Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 2: Uncompressed Solid Products

Features:

• Includes readily accessible formulations listed 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

The second volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers uncompressed solids, which include formulations of powders, capsules, powders ready for reconstitution and other similar products 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. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing uncompressed drugs, the common elements of formulations.

The section on regulatory and manufacturing guidance deals with the topics of cGMP considerations in liquid manufacturing, stability testing of new drugs substances and products, container closure systems, pre-approval inspection, in addition to providing quick tips on resolving the common problems in formulating liquid drugs.

Part I: Regulatory and Manufacturing Guidelines

Chapter 1: Global Good Manufacturing Practices Compliance

General Provisions
Organization and Personnel
Buildings and Facilities
Equipment
Control of Components and Drug Product Containers and Closures
Production and Process Controls
Packaging and Labeling Controls
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged Drug Products

Chapter 2: Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections,p>

Background
Implementation
Program Management Instructions
Inspectional Observations
Analytical Observations
Regulatory/Administrative Strategy

Chapter 3: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification

The Biopharmaceutics Classification System
Methodology for Classifying a Drug Substance and for Determining the Dissolution Characteristics
Additional Considerations for Requesting a Biowaiver
Regulatory Applications of the BCS
Data to Support a Request for Biowaivers

Chapter 4: Guidelines on Formulating Uncompressed Solids

Relative Humidity
Surface Area
Sieve Analysis
Particle Size Distribution
Powder Flow Properties
Real, Tapped, and Bulk Density
Solid Handling
Mixing of Powders
Oral Powders
Capsules
FDA Classification of Capsule Types
FDA Classification of Powders
Inhalers and Lung Delivery
Problems in Powder Handling
Capsulation Equipment
Capsule Finishing
Modified-Release Products
Clinical Test Supplies and Placebos
Coated Particles
Mixing Mechanisms
Segregation Mechanisms
Mixing Equipment
Milling

Part II: Uncompressed Solids Formulations

Contains almost 300 formulations. Partial list of formulations:

Acