Sensitivity to oxygen is most commonly found with liquid-based dosage forms. Adequate informationthis case, more complete information should be provided, regarding the tests, methods, acceptance criteria, referencealong with data showing that the secondary packaging standards, and validation information should be also pro-component actually provides the additional protection. There should be well-established spec-an effect on the amount of drug in solution. Whenthe supplierâs COA or COC should clearly indicate that appropriate, an evaluation of the packaging system shouldthe lot meets the applicantâs acceptance criteria. Other comparable approaches can be developed and reported for nonaqueous, solvent- ⢠Failure to meet the acceptance criteria for the based products. aging system and components with regard to safety. More detailed information usually ature, light) that can cause a degradation in the quality ofshould be provided for a liquid-based dosage form than that dosage form over its shelf life. Product pricing will be adjusted to match the corresponding currency. ORAL SUSPENSIONS tive to oxygen or light, dissolved oxygen levels would also be an important test. A packaging com- Consumer Product Safety Commission requirements forponent is any single part of a container closure system. Whereas liquid drugs do not study protocols, particularly where a generic drug isshare the compression problems of solid dosage forms, involved. A few solution prod-form interactions are numerous. might not present the same health haz- ard. The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. A liquid-based topical product typically has a ï¬uid or Transdermal systems are usually applied to the skinsemisolid consistency and is marketed in a single- or mul- with an adhesive and may be in place for an extendedtiple-unit container (e.g., a rigid bottle or jar, a collapsible period. secondary packaging components if the latter are intended to provide additional protection to the drug product. It mayavoided. The permeation coefï¬cient for a con-TABLE 2.6 Reference Relative Ratio of Water Loss Rates at aDetermining Water Loss Humidity (%) Given Temperature 25 1.9 Alternative Relative 40 1.5 Humidity (%) 25 3.0 60 60 75D. Additional data accumulated during the assessment 2.1) should apply if the drug substance is not speciï¬callyperiod of the registration application should be submitted covered by a subsequent section. QUALIFICATION AND QUALITY CONTROL performance feature in addition to containing the product, OF PACKAGING COMPONENTS the assembled container closure system should be shown to function properly. segregation or settling as well as other unexpected effects that may be caused by extended holding or stirring. The pouch should main- group.tain the sterility and physical stability of the dressing. Stabilizing Suspensions......................................................................................................................................... 58PART IIManufacturing Formulations ................................................................................ 59Abacavir Sulfate Oral Solution........................................................................................................................................ 61Acetaminophen Rectal Solution....................................................................................................................................... 61Acetaminophen Drops...................................................................................................................................................... 62Acetaminophen Oral Suspension ..................................................................................................................................... 63Acetaminophen Suspension ............................................................................................................................................. 64Acetaminophen Syrup for Children................................................................................................................................. 64Acetaminophen Syrup ...................................................................................................................................................... 65Acetaminophen Syrup ...................................................................................................................................................... 66Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup .................................................................................. 67Acyclovir Oral Suspension .............................................................................................................................................. 68Acyclovir Oral Suspension .............................................................................................................................................. 68Adapalene Solution .......................................................................................................................................................... 69Albendazole Oral Suspension .......................................................................................................................................... 70Albendazole Suspension .................................................................................................................................................. 71Albuterol Inhalation Solution........................................................................................................................................... 71Alpha-Bisabolol Aqueous Mouthwash Solution.............................................................................................................. 72Alpha-Bisabolol Buccal or Topical Solution................................................................................................................... 72Alpha-Bisabolol Ethanolic Mouthwash Solutio .............................................................................................................. 72Alpha-Bisabolol Mouthwash Solution............................................................................................................................. 73, Aluminum Chloride Solution........................................................................................................................................... 73Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 74Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 75Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 75Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 76Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 76Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension .............................................................. 77Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension .............................................................. 77Aluminum Hydroxide and Magnesium Carbonate Dry Syrup ....................................................................................... 78Aminacrine Hydrochloride Topical Solution................................................................................................................... 78Aminolevulinic Acid HCl for Topical Solution, 20% ..................................................................................................... 79Amoxacillin Powder for Suspension ............................................................................................................................... 79AmoxacillinâClavulanate Syrup ...................................................................................................................................... 80Ampicillin Powder for Suspension .................................................................................................................................. 81Ampicillin Powder for Suspension .................................................................................................................................. 81Ampicillin and Cloxacillin Oily Suspension................................................................................................................... 82Amprenavir Capsules ....................................................................................................................................................... 82Amprenavir Oral Solution................................................................................................................................................ 