Features of Sterile Products

• Maintains the largest reference on pharmaceutical formulations
• Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
• Provides instant substantial time and cost savings in pharmaceutical research and development
• Speeds generic drug formulation regulatory submissions

The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, Sterile Products covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, 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 sterile products, the common elements of formulation.

The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.

Contents:

Section I: Sterile Manufacturing Practice

Chapter 1: Inspection of Sterile Product Manufacturing Facilities

• cGMP Compliance Basics
• Aseptic Processing
• Processing Prior to Filling and Sealing Operations
• Aseptic Processing Isolators
• Blow-Fill-Seal Technology
• Lyophilization of Parenterals
• High-Purity Water Systems

Chapter 2: New Drug Application for Sterilized Products

• Terminal Heat Sterilization
• Other Terminal Sterilization Processes
• Aseptic Fill Manufacturing
• Maintenance of Microbiological Control and Quality: Stability Considerations

Chapter 3: Manufacturing Formulations Template

• Autoclaves
• Aseptic Contract Manufacturers
• Clean Room Design and Construction
• Clean-in-Place/Steam-in-Place (CIPISIP)
• Closure Washing and Sterilization
• Consultants
• Disinfectants and Preservatives
• Distillation Equipment
• Engineering and Construction
• Filling Machines
• Filter Aids
• Flowmeters (Sanitary)
• Freeze-Dryers (Sterilizable)
• Microfiltration Equipment and Filters
• Pumps (Sanitary)
• Sterile Tanks and Related Stainless Equipment
• Sterility Test Equipment
• Sterilizing and Drying Tunnels (Hot Air)
• Stoppering Machines
• Vial and Bottle Washers

Section II: Sterile Pharmaceutical Formulations

Contains more than 400 formulations. Partial list follows:

• Abciximab Injection
• Acetazolamide Injection
• Acetylcholine Chloride Intraocular Solution
• Acyclovir Sodium Injection
• Adenosine Injection
• Adrenal Cortex Injection
• Adrenaline Tartarate Injection
• Alatrofloxacin Mesylate Injection
• Albumin (Human)
• Albuterol Sulfate Inhalation Solution
• Aldesleukin for Injection
• Alemtuzumab Injection
• Alpha Tocopherol (Vitamin E) Injection
• Alprostadil for Injection
• Alteplase Recombinant Injection
• Amikacin Sulfate Injection
• Amino Acid Parenteral Nutrition Solution
• Aminohippurate Sodium for Injection
• Aminophylline Injection
• Amiodarone Injection
• Amoxicillin–Clavulanic Acid Injection
• Amoxicillin Powder for Injection
• Amphotericin B Cholesteryl Sulfate Complex for Injection
• Amphotericin B Injection
• Amphotericin B Lipid Complex Injection
• Amphotericin B Liposome for Injection
• Antazoline Sulfate and Xylometazoline Hydrochloride Ophthalmic Drops
• Antipyrine, Phenylephrine, and Pyrilamine Maleate Ophthalmic Drops
• Antipyrine, Phenylephrine, and Sodium Thiosulfate Ophthalmic Solution
• Antithymocyte Globulin (Rabbit) for Injection
• Aprotinin Injection
• Argatroban (Thrombin Inhibitor) Injection
• Arsenic Trioxide Injection
• Ascorbic Acid and B-Complex Vitamins
• Ascorbic Acid, B-Complex Vitamin, with Beta Carotene Injection
• Ascorbic Acid Injection
• Ascorbic Acid, USP, Injection
• Ascorbic Acid, USP, 250 mg/mL Injection
• Asparaginase for Injection
• Atropine, Chlorpheniramine Maleate, and Phenylpropanolamine Injection
• Atropine Sulfate Injection
• Aztreonam for Injection
• Basiliximab for Injection
• B-Complex Injection
• B-Complex, Vitamin D, Vitamin E Lyophilized Injection
• B-Complex Vitamin Veterinary
• B-Complex with Minerals Injection (Veterinary)
• B-Complex Vitamins with Hormones
• B-Complex Vitamins with Liver Extract Injection
• Benzodiazepine Injection
• Benztropine Mesylate Injection
• Beta-Carotene Injection
• Betamethasone Suspension Injection
• Bethanechol Chloride Injection
• Biotin Injection
• Biperiden Lactate Injection
• Bisantrene Emulsion Injection
• Borax Sodium Lubricating Ophthalmic Drops
• Botulinum Toxin
• Bretylium Tosylate in Dextrose Injection
• Buflomedil Injection
• Bupivacaine Hydrochloride Injection
• Buprenorphine Hydrochloride Injectable
• Caffeine Citrate Injection
• Calcitonin Injection
• Calcitriol Injection
• Calcium Glycerophosphate Injection
• Calcium Injection
• Camphor Injection
• Camptothecin Injection
• Carboplatin for Infusion
• Carboplatin Injection
• Carprofen Injection
• Cefamandole Nafate for Injection
• Cefazolin Injection
• Cefepime Hydrochloride for Injection
• Cefotaxime Injection
• Cefotetan Injection
• Cefoxitin Injection Premixed Intravenous Solution
• Ceftazidime for Injection — L-Arginine Formulation
• Ceftazidime Injection
• Cefuroxime for Injection
• Cetrorelix Acetate for Injection
• Chloramphenicol and Phenylmercuric Nitrate Ophthalmic Drops
• Chloramphenicol for Injection
• Chloramphenicol Injection
• Chloramphenicol Sodium Succinate for Injection
• Chlordiazepoxide Hydrochloride Injection
• Chloroprocaine Hydrochloride Injection
• Chloroquine Phosphate Injection
• Chlorothiazide Sodium for Injection
• Chlorpheniramine Maleate Injection
• Chlorpromazine Hydrochloride Injection
• Choriogonadotropin Alfa (Recombinant) for Injection
• Chorionic Gonadotropin for Injection
• Chromium Chloride Additive Injection
• Cidofovir Injection
• Cimetidine Injection
• Ciprofloxacin Hydrochloride Ophthalmic Solution
• Ciprofloxacin Injection
• Cisplatin Diaminedichloride Injection
• Cisplatin with 2,2¢-Dithio-bis-Ethane Sulfonate Injection
• Cladribine Injection Infusion
• Clarithromycin Injection
• Clindamycin Injection in 5% Dextrose
• Clindamycin Phosphate Injection
• Clonidine Hydrochloride Injection
• Coagulation Factor VIIa (Recombinant) for Injection
• Coagulation Factor IX (Recombinant) for Injection
• Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide, and Hydrocortisone Acetate Otic Suspension
• Conjugated Estrogens for Injection
• Copper Sulfate Additive Injection
• Corticorelin Ovine Triflutate for Injection
• Cortisone Acetate Injectable Suspension
• Cosyntropin for Injection
• Cromolyn Sodium Ophthalmic Solution
• Crude Liver Extract Injection
• Cyanocobalamin and Thiamine Injection
• Cyanocobalamin, Choline, and Niacinamide Injection
• Cyanocobalamin Injection
• Cyanocobalamin Injection for Veterinary Use
• Cyanocobalamin Repository Injection 1000 mg/mL
• Cyanocobalamin, Pyridoxine, and Thiamine Injection
• Cyclosporine Ampoules for Infusion
• Cytarabine Liposome Injection for Intrathecal Use, 50 mg/5 mL Vial
• Cytomegalovirus Immune Globulin Intravenous (Human)

Index

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