Pharmaceutical Manufacturing Formulations
Six Volume Handbook from C.H.I.P.S.

Volume 1
Compressed Solid Products
Volume 2
Uncompressed Drug Products
Volume 3
Liquid Products
Volume 4
Semi-Solid Products
Volume 5
Over the Counter Products
Volume 6
Sterile Products
Complete Six Volume Set

Handbook of Pharmaceutical Manufacturing Formulations
Volume Three
Liquid Products

Second edition
edited by Sarfaraz K. Niazi

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.

Highlights from Liquid Products, Volume Three include:

  • practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
  • access to what an FDA auditor would be looking for during a liquid manufacturing audit
  • issues that may arise during a US FDA inspection
  • the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines


Section I: Regulatory and Manufacturing Guidance

Chapter 1: Current Good Manufacturing Practice Considerations in Liquid Manufacturing

  • Facilities
  • Equipment
  • Raw Materials
  • Compounding
  • Microbiological Quality
  • Oral Suspensions
  • Product Specifications
  • Process Validation
  • Stability
  • Packaging

Chapter 2: Stability Testing of New Drug Substances and Products

  • Drug Substance
  • Drug Product

Chapter 3: Container Closure Systems

  • Qualification and Quality Control of Packaging Components
  • Postapproval Packaging Changes
  • Type III Drug Master Files
  • Bulk Containers

Chapter 4: Preapproval Inspections

  • Regulatory/Administrative Strategy

Chapter 5: Formulation Considerations of Liquid Products

  • Solubility
  • Chemical Modification
  • Preservation
  • Sweetening Agents
  • Flavors
  • Viscosity
  • Appearance
  • Chemical Stability
  • Physical Stability
  • Raw Material
  • Manufacturing Equipment
  • Manufacturing Directions
  • Packaging
  • Particle Size and Shape
  • Suspensions
  • Emulsions
  • Powder for Reconstitution
  • Nasal Spray Products
  • Emulsification and Solubilization
  • Complexing
  • Hydrophilization
  • Stabilizing Suspensions

Section II: Manufacturing Formulations

Contains more than 300 formulations. Partial list of formulations:

  • 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
  • Aminolevulinic Acid HCl for Topical Solution, 20%
  • Amoxacillin Powder for Suspension
  • Amoxacillin-Clavulanate 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
  • SaBromhexin HClkB Bromhexine Hydrochloride Syrup-Alcohol Free
  • SaBromhexin HClkB Bromhexine Hydrochloride Syrup
  • BudesonideInhaler
  • 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 TopicalEmulsion
  • 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
  • .....and more (d - z)!


Click here to see books of related interest

Handbook of Pharmaceutical Manufacturing Formulations
Volume Three: Liquid Products • Second edition
2009 • 344 pages • $399.95 + shipping
or buy the complete set:
Handbook of Pharmaceutical Manufacturing Formulations
Complete Six Volume Set • Second edition

2009 • 6 Volume Set • 2,152 pages • $2,350.00 + shipping
Texas residents please add 6.75 % sales tax

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