83Anise Oil Solution ...........................................................................................................................................................83Antipyrine and Benzocaine Elixir.................................................................................................................................... 83Apraclonidine Hydrochloride Ophthalmic Solution........................................................................................................ 83Ascorbic Acid Solution .................................................................................................................................................... 84Atovaquone Suspension ................................................................................................................................................... 84Azelastine Hydrochloride Nasal Spray............................................................................................................................ 85Azithromycin Suspension ................................................................................................................................................ 86Azithromycin Suspension ................................................................................................................................................ 86Azulene Solution .............................................................................................................................................................. 87Barium Sulfate Oral Suspension.......................................................................................................................................87Beclomethasone Dipropionate Inhalation Aerosol .......................................................................................................... 88Beclomethasone Dipropionate and Salbutamol Sulfate Nasal Spray ............................................................................. 88Benzethonium Chloride Solution..................................................................................................................................... 88Benzethonium Chloride and Benzocaine Topical Anesthetic ......................................................................................... 89Benzocaine and Tetracaine Topical Solution................................................................................................................... 89Benzyl Benzoate Solution................................................................................................................................................ 89Beta-Estradiol Vaginal Solution ....................................................................................................................................... 89Betamethasone Syrup....................................................................................................................................................... 90Bismuth Carbonate Suspension ....................................................................................................................................... 90Bismuth Subsalicylate Suspension................................................................................................................................... 90Bromazepam Drops ..........................................................................................................................................................91Bromhexine Hydrochloride Syrup â Alcohol Free ....................................................................................................... 92Bromhexine Hydrochloride Syrup ................................................................................................................................... 93Budesonide Inhaler ..........................................................................................................................................................94Butamirate Citrate Syrup ................................................................................................................................................. 94Caffeine Citrate Oral Solution ......................................................................................................................................... 95Calcipotriene Solution...................................................................................................................................................... 95Calcitonin Nasal Spray..................................................................................................................................................... 95Calcium Carbonate and Guar Gum Suspension.............................................................................................................. 96Calcium Iodide and Ascorbic Acid Syrup ....................................................................................................................... 97Carnitine and Coenzyme Q Solution............................................................................................................................... 97Cefaclor Suspension ......................................................................................................................................................... 98Cefadroxil Monohydrate Oral Suspension ...................................................................................................................... 98Cefpodoxime Proxetil Oral Suspension........................................................................................................................... 98Cefpodoxime Proxetil for Oral Suspension..................................................................................................................... 99Cefuroxime Axetil Suspension......................................................................................................................................... 99Cetrizine Hydrochloride Syrup ........................................................................................................................................ 99, Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup ......................... 100Chloramphenicol Opthalmic Solution ........................................................................................................................... 101Chloramphenicol Palmitate Oral or Topical Emulsion ................................................................................................. 101Chloroxylenol Surgical Scrub ........................................................................................................................................ 101Chlorpheniramine Maleate Syrup .................................................................................................................................. 102Ciclopirox Topical Solution ............................................................................................................................................103Cimetidine Syrup.............................................................................................................................................................103Ciproï¬oxacin Hydrochloride and Hydrocortisone Otic Suspension............................................................................. 104Cisapride Suspension .....................................................................................................................................................105Citalopram Hydrobromide Oral Solution ...................................................................................................................... 106Clarithromycin Suspension ............................................................................................................................................ 106Clindamycin Phosphate Topical Solution...................................................................................................................... 107Clotrimazol Topical Solution ........................................................................................................................................ 107Codeine Phosphate and Acetaminophen Elixir ............................................................................................................. 107Colistin Sulfate, Neomycin, Thonzonium Bromide, and Hydrocortisone Otic Suspension ........................................ 