Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 3: Liquid Products

Features:

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

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, Liquid Products covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations 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 liquid drugs, the common elements of formulation.

The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.

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)!

Index