPHOTOREACTIVE
DRUGS FOR LONG-TERM PHOTOSAFETY 83 C. MECHANISTICALLY BASED AND OTHER
ASSAYS 84 REFERENCES 84 GLOSSARY 86 CHAPTER 8 GUIDANCE ON FORMULATING
SEMISOLID DRUGS 87 I. POTENCY UNIFORMITY 87 II. EQUIPMENT AND PRODUCTION
CONTROL 87 A. MIXERS 87 B. FILLING AND PACKAGING 87 C. PROCESS
TEMPERATURE CONTROL 88 III. CLEANING VALIDATION 88 A. DETAILED CLEANING
PROCEDURES 88 B. SAMPLING PLAN FOR CONTAMINANTS 88 C. EQUIPMENT RESIDUE
LIMITS 88 IV. MICROBIOLOGICAL 89 A. CONTROLS (NONSTERILE TOPICALS) 89 B.
PRESERVATIVE ACTIVITY 90 V. CHANGE CONTROL 90 VI. TRANSDERMAL TOPICAL
PRODUCTS 90 A. FORMULATIONS OF SEMISOLID DRUGS 90 B. THE ROLE OF IN
VITRO RELEASE TESTING 91 C. IN VIVO BIOEQUIVALENCE STUDIES 91 REFERENCES
92 GLOSSARY 92 PART II FORMULATIONS OF SEMISOLID DRUGS 95 ACECLOFENAC
GEL-CREAM 97 ACETAMINOPHEN SUPPOSITORIES 97 ACETAMINOPHEN SUPPOSITORIES
98 ACETYLSALICYLIC ACID SUPPOSITORIES 98 ALCLOMETASONE DIPROPIONATE
CREAM AND OINTMENT 99 ACYCLOVIR CREAM 99 ACYCLOVIR OINTMENT 100
ADAPALENE CREAM 100 ALOE VERA GEL 100 ALUM CREAM 101 AMINACRINE
HYDROCHLORIDE CREAM 101 AMOXACILLIN LOTION 102 AMPICILLIN LOTION 102
ANTHRALIN CREAM 102 ANTIFUNGAL TOPICAL CREAM 103 ARGININE AND OLEORESIN
CAPSICUM CREAM 103 ARGININE CREAM 103 ARGININE-ASPARTATE CREAM 104
ATROPINE OPTHALMIC OINTMENT 104 AZELAIC ACID CREAM AND GEL 105 BABY
LOTION 105 BACITRACIN ZINC AND POLYMYXIN B SULFATE OPTHALMIC OINTMENT
105 BASE OINTMENT 106 BASE OINTMENT 107 BASE CREAM FOR EXTEMPORANEOUS
PREPARATIONS 107 BASE OINTMENT FOR THERAPEUTIC DELIVERY 108 BECAPLERMIN
GEL 0.01% 108 BENZALKONIUM CHLORIDE AND ZINC OXIDE CREAM 109
BENZALKONIUM CHLORIDE CONTRACEPTIVE GEL. BENZOCAINE CREAM BENZOYL
PEROXIDE AND ALPHA-BISABOLOL GEL. BENZOYL PEROXIDE CREAM BENZOYL
PEROXIDE GEL BENZOYL PEROXIDE LOTION 10 10 12 13 BETAMETHASONE AND
CINCHOCAINE SUPPOSITORIES 113 BETAMETHASONE AND NEOMYCIN GEL-CREAM 114
BETAMETHASONE AND SALICYLIC ACID LOTION 114 BETAMETHASONE CREAM 115
BETAMETHASONE DIPROPIONATE CREAM, LOTION, AND OINTMENT 115 BETAMETHASONE
DIPROPIONATE OINTMENT 116 BETAMETHASONE GEL 116 BETAMETHASONE OPTHALMIC
OINTMENT 117 BETAMETHASONE VALERATE AND CINCHOCAINE OINTMENT 117
BETAMETHASONE VALERATE CREAM 118 BETAMETHASONE VALERATE FOAM 118
BETAMETHASONE VALERATE OINTMENT 119 BISACODYL SUPPOSITORIES 120
BISCARBOXYCHROMONYLOXY PROPANOL OINTMENT 121 BREAST CARE CREAM 121
BUDESONIDE CREAM 122 BUDESONIDE OINTMENT 122 BURN CREAM 123 BUTENAFINE
HYDROCHLORIDE CREAM 124 BUTESIN PICRATE AND METAPHEN OINTMENT 124
BUTESIN PICRATE OINTMENT 125 BUTOCONAZOLE NITRATE VAGINAL CREAM 126
CALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDE LOTION 126 CALAMINE CREAM 127
CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION 127 CALAMINE CREAM 128
