Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 5: Over-the-Counter Products

Features of Over the Counter Products

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

The fifth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, Over the Counter Products includes formulations of products classified by the US FDA under OTC category, 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.

Over the Counter Products provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products, the common elements of formulation.

The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.

Section I: Regulatory Guidance

Chapter 1: Good Manufacturing Practices in Over-the-Counter Drug Product Manufacturing

Buildings and Facilities (21 CFR 211, Subpart C)
Equipment (21 CFR 211, Subpart D)
Components and Product Containers (21 CFR 211, Subpart E)
Production and Process Controls (21 CFR 211, Subpart F)
Packaging and Labeling (21 CFR, Subpart
Holding and Distribution (21 CFR, Subpart H)
Laboratory Controls (21 CFR, Subpart I)
Control Records (21 CFR 211, Subpart J)
Returned Drug Products (21 CFR 211, Subpart K)

Chapter 2: Solid Oral Dosage Forms

Background
Product Development
Validation Protocols
Demonstration Runs (Validation of the Process)

Chapter 3: Oral Solutions and Suspensions

Facilities
Equipment
Raw Materials
Compounding
Microbiological Quality
Oral Suspension Uniformity
Product Specifications
Process Validation
Stability
Packaging

Chapter 4: Validation of Cleaning Process

Background
General Requirements
Evaluation of Cleaning Validation
Establishment of Limits
Other Issues

Section II: Over-the-Counter Product Formulations

Contains more than 400 formulations. Partial list follows:

Acetaminophen and Caffeine Tablets
Acetaminophen and Diphenhydramine Hydrochloride Hot Therapy
Acetaminophen and Pseudoephedrine Hydrochloride Hot Therapy Sachets
Acetaminophen and Diphenhydramine Hydrochloride Tablets
Acetaminophen and Pseudoephedrine Hydrochloride Tablets
Acetaminophen Chewable Tablets
Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup
Acetaminophen, Chlorpheniramine Maleate, and Pseudoephedrine Caplets
Acetaminophen, Dextromethorphan, and Pseudoephedrine Caplets
Acetaminophen, Doxylamine, and Caffeine Effervescent Granules
Acetaminophen Drops
Acetaminophen Effervescent Tablets
Acetaminophen, Ibuprofen, and Orphenadine Hydrochloride Tablets
Acetaminophen Instant Granules Acetaminophen Instant Granules
Acetaminophen, Norephedrine, and Phenyltoloxamine Tablets
Acetaminophen Oral Suspension
Acetaminophen, Phenylpropanoloamine, Dextromethorphan, and Chlorpheniramine Tablets
Acetaminophen, Propoxyphenazone, and Caffeine Tablets
Acetaminophen, Pseudoephedrine Hydrochloride, and Chlorpheniramine Hot Therapy Sachet
Acetaminophen Suppositories
Acetaminophen Suspension
Acetaminophen Syrup
Acetaminophen Syrup for Children
Acetaminophen Tablets
Acetaminophen Tablets for Children
Acetylcysteine Sachets
Acetylsalicylic Acid, Acetaminophen, and Caffeine Tablets
Acetylsalicylic Acid, Acetaminophen, and Caffeine Tablets (Direct Compression)
Acetylsalicylic Acid and Acetaminophen Tablets
Acetylsalicylic Acid and Ascorbic Acid Tablets
Acetylsalicylic Acid Suppositories
Acetylsalicylic Acid Tablets, Buffered
Acetylsalicylic Acid Tablets (Direct Compression)
Acne Cover Cream
Acne Scrub
Acne Treatment Cream
Aloe Vera Gel
Alpha-Bisabolol Aqueous Mouthwash Solution
Alpha-Bisabolol Buccal or Topical Solution
Alpha-Bisabolol Ethanolic Mouthwash Solution
Alpha-Bisabolol Mouthwash Solution
Aluminum Hydroxide and Magnesium Carbonate Dry Syrup
Aluminum Acetylsalicylate Tablets
Aluminum Hydroxide and Magnesium Hydroxide Chewable Tablets
Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension
Aluminum Hydroxide and Magnesium Hydroxide Suspension
Aluminum Hydroxide and Magnesium Hydroxide Tablets
Aluminum Hydroxide and Magnesium Silicate Chewable Tablets
Aluminum Hydroxide, Magnesium Carbonate (or Oxide), and Simethicone Tablets
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension
Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Tablets
Analgesic Clear Gel
Analgesic Cream
nalgesic Lotion
Anise Oil Solution
Antazoline and Xylometazoline Eye Drops
Anti-Acne Gel
Antifungal Foot Powder
Antiseptic Cream
Antiseptic Lotion
Antiseptic Wet Wipes
Aspartame Granules in Sachets
Aspartame Powder in Sachets
Aspartame Tablets
Aspartame Tablets, Effervescent
Aspirin, Acetaminophen, and Caffeine Tablets
Aspirin, Acetaminophen, Caffeine, and Salicylamide Tablets
Attapulgite Tablets
Baby Cream, Benzalkonium Chloride and Zinc Oxide
Baby Lotion
Baby Shampoo
Basic Cream for Varioius Active Ingredients
Benzalkonium Chloride Contraceptive Gel
Benzyl Benzoate Solution
Benzoyl Peroxide and á-Bisabolol Gel
Benzoyl Peroxide Anti-Acne Cream
Benzoyl Peroxide Anti-Acne Gel
Benzoyl Peroxide Anti-Acne Lotion
Benzoyl Peroxide Anti-Acne Microemulsion
Berberine Tablets
Beta-Carotene Effervescent Tablets
Beta-Carotene Tablets
Beta-Carotene, Vitamin C, and Vitamin E Chewable Tablets
Beta-Carotene, Vitamin C, and Vitamin E Tablets
Betamethasone and Neomycin Gel-Cream
Betamethasone Cream
Betamethasone Gel
Betamethasone Valerate Cream
Betamethasone Valerate Ointment
Bisacodyl Delayed-Release Tablets
Bisacodyl Suppositories
Bismuth Carbonate Suspension
Bismuth Subsalicylate Suspension
Bran Tablets
Breast Care Cream
Bromhexine Hydrochloride Syrup
Bromhexine Hydrochloride Syrup, Alcohol Free
Bromhexine Hydrochloride Tablets
Burn Cream
Caffeine Tablets
Calamine Cream
Calamine Lotion
Calcium and Vitamin D Tablets
Calcium Carbonate and Glycine Tablets
Calcium Carbonate and Vitamin D Tablets
Calcium Carbonate Tablets
Calcium D-Pantothenate Chewable Tablets
Calcium D-Pantothenate Tablets
Calcium Effervescent Tablets
Calcium Gluconate Tablets
Calcium Glycerophosphate Tablets
Calcium Iodide and Ascorbic Acid Syrup
Calcium Phosphate Tablets for Cats and Dogs (Direct Compression)
Calcium Phosphate Tablets for Cats and Dogs
Carbinoxamine Maleate, Phenylpropanolamine, and Acetaminophen Sustained-Release Tablets
Carbonyl Iron, Copper Sulfate, and Manganese Sulfate Tablets
Carnitine and Coenzyme Q Solution
Cetrimide Antiseptic Cream
Charcoal Tablets
Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup
Chlorhexidine Lozenges
Chlorpheniramine Maleate Syrup
Chymotrypsine Tablets
Citrate Effervescent Powder
Crospovidone Effervescent Tablets
Crospovidone Water Dispersible Tablets
Cyanocobalamin Tablets

Section III: Appendix

Hydroxypropyl Methylcellulose (Methocel, HPMC) Aqueous Coatings
Hydroxypropyl Methylcellulose Opaque Organic Coating
Hydroxypropyl Methyl Cellulose/Hydroxypropyl Cellulose (Klucel ® ) Coating
Hydroxypropyl Methyl Cellulose/Ethyl Cellulose Coating
Hydroxy Methyl Cellulose/Hydroxy Cellulose Coating
Hydroxy Methyl Cellulose/Ethyl Cellulose Coating
Polyvinylpyrrolidone (PVP) Coatings

Index