Handbook of Pharmaceutical Manufacturing Formulations Volume 5 of 6: Over-the-Counter Products

The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs. Handbook of Pharmaceutical Manufacturing Formulations: Over-the-Counter Products......Page 3 Dedication......Page 5 Preface to the Series......Page 6 Preface to the Volume......Page 7 About the Author......Page 11 Acknowledgments......Page 12 Table of Contents......Page 13 I. INTRODUCTION......Page 27 Part III. Appendix......Page 26 C. Geranium Rose......Page 28 F. Moderate Red......Page 29 I. Holberry Red......Page 30 L. Opadry Yellow......Page 31 N. Opadry Green......Page 32 A. Brite Green......Page 33 E. Deep Yellow......Page 34 A. White......Page 35 B. Subcoating Solution......Page 36 B. Clear 50:50......Page 37 A. Subcoating......Page 38 B. Kollidon VA 64 Polyvinylpyrrolidone/Vinylacetate Copolymer, BASF......Page 39 D. Kollidon 30 and Shellac......Page 40 F. Povidone, Ethyl Cellulose, and Talc......Page 41 D. Orange......Page 42 A. Basic......Page 43 C. Manual, White......Page 44 A. Kollicoat and Kollidon Enteric Film Coating......Page 45 C. Brown......Page 46 F. Dispersed Orange......Page 47 C. Light Apricot Orange......Page 48 III. EQUIPMENT 21 CFR 211, SUBPART D......Page 50 Part I. Regulatory Guidance......Page 49 A. CRITICAL MANUFACTURING STEPS 21 CFR 211.101......Page 51 G. STERILE PRODUCTS......Page 52 1. Methods......Page 53 3. Filled Containers......Page 54 VI. PACKAGING AND LABELING 21 CFR, SUBPART G......Page 55 A. STERILITY TESTING PROCEDURES......Page 57 X. RETURNED DRUG PRODUCTS 21 CFR 211, SUBPART K......Page 58 HYGIENE......Page 59 WAREHOUSE......Page 60 SOLIDS MANUFACTURING......Page 62 LIQUIDS MANUFACTURING......Page 65 PACKAGING......Page 70 DOCUMENTATION......Page 72 QUALITY CONTROL......Page 75 SELF INSPECTION......Page 78 CONTRACT MANUFACTURE AND ANALYSIS......Page 79 AUDIT OF SUPPLIERS......Page 80 A. PRODUCT DEVELOPMENT REPORTS......Page 81 1. Drug Substance Characterization......Page 82 B. PRE-APPROVAL INSPECTIONS......Page 83 6. Laboratory......Page 84 2. Manufacturing Procedures and Equipment......Page 85 3. Granulation/Mix Analysis......Page 88 6. Investigations and Product Failures......Page 89 7. Site Review......Page 90 IV. RAW MATERIALS......Page 91 VIII. PRODUCT SPECIFICATIONS......Page 92 XI. PACKAGING......Page 93 III. GENERAL REQUIREMENTS......Page 94 A. EQUIPMENT DESIGN......Page 95 V. ESTABLISHMENT OF LIMITS......Page 96 C. TEST UNTIL CLEAN......Page 97 Part II. Over-the-Counter Product Formulations......Page 98 Acetaminophen and Caffeine Tablets......Page 99 Acetaminophen and Pseudoephedrine Hydrochloride Hot Therapy Sachets......Page 100 Acetaminophen and Diphenhydramine Hydrochloride Tablets......Page 101 Acetaminophen Chewable Tablets......Page 102 Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup......Page 103 Acetaminophen, Chlorpheniramine Maleate, and Pseudoephedrine Caplets......Page 104 Acetaminophen, Doxylamine, and Caffeine Effervescent Granules......Page 105 Acetaminophen Effervescent Tablets......Page 106 Acetaminophen Instant Granules......Page 107 Acetaminophen Instant Granules......Page 108 Acetaminophen, Norephedrine, and Phenyltoloxamine Tablets......Page 109 Acetaminophen Oral Suspension......Page 110 Acetaminophen, Phenylpropanoloamine, Dextromethorphan, and Chlorpheniramine Tablets......Page 111 Acetaminophen, Propoxyphenazone, and Caffeine Tablets......Page 112 Acetaminophen Suppositories......Page 113 Acetaminophen Suppositories......Page 114 Acetaminophen Syrup......Page 115 Acetaminophen Syrup for Children......Page 116 Acetaminophen Tablets......Page 117 Acetaminophen Tablets for Children......Page 