CALAMINE LOTION 129 CALCIPOTRIENE CREAM 129 CAMPHOR, EUCALYPTUS OIL, AND
MENTHOL OINTMENT 129 CARBAMAZEPINE GEL 130 CARBAMAZEPINE CREAM 130
CARBAMAZEPINE OINTMENT 130 CASTOR OIL OINTMENT 131 CEFACLOR AND BENZOYL
PEROXIDE GEL 131 CEFACLOR AND BENZOYL PEROXIDE LOTION 132 CETRIMONIUM
BROMIDE CREAM 132 CHLORHEXIDINE AND CETRIMONIUM BROMIDE CREAM 133
CHLORHEXIDINE GEL 133 CHLORAMPHENICOL OPTHALMIC OINTMENT 133
CHLORPROMAZINE SUPPOSITORIES 133 CICLOPIROX CREAM, LOTION, AND GEL 134
CICLOPIROX NAIL VARNISH 134 CIPROFLOXACIN HYDROCHLORIDE OPTHALMIC
OINTMENT 134 CLINDAMYCIN GEL 135 CLINDAMYCIN LOTION AND GEL 135
CLINDAMYCIN PHOSPHATE TOPICAL GEL 135 CLINDAMYCIN PHOSPHATE VAGINAL
CREAM 136 CLINDAMYCIN PHOSPHATE VAGINAL SUPPOSITORY 136 CLOBETASOL
PROPIONATE CREAM 136 CLOBETASOL PROPIONATE CREAM, OINTMENT, AND GEL 137
CLOBETASOL PROPIONATE OINTMENT 137 CLOTRIMAZOLE AND BETAMETHASONE CREAM
AND LOTION 137 CLOTRIMAZOLE CREAM 138 CLOTRIMAZOLE LOTION 139
CLOTRIMAZONE VAGINAL CREAM INSERTS 139 CLOTRIMAZONE VAGINAL CREAM 140
CLOTRIMAZOLE AND CLINDAMYCIN CREAM 141 CLOTRIMAZOLE AND CLINDAMYCIN
SUPPOSITORIES 141 CLOTRIMAZOLE AND CLINDAMYCIN SUPPOSITORIES 142 COAL
TAR AND ALLANTOIN CREAM 142 COAL TAR AND ALLANTOIN CREAM 143 COAL TAR
CREAM 143 COLLAGENASE OINTMENT 143 CONJUGATED ESTROGENS VAGINAL CREAM
143 CYANOCOBALAMIN GEL 144 DBCAMP OINTMENT 144 DESONIDE CREAM, OINTMENT,
AND LOTION 144 DESOXIMETASONE EMOLLIENT CREAM, GEL, AND OINTMENT 145
DEXAMETHASONE SODIUM PHOSPHATE OINTMENT 145 DEXPANTHENOL CREAM 145
DEXPANTHENOL GEL-CREAM 146 DICLOFENAC DIETHYLAMINE GEL 146 DICLOFENAC
DIETHYLAMMONIUM GEL 147 DICLOFENAC SODIUM SUPPOSITORIES 147 DICLOFENAC
SODIUM SUPPOSITORIES 148 DICLOFENAC SODIUM SUPPOSITORIES 149
DICHLOROBENZYL ALCOHOL TOOTH GEL 149 DIENESTROL VAGINAL CREAM 149
DIETHYLAMINE SALICYLATE CREAM 150 DIFLORASONE DIACETATE CREAM AND
OINTMENT 150 DIMETHICONE AND ZINC OXIDE OINTMENT 151 DINOPROSTONE
CERVICAL GEL 151 DINOPROSTONE VAGINAL INSERT AND SUPPOSITORIES 151
DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE OINTMENT 151 DOCOSANOL
LOTION 151 ECONAZOLE NITRATE AND BENZOYL PEROXIDE CREAM 152 ECONAZOLE
NITRATE AND BENZOYL PEROXIDE LOTION 152 EFLORNITHINE HYDROCHLORIDE CREAM
152 ENZYME EXTRACT OINTMENT 153 ERYTHROMYCIN OINTMENT 153 ERYTHROMYCIN
OINTMENT 154 ERYTHROMYCIN AND NEOMYCIN OINTMENT 154 ERYTHROMYCIN GEL 155
ESTRADIOL AND NORETHINDRONE ACETATE TRANSDERMAL SYSTEM 155 ESTRADIOL
TRANSDERMAL SYSTEM 155 ESTRADIOL VAGINAL CREAM 156 ETHYLENEDIAMINE
TETRACETATE OINTMENT 157 FLUOCINONIDE CREAM, OINTMENT, AND GEL 157
FLUOCINONIDE CREAM 158 FLUOROMETHOLONE OPTHALMIC OINTMENT 158
FLUOROURACIL CREAM 158 FLURANDRENOLIDE LOTION 158 FLURANDRENOLIDE
TOPICAL FILM 159 FLUTICASONE PROPIONATE OINTMENT 159 FLUTICASONE
OINTMENT 160 FLUTICASONE PROPIONATE CREAM 160 FOSCARNET CREAM 161 GAMMA
BENZENE HEXACHLORIDE LOTION 161 GENTAMICIN SULFATE OINTMENT 162
GENTAMICIN SULFATE CREAM 163 GENTAMICIN SULFATE OINTMENT 163 GLYCERIN
SUPPOSITORIES 164 GLYCOLIC ACID CREAM 165 GRAMICIDIN, NEOMYCIN,
NYSTATIN, AND TRIAMCINOLONE OINTMENT 165 HALOBETASOL PROPIONATE CREAM
AND OINTMENT 166 HEPARIN GEL-CREAM 166 HEXACHLOROPHEN CREAM 167
HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE CREAM AND LOTION 168
HYDROCORTISONE OINTMENT 168 HYDROCORTISONE ACETATE SUPPOSITORIES 168
HYDROCORTISONE AND NITROFURAZONE CREAM 169 HYDROCORTISONE BUTYRATE CREAM
AND OINTMENT 169 HYDROCORTISONE CREAM 170 HYDROCORTISONE CREAM 171
HYDROCORTISONE CREAM AND OINTMENT 172 HYDROCORTISONE GEL 172
HYDROCORTISONE GEL 173 HYDROCORTISONE OINTMENT 174 HYDROGEN PEROXIDE
OINTMENT 174 HYDROPHILIC OINTMENT USP 175 HYDROQUINONE CREAM AND GEL 175
HYDROQUINONE GEL 176 HYDROQUINONE CREAM 177 IBUPROFEN CREAM 178
IBUPROFEN GEL-CREAM 178 IBUPROFEN GEL-CREAM 179 IBUPROFEN GEL 180
IBUPROFEN GEL 181 IMIQUIMOD CREAM 181 INDOMETHACIN GEL 181 INDOMETHACIN
GEL 182 INDOMETHACIN SUPPOSITORIES 182 INDOMETHACIN SUPPOSITORIES 183
KOJIC DIPALMITATE CREAM 184 KETOCONAZOLE CREAM 184 LACTIC ACID CREAM 185
LANOLIN CREAM 186 LIDOCAINE AND PRILOCAINE TOPICAL ADHESIVE SYSTEM CREAM
186 LIDOCAINE ADHESIVE SYSTEM GEL 187 LIDOCAINE AND TRIBENOSIDE CREAM
187 LIDOCAINE AND TRIBENOSIDE OINTMENT 188 LIDOCAINE AND TRIBENOSIDE
SUPPOSITORIES 188 LIDOCAINE ANORECTAL CREAM 188 LIDOCAINE GELS 189
LIDOCAINE OINTMENT 190 LIDOCAINE, EUGENOL, AND MENTHOL DENTAL OINTMENT
191 LINDANE LOTION 191 MAFENIDE ACETATE CREAM 191 MALATHION LOTION 191
MANDELIC ACID CREAM 192 MENTHOL, METHYL SALICYLATE, AND MENTHOL CREAM
AND OINTMENT 192 MESALAMINE SUPPOSITORY 192 METHOTREXATE CATAPLASMS 193
METHOTREXATE GEL 193 METHOTREXATE CREAM 194 METHOTREXATE LOTION 194
METHOXSALEN LOTION 195 METHYL SALICYLATE AND MENTHOL GEL 195 METHYL
SALICYLATE AND MENTHOL OINTMENT 195 METHYL SALICYLATE CREAM 196 METHYL
SALICYLATE CREAM 197 METHYL SALICYLATE LOTION 197 METHYL SALICYLATE,
THYME, PINE, AND MENTHOL FOOT CREAM 198 METHYL SALICYLATE AND MENTHOL
CREAM 199 METHYL SALICYLATE AND MENTHOL LOTION 199 METHYL SALICYLATE
CLEAR GEL 200 METOCLOPRAMIDE SUPPOSITORIES 200 METOCLOPRAMIDE
SUPPOSITORIES 201 METOCLOPRAMIDE SUPPOSITORIES 202 METRONIDAZOL VAGINAL
GEL 203 METRONIDAZOLE CREAM 203 METRONIDAZOLE LOTION 203 METRONIDAZOLE
GEL SOLUTION 203 MICONAZOLE CREAM 204 MICONAZOLE MOUTH GEL 204
MICONAZOLE NITRATE VAGINAL SUPPOSITORIES 205 MICONAZOLE NITRATE VAGINAL
SUPPOSITORIES 400 MG 206 MOMETASONE FUROATE LOTION 206 MOMETASONE
FUROATE CREAM 207 MONOBENZONE CREAM 207 MULTIVITAMIN ORAL GEL VETERINARY
208 MULTIVITAMIN ORAL GEL WITH LINOLEIC AND LINOLENIC ACID 209 MUPIROCIN
CALCIUM CREAM 209 MUPIROCIN OINTMENT 210 NAFTIFINE HYDROCHLORIDE CREAM
211 NANOXYNOL SUPPOSITORY WITH BACTERIAL CULTURE 212 NEOMYCIN AND
BACITRACIN OINTMENT 213 NEOMYCIN GEL 213 NEOMYCIN, POLYMYXIN B SULFATE,
AND BACITRACIN ZINC OPTHALMIC OINTMENT 214 NICOTINE POLYMER GEL 214
NITROFURAZONE CREAM 214 NYSTATIN OINTMENT 215 NYSTATIN, NEOMYCIN
SULFATE, GRAMICIDIN, AND TRIAMCINOLONE ACETONIDE CREAM 216 NYSTATIN,
NEOMYCIN SULFATE, GRAMICIDIN, AND TRIAMCINOLONE ACETONIDE OINTMENT 217
OCTYL METHOXYCINNAMATE, OCTYL SALICYLATE, AND OXYBENZONE GEL 217
OLIBANUM GUM CREAM 218 OXICONAZOLE CREAM AND LOTION 218 OXYMORPHONE
HYDROCHLORIDE SUPPOSITORIES 218 OXYTETRACYCLINE OINTMENT 219 PANTHENOL
AND CHLORHEXIDINE LOTION 219 PANTHENOL OINTMENT 220 PAPAIN OINTMENT 220
PENCICLOVIR CREAM 220 PEPPERMINT CREAM 221 PERMETHRIN CREAM AND LOTION
221 PETROLATUM AND LANOLIN OINTMENT 221 PHENYLEPHRINE OINTMENT, CREAM,
SUPPOSITORIES, AND GEL 221 PIROXICAM OINTMENT 222 PIROXICAM AND
DEXPANTHENOL GEL 222 POLYMYXIN, BACITRACIN, HYDROCORTISONE, AND ZINC
OINTMENT 223 POVIDONE-IODINE AND LIDOCAIN GEL 223 POVIDONE-IODINE CREAM
224 POVIDONE-IODINE GEL 225 POVIDONE-IODINE GEL 226 POVIDONE-IODINE
GLUCOSE OINTMENT 226 POVIDONE-IODINE VAGINAL OVULES 227 PRAMOXINE CREAM
228 PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION AND OINTMENT 228
PRAMOXINE SUPPOSITORIES 229 PRANOPROFEN OINTMENT 230 PREDNICARBATE
EMOLLIENT CREAM 230 PROCHLORPERAZINE SUPPOSITORIES 230 PROGESTERONE GEL
231 PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES 231 PROMETHAZINE
SUPPOSITORY 231 RESORCINOL ACNE CREAM 231 SALICYLIC ACID CREAM 232
SALICYLIC ACID GEL 233 SCOPOLAMINE TRANSDERMAL THERAPEUTIC SYSTEM 233
SELENIUM SULFIDE DETERGENT LOTION 234 SELENIUM SULFIDE LOTION 234
SILICONE CREAM 235 SILVER SULFADIAZINE CREAM 235 SODIUM CHLORIDE
OINTMENT 236 SODIUM SULFACETAMIDE LOTION 236 SQUALENE CREAM 237 STARCH
OINTMENT 237 SUCRALAFATE OINTMENT 237 SUCRALAFATE AND HYALURONIC ACID
OINTMENT 238 SUCRALAFATE OPTHALMIC OINTMENT 238 SULFACETAMIDE OINTMENT
238 SULFACETAMIDE SODIUM AND PREDNISOLONE AETATE OPTHALMIC OINTMENT 238
SULFANILAMIDE SUPPOSITORIES 239 SULFATHIAZOLE CREAM 239 SULFUR OINTMENT
239 TACROLIMUS OINTMENT 239 TERCONAZOLE VAGINAL CREAM 240 TERCONAZOLE
VAGINAL SUPPOSITORIES 240 TESTOSTERONE GEL 240 TESTOSTERONE TRANSDERMAL
SYSTEM 240 TESTOSTERONE TRANSDERMAL SYSTEM CONTROLLED DELIVERY 241
TETRACAINE GEL AND CREAM 241 TETRACYCLINE HYDROCHLORIDE OINTMENT 241
TGF-OC OINTMENT 242 THERAPEUTIC SKIN LOTION 242 TOLNAFATE AND
UNDECYLANATE CREAM 243 TRETINOIN AND ALPHA BISABOLOL GEL 243 TRETINOIN
AND DEXPANTHENOL GEL 244 TRETINOIN CREAM 244 TRETINOIN GEL 245 TRETINOIN
GEL MICROSPHERE 245 TRIACONTANOL OINTMENT 245 TRICLOSAN FOOT CREAM 246
TRIDAX PROCUMBENS OINTMENT 246 TROLAMINE SALICYLATE CREAM 247 ULTRASONIC
ADHESIVE GEL 247 VITAMIN A SUPPOSITORIES 248 VITAMIN A OINTMENT 248
VITAMIN C VAGINAL OINTMENT 249 VITAMIN E GEL-CREAM 249 ZINC OXIDE AND
VITAMIN E CREAM 250 ZINC OXIDE LOTION 251 ZINC OXIDE OINTMENT 251 ZINC
OXIDE OINTMENT WITH VITAMIN E AND ALOE 252 ZINC PYRITHIONE DETERGENT
LOTION 252 ZINC UNDECYLENATE CREAM 252 ZIRCONIUM OXIDE LOTION 253 INDEX
255 |
| any_adam_object | 1 |
| any_adam_object_boolean | 1 |
| author | Niazi, Sarfaraz K. |
| author_facet | Niazi, Sarfaraz K. |
| author_role | aut |
| author_sort | Niazi, Sarfaraz K. |
| author_variant | s k n sk skn |
| building | Verbundindex |
| bvnumber | BV021245629 |
| ctrlnum | (OCoLC)634114889 (DE-599)BVBBV021245629 |
| format | Book |
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| id | DE-604.BV021245629 |
| illustrated | Not Illustrated |
| index_date | 2024-07-02T13:38:05Z |
| indexdate | 2024-07-09T20:33:44Z |
| institution | BVB |
| isbn | 0849317495 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-014567130 |
| oclc_num | 634114889 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | 263 S. 29 cm |
| publishDate | 2004 |
| publishDateSearch | 2004 |
| publishDateSort | 2004 |
| publisher | CRC Press |
| record_format | marc |
| spelling | Niazi, Sarfaraz K. Verfasser aut Handbook of pharmaceutical manufacturing formulations 4 Semisolid products Sarfaraz K. Niazi Boca Raton [u.a.] CRC Press 2004 263 S. 29 cm txt rdacontent n rdamedia nc rdacarrier (DE-604)BV021244478 4 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014567130&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Niazi, Sarfaraz K. Handbook of pharmaceutical manufacturing formulations |
| title | Handbook of pharmaceutical manufacturing formulations |
| title_auth | Handbook of pharmaceutical manufacturing formulations |
| title_exact_search | Handbook of pharmaceutical manufacturing formulations |
| title_exact_search_txtP | Handbook of pharmaceutical manufacturing formulations |
| title_full | Handbook of pharmaceutical manufacturing formulations 4 Semisolid products Sarfaraz K. Niazi |
| title_fullStr | Handbook of pharmaceutical manufacturing formulations 4 Semisolid products Sarfaraz K. Niazi |
| title_full_unstemmed | Handbook of pharmaceutical manufacturing formulations 4 Semisolid products Sarfaraz K. Niazi |
| title_short | Handbook of pharmaceutical manufacturing formulations |
| title_sort | handbook of pharmaceutical manufacturing formulations semisolid products |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014567130&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV021244478 |
| work_keys_str_mv | AT niazisarfarazk handbookofpharmaceuticalmanufacturingformulations4 |