Over-the-Counter Products comprise a special category of healthcare products. While these formulations have much in common with their prescription counterparts, they are presented in this series separately because of their development approach taken, labeling considerations required, and support available from suppliers of ingredients in designing these products. Highlights from Over-the-Counter Products, Volume Five include:

• solids, liquids, and suspensions
• practical advice on how to bring manufacturing practices into compliance with regulatory requirements
• cGMP considerations in great detail
• a large number of formulations of coatings of solid dosage forms

Contents

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

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