Handbook of pharmaceutica vol 3 liquid products

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Handbook of pharmaceutica vol 3 liquid products

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.. .Handbook of Pharmaceutical Manufacturing Formulations Volume Series Sarfaraz K Niazi Volume Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products Volume Handbook of. .. Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products Volume Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products Volume Handbook of Pharmaceutical... Semisolid Products Volume Handbook of Pharmaceutical Manufacturing Formulations: V O L U MProducts E Over-the-Counter Volume Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products

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  • 1748_fm

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Dedication

      • Preface to the Series

      • Preface to the Volume

      • About the Author

      • Table of Contents

  • 1748_C01

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Part I. Regulatory and Manufacturing Guidance

        • Chapter 1. Current Good Manufacturing Practice Considerations in Liquid Manufacturing

          • I. INTRODUCTION

          • II. FACILITIES

          • III. EQUIPMENT

          • IV. RAW MATERIALS

          • V. COMPOUNDING

          • VI. MICROBIOLOGICAL QUALITY

          • VII. ORAL SUSPENSIONS

          • VIII. PRODUCT SPECIFICATIONS

          • IX. PROCESS VALIDATION

          • X. STABILITY

          • XI. PACKAGING

  • 1748_C02

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Chapter 2. Stability Testing of New Drug Substances and Products

        • I. INTRODUCTION

        • II. DRUG SUBSTANCE

          • A. GENERAL CASE

          • B. DRUG SUBSTANCES INTENDED FOR STORAGE IN A REFRIGERATOR

          • C. DRUG SUBSTANCES INTENDED FOR STORAGE IN A FREEZER

          • D. DRUG SUBSTANCES INTENDED FOR STORAGE BELOW -20 C

        • III. DRUG PRODUCT

          • A. GENERAL CASE

          • B. DRUG PRODUCTS PACKAGED IN IMPERMEABLE CONTAINERS

          • C. DRUG PRODUCTS PACKAGED IN SEMIPERMEABLE CONTAINERS

          • D. DRUG PRODUCTS INTENDED FOR STORAGE IN A REFRIGERATOR

          • E. DRUG PRODUCTS INTENDED FOR STORAGE IN A FREEZER

          • F. DRUG PRODUCTS INTENDED FOR STORAGE BELOW - 20 C

        • IV. GLOSSARY

        • REFERENCES

  • 1748_C03

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Chapter 3. Container Closure Systems

        • I. INTRODUCTION

          • A. DEFINITIONS

          • B. CURRENT GOOD MANUFACTURING PRACTICE, THE CONSUMER PRODUCT SAFETY COMMISSION, AND REQUIREMENTS ON CONTAINERS AND CLOSURES

          • C. ADDITIONAL CONSIDERATIONS

        • II. QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS

          • A. DESCRIPTION

          • B. INFORMATION ABOUT SUITABILITY

          • C. STABILITY DATA (PACKAGING CONCERNS)

          • D. INHALATION DRUG PRODUCTS

          • E. INJECTION AND OPHTHALMIC DRUG PRODUCTS

          • F. LIQUID-BASED ORAL AND TOPICAL DRUG PRODUCTS AND TOPICAL DELIVERY SYSTEMS

          • G. SOLID ORAL DOSAGE FORMS AND POWDERS FOR RECONSTITUTION

            • 1. Polyethylene Containers (USP <661>)

            • 2. Single-Unit Containers and Unit-Dose Containers for Capsules and Tablets (USP <671>)

            • 3. Multiple-Unit Containers for Capsules and Tablets (USP <671>)

          • H. OTHER DOSAGE FORMS

        • III. POSTAPPROVAL PACKAGING CHANGES

        • IV. TYPE III DRUG MASTER FILES

        • V. BULK CONTAINERS

        • REFERENCES

  • 1748_C04

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Chapter 4. Preapproval Inspections

        • I. INTRODUCTION

          • A. BACKGROUND

          • B. OBJECTIVE

          • C. TRIGGERING OF INSPECTIONS

          • D. INSPECTIONS/AUDITS

            • 1. Manufacturing Process

              • i. Drug Product (Dosage Form)

              • ii. Drug Substance (Bulk Drug Chemical)

            • 2. Reprocessing

            • 3. Laboratory

            • 4. Components

            • 5. Building and Facilities

            • 6. Equipment

            • 7. Packaging and Labeling Controls

        • II. REGULATORY/ADMINISTRATIVE STRAGEGY

          • A. GENERAL

          • B. PROCESS VALIDATION

          • C. KEY ELEMENTS

          • D. STRATEGIES FOR PREINSPECTION

          • E. INTERNATIONAL INSPECTION

          • F. PRODUCT STABILITY DATA

          • G. VALIDATION OF PROCESSES

          • H. CHANGE CONTROL

            • 1. Cleaning Validation

            • 2. Analytical Methods Validation

            • 3. Computer System Validation

          • I. DOCUMENTATION STANDARDS

            • 1. Development History Report

            • 2. Deviation Records

            • 3. Installation, Operational, and Performance Qualification

            • 4. Organizational Chart

            • 5. Products List

            • 6. Drawings

            • 7. Stability Data

            • 8. SOPs

            • 9. Training Records

            • 10. Validation Records

            • 11. Technology Transfer and Scale-Up

            • 12. Quality Policy

            • 13. Vendor Approval

            • 14. Outside Contractors

  • 1748_C05

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Chapter 5. Formulation Considerations of Liquid Products

        • I. SOLUBILITY

        • II. CHEMICAL MODIFICATION

        • III. PRESERVATION

        • IV. SWEETENING AGENTS

        • V. FLAVORS

        • VI. VISCOSITY

        • VII. APPEARANCE

        • VIII. CHEMICAL STABILITY

        • IX. PHYSICAL STABILITY

        • X. RAW MATERIAL

        • XI. MANUFACTURING EQUIPMENT

        • XII. MANUFACTURING DIRECTIONS

        • XIII. PACKAGING

        • XIV. PARTICLE SIZE AND SHAPE

        • XV. SUSPENSIONS

        • XVI. EMULSIONS

        • XVII. POWDER FOR RECONSTITUTION

        • XVIII. NASAL SPRAY PRODUCTS

          • A. INHALATION SOLUTIONS AND SUSPENSIONS

          • B. INHALATION SPRAYS

          • C. PUMP DELIVERY OF NASAL PRODUCTS

          • D. SPRAY CONTENT UNIFORMITY FOR NASAL PRODUCTS

          • E. SPRAY PATTERN AND PLUME GEOMETRY OF NASAL PRODUCTS

          • F. DROPLET SIZE DISTRIBUTION IN NASAL PRODUCTS

          • G. PARTICLE SIZE DISTRIBUTION FOR NASAL SUSPENSIONS

        • XIV. EMULSIFICATION AND SOLUBILIZATION

        • XV. COMPLEXING

        • XVI. HYDROPHILIZATION

        • XVII. STABILIZING SUSPENSIONS

  • 1748_Part2

    • Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products

      • Table of Contents

      • Part II. Manufacturing Formulations

        • Abacavir Sulfate Oral Solution

        • Acetaminophen Rectal Solution

        • Acetaminophen Drops

        • Acetaminophen Oral Suspension

        • Acetaminophen Suspension

        • Acetaminophen Syrup for Children

        • Acetaminophen Syrup

        • Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup

        • 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, Magnesium Hydroxide, and Simethicone Suspension

        • Aluminum Hydroxide and Magnesium Carbonate Dry Syrup

        • Aminacrine Hydrochloride Topical Solution

        • Aminolevulinic Acid HCl for Topical Solution, 20%

        • Amoxacillin Powder for Suspension

        • AmoxacillinÒClavulanate Syrup

        • 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

        • 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 Û 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 Suspension

        • Cisapride 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 Suspension

        • 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 Solution

        • 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

        • KaolinÒPectin 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

        • 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

        • MintÒMenthol Mouthwash

        • Mometasone Furoate Nasal Spray

        • Monosulfiram Solution

        • Multivitamin and Calcium Syrup

        • Multivitamin Drops

        • 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 PyrrolidoneÒIodine Gargle Solution

        • Polyvinyl PyrrolidoneÒIodine Gargle Solution Concentrate

        • Polyvinyl PyrrolidoneÒIodine Liquid Spray

        • Polyvinyl PyrrolidoneÒIodine Mouthwash

        • Polyvinyl PyrrolidoneÒIodine Mouthwash and Gargle Solution Concentrate

        • Polyvinyl PyrrolidoneÒIodine

        • Scrub

        • Polyvinyl PyrrolidoneÒIodine Solution

        • Polyvinyl PyrrolidoneÒIodine

        • Solution

        • Polyvinyl PyrrolidoneÒIodine Solution

        • Polyvinyl PyrrolidoneÒIodine Surgical Scrub

        • Polyvinyl PyrrolidoneÒIodine Vaginal Douche Concentrate

        • Polyvinyl PyrrolidoneÒIodine 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 Carbinoxamine 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

        • 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 Drops

        • 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 Concentrate, Water-Miscible

        • Vitamin A Drops

        • 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 Syrup

        • Vitamin B-Complex and Vitamin C 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 Capsules

        • Vitamin E Drops

        • Vitamin E Solution with Ethanol

        • Xylometazoline Hydrochloride Nasal Solution

        • Xylometazoline Hydrochloride ChildrenÌs Nasal Solution

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