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Pharmaceutical Manufacturing Formulations
Six Volume Handbook from C.H.I.P.S.

Volume 1
Compressed Solid Products
Volume 2
Uncompressed Drug Products
Volume 3
Liquid Products
Volume 4
Semi-Solid Products
Volume 5
Over the Counter Products
Volume 6
Sterile Products
Complete Six Volume Set

Handbook of Pharmaceutical Manufacturing Formulations
Volume One
Compressed Solid Products

Second edition
edited by Sarfaraz K. Niazi

The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products,tackles these challenges head on. Highlights from Compressed Solid Products, Volume One include:

  • formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition
  • the essentials of what you need to be aware of when establishing a manufacturing process based on the formulations presented
  • identification and inclusion of the most popular prescription products, a critical list for the selection of products

Contents

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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ORDER NOW
Handbook of Pharmaceutical Manufacturing Formulations
Volume One: Compressed Solid Products • Second edition
2009 • Volume 1 • 448 pages • $399.95 + shipping
or buy the complete set:
Handbook of Pharmaceutical Manufacturing Formulations
Complete Six Volume Set • Second edition

2009 • 6 Volume Set • 2,152 pages • $2,350.00 + shipping
Texas residents please add 6.75 % sales tax

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