Handbook of pharmaceutical manufacturing formulations Volume 3

Cover......Page 1
   E. Data Evaluation......Page 2
Title Page......Page 4
Copyright Page......Page 5
Dedication......Page 6
Contents......Page 8
Preface to the Series—Third Edition......Page 26
Preface to the Series—Second Edition......Page 28
Preface to the Series—First Edition......Page 32
Preface to the Volume—First Edition......Page 34
Author......Page 36
Part I: Regulatory and Manufacturing Guidance......Page 38
  II. Facilities......Page 40
  IV. Raw Materials......Page 41
  VI. Microbiological Quality......Page 42
  XI. Packaging......Page 43
  V. Compounding......Page 46
  IX. Process Validation......Page 47
  XI. Packaging......Page 48
    1. Biennial Inspection of Manufacturing Sites......Page 50
    3. A Scheme of Systems for the Manufacture of Drugs and Drug Products......Page 51
    3. State of Control......Page 52
    1. General......Page 53
    3. System Inspection Coverage......Page 54
    6. Reporting......Page 57
  VI. Regulatory/Administrative Strategy......Page 58
  III. General Requirements......Page 60
   B. Equivalence......Page 61
   B. Major Changes (Prior Approval Supplement)......Page 62
   A. General Considerations......Page 63
   C. Moderate Changes (Supplement—Changes Being Effected)......Page 64
   A. General Considerations......Page 65
   D. Minor Changes (Annual Report)......Page 66
   C. Moderate Changes (Supplement—Changes Being Effected)......Page 67
   B. Major Changes (Prior Approval Supplement)......Page 68
   C. Minor Changes (Annual Report)......Page 69
  XII. Multiple Related Changes......Page 70
  Glossary......Page 71
  III. Preservation......Page 72
  X. Raw Material......Page 73
  XIV. Particle Size and Shape......Page 74
   Emulsions......Page 75
  XVIII. Nasal Spray Products......Page 77
   C. Pump Delivery of Nasal Products......Page 78
   F. Droplet-Size Distribution in Nasal Products......Page 79
  XXII. Stabilizing Suspensions......Page 80
   C. Additional Considerations......Page 82
  II. Qualification and Quality Control of Packaging Components......Page 83
   B. Information about Suitability......Page 86
   E. Injection and Ophthalmic Drug Products......Page 87
   F. Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems......Page 88
   G. Solid Oral Dosage Forms and Powders for Reconstitution......Page 89
  III. Postapproval Packaging Changes......Page 90
  V. Bulk Containers......Page 91
  Bibliography......Page 92
  I. Glass Containers......Page 94
  VII. Polyolefins......Page 95
  VIII. Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations......Page 96
  X. Poly(Ethylene/Vinyl Acetate) for Containers and Tubing for Total Parenteral Nutrition Preparations......Page 97
  XII. Sterile Single-Use Plastic Syringes......Page 98
  XV. Silicone Elastomer for Closures and Tubing......Page 99
    3. Selection of Batches......Page 100
    7. Storage Conditions......Page 101
    10. Statements/Labeling......Page 102
    7. Storage Conditions......Page 103
    8. Stability Commitment......Page 105
  Glossary......Page 106
  Bibliography......Page 108
   C. Procedure......Page 110
  II. Drug Substance......Page 111
   A. Presentation of Samples......Page 112
   A. Quinine Chemical Actinometry......Page 113
    1. Design Factors......Page 114
    1. Design Factors......Page 115
    3. Design Examples......Page 116
    5. Potential Risk......Page 117
   A. General Principles......Page 118
    1. No Significant Change at Accelerated Condition......Page 119
    1. Drug Substances or Products Intended for Storage in a Refrigerator......Page 120
   F. General Statistical Approaches......Page 121
   Appendix A: Decision Tree for Data Evaluation for Retest Period or Shelf-Life Estimation for Drug Substances or Products (Excluding Frozen Products)......Page 122
    B.1. Data Analysis for a Single Batch......Page 123
    B.2. Data Analysis for One-Factor, Full-Design Studies......Page 124
    B.3. Data Analysis for Multifactor, Full-Design Studies......Page 125
  References......Page 126
    1. General Case......Page 128
  References......Page 129
  I. Introduction......Page 130
    Good Manufacturing Practice for Medicinal Products (GMP)......Page 131
    Product Quality Review......Page 132
    Key Personnel......Page 133
    Personnel Hygiene......Page 134
    Production Area......Page 135
    General......Page 136
    Manufacturing Formula and Processing Instructions......Page 137
    Procedures and Records......Page 138
    General......Page 139
    Starting Materials......Page 140
    Rejected, Recovered, and Returned Materials......Page 141
    Documentation......Page 142
    Ongoing Stability Program......Page 143
    The Contract Acceptor......Page 144
    Recalls......Page 145
   A. Classification of Residual Solvents by Risk Assessment......Page 146
   C. Options for Describing Limits of Class 2 Solvents......Page 147
   E. Reporting Levels of Residual Solvents......Page 148
  Glossary......Page 149
  Appendix 1 List of Solvents Included in the Guideline......Page 150
  Appendix 3 Methods for Establishing Exposure Limits......Page 152
 Chapter 15: Electronic Records and Signatures (CFR 21 Part 11 Compliance)......Page 154
   Sec. 11.10 Controls for Closed Systems......Page 155
   Sec. 11.200 Electronic Signature Components and Controls......Page 156
   Sec. 11.300 Controls for Identification Codes/Passwords......Page 157
 Chapter 16: Product-Specific Bioequivalence Testing Protocols......Page 158
  3. Ion Exchange Resins......Page 162
   3.2 Coating Drug–Resin Complexes......Page 163
  4. Cyclodextrins......Page 164
  The Main Points in the Regulation......Page 166
  Implications......Page 167
 Chapter 19: Pediatric Formulations......Page 170
  Conclusions......Page 171
  Bibliography......Page 172
   5.1 Materials......Page 174
  8. References......Page 175
   11.3 Scope......Page 176
    11.5.3 Procedure......Page 177
   11.6 Approach to Documentation and Use of the eCTD Specification......Page 178
  1.6 Life Cycle Management......Page 180
  2.6 Common Formats......Page 182
  2.12 File extension......Page 183
  2.14 References......Page 184
  3.5 Module 2 Summaries......Page 186
  3.6 Module 3 Quality......Page 187
  3.7 Module 4 Nonclinical Study Reports......Page 189
  3.8 Module 5 Clinical Study Reports......Page 191
 Appendix 4: File Organization for the eCTD......Page 194
  5.8 Security......Page 238
  5.10 Acknowledgment......Page 240
  6.4 Operation Attribute......Page 242
  6.7 Instructions for a Simple New Submission......Page 245
  6.9 Instructions for Multiple Indications......Page 246
  6.11 Instructions for extending XML eCTD DTD elements......Page 248
  6.12 Instructions for Submitting Sections as Paper......Page 249
   7.2.5 Page Size and Margins......Page 250
   7.2.9 Page Numbering......Page 251
  7.4 SVG Files......Page 252
 Appendix 8: XML eCTD DTD......Page 254
  Logical Document......Page 262
 Appendix A: GMP Audit Template......Page 264
  GLOSSARY......Page 280
 Appendix B: Dissolution Testing......Page 284
 Appendix C: Excipients......Page 286
Part II: Manufacturing Formulations......Page 314
  Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup......Page 316
  Acetaminophen Oral Suspension......Page 317
  Acetaminophen Syrup......Page 318
  Acetaminophen Syrup......Page 319
  Acyclovir Oral Suspension (2% = 200 mg/10 mL)......Page 320
  Albendazole Oral Suspension......Page 321
  Albuterol Inhalation Solution......Page 322
  Alpha-Bisabolol Mouthwash Solution......Page 323
  Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension......Page 324
  Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 325
  Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 326
  Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 327
  Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension......Page 328
  Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Tablets......Page 329
  Amoxicillin–Clavulanate Syrup......Page 330
  Ampicillin Powder for Suspension......Page 331
  Antipyrine and Benzocaine Elixir......Page 332
  Azelastine Hydrochloride Nasal Spray......Page 333
  Azithromycin Suspension......Page 334
  Beclomethasone Dipropionate Inhalation Aerosol......Page 335
  Beta-Estradiol Vaginal Solution......Page 336
  Bromazepam Drops......Page 337
  Bromhexine Hydrochloride Syrup—Alcohol Free......Page 338
  Budesonide Inhaler......Page 339
  Calcium Carbonate and Guar Gum Suspension......Page 340
  Calcium Iodide and Ascorbic Acid Syrup......Page 341
  Cefpodoxime Proxetil Oral Suspension......Page 342
  Cetirizine Hydrochloride Syrup......Page 343
  Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup......Page 344
  Chloramphenicol Palmitate Oral or Topical Emulsion......Page 345
  Ciclopirox Topical Solution......Page 346
  Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension......Page 347
  Clarithromycin Suspension, 125 mg/5 ml reconstituted......Page 348
  Colistin Sulfate, Neomycin, Thonzonium Bromide, and Hydrocortisone Otic Suspension......Page 349
  Cromolyn Sodium Oral Concentrate......Page 350
  Dextromethorphan and Chlorpheniramine Maleate Solution......Page 351
  Dextromethorphan Liquid......Page 352
  Dextromethorphan Solution......Page 353
  Dihydroergotamine Mesylate Drops......Page 354
  Diphenhydramine Hydrochloride Liquid......Page 355
  Erythromycin Drops......Page 356
  Estradiol Nasal Spray......Page 357
  Fentanyl Citrate Nasal Spray......Page 358
  Fir Needle Oil Solution......Page 359
  Furosemide Syrup......Page 360
  Guaifenesin, Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops......Page 361
  Hydroxyzine Pamoate Oral Suspension......Page 362
  Ibuprofen Pediatric Suspension......Page 363
  Iron Polystyrene and Vitamin C Syrup......Page 364
  Ibuprofen Suspension, Sugar Free......Page 365
  Ipratropium Bromide Nasal Spray......Page 366
  Kaolin, Pectin, and Aluminum Hydroxide Suspension......Page 367
  Kaolin–Pectin Suspension......Page 368
  Lithium Carbonate Solution......Page 369
  Magaldrate Instant Powder for Dry Syrup......Page 370
  Magaldrate with Simethicone Suspension......Page 371
  Mebendazole Oral Suspension......Page 372
  Menthol and Benzocaine Solution......Page 373
  Metoclopramide Oral Solution......Page 374
  Metoclopramide Syrup......Page 375
  Mineral and Multivitamin Syrup......Page 376
  Mint–Menthol Mouthwash......Page 377
  Multivitamin and Calcium Syrup......Page 378
  Multivitamin and Mineral Syrup......Page 379
  Multivitamin Infant Drops......Page 380
  Multivitamin Infant Drops......Page 381
  Multivitamin Mineral Syrup......Page 382
  Multivitamin Syrup......Page 383
  Multivitamin with Fluoride Infant Drops......Page 384
  Multivitamin Syrup......Page 385
  Naproxen Suspension......Page 386
  Norephedrine Syrup......Page 387
  Nystatin Suspension......Page 388
  Orciprenaline Sulfate and Clobutinol Hydrochloride Syrup......Page 389
  Oxymetazoline Sinus Nasal Spray......Page 390
  Phenylephrine Tannate and Pyrilamine Tannate Suspension......Page 391
  Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, and Vitamin C Syrup......Page 392
  Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, and Vitamin C Syrup......Page 393
  Podofilox Solution......Page 394
  Polyvinylpyrrolidone–Iodine Liquid Spray......Page 395
  Polyvinylpyrrolidone–Iodine Scrub......Page 396
  Polyvinylpyrrolidone–Iodine Solution......Page 397
  Polyvinylpyrrolidone–Iodine Vaginal Douche Concentrate......Page 398
  Povidone–Iodine Gargle......Page 399
  Povidone–Iodine Powder Spray......Page 400
  Povidone–Iodine Solution......Page 401
  Povidone–Iodine Scrub......Page 402
  Povidone–Iodine Vaginal Douche Concentrate......Page 403
  Promethazine Hydrochloride Syrup......Page 404
  Promethazine Rectal Solution......Page 405
  Pseudoephedrine Hydrochloride and Carbinoxamine Maleate Oral Drops......Page 406
  Pseudoephedrine Hydrochloride Syrup......Page 407
  Salbutamol Aerosol......Page 408
  Salmeterol Xinafoate Inhalation Aerosol......Page 409
  Selenium Sulfide Shampoo with Conditioner......Page 410
  Simethicone Drops......Page 411
  Sulfacetamide Sodium and Sulfur Cleanser and Suspension......Page 412
  Sulfamethoxazole and Trimethoprim Suspension......Page 413
  Sulfidoxine and Pyrimethamine Suspension......Page 414
  Terfenadine Suspension......Page 415
  Tolnaftate Foot Care Microemulsion......Page 416
  Tolu Balsam Cough Syrup......Page 417
  Triamcinolone Acetonide Nasal Spray......Page 418
  Tulobuterol Syrup......Page 419
  Urea Peroxide Ear Drops......Page 420
  Vitamin A and Vitamin D Infant Drops......Page 421
  Vitamin A and Vitamin D3 Oral Solution......Page 422
  Vitamin A Concentrate, Water-Miscible......Page 423
  Vitamin B Complex Syrup......Page 424
  Vitamin B Complex (without B12) Syrup......Page 425
  Vitamin B Complex, A, C, D, and Calcium Drops......Page 426
  Vitamin B Complex and Iron Syrup......Page 427
  Vitamin B Complex, A, C, and D Syrup......Page 428
  Vitamin B Complex, Vitamin A, Vitamin C, Vitamin D, and Vitamin E Pediatric Drops......Page 429
  Vitamin C Drops......Page 430
  Vitamin E Solution with Ethanol......Page 431
  Zinc Pyrithione Shampoo......Page 432
Part III: Commercial Pharmaceutical Products......Page 434
 Commercial Pharmaceutical Products......Page 436
Index......Page 444