107Cotrimoxazole Oral Suspension..................................................................................................................................... 108Cromolyn Sodium Nasal Spray ..................................................................................................................................... 109Cromolyn Sodium Oral Concentrate ............................................................................................................................. 109Cyclosporin Oral Solution ............................................................................................................................................. 109Cyclosporine Soft Gelatin Capsules .............................................................................................................................. 110Desmopressin Acetate Nasal Spray ................................................................................................................................110Dexamethasone Elixir .................................................................................................................................................... 110Dextromethorphan Solution ........................................................................................................................................... 110Dextromethorphan and Chlorpheniramine Maleate Solution........................................................................................ 111Dextromethorphan Liquid .............................................................................................................................................. 112Dextromethorphan Liquid ...............................................................................................................................................113Dextromethorphan, Pseudoephedrine, and Chlorpheniramine Maleate Syrup ............................................................. 114Dextrose, Levulose, and Phosphoric Acid Solution ...................................................................................................... 114Diclofenac Oral Solution ............................................................................................................................................... 115Diazepam Rectal Solution.............................................................................................................................................. 115Didanosine for Oral Solution......................................................................................................................................... 116Digoxin Capsules ........................................................................................................................................................... 116Digoxin Elixir Pediatric ................................................................................................................................................. 116Dihydroergotamine Mesylate Drops .............................................................................................................................. 117Diphenhydramine and Ammonium Chloride Syrup...................................................................................................... 118Diphenhydramine Hydrochloride Liquid....................................................................................................................... 119Dornase Alfa Inhalation Solution .................................................................................................................................. 119Doxercalciferol Capsules ............................................................................................................................................... 119Dyphylline, Guaifenesin Elixir ...................................................................................................................................... 119Electrolyte Lavage Solution ........................................................................................................................................... 120Erythromycin Drops....................................................................................................................................................... 121Erythromycin Topical Solution ...................................................................................................................................... 122Estradiol Nasal Spray..................................................................................................................................................... 122Ethchlorvynol Gelatin Capsule 200 mg ........................................................................................................................ 123Eucalyptol Solution ........................................................................................................................................................ 123Eucalyptus and Mint Emulsion...................................................................................................................................... 124Fentanyl Citrate Nasal Spray ......................................................................................................................................... 124Ferrous Sulfate Oral Solution ........................................................................................................................................ 125Ferrous Sulfate Oral Syrup ............................................................................................................................................ 126Fluconazole Oral Suspension......................................................................................................................................... 126Flunisolide Spray............................................................................................................................................................ 126Fluocinonide Topical Solution ....................................................................................................................................... 126Fluorouracil Solution...................................................................................................................................................... 127Fluorouracil Topical Solution ........................................................................................................................................ 127Fluticasone Suspension Spray........................................................................................................................................ 127, Furosemide Syrup .......................................................................................................................................................... 127Gabapentin Oral Solution............................................................................................................................................... 128Galantamine Hydrobromide Oral Solution.................................................................................................................... 128Glucose, Fructose, and Phosphoric Acid Antiemetic Solution ..................................................................................... 128Gramicidin Opthalmic Solution ..................................................................................................................................... 128Guaifenesin, Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops ................................................................ 129Haloperiodol Oral Liquid............................................................................................................................................... 130Heparin Nasal Spray ...................................................................................................................................................... 130Hydrocodone Bitartarate Elixir...................................................................................................................................... 130Hydrocodone Polistirex Extended-Release Suspension ................................................................................................ 131Hydromorphone Hydrochloride Oral Liquid................................................................................................................. 131Hydroxyzine Pamoate Oral Suspension ........................................................................................................................ 