Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 1: Compressed Solid Products

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