Handbook of Pharmaceutical Manufacturing Formulations Volume 2 of 6: Uncompressed Solid Products

Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products......Page 3
Dedication......Page 5
Preface to the Series......Page 6
Preface to the Volume......Page 7
About the Author......Page 9
Table of Contents......Page 10
I. INTRODUCTION......Page 19
Part I. Regulatory and Manufacturing Guidelines......Page 18
B. ORGANIZATION AND PERSONNEL......Page 21
C. BUILDINGS AND FACILITIES......Page 22
D. E QUIPMENT......Page 23
E. CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES......Page 24
F. PRODUCTION AND PROCESS CONTROLS......Page 25
G. PACKAGING AND LABELING CONTROLS......Page 26
I. LABORATORY CONTROLS......Page 29
J. RECORDS AND REPORTS......Page 31
K. RETURNED AND SALVAGED DRUG PRODUCTS......Page 34
1. Biennial Inspection of Manufacturing Sites......Page 36
3. A Scheme of Systems for the Manufacture of Drugs and Drug Products......Page 37
1. Surveillance Inspections......Page 38
C. PROFILES......Page 39
2. Inspection Approaches......Page 40
3. System Inspection Coverage......Page 41
6. Reporting......Page 44
VI. REGULATORY/ADMINISTRATIVE STRATEGY......Page 45
A. SOLUBILITY......Page 48
B. DETERMINING DRUG SUBSTANCE PERMEABILITY CLASS......Page 49
2. Intestinal Permeability Methods......Page 50
C. DETERMINING DRUG PRODUCT DISSOLUTION CHARACTERISTICS AND DISSOLUTION PROFILE SIMILARITY......Page 51
A. INDs/NDAs......Page 52
B. DATA SUPPORTING HIGH PERMEABILITY......Page 53
APPENDIX A......Page 54
III. SIEVE ANALYSIS......Page 55
V. POWDER FLOW PROPERTIES......Page 56
X. CAPSULES......Page 57
XI. FDA CLASSIFICATION OF CAPSULE TYPES......Page 58
XIV. PROBLEMS IN POWDER HANDLING......Page 59
XXI. SEGREGATION MECHANISMS......Page 60
XXIII. MILLING......Page 61
Aceclofenac Instant Granules......Page 63
Part II. Uncompressed Solids Formulations......Page 62
Acetaminophen Capsules 500 mg......Page 64
Acetaminophen, Doxylamine, and Caffeine Effervescent......Page 65
Acetaminophen Instant Granules......Page 66
Acetaminophen, Pseudoephedrine Hydrochloride, Chlorpheniramine Hot Therapy Sachet......Page 67
Acetaminophen Swallow Capsules......Page 68
Acetylcysteine Sachets......Page 69
Acitretin Capsules......Page 70
Acyclovir Capsules......Page 71
Aluminum Hydroxide and Magnesium Carbonate Dry Syrup......Page 72
Amlodipine Besylate and Benazepril Hydrochloride Capsules......Page 73
Amoxicillin and Bromhexine Hydrochloride Capsules......Page 74
Amoxicillin and Clavulanic Acid Powder for Suspension, 125 mg and 31.25 mg per 5 ml......Page 75
Amoxicillin and Clavulanate Potassium for Suspension......Page 76
Amoxicillin Trihydrate Capsules 250 and 500 mg......Page 77
Ampicillin Trihydrate Capsules......Page 78
Ampicillin Trihydrate Powder for Suspension......Page 79
Antifungal Foot Powder......Page 80
Aspirin and Chlorpheniramine Powder......Page 81
Aspirin, Salicylamide, and Caffeine Powder......Page 82
Azithromycin Capsules......Page 83
Azithromycin for Oral Suspension......Page 84
Azithromycin Sachet for Oral Suspension......Page 85
Balsalazide Disodium Capsules......Page 86
Benazepril Hydrochloride and Amlodipine Besylate Capsules......Page 87
Brompheniramine and Pseudoephedrine Capsules......Page 88
Butalbital and Acetaminophen Capsules......Page 89
Calcitonin Salmon Capsules......Page 90
Calcitriol Capsules......Page 91
Camptothecin Capsules......Page 92
Carbamazepine Extended-Release Capsules......Page 93
Cefpodoxime Proxetil for Oral Suspension......Page 94
Ceftibutin for Oral Suspension......Page 95
Celecoxib Capsules......Page 96
Cephalexin Capsules......Page 97
Cephradine Capsules......Page 98
Cevimeline Capsules......Page 99
Chloroxylenol and Chlorhexidine Topical Powder......Page 100
Cimetidine Microencapsulated Sustained-Release Capsules......Page 101
Clindamycin Capsules 150 mg......Page 102
Clonidine Sustained-Release Capsules......Page 103
Cyclosporin A Capsules......Page 104
Diclofenac and Misoprostol Capsules......Page 105
Diclofenac Sustained-Release Capsules......Page 106
Didanosine for Oral Suspension......Page 107
Diethyl Toluamide Topical Powder......Page 108
Difluoromethylornithine-Alpha Capsules......Page 109
Diltiazem Hydrochloride Extended-Release Capsules......Page 111
Dofetilide Capsules......Page 112
Doxycycline Hyclate Capsules......Page 113
Enalapril Maleate Capsules......Page 114
Erythromycin and Bromhexine Powder for Suspension......Page 115
Erythromycin and Sulfisoxazole Granules for Suspension......Page 116
Erythromycin Delayed-Release Capsules......Page 117
Erythromycin Ethylsuccinate for Oral Suspension......Page 118
Erythromycin Ethylsuccinate for Oral Suspension 200 mg/5 ml......Page 119
Erythromycin Stearate for Oral Suspension......Page 120
Erythropoietin Capsules......Page 122
Estramustine Phosphate Capsules......Page 123
Felbamate for Oral Suspension......Page 124
Fenofibrate Capsules......Page 125
Flucytosine Capsules......Page 126
Fluoxetine Hydrochloride Capsules......Page 127
Fluticasone Propionate and Salmeterol Xinafolate Inhalation Powder......Page 128
Formoterol Fumarate Inhaler Capsules......Page 129
Ganciclovir Capsules......Page 130
Glycoprotein IIa/IIb Capsules......Page 131
Histadine Capsules......Page 132
Human Growth Hormone Capsules......Page 133
Hyoscyamine Sulfate Capsules......Page 134
Ibuprofen Microencapsulated Sustained-Release Capsules......Page 135
Ibuprofen Sustained-Release Capsules......Page 136
Imatinib Mesylate Capsules......Page 137
Indinavir Sulfate Capsules......Page 138
Indomethacin Capsules......Page 139
Indomethacin Microencapsulated Sustained-Release Capsules......Page 141
Indomethacin Sustained-Release Capsules......Page 142
Insulin Capsules......Page 143
Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsules......Page 144
Isradipine Capsules......Page 145
Ketoprofen and Misoprostol Capsules......Page 146
Lansoprazole Delayed-Release Capsules......Page 147
Lithium Carbonate Capsules......Page 148
Loxapine Succinate Capsules......Page 149
Mesalamine Capsules......Page 150
Methsuximide Capsules......Page 151
Methylphenidate Immediate- and Extended-Release Capsules......Page 152
Metoclopramide Hydrochloride Sustained-Release Capsules......Page 153
Minocycline Hydrochloride Capsules......Page 154
Mixed Amphetamine Salts Enteric-Release Capsules......Page 155
Morphine Sulfate Capsules......Page 156
Morphine Sulfate Controlled-Release Capsules......Page 157
Morphine Sulfate Sustained-Release Capsules......Page 158
Multivitamin Effervescent Granules......Page 159
Mycophenolate Mofetil Capsules and Oral Suspension......Page 160
Nanoparticle Polymer Particle Powders......Page 161
Nitrofurantoin Capsules......Page 162
Nystatin Powder......Page 163
Omeprazole and Piroxicam Capsules......Page 164
Omeprazole Delayed-Release Capsules......Page 165
Oral Rehydration Salt 45 mEq......Page 166
Orlistat Capsules......Page 167
Oxycodone Hydrochloride and Acetaminophen Capsules......Page 168
Pancrealipase Capsules......Page 169
Phenobarbital and Hyoscyamine Sulfate Capsules......Page 170
Phenytoin Sodium Extended-Release Capsules......Page 171
Piroxicam and Beta-cyclodextrin Topical Powder......Page 172
Piroxicam Capsules......Page 173
Potassium Chloride for Oral Solution......Page 174
Potassium Chloride Microencapsulated Sustained-Release Capsules......Page 175
Prazosin and Polythiazide Capsules......Page 176
Prochlorperazine Sustained-Release Capsules......Page 177
Propranolol Hydrochloride Long-Acting Capsules......Page 178
Propranolol Hydrochloride Multiple Bead Capsules......Page 179
Propranolol Hydrochloride Sustained-Release Capsules......Page 181
Pseudoephedrine Hydrochloride Capsules......Page 182
Rifampin and Isoniazid Capsules......Page 183
Saquinavir Mesylate Capsules......Page 184
Stavudine Capsules......Page 185
Tacrine Hydrochloride Capsules......Page 186
Talc, Crospovidone, and Starch Topical Powder......Page 187
Tamsulosin Hydrochloride Capsules......Page 188
Temozolomide Capsules......Page 189
Tetracycline Hydrochloride Capsules......Page 190
Thiothixene Capsules......Page 191
Tiotropium Inhalation Powder......Page 192
Topiramate Capsules......Page 193
Triamterene Capsules......Page 194
Trimipramine Maleate Capsules......Page 195
Valsartan and Hydrochlorothiazide Capsules......Page 196
Vancomycin Hydrochloride Capsules......Page 197
Verapamil Hydrochloride Capsules......Page 198
Verapamil Hydrochloride Sustained-Release Capsules......Page 199
Vincamine Capsules......Page 200
Vinpocetine Multiple Bead Capsules......Page 201
Vitamin B-Complex, Amino Acids, and Magnesium Effervescent Granules Sugar-Free......Page 202
Vitamin C and Calcium Carbonate Effervescent Tablets......Page 203
Zinc Oxide and Cornstarch Powder......Page 204
Ziprasidone Hydrochloride Capsules......Page 205
Zonisamide Capsules......Page 206