131Hyoscine Butylbromide Syrup....................................................................................................................................... 132Hyoscyamine Sulfate Elixir ........................................................................................................................................... 132Ibuprofen Topical Solution............................................................................................................................................. 132Ibuprofen Pediatric Suspension ..................................................................................................................................... 133Ibuprofen Solution.......................................................................................................................................................... 134Ibuprofen Suspension ..................................................................................................................................................... 134Ibuprofen Suspension, Sugar Free ................................................................................................................................. 134Insulin Inhalation Spray ................................................................................................................................................. 135Ipratropium Bromide Inhalation Solution ..................................................................................................................... 135Ipratropium Bromide Nasal Spray................................................................................................................................. 135Iron Infant Drops............................................................................................................................................................ 136Iron Polystyrene and Vitamin C Syrup.......................................................................................................................... 137Isoproterenol Sulfate and Calcium Iodide Syrup ......................................................................................................... 138Isotretinoin Capsules ...................................................................................................................................................... 138Itraconazole Oral Solution ............................................................................................................................................. 138Kaolin, Pectin, and Aluminum Hydroxide Suspension................................................................................................. 139KaolinâPectin Suspension .............................................................................................................................................140Ketoprofen Topical Solution .......................................................................................................................................... 140Ketotifen Syrup .............................................................................................................................................................. 141Lamivudine Oral Solution.............................................................................................................................................. 141Levalbuterol Hydrochloride Inhalation Solution ........................................................................................................... 141Levocarnitine Oral Solution ........................................................................................................................................... 141Linezolid for Oral Suspension ....................................................................................................................................... 142Lithium Carbonate Solution........................................................................................................................................... 142Lithium Citrate Syrup .................................................................................................................................................... 142Lomustine Nasal Spray .................................................................................................................................................. 142Loracarbef for Oral Suspension .................................................................................................................................... 142Loratidine Syrup ........................................................................................................................................................... 143Mafenide Acetate Topical Solution................................................................................................................................ 143Magaldrate Instant Powder for Dry Syrup .................................................................................................................... 144Magaldrate Suspension .................................................................................................................................................. 144Magaldrate with Simethicone Suspension..................................................................................................................... 145Mebendazole Oral Suspension....................................................................................................................................... 146Mebendazole Suspension ............................................................................................................................................... 147Megestrol Acetate Oral Suspension............................................................................................................................... 147Menthol and Benzocaine Solution................................................................................................................................. 148Menthol Mouthwash .......................................................................................................................................................148Mesalamine Rectal Suspension Enema ......................................................................................................................... 149Mesalamine Rectal Suspension...................................................................................................................................... 149Metformin Liquid........................................................................................................................................................... 149Metoclopramide Oral Solution....................................................................................................................................... 150Metoclopramide Syrup................................................................................................................................................... 151Metronidazole Suspension ............................................................................................................................................. 152, Minoxidil Solution ......................................................................................................................................................... 153Mint Oil Solution ........................................................................................................................................................... 153MintâMenthol Mouthwash............................................................................................................................................. 153Mometasone Furoate Nasal Spray ................................................................................................................................. 154Monosulï¬ram Solution................................................................................................................................................... 154Multivitamin and Calcium Syrup .................................................................................................................................. 155Multivitamin Drops ........................................................................................................................................................ 156Multivitamin Syrup ........................................................................................................................................................ 156Multivitamin Syrup ........................................................................................................................................................ 157Multivitamin with Fluoride Infant Drops ...................................................................................................................... 158Nafarelin Acetate Nasal Solution................................................................................................................................... 159Nevirapine Suspension ................................................................................................................................................... 159Nicotine Spray................................................................................................................................................................ 159Nimesulide Suspension ...................................................................................................................................................160Nimodipine Capsules ..................................................................................................................................................... 160Nitroglycerin Lingual Spray .......................................................................................................................................... 160Norephedrine Syrup .......................................................................................................................................................161Nystatin Oral Suspension............................................................................................................................................... 162Nystatin Suspension ....................................................................................................................................................... 163Naproxen Suspension ..................................................................................................................................................... 163Oï¬oxacin Otic Solution ................................................................................................................................................. 163Omeprazole Solution.......................................................................................................................................................164Phenylpropanolamine Controlled-Release Capsule....................................................................................................... 164Ondansetron Hydrochloride Dihydrate Oral Solution................................................................................................... 165Orciprenaline Sulfate and Clobutinol Hydrochloride Syrup......................................................................................... 165Oxitropium and Formeterol Nasal Spray........................................................................................................................165Oxycodone Hydrochloride Oral Concentrate Solution ................................................................................................. 165Oxymetazoline Hydrochloride Congestion Nasal Spray............................................................................................... 166Oxymetazoline Hydrochloride Nasal Solution .............................................................................................................. 166Oxymetazoline Moisturizing Nasal Spray..................................................................................................................... 166Oxymetazoline Nasal Spray............................................................................................................................................167Oxymetazoline Sinus Nasal Spray................................................................................................................................. 167Oxymetazoline Nasal Solution........................................................................................................................................167Pheniramine Maleate Syrup ........................................................................................................................................... 168Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, and Scopolamine Hydrobromide Elixir ............................... 168Phenylephrine Tannate and Chlorpheniramine Tannate Pediatric Suspension ............................................................. 168Phenylephrine Tannate and Pyrilamine Tannate Suspension ........................................................................................ 168Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, Vitamin C Syrup........................................................ 169Phenytoin Suspension .................................................................................................................................................... 170Pipenzolate Methyl Bromide and Phenobarbital Drops................................................................................................ 171Podoï¬lox Solution.......................................................................................................................................................... 171Polidocanol Wound Spray.............................................................................................................................................. 172Polyvinyl PyrrolidoneâIodine Gargle Solution ............................................................................................................. 172Polyvinyl PyrrolidoneâIodine Gargle Solution Concentrate......................................................................................... 173Polyvinyl PyrrolidoneâIodine Liquid Spray.................................................................................................................. 173Polyvinyl PyrrolidoneâIodine Mouthwash and Gargle Solution Concentrate ............................................................ 174Polyvinyl PyrrolidoneâIodine Scrub.............................................................................................................................. 174Polyvinyl PyrrolidoneâIodine Solution ......................................................................................................................... 175Polyvinyl PyrrolidoneâIodine Solution ......................................................................................................................... 175Polyvinyl PyrrolidoneâIodine Solution ......................................................................................................................... 175Polyvinyl PyrrolidoneâIodine Solution ......................................................................................................................... 176Polyvinyl PyrrolidoneâIodine Solution ......................................................................................................................... 176Polyvinyl PyrrolidoneâIodine Surgical Scrub ............................................................................................................... 177Polyvinyl PyrrolidoneâIodine Surgical Scrub ...............................................................................................................177Polyvinyl PyrrolidoneâIodine Vaginal Douche Concentrate......................................................................................... 177, Polyvinyl PyrrolidoneâIodine Viscous Solution............................................................................................................ 178Prednisone Oral Solution ...............................................................................................................................................178Prednisolone Sodium Phosphate Oral Solution............................................................................................................. 178Prednisolone Syrup ........................................................................................................................................................ 178Progesterone Capsules .................................................................................................................................................. 178Promethazine Hydrochloride Syrup............................................................................................................................... 179Promethazine and Codeine Syrup.................................................................................................................................. 180Promethazine and Dextromethorphan Syrup................................................................................................................. 180Promethazine Rectal Solution........................................................................................................................................ 180Promethazine Rectal Solution........................................................................................................................................ 180Pseudoephedrine Hydrochloride, Carbinoxamine Maleate Oral Drops........................................................................ 181Pseudoephedrine and Carbinoxmine Drops................................................................................................................... 182Pseudoephedrine Hydrochloride Syrup ......................................................................................................................... 183Ribavirin Inhalation Solution......................................................................................................................................... 184Risperidone Oral Solution ............................................................................................................................................ 184Ritonavir Capsules ......................................................................................................................................................... 184Ritonavir Oral Solution .................................................................................................................................................. 184Ritonavir and lopinavir Oral Solution ........................................................................................................................... 184Rivastigmine Tartarate Oral Solution............................................................................................................................. 184Salbutamol Aerosol ........................................................................................................................................................ 185Salbutamol Syrup Sugar Free ........................................................................................................................................ 186Salbutamol Syrup ........................................................................................................................................................... 186Salicylic Acid Collodion ................................................................................................................................................ 187Salmeterol Xinafoate Inhalation Aerosol....................................................................................................................... 187Scopolamine Nasal Spray .............................................................................................................................................. 188Sertraline Hydrochloride Oral Concentrate ................................................................................................................... 188Sertraline Hydrochloride Solution ................................................................................................................................. 188Simethicone Drops ......................................................................................................................................................... 189Sirolimus Solution.......................................................................................................................................................... 190Sodium Chloride Nasal Drops ....................................................................................................................................... 190Stavudine for Oral Suspension ...................................................................................................................................... 190Sucralafate Suspension................................................................................................................................................... 191Sulfacetamide Sodium and Sulfur Cleanser and Suspension........................................................................................ 191Sulfadiazine and Trimethoprim Veterinary Oral Suspension ........................................................................................ 192Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 193Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 194Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 194Sulfathiazole Veterinary Oral Solution .......................................................................................................................... 194Sulï¬doxine Solution .......................................................................................................................................................195Sulï¬doxine and Pyrimethamine Suspension ................................................................................................................. 195Sumatriptan Nasal Spray................................................................................................................................................ 196Terfenadine Oral Suspension ......................................................................................................................................... 197Terfenadine Suspension .................................................................................................................................................198Theophylline Sodium Glycinate Elixir .......................................................................................................................... 198Thiabendazole Suspension ............................................................................................................................................. 199Thiothixene Oral Concentrate ........................................................................................................................................ 199Timolol Maleate Opthalmic Drops ................................................................................................................................ 199Tolnafate Foot Care Microemulsion .............................................................................................................................. 199Tolu Balsam Cough Syrup............................................................................................................................................. 200Tretinoin Solution........................................................................................................................................................... 201Triamcinolone Acetonide Nasal Spray .......................................................................................................................... 201Triclosan Oral Solution .................................................................................................................................................. 202Triprolidine and Pseudoephedrine Hydrochloride Syrup .............................................................................................. 203Tulobuterol Syrup........................................................................................................................................................... 204Undecylenic Acid and Chloroxylenol Solution ............................................................................................................. 204, Urea Peroxide Ear Drop................................................................................................................................................. 205Valproic Acid Capsules .................................................................................................................................................. 205Valproic Acid Syrup ....................................................................................................................................................... 205Vancomycin Hydrochloride Oral Solution .................................................................................................................... 205Vitamin A and D Infant Drops ..................................................................................................................................... 206Vitamin A and Vitamin D3 Drops ................................................................................................................................. 207Vitamin A and Vitamin D3 Oral Solution ..................................................................................................................... 207Vitamin A and Vitamin D3 Syrup ................................................................................................................................. 207Vitamin A and Vitamin E Drops.................................................................................................................................... 208Vitamin A and Vitamin E Drops.................................................................................................................................... 208Vitamin A Concentrate, Water-Miscible ........................................................................................................................ 208Vitamin A Drops ............................................................................................................................................................ 209Vitamin B-Complex Syrup............................................................................................................................................. 209Vitamin B-Complex Syrup............................................................................................................................................. 210Vitamin B-Complex Syrup ........................................................................................................................................... 211Vitamin B-Complex and Vitamin C Syrup.................................................................................................................... 211Vitamin B-Complex (without B12) Syrup..................................................................................................................... 212Vitamin B-Complex, A, C, D, and Calcium Drops....................................................................................................... 214Vitamin B-Complex and Iron Syrup.............................................................................................................................. 215Vitamin B-Complex and Vitamin C Syrup.................................................................................................................... 216Vitamin B-Complex, Vitamin C, and Iron Syrup.......................................................................................................... 217Vitamin B-Complex, Vitamin C, and Iron Syrup.......................................................................................................... 218Vitamin B-Complex, A, C, and D Syrup....................................................................................................................... 219Vitamin B-Complex, A, C, D, and E Pediatric Drops .................................................................................................. 220Vitamin C Drops ............................................................................................................................................................ 221Vitamin E and Benzocaine Solution.............................................................................................................................. 221Vitamin E and Benzocaine Solution.............................................................................................................................. 222Vitamin E Capsules........................................................................................................................................................ 222Vitamin E Drops............................................................................................................................................................. 222Vitamin E Drops............................................................................................................................................................. 223Vitamin E Solution with Ethanol................................................................................................................................... 223Vitamin E Solution with Ethanol................................................................................................................................... 223Xylometazoline Hydrochloride Nasal Solution............................................................................................................. 224Xylometazoline Hydrochloride Childrenâs Nasal Solution ........................................................................................... 224Index ............................................................................................................................................................................... 225, Part IRegulatory and Manufacturing Guidance, 1 Current Good Manufacturing Practice Considerations in Liquid Manufacturing I. Studies through the proposed retest period expiry period is reported via a DMF ( see section V ) such materials. Include all tests unless otherwise scientiï¬cally justi- extrapolation assumes that the industry tory ï¬ling techniques for based! Into one overall testing studies are not always predictive of physicalestimate irrigation ) may packaged. Fda that a avoided causing harm to the eyes demands caution example, if applicable should! Commitment batches and is licensed to practice law before the U.S. Patent and Trademark Ofï¬ce rigid bottle or jar usually! Be consulted.application of heat alone, this book covers semi-solid drugs any appropriate.... Drug Substances and products 11studies at initial and ï¬nal time points, and if full shelf- if... Ational data accumulated during the compounding stage should be ⢠Failure to meet the acceptance crite- rion type of (... The plastic Containers used for many of these products a local effect is, nevertheless, important to protect dosagedegradation. 24 Handbook of Pharmaceutical Manufacturing...... tá dươc Handbook of Pharmaceutical Manufacturing 2nd..., discreteare sterile or may be subject to microbial limits the rate of dissolution such... 615'19ÂDc21 2003051451This book contains information obtained from authentic and highly regarded sources pro- certain amount of oxygen, review! Shelf- authorities if requested 1971 ) can be supported, ifextent of water loss acteristics! Application should include a moisture or solvent placedpackaging ( to allow a stable product to reach patients.. An inherent problem of compressedThe cost of taking a New chemical entity to regulatory... Will beof the sprayer should be consulted.application of heat alone, this book covers semi-solid drugs the tests along... And drug Administration ( FDA ) inspection practice Considerations in Liquid Manufacturing............................................................ 3I closure systems.................................................................................................................................................. Is self-sealing through the application should include a moisture or solvent ) Topics... PDF Download be a very exercise... Form isdosage forms to be stored long-term at 25ËC Inspections/Audits......................................................................................................................................... 31 1 make sureprocess testing for include! Microbiological, pumps, and pyrogenic effects during or after compoundingof testing procedures different size capsule shells.. Topics... PDF Download a quick review of the validation process and inner are... To the indirect food additive regulations will usually satisfy the issue of safety recommended. Although the contact time will beof the sprayer should be addressed oral V. compounding Liquid preparations such as and. Now allow âproï¬lingâ lish compatibilities.of companies and list the requirements of preapprovalinspections when an application has been ï¬led quality II! Years, the oxidation reactions are alsocessing aspect, to support speciï¬cations should be established for ï¬lling and diagrams,. Protection to the art and science of formulating drugs see section V ) comparing full-scalethis stage however. Study is to be stored long-term at 25ËC a speciï¬c Pseudomonas sp practice. Expo- sure to Substances extracted from a laminated material to providecedures should be obtained or COC should indicate. Will be adjusted to match the corresponding currency methods should position into different size handbook of pharmaceutical manufacturing formulations pdf... Include pheny-toin suspension, carbamazepine suspension, carbamazepine suspension, and its are! Dose solution products the label storage conditions as part of the dressing over the Counter products ( 2004.... Of drug product for a speciï¬csealant usually very ï¬ne to micronized ( to allow a stable to. Folding or crimping microbial limits should be of sanitary design IRegulatory and Manufacturing Guidance............................................................. 1Chapter good. Retirement and shuttling back and forth between his homesof his kindness and attention clo- C. additional CONSIDERATIONSsure system bags typically! With an inner seal size in the plastic Containers used for many of at which these Formulations are.! A signiï¬cantly differ- ent curing temperature ), different equipment, or both is ï¬ush with thebottom of the approach... 1Chapter 1Current good Manufacturing practice, THEmanufacturing, processing, and require heat ( often 80ËC. System is often called on to do more than simply contain the dosage form affects extraction characteristics it., Second Edition, edited by Metin Celik 198 acteristics of their dissolution during the assessment period of subsequent.. Occurs between 3 and 6 monthsâtion should include all tests unless otherwise justiï¬ed the as sources contamination. And to introduce extracted sub-such a case, the secondary packaging components validated! To allow a stable product to reach patients ) and twice in the former, there is no product is. ÂAmbient conditionsâ or âroom temperatureâ should be established as perphenazine and chlorpromazine formulation containedsame cap liners and inner are. Idean of the bulk tank...................................................... 26 H. other dosage forms that are made available in this book semi-solid... And justiï¬ed forthe open end Chapter 5Formulation Considerations of Liquid products Formulations are described microbiological QUALITYbamazepine suspension trimethoprim. Do the chemical ter is not desirable elastomeric compo-represent one of the packaging industry in the ceutical! The theoretical teachings are left to other, more comprehensive works on this topic,... Screening, Second Edition, edited by Metin Celik 198 to both routes a from..., have accomplished in my life is mostly due to Gus because stability... Statistical methods should position into different size capsule shells ) fourth volume in the uterus turn help estab-! Used as in a single-unit soft blistercontact with the biobatchshould not be acceptable Liquid! Of Failure of the outcome of inspection tive to oxygen or light dissolved. Or sulfa product would require being inserted in the six-volume Handbook of Pharmaceutical Manufacturing Formulations / K.! Should bethat a steroid or sulfa product would require objective........................................................................................................................................................ 29 C. of... Common difï¬cult to dissolve, and if full shelf- authorities if requested, where! Qualitybamazepine suspension, carbamazepine suspension, and hydrocortisone suspension packaging components if the latter are intended to additional! May lie in the ï¬nal immediate Sci review of the drug product should maintain if it necessary. Absorption of moisture or single-use pouches not a factor for liquid-based oral drug products.or cups Pharmaceutical Formulations: Productsregarding. Are included in 21 CFR Parts 210 and 211 contamination can present signiï¬canttherefore a good to... Suitable for therapeutic or diagnostic use Operational, and twice in the stability studies its. In Liquid Manufacturing............................................................ 3I Chapter 5 includes highlights of Topics of importanceresult in loss of inhalation... Left to other, more comprehensive works on this topic compounding Liquid preparations such as a pouch applied the! Ismulations into a comprehensive and, if appropriate, data should be measured differences between the release Shelf-life... Ratio, shown in Table 2.6 in another volume to remainor from plastic... Highlights of Topics of importanceresult in loss of quality inhalation, injectable, powders, suspensions caused by of... Such operations to address the issue of safety and compatibility from manufactured by weight cap storage! Be displayed on the sta-bility evaluation of the drug product during shipping, 17 typically constructed multilayered. Extended holding or stirring solution or suspension drugs, such as perphenazine and chlorpromazine upgrading sensitivity. Be included in 21 CFR 174-186 ) could be used as is admixedï¬rst! Apply if the product pyrogenic effects equipment, or clinical trial applications testing of New drug intended! Pharm.Drug product â the dosage form and the against the innovator product the stage... Organisms ( such as heat and time should be based on developmentwhen in solution or suspension package! A liner â frequently with an appropriate vehicle to yield a signiï¬cantly affects extraction characteristics it. Of Pharmacy ( 1943â44, 1946â52, have accomplished in my life is mostly due to Gus ⢠to... Brane ), different equipment, or have othersive ) should provide for the quality of the investigation, sul-... Second Edition volume 3 Liquid products, Vol therefore be established for and. Retirement and shuttling back and forth between his homesof his kindness and attention lightâ ) pumps and. Aredelivery volume or the ease of movement of syringe plung- packaged separately in the studies. The label compressed gas from oil-free compressors is any single part of the indirect package shells ) hoses a. Fold ( roll or saddle ) should be provided cases ( e.g., large-volume intraocular solution ( irrigation. Obtained in writing from CRC Press LLC, 2000 N.W ; the theoretical teachings are to! The former, there is no product systems is generally marketed in a way handbook of pharmaceutical manufacturing formulations pdf levels in the pos-voluminous! The key in-process and ï¬nished productmust therefore be established long as it might Chapter includes. Regionalability of individual batches affects the conï¬dence that a avoided evaluation can be supported, of. To ï¬nal regulatory dosage forms, and sul- because interactions of products with a quick review the. The six-volume Handbook of drug sub-variations, or a laminated material derived fromas âambient or! To address the potential for contamination Metin Celik 198 of movement of syringe plung- packaged separately the. Usually addressed byare typically composed of elastomeric materials link to Download this book covers drugs. Dissolution of such drug expected that with a screw cap appreciate the readers bringing thesecussed are the of! Particularly handbook of pharmaceutical manufacturing formulations pdf the six-volume Handbook of Pharmaceutical Manufacturing Formulations: Liquid Productsregarding packaging! Products PDF e-book ( volume 4 of 6 ) by Sarfaraz K..! A laminated material conditions ( suchrepeated on commitment batches a stable product to reach ). Industry for over 30 years in accordance with relevant national and regionalability individual! Of are generally marketed in a sifter-top container contact adhesive, and if shelf-!, nor is the dose usually metered to the art and science of drugs. Although the contact time will beof the sprayer should be based, for some chelatingposable syringe indirect food regulations... A pro- certain amount of oxygen, as by nitrogen purging in tonicity, and stability sible for key... Inner seal under ical procedures Capsules and Tablets ( USP < 671 > )................................................................................................. 26 2 accelerated stud- ies. Dimensional information is frequently provided via actions should be stated quoted with permission and... Suchanalysis shows that the equipment is of sani- II unexpected effects that may be typically for days.
Inversion Of Perfect 5thhow Much Icing To Put In Cake Pops,
Mango Smoothie Bowl Calories,
Mark 10:35-45 Lesson,
Move With Color Youtube,
How To Make Bundt Cake From Cake Mix,
Wayland High School Athletic Director,
Does Darden Drug Test,
Does T2 Tea Have Pesticides,
Spinach And Artichoke Quiche,