The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations 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 liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.
REGULATORY AND MANUFACTURING GUIDANCE Current Good Manufacturing Practice Considerations in Liquid Manufacturing Stability Testing of New Drug Substances and Products Container Closure Systems Preapproval Inspections Formulation Considerations of Liquid Products
MANUFACTURING FORMULATIONS Abacavir Sulfate Oral Solution Acetaminophen Rectal Solution Acetaminophen Drops Acetaminophen Oral Suspension Acetaminophen Suspension Acetaminophen Syrup for Children Acetaminophen Syrup Acetaminophen Syrup Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup Acyclovir Oral Suspension Acyclovir Oral Suspension Adapalene Solution Albendazole Oral Suspension Albendazole Suspension Albuterol Inhalation Solution Alpha-Bisabolol Aqueous Mouthwash Solution Alpha-Bisabolol Buccal or Topical Solution Alpha-Bisabolol Ethanolic Mouthwash Solution Alpha-Bisabolol Mouthwash Solution Aluminum Chloride Solution Aluminum Hydroxide and Magnesium Hydroxide Suspension Aluminum Hydroxide and Magnesium Hydroxide Suspension Aluminum Hydroxide and Magnesium Hydroxide Suspension Aluminum Hydroxide and Magnesium Hydroxide Suspension Aluminum Hydroxide and Magnesium Hydroxide Suspension Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension Aluminum Hydroxide and Magnesium Carbonate Dry Syrup Aminolevulinic Acid HCl for Topical Solution, 20%
Amoxacillin Powder for Suspension Amoxacillin-Clavulanate Syrup Ampicillin Powder for Suspension Ampicillin Powder for Suspension Ampicillin and Cloxacillin Oily Suspension Amprenavir Capsules Amprenavir Oral Solution Anise Oil Solution Antipyrine and Benzocaine Elixir Apraclonidine Hydrochloride Ophthalmic Solution Ascorbic Acid Solution Atovaquone Suspension Azelastine Hydrochloride Nasal Spray Azithromycin Suspension Azithromycin Suspension Azulene Solution Barium Sulfate Oral Suspension Beclomethasone Dipropionate Inhalation Aerosol Beclomethasone Dipropionate and Salbutamol Sulfate Nasal Spray Benzethonium Chloride Solution Benzethonium Chloride and Benzocaine Topical Anesthetic Benzocaine and Tetracaine Topical Solution Benzyl Benzoate Solution Beta-Estradiol Vaginal Solution Betamethasone Syrup Bismuth Carbonate Suspension Bismuth Subsalicylate Suspension Bromazepam Drops Bromhexine Hydrochloride Syrup - Alcohol Free Bromhexine Hydrochloride Syrup Budesonide Inhaler Butamirate Citrate Syrup Caffeine Citrate Oral Solution Calcipotriene Solution Calcitonin Nasal Spray Calcium Carbonate and Guar Gum Suspension Calcium Iodide and Ascorbic Acid Syrup Carnitine and Coenzyme Q Solution Cefaclor Suspension Cefadroxil Monohydrate Oral Suspension Cefpodoxime Proxetil Oral Suspension Cefpodoxime Proxetil for Oral Suspension Cefuroxime Axetil Suspension Cetrizine Hydrochloride Syrup Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup Chloramphenicol Opthalmic Solution Chloramphenicol Palmitate Oral or Topical Emulsion Chloroxylenol Surgical Scrub Chlorpheniramine Maleate Syrup Ciclopirox Topical Solution Cimetidine Syrup Ciprofloxacin Hydrochloride and Hydrocortisone Otic SuspensionCisapride Suspension Citalopram Hydrobromide Oral Solution Clarithromycin Suspension Clindamycin Phosphate Topical Solution Clotrimazol Topical Solution Codeine Phosphate and Acetaminophen Elixir Colistin Sulfate, Neomycin, Thonzonium Bromide, and Hydrocortisone Otic Suspensio Cotrimoxazole Oral Suspension Cromolyn Sodium Nasal Spray Cromolyn Sodium Oral Concentrate Cyclosporin Oral Solution Cyclosporine Soft Gelatin Capsules Desmopressin Acetate Nasal Spray Dexamethasone Elixir Dextromethorphan Solution Dextromethorphan and Chlorpheniramine Maleate SolutionDextromethorphan Liquid Dextromethorphan Liquid Dextromethorphan, Pseudoephedrine, and Chlorpheniramine Maleate Syrup Dextrose, Levulose, and Phosphoric Acid Solution Diclofenac Oral Solution Diazepam Rectal Solution Didanosine for Oral Solution Digoxin Capsules Digoxin Elixir Pediatric Dihydroergotamine Mesylate Drops Diphenhydramine and Ammonium Chloride Syrup Diphenhydramine Hydrochloride Liquid Dornase Alfa Inhalation Solution Doxercalciferol Capsules Dyphylline, Guaifenesin Elixir Electrolyte Lavage Solution Erythromycin Drops Erythromycin Topical Solution Estradiol Nasal Spray Ethchlorvynol Gelatin Capsule 200 mg Eucalyptol Solution Eucalyptus and Mint Emulsion Fentanyl Citrate Nasal Spray Ferrous Sulfate Oral Solution Ferrous Sulfate Oral Syrup Fluconazole Oral Suspension Flunisolide Spray Fluocinonide Topical Solution Fluorouracil Solution Fluorouracil Topical Solution Fluticasone Suspension Spray Furosemide Syrup Gabapentin Oral Solution Galantamine Hydrobromide Oral Solution Glucose, Fructose, and Phosphoric Acid Antiemetic Solution Gramicidin Opthalmic Solution Guaifenesin, Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops Haloperiodol Oral Liquid Heparin Nasal Spray Hydrocodone Bitartarate Elixir Hydrocodone Polistirex Extended-Release Suspension Hydromorphone Hydrochloride Oral Liquid Hydroxyzine Pamoate Oral Suspension Hyoscine Butylbromide Syrup Hyoscyamine Sulfate Elixir Ibuprofen Topical Solution Ibuprofen Pediatric Suspension Ibuprofen Solution Ibuprofen Suspension Ibuprofen Suspension, Sugar Free Insulin Inhalation Spray Ipratropium Bromide Inhalation Solution Ipratropium Bromide Nasal Spray Iron Infant Drops Iron Polystyrene and Vitamin C Syrup Isoproterenol Sulfate and Calcium Iodide Syrup Isotretinoin Capsules Itraconazole Oral Solution Kaolin, Pectin, and Aluminum Hydroxide Suspension Kaolin-Pectin Suspension Ketoprofen Topical Solution Ketotifen Syrup Lamivudine Oral Solution Levalbuterol Hydrochloride Inhalation Solution Levocarnitine Oral Solution Linezolid for Oral Suspension Lithium Carbonate Solution Lithium Citrate Syrup Lomustine Nasal Spray Loracarbef for Oral Suspension Loratidine Syrup Mafenide Acetate Topical Solution 143
Magaldrate Instant Powder for Dry Syrup Magaldrate Suspension Magaldrate with Simethicone Suspension Mebendazole Oral Suspension Mebendazole Suspension Megestrol Acetate Oral Suspension Menthol and Benzocaine Solution Menthol Mouthwash Mesalamine Rectal Suspension Enema Mesalamine Rectal Suspension Metformin Liquid Metoclopramide Oral Solution Metoclopramide Syrup Metronidazole Suspension Minoxidil Solution Mint Oil Solution Mint-Menthol Mouthwash Mometasone Furoate Nasal Spray Monosulfiram Solution Multivitamin and Calcium Syrup Multivitamin Drops Multivitamin Syrup Multivitamin Syrup Multivitamin with Fluoride Infant Drops Nafarelin Acetate Nasal Solution Nevirapine Suspension Nicotine Spray Nimesulide Suspension Nimodipine Capsules Nitroglycerin Lingual Spray Norephedrine Syrup Nystatin Oral Suspension Nystatin Suspension Naproxen Suspension Ofloxacin Otic Solution Omeprazole Solution Phenylpropanolamine Controlled-Release Capsule Ondansetron Hydrochloride Dihydrate Oral Solution Orciprenaline Sulfate and Clobutinol Hydrochloride Syrup Oxitropium and Formeterol Nasal Spray Oxycodone Hydrochloride Oral Concentrate Solution Oxymetazoline Hydrochloride Congestion Nasal Spray Oxymetazoline Hydrochloride Nasal Solution Oxymetazoline Moisturizing Nasal Spray Oxymetazoline Nasal Spray Oxymetazoline Sinus Nasal Spray Oxymetazoline Nasal Solution Pheniramine Maleate Syrup Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, and Scopolamine Hydrobromide Elixir Phenylephrine Tannate and Chlorpheniramine Tannate Pediatric Suspension Phenylephrine Tannate and Pyrilamine Tannate Suspension Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, Vitamin C Syrup Phenytoin Suspension Pipenzolate Methyl Bromide and Phenobarbital Drops Podofilox Solution Polidocanol Wound Spray Polyvinyl Pyrrolidone-Iodine Gargle Solution Polyvinyl Pyrrolidone-Iodine Gargle Solution Concentrate Polyvinyl Pyrrolidone-Iodine Liquid Spray Polyvinyl Pyrrolidone-Iodine Mouthwash and Gargle Solution Concentrate Polyvinyl Pyrrolidone-Iodine Scrub Polyvinyl Pyrrolidone-Iodine Solution Polyvinyl Pyrrolidone-Iodine Solution Polyvinyl Pyrrolidone-Iodine Solution Polyvinyl Pyrrolidone-Iodine Solution Polyvinyl Pyrrolidone-Iodine Solution Polyvinyl Pyrrolidone-Iodine Surgical Scrub Polyvinyl Pyrrolidone-Iodine Surgical Scrub Polyvinyl Pyrrolidone-Iodine Vaginal Douche Concentrate Polyvinyl Pyrrolidone-Iodine Viscous Solution Prednisone Oral Solution Prednisolone Sodium Phosphate Oral Solution Prednisolone Syrup Progesterone Capsules Promethazine Hydrochloride Syrup Promethazine and Codeine Syrup Promethazine and Dextromethorphan Syrup Promethazine Rectal Solution Promethazine Rectal Solution Pseudoephedrine Hydrochloride, Carbinoxamine Maleate Oral Drops Pseudoephedrine and Carbinoxmine Drops Pseudoephedrine Hydrochloride Syrup Ribavirin Inhalation Solution Risperidone Oral Solution Ritonavir Capsules Ritonavir Oral Solution Ritonavir and lopinavir Oral Solution Rivastigmine Tartarate Oral Solution Salbutamol Aerosol Salbutamol Syrup Sugar Free Salbutamol Syrup Salicylic Acid Collodion Salmeterol Xinafoate Inhalation Aerosol Scopolamine Nasal Spray Sertraline Hydrochloride Oral Concentrate Sertraline Hydrochloride Solution Simethicone Drops Sirolimus Solution Sodium Chloride Nasal Drops Stavudine for Oral Suspension Sucralafate Suspension Sulfacetamide Sodium and Sulfur Cleanser and Suspension Sulfadiazine and Trimethoprim Veterinary Oral Suspension Sulfamethoxazole and Trimethoprim Suspension Sulfamethoxazole and Trimethoprim Suspension Sulfamethoxazole and Trimethoprim Suspension Sulfathiazole Veterinary Oral Solution Sulfidoxine Solution Sulfidoxine and Pyrimethamine Suspension Sumatriptan Nasal Spray Terfenadine Oral Suspension Terfenadine Suspension Theophylline Sodium Glycinate Elixir Thiabendazole Suspension Thiothixene Oral Concentrate Timolol Maleate Opthalmic Drops Tolnafate Foot Care Microemulsion Tolu Balsam Cough Syrup Tretinoin Solution Triamcinolone Acetonide Nasal Spray Triclosan Oral Solution Triprolidine and Pseudoephedrine Hydrochloride Syrup Tulobuterol Syrup Undecylenic Acid and Chloroxylenol Solution Urea Peroxide Ear Drop Valproic Acid Capsules Valproic Acid Syrup Vancomycin Hydrochloride Oral Solution Vitamin A and D Infant Drops Vitamin A and Vitamin D3 Drops Vitamin A and Vitamin D3 Oral Solution Vitamin A and Vitamin D3 Syrup Vitamin A and Vitamin E Drops Vitamin A and Vitamin E Drops Vitamin A Concentrate, Water-Miscible Vitamin A Drops Vitamin B-Complex Syrup Vitamin B-Complex Syrup Vitamin B-Complex Syrup Vitamin B-Complex and Vitamin C Syrup Vitamin B-Complex (without B12) Syrup Vitamin B-Complex, A, C, D, and Calcium Drops Vitamin B-Complex and Iron Syr 216
Vitamin B-Complex and Vitamin C Syrup Vitamin B-Complex, Vitamin C, and Iron Syrup Vitamin B-Complex, Vitamin C, and Iron Syrup Vitamin B-Complex, A, C, and D Syrup Vitamin B-Complex, A, C, D, and E Pediatric Drops Vitamin C Drops Vitamin E and Benzocaine Solution Vitamin E and Benzocaine Solution Vitamin E Capsules Vitamin E Drops Vitamin E Drops Vitamin E Solution with Ethanol Vitamin E Solution with Ethanol Xylometazoline Hydrochloride Nasal Solution Xylometazoline Hydrochloride Children's Nasal Solution
Overview
The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and ...