Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 6: Sterile Products

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.

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