118 Acetylsalicylic Acid, Acetaminophen, and Caffeine Tablets......Page 119 Acetylsalicylic Acid and Acetaminophen Tablets......Page 120 Acetylsalicylic Acid Suppositories......Page 121 Acetylsalicylic Acid Tablets Direct Compression......Page 122 Acetylsalicylic Acid Tablets Direct Compression......Page 123 Acne Scrub......Page 124 Aloe Vera Gel......Page 125 alpha-Bisabolol Ethanolic Mouthwash Solution......Page 126 Aluminum Hydroxide and Magnesium Carbonate Dry Syrup......Page 127 Aluminum Hydroxide and Magnesium Hydroxide Chewable Tablets......Page 128 Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension......Page 129 Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension......Page 130 Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 131 Aluminum Hydroxide and Magnesium Hydroxide Suspension......Page 132 Aluminum Hydroxide and Magnesium Silicate Chewable Tablets......Page 133 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension......Page 134 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension......Page 135 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Tablets......Page 136 Analgesic Cream......Page 137 Anise Oil Solution......Page 138 Anti-Acne Gel......Page 139 Antiseptic Lotion......Page 140 Antiseptic Wet Wipes......Page 141 Aspartame Powder in Sachets......Page 142 Aspartame Tablets......Page 143 Aspirin, Acetaminophen, and Caffeine Tablets......Page 144 Aspirin, Acetaminophen, Caffeine, and Salicylamide Tablets......Page 145 Attapulgite Tablets......Page 146 Baby Cream, Benzalkonium Chloride and Zinc Oxide......Page 147 Baby Shampoo......Page 148 Benzoyl Peroxide and a Bisabolol Gel......Page 149 Benzoyl Peroxide Anti-Acne Gel......Page 150 Benzoyl Peroxide Anti-Acne Microemulsion......Page 151 Beta-Carotene Effervescent Tablets......Page 152 Beta-Carotene Tablets......Page 153 Beta-Carotene, Vitamin C, and Vitamin E Tablets......Page 154 Beta-Carotene, Vitamin C, and Vitamin E Tablets......Page 155 Betamethasone Gel......Page 156 Betamethasone Valerate Cream......Page 157 Bisacodyl Delayed-Release Tablets......Page 158 Bismuth Carbonate Suspension......Page 159 Breast Care Cream......Page 160 Bromhexine Hydrochloride Syrup......Page 161 Bromhexine Hydrochloride Syrup, Alcohol Free......Page 162 Burn Cream......Page 163 Caffeine Tablets......Page 164 Calamine Cream......Page 165 Calcium and Vitamin D Tablets......Page 166 Calcium Carbonate and Vitamin D Tablets......Page 167 Calcium D-Pantothenate Tablets......Page 168 Calcium Effervescent Tablets......Page 169 Calcium Glycerophosphate Tablets......Page 170 Calcium Phosphate Tablets for Cats and Dogs Direct Compression......Page 171 Carbinoxamine Maleate, Phenylpropanolamine, and Acetaminophen Sustained-Release Tablets......Page 172 Cetrimide Antiseptic Cream......Page 173 Charcoal Tablets......Page 174 Chlorhexidine Gel......Page 175 Chlorpheniramine Maleate Syrup......Page 176 Citrate Effervescent Powder......Page 177 Crospovidone Water Dispersible Tablets......Page 178 Dexpanthenol Gel-Cream......Page 179 Dihydroxyaluminum Sodium Carbonate Tablets......Page 180 Dimenhydrinate Tablets......Page 181 Econazole Nitrate and Benzoyl Peroxide Anti-Acne Cream......Page 182 Eucalyptus and Mint Emulsion......Page 183 Ferrous Sulfate, Manganese Sulfate, and Copper Sulfate Tablets......Page 184 Ferrous Sulfate Oral Syrup......Page 185 Fir Needle Oil Solution......Page 186 Folic Acid Tablets......Page 187 Foot Freshener Cream......Page 188 Garlic Tablets......Page 189 Glycol Foam, Nonaqueous......Page 190 Guaifenesin Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops......Page 191 Horsetail Extract Tablets......Page 192 Hydrocortisone Aqueous Gel......Page 193 Hydrocortisone Cream......Page 194 Hydrocortisone Ointment......Page 195 Ibuprofen Pediatric Suspension......Page 196 Ibuprofen Tablets......Page 197 Inosin Tablets......Page 198 Iron Polymer Coated Particle Tablets......Page 199 Iron Infant Drops......Page 200 Iron Polystyrene and Vitamin C Syrup......Page 201 KaolinÒPectin Suspension......Page 202 KaolinÒPectin Tablets......Page 203 Khellin Tablets......Page 204 Lidocaine GelÒCream......Page 205 Lidocaine, Eugenol, and Menthol Dental Ointment......Page 206 Loratidine Fastab......Page 207 Magaldrate Dispersible Tablets......Page 208 Magaldrate Suspension......Page 209 Magaldrate Tablets......Page 210 Magaldrate with Simethicone Suspension......Page 211 Magaldrate with Simethicone Tablet......Page 212 Medicated Foot Cream......Page 213 Methyl Salicylate Analgesic Cream......Page 214 Methyl Salicylate and Menthol Gel......Page 215 Miconazole Nitrate Cream......Page 216 Mineral and Multivitamin Syrup......Page 217 Mint-Menthol Mouthwash......Page 218 Mint Oil Solution......Page 219 Multivitamin and Calcium Syrup......Page 220 Multivitamin and Mineral Tablets with Beta Carotene......Page 221 Multivitamin and Mineral Syrup......Page 222 Multivitamin and Mineral Tablets......Page 224 Multivitamin Drops......Page 225 Multivitamin Effervescent Granules......Page 226 Multivitamin Effervescent Tablets with Beta Carotene......Page 227 Multivitamin Effervescent Tablets......Page 228 Multivitamin Effervescent Tablets......Page 229 Multivitamin Infant Drops......Page 230 Multivitamin Infant Drops......Page 231 Multivitamin Instant Granules......Page 232 Multivitamin Mineral Syrup......Page 233 Multivitamin Oral Gel with Linoleic and Linolenic Acid......Page 234 Multivitamin Oral Gel Veterinary......Page 235 Multivitamin Syrup......Page 236 Multivitamin Tablets with Beta-Carotene......Page 237 Multivitamin and Beta-Carotene Tablets......Page 238 Multivitamin Tablets......Page 239 Multivitamin Tablets......Page 240 Multivitamin Tablets......Page 241 Multivitamin Tablets......Page 242 Multivitamin Tablets for Dogs......Page 243 Multivitamin and Fluoride Chewable Tablets......Page 244 Multivitamin with Fluoride Infant Drops......Page 245 Multivitamin with Zinc Tablets......Page 246 Neomycin Gel......Page 247 Nondetergent Neutral Dry Skin Cream......Page 248 Norephedrine Syrup......Page 249 Nystatin Cream......Page 250 Nystatin Ointment......Page 251 Nystatin, Neomycin Sulfate, Gramicidin, and Triamcinolone Acetonide Cream......Page 252 Omega Fatty Acids Tablets......Page 253 Pancreatin Tablets......Page 254 Pancreatin and Cholic Acid Tablets......Page 255 Panthenol Lotion......Page 256 Peppermint Rub Cream......Page 257 Phenolphthalein Tablets......Page 258 Phenylpropanolamine Hydrochloride Tablets......Page 259 Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, Vitamin C Syrup......Page 260 PolyvinylpyrrolidoneÒIodine Mouthwash......Page 261 PovidoneÒIodine Bar Soap......Page 262 PovidoneÒIodine Cream......Page 263 PovidoneÒIodine Gargle......Page 264 PovidoneÒIodine Gels......Page 265 PovidoneÒIodine Lozenges......Page 266 PovidoneÒIodine Powder Spray......Page 267 PovidoneÒIodine Soft Gel......Page 268 PovidoneÒIodine Solution......Page 269 PovidoneÒIodine Solution......Page 270 PovidoneÒIodine Surgical Scrub......Page 271 PovidoneÒIodine Vaginal Douche Concentrate......Page 272 PovidoneÒIodine Viscous Solution......Page 273 Promethazine Hydrochloride Syrup......Page 274 Promethazine Hydrochloride Tablets......Page 275 Pseudoephedrine Hydrochloride Syrup......Page 276 Pseudoephedrine Tablets......Page 277 Psoriasis Cream......Page 278 Pyridoxine Tablets......Page 279 Pyridoxine Tablets......Page 280 Ranitidine Tablets......Page 281 Riboflavin Tablets......Page 282 Riboflavin Tablets......Page 283 Saccharin Effervescent Tablets......Page 284 Saccharin Tablets......Page 285 Selegiline Tablets......Page 286 Serratio Peptidase Tablets......Page 287 Simethicone Chewable Tablets......Page 288 Simethicone Tablets......Page 289 Spirulina Extract Chewable Tablets......Page 290 Sulfur Antiseptic Ointment......Page 291 Tetrahydrozoline Eye Drops......Page 292 Thiamine Hydrochloride Tablets......Page 293 Thiamine Hydrochloride Tablets, Sugar-Coated......Page 294 Thiamine, Pyridoxine, and Cyanocobalamin Tablets......Page 295 Thiamine, Pyridoxine, and Cyanocobalamin Tablets......Page 296 Thiamine Tablets......Page 297 Thiamine Tablets......Page 298 Tolnafate and Undecylanate Foot Care Cream......Page 299 Tolnafate Foot Care Microemulsion......Page 300 Tolu Balsam Cough Syrup......Page 301 Triclosan Foot Care Cream......Page 302 Triprolidine and Pseudoephedrine Hydrochloride Syrup......Page 303 Trolamine Salicylate Cream......Page 304 Urea Peroxide Ear Drops......Page 305 Valeriana and Passiflora Extract Tablets......Page 306 Vitamin A and Vitamin D Infant Drops......Page 307 Vitamin A and Vitamin D3 Syrup......Page 308 Vitamin A and Vitamin E Tablets......Page 309 Vitamin A Drops......Page 310 Vitamin A Tablets......Page 311 Vitamin A Tablets......Page 312 Vitamin A, Vitamin C, and Vitamin D3 Chewable Tablets......Page 313 Vitamin B-Complex, Amino Acids, and Magnesium Effervescent Granules Sugar-Free......Page 314 Vitamin B-Complex and Carnitine Tablets......Page 315 Vitamin B-Complex and Folic Acid Dragees......Page 316 Vitamin B-Complex and Iron Syrup......Page 317 Vitamin B-Complex and Vitamin C Effervescent Tablets......Page 318 Vitamin B-Complex and Vitamin C Syrup......Page 319 Vitamin B-Complex and Vitamin C Tablets......Page 320 Vitamin B-Complex, Choline, and Bile Tablets......Page 321 Vitamin B-Complex Syrup......Page 322 Vitamin B-Complex Syrup......Page 323 Vitamin B-Complex Syrup without B12......Page 324 Vitamin B-Complex Tablets......Page 325 Vitamin B-Complex Tablets......Page 326 Vitamin B-Complex, Vitamin A, Vitamin C, and Vitamin D Syrup......Page 327 Vitamin B-Complex, Vitamin A, Vitamin C, and Vitamin D Tablets......Page 328 Vitamin B-Complex, Vitamin A, Vitamin C, Vitamin D, and Calcium Drops......Page 329 Vitamin B-Complex, Vitamin A, Vitamin C, Vitamin D, and Mineral Tablets......Page 330 Vitamin B-Complex, Vitamin A, Vitamin C, Vitamin D, and Vitamin E Pediatric Drops......Page 331 Vitamin B-Complex, Vitamin C, and Ferrous Sulfate Tablets......Page 332 Vitamin B-Complex, Vitamin C, and Iron Syrup......Page 333 Vitamin B-Complex, Vitamin C, and Iron Syrup......Page 334 Vitamin B-Complex, Vitamin C, and Vitamin E Tablets......Page 335 Vitamin C and Vitamin E Lozenges......Page 336 Vitamin C Chewable Tablets......Page 337 Vitamin C Chewable Tablets......Page 338 Vitamin C Chewable Tablets with Dextrose......Page 339 Vitamin C Drops......Page 340 Vitamin C Effervescent Tablets......Page 341 Vitamin C Effervescent Tablets......Page 342 Vitamin C Tablets......Page 343 Vitamin E and Benzocaine Solution......Page 344 Vitamin E Chewable Tablets......Page 345 Vitamin E Gel-Cream......Page 346 Vitamin E Tablets......Page 347 Zinc Oxide Lotion......Page 348 Zinc Pyrithione Shampoo......Page 349 Zirconium Oxide Lotion......Page 350 The fifth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers over-the-counter products, which include formulations of products classified by the US FDA under OTC category, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.