The first volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, Compressed Solid Products covers the largest category of pharmaceutical formulations, compressed solids, which include formulations of tablets and other compressed solids from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations.

• 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

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 compressed solid products, the common elements of formulation.

The section on regulatory and manufacturing guidance deals with the topics of bioavailability and bioequivalence studies of orally administered drug products, in addition to providing quick tips on resolving the common problems in formulating compressed solids.

Part I: Regulatory and Manufacturing Requirements
in Compressed Solid Dosage Forms

Chapter 1: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products

• Methods to Document BA and BE
• Comparison of BA Measures in BE Studies
• Documentation of BA and BE
• Special Topics

Chapter 2: Guidance on Formulating Compressed Solids

• Abbreviated Directions
• API
• Bio vs. Production Batches
• Cleaning Validation
• Coatings
• Compliance with Regulatory Requirements
• Compression Process Control
• Content Uniformity
• Cross-Contamination
• Desegregation of Powders
• Disintegration Test
• Dissolution
• Disintegration and Dissolution
• Drug Substance Characterization
• Drying Process
• Dyes in Formulations
• Equipment
• Excipients
• Fill Weights
• Final Packaging
• Final Testing
• Fines
• Formula Excesses
• Geometric Dilution
• Granulation/Mix Analysis
• Ingredient Warning
• In-Process Testing
• Loss on Drying (LOD)
• Manufacturing Yields
• Master Formula
• Multiple-Item Entries
• Multiple Strengths of Formulations
• Novel Drug Delivery Systems
• Particle Coating
• Preservatives in Compressed Solid Dosage Formulations
• Punch Size and Shape
• Reworking Culls
• Scale-Up
• Segregation
• Sifting Ingredients and Granules
• Specifications
• Stability Testing
• Storage of In-Process Material
• Tablet Friability
• Tablet Manufacturing
• Tablets
• Water-Purified USP
• Weight Variation and Content Uniformity
• Wet Granulation vs. Dry Granulation or Direct Compression

Part II: Compressed Solid Formulations

Contains more than 400 formulations. Partial list follows:

• Acetaminophen, Ibuprofen, and Orphenadrine Tablets (250 mg/200 mg/200 mg)
• Acetaminophen, Norephedrine, and Phenyltoloxamine Tablets (300 mg/25 mg/22 mg)
• Acetaminophen and Phenprobamat Tablets (200 mg/200 mg)
• Acetaminophen and Orphenadrine Citrate Tablets (450 mg/35 mg)
• Acetaminophen Tablets, Chewable
• Acetaminophen, Dextropropoxyphen Hydrochloride Tablets (325 mg/32 mg)
• Acetaminophen and Codeine Tablets [34]
• Acetaminophen, Salicylamide, Caffeine, and Codeine Tablets (150 mg/200 mg/50 mg/10 mg)
• Acyclovir Tablets [162]
• Acyclovir Water-Dispersible Tablets (800 mg)
• Albendazole Tablets (200 mg)
• Alendronate Tablets [38]
• Alendronate Tablets, Effervescent (10 mg)
• Alendronate Sodium Tablets (50 mg)
• Allopurinol Tablets (100 mg) [84]
• Allopurinol Tablets (300 mg)
• Alprazolam Tablets (0.25 mg/0.50 mg/1.0 mg)
• 4-Amino-1-hydroxybutylidene-1,1-bisphosphonic Acid Tablets (5 mg)
• Aminophylline Tablets (100 mg)
• Amiodarone Tablets (200 mg)
• Amlodipine Besylate Tablets [9]
• Amitriptyline Tablets (50 mg) [42]
• Amoxicillin Tablets (250 mg/500 mg/1 g)
• Amoxicillin Trihydrate and Clavulanate Potassium Tablets (500 mg/125 mg)
• Amoxicillin and Potassium Clavulanate Tablets (250 mg/62.5 mg)
• Amphetamine Salts Tablets
• Atenolol Tablets (50 mg/100 mg)
• Atorvastatin Tablets (10 mg/20 mg)
• Azithromycin Tablets (250 mg)
• Benzafibrate Tablets (200 mg)
• Benazepril Hydrochloride Tablets
• Betamethasone Tablets (0.50 mg)
• BIRB 796 Tablets (100 mg)
• Bisoprolol Fumarate and Hydrochlorothiazide Tablets
• Bromazepam Tablets (3 mg)
• Bromhexine Tablets (8 mg)
• Bromocriptine Tablets
• Buflomedil Hydrochloride Tablets (150 mg/300 mg)
• Buflomedil Hydrochloride Tablets (600 mg)
• Bupropion Hydrochloride Tablets
• Buspirone Hydrochloride Tablets
• Buspirone Hydrochloride Tablets, Controlled-Release (30 mg)
• Captopril Tablets (25 mg)
• Carbamazepine Tablets (200 mg)
• Carbamazepine Tablets (200 mg)
• Carbidopa and Levodopa Tablets
• Carisoprodol Tablets
• Carvedilol Tablets
• Cefadroxil Dispersible Tablets (250 mg)
• Cefdinir Tablets (300 mg)
• Cefixime Tablets (400 mg)
• Cefprozil Tablets (250 mg)
• Celecoxib Tablets
• Cephalexin Tablets
• Cetirizine and Pseudoephedrine Delayed-Release Tablets (5 mg/120 mg)
• Cetirizine Hydrochloride Tablets (10 mg)
• Chlorcyclizine Hydrochloride Tablets (50 mg)
• Chlordiazepoxide and Clinidium Bromide Tablets (5 mg/2.5 mg)
• Chlordiazepoxide Tablets (10 mg)
• Chloroquine Tablets (250 mg)
• Choline Theophyllinate Tablets (100 mg)
• Chymotrypsine Tablets (25 mg)
• Cilazapril Tablets (2.5 mg)
• Cimetidine Tablets (200 mg)
• Ciprofloxacin Tablets (500 mg)
• Ciprofloxacin Tablets (750 mg)
• Cisapride Tablets (5 mg)
• Citalopram Hydrobromide Tablets
• Clarithromycin Tablets (250 mg/500 mg)
• Clenbuterol Tablets (20 mcg)
• Clindamycin Tablets (20 mg)
• Clobazam Tablets (10 mg)
• Clomifen Citrate Tablets (50 mg)
• Clomipramine Hydrochloride Tablets, Effervescent (300 mg)
• Clomipramine Hydrochloride Tablets, Buccal (10 mg)
• Clonazepam Tablets (1 mg/2 mg)
• Clonidine Tablets (0.1 mg/0.2 mg/0.3 mg)
• Clopidogrel Bisulfate Tablets (75 mg)
• Codeine, Acetaminophen, and Pentobarbital Tablets (15 mg/300 mg/30 mg)
• Conjugated Estrogens (0.3–2.50 mg)
• Conjugated Estrogens and Medroxyprogesterone Tablets
• Coumadin Tablets
• Cyclobenzaprine Hydrochloride Tablets (10 mg) [64]
• Cyproheptadine Tablets (4 mg)
• ...and more from d - z!

Appendix: Coating Solutions

• Introduction
• Hydroxypropyl Methylcellulose (Methocel, HPMC) Aqueous Coatings
• Hydroxypropyl Methylcellulose Opaque Organic Coating
• Hydroxypropyl Methyl Cellulose–Hydroxypropyl Cellulose (Klucel) Coating
• Hydroxymethyl Cellulose and Hydroxy Cellulose Coating
• Hydroxymethyl Cellulose and Ethyl Cellulose Coating
• Polyvinylpyrrolidone Coatings
• Cellulose Acetate Phthalate and Carbowax Coatings
• Enteric Coatings

Index

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