Handbook of Pharmaceutical Manufacturing Formulations - Liquid Products (Volume 3 of 6)

Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products......Page 3
Dedication......Page 5
Preface to the Series......Page 6
Preface to the Volume......Page 7
About the Author......Page 10
Table of Contents......Page 11
Part I. Regulatory and Manufacturing Guidance......Page 20
III. EQUIPMENT......Page 21
VI. MICROBIOLOGICAL QUALITY......Page 22
X. STABILITY......Page 23
XI. PACKAGING......Page 24
II. DRUG SUBSTANCE......Page 25
C. DRUG SUBSTANCES INTENDED FOR STORAGE IN A FREEZER......Page 26
D. DRUG SUBSTANCES INTENDED FOR STORAGE BELOW -20 C......Page 27
III. DRUG PRODUCT......Page 28
C. DRUG PRODUCTS PACKAGED IN SEMIPERMEABLE CONTAINERS......Page 29
D. DRUG PRODUCTS INTENDED FOR STORAGE IN A REFRIGERATOR......Page 30
F. DRUG PRODUCTS INTENDED FOR STORAGE BELOW - 20 C......Page 31
IV. GLOSSARY......Page 32
REFERENCES......Page 34
C. ADDITIONAL CONSIDERATIONS......Page 35
II. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS......Page 36
B. INFORMATION ABOUT SUITABILITY......Page 39
C. STABILITY DATA PACKAGING CONCERNS......Page 40
E. INJECTION AND OPHTHALMIC DRUG PRODUCTS......Page 41
F. LIQUID-BASED ORAL AND TOPICAL DRUG PRODUCTS AND TOPICAL DELIVERY SYSTEMS......Page 42
G. SOLID ORAL DOSAGE FORMS AND POWDERS FOR RECONSTITUTION......Page 43
H. OTHER DOSAGE FORMS......Page 44
V. BULK CONTAINERS......Page 45
REFERENCES......Page 46
B. OBJECTIVE......Page 47
i. Drug Product Dosage Form......Page 49
A. GENERAL......Page 50
D. STRATEGIES FOR PREINSPECTION......Page 51
E. INTERNATIONAL INSPECTION......Page 53
F. PRODUCT STABILITY DATA......Page 55
G. VALIDATION OF PROCESSES......Page 57
1. Cleaning Validation......Page 59
2. Analytical Methods Validation......Page 60
3. Computer System Validation......Page 61
I. DOCUMENTATION STANDARDS......Page 64
5. Products List......Page 65
11. Technology Transfer and Scale-Up......Page 66
14. Outside Contractors......Page 67
II. CHEMICAL MODIFICATION......Page 68
IX. PHYSICAL STABILITY......Page 69
XIII. PACKAGING......Page 70
XVI. EMULSIONS......Page 71
B. INHALATION SPRAYS......Page 72
D. SPRAY CONTENT UNIFORMITY FOR NASAL PRODUCTS......Page 73
XIV. EMULSIFICATION AND SOLUBILIZATION......Page 74
XVII. STABILIZING SUSPENSIONS......Page 75
Part II. Manufacturing Formulations......Page 76
Acetaminophen Rectal Solution......Page 77
Acetaminophen Drops......Page 78
Acetaminophen Oral Suspension......Page 79
Acetaminophen Syrup for Children......Page 80
Acetaminophen Syrup......Page 81
Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup......Page 83
Acyclovir Oral Suspension......Page 84
Adapalene Solution......Page 85
Albendazole Oral Suspension......Page 86
Albuterol Inhalation Solution......Page 87
Alpha-Bisabolol Ethanolic Mouthwash Solution......Page 88
Aluminum Chloride Solution......Page 89
Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 90
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension......Page 93
Aminacrine Hydrochloride Topical Solution......Page 94
Amoxacillin Powder for Suspension......Page 95
AmoxacillinÒClavulanate Syrup......Page 96
Ampicillin Powder for Suspension......Page 97
Amprenavir Capsules......Page 98
Apraclonidine Hydrochloride Ophthalmic Solution......Page 99
Atovaquone Suspension......Page 100
Azelastine Hydrochloride Nasal Spray......Page 101
Azithromycin Suspension......Page 102
Barium Sulfate Oral Suspension......Page 103
Benzethonium Chloride Solution......Page 104
Beta-Estradiol Vaginal Solution......Page 105
Bismuth Subsalicylate Suspension......Page 106
Bromazepam Drops......Page 107
Bromhexine Hydrochloride Syrup Û Alcohol Free......Page 108
Bromhexine Hydrochloride Syrup......Page 109
Butamirate Citrate Syrup......Page 110
Calcitonin Nasal Spray......Page 111
Calcium Carbonate and Guar Gum Suspension......Page 112
Carnitine and Coenzyme Q Solution......Page 113
Cefpodoxime Proxetil Oral Suspension......Page 114
Cetrizine Hydrochloride Syrup......Page 115
Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup......Page 116
Chloroxylenol Surgical Scrub......Page 117
Chlorpheniramine Maleate Syrup......Page 118
Cimetidine Syrup......Page 119
Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension......Page 120
Cisapride Suspension......Page 121
Clarithromycin Suspension......Page 122
Colistin Sulfate, Neomycin, Thonzonium Bromide, and Hydrocortisone Otic Suspension......Page 123
Cotrimoxazole Oral Suspension......Page 124
Cyclosporin Oral Solution......Page 125
Dextromethorphan Solution......Page 126
Dextromethorphan and Chlorpheniramine Maleate Solution......Page 127
Dextromethorphan Liquid......Page 128
Dextrose, Levulose, and Phosphoric Acid Solution......Page 130
Diazepam Rectal Solution......Page 131
Digoxin Elixir Pediatric......Page 132
Dihydroergotamine Mesylate Drops......Page 133
Diphenhydramine and Ammonium Chloride Syrup......Page 134
Dyphylline, Guaifenesin Elixir......Page 135
Electrolyte Lavage Solution......Page 136
Erythromycin Drops......Page 137
Estradiol Nasal Spray......Page 138
Eucalyptol Solution......Page 139
Fentanyl Citrate Nasal Spray......Page 140
Ferrous Sulfate Oral Solution......Page 141
Fluocinonide Topical Solution......Page 142
Furosemide Syrup......Page 143
Gramicidin Opthalmic Solution......Page 144
Guaifenesin, Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops......Page 145
Hydrocodone Bitartarate Elixir......Page 146
Hydroxyzine Pamoate Oral Suspension......Page 147
Ibuprofen Topical Solution......Page 148
Ibuprofen Pediatric Suspension......Page 149
Ibuprofen Suspension, Sugar Free......Page 150
Ipratropium Bromide Nasal Spray......Page 151
Iron Infant Drops......Page 152
Iron Polystyrene and Vitamin C Syrup......Page 153
Itraconazole Oral Solution......Page 154
Kaolin, Pectin, and Aluminum Hydroxide Suspension......Page 155
Ketoprofen Topical Solution......Page 156
Levocarnitine Oral Solution......Page 157
Loracarbef for Oral Suspension......Page 158
Mafenide Acetate Topical Solution......Page 159
Magaldrate Suspension......Page 160
Magaldrate with Simethicone Suspension......Page 161
Mebendazole Oral Suspension......Page 162
Megestrol Acetate Oral Suspension......Page 163
Menthol Mouthwash......Page 164
Metformin Liquid......Page 165
Metoclopramide Oral Solution......Page 166
Metoclopramide Syrup......Page 167
Metronidazole Suspension......Page 168
MintÒMenthol Mouthwash......Page 169
Monosulfiram Solution......Page 170
Multivitamin and Calcium Syrup......Page 171
Multivitamin Syrup......Page 172
Multivitamin with Fluoride Infant Drops......Page 174
Nicotine Spray......Page 175
Nitroglycerin Lingual Spray......Page 176
Norephedrine Syrup......Page 177
Nystatin Oral Suspension......Page 178
Ofloxacin Otic Solution......Page 179
Phenylpropanolamine Controlled-Release Capsule......Page 180
Oxycodone Hydrochloride Oral Concentrate Solution......Page 181
Oxymetazoline Moisturizing Nasal Spray......Page 182
Oxymetazoline Nasal Solution......Page 183
Phenylephrine Tannate and Pyrilamine Tannate Suspension......Page 184
Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, Vitamin C Syrup......Page 185
Phenytoin Suspension......Page 186
Podofilox Solution......Page 187
Polyvinyl PyrrolidoneÒIodine Gargle Solution......Page 188
Polyvinyl PyrrolidoneÒIodine Mouthwash......Page 189
Scrub......Page 190
Polyvinyl PyrrolidoneÒIodine Solution......Page 191
Polyvinyl PyrrolidoneÒIodine Solution......Page 192
Polyvinyl PyrrolidoneÒIodine Vaginal Douche Concentrate......Page 193
Progesterone Capsules......Page 194
Promethazine Hydrochloride Syrup......Page 195
Promethazine Rectal Solution......Page 196
Pseudoephedrine Hydrochloride, Carbinoxamine Maleate Oral Drops......Page 197
Pseudoephedrine and Carbinoxamine Drops......Page 198
Pseudoephedrine Hydrochloride Syrup......Page 199
Rivastigmine Tartarate Oral Solution......Page 200
Salbutamol Aerosol......Page 201
Salbutamol Syrup......Page 202
Salmeterol Xinafoate Inhalation Aerosol......Page 203
Sertraline Hydrochloride Solution......Page 204
Simethicone Drops......Page 205
Stavudine for Oral Suspension......Page 206
Sulfacetamide Sodium and Sulfur Cleanser and Suspension......Page 207
Sulfadiazine and Trimethoprim Veterinary Oral Suspension......Page 208
Sulfamethoxazole and Trimethoprim Suspension......Page 209
Sulfathiazole Veterinary Oral Solution......Page 210
Sulfidoxine and Pyrimethamine Suspension......Page 211
Sumatriptan Nasal Spray......Page 212
Terfenadine Oral Suspension......Page 213
Theophylline Sodium Glycinate Elixir......Page 214
Tolnafate Foot Care Microemulsion......Page 215
Tolu Balsam Cough Syrup......Page 216
Triamcinolone Acetonide Nasal Spray......Page 217
Triclosan Oral Solution......Page 218
Triprolidine and Pseudoephedrine Hydrochloride Syrup......Page 219
Undecylenic Acid and Chloroxylenol Solution......Page 220
Vancomycin Hydrochloride Oral Solution......Page 221
Vitamin A and D Infant Drops......Page 222
Vitamin A and Vitamin D3 Syrup......Page 223
Vitamin A Concentrate, Water-Miscible......Page 224
Vitamin B-Complex Syrup......Page 225
Vitamin B-Complex and Vitamin C Syrup......Page 227
Vitamin B-Complex without B12 Syrup......Page 228
Vitamin B-Complex, A, C, D, and Calcium Drops......Page 230
Vitamin B-Complex and Iron Syrup......Page 231
Vitamin B-Complex and Vitamin C Syrup......Page 232
Vitamin B-Complex, Vitamin C, and Iron Syrup......Page 233
Vitamin B-Complex, A, C, and D Syrup......Page 235
Vitamin B-Complex, A, C, D, and E Pediatric Drops......Page 236
Vitamin E and Benzocaine Solution......Page 237
Vitamin E Drops......Page 238
Vitamin E Solution with Ethanol......Page 239
Xylometazoline Hydrochloride ChildrenÌs Nasal Solution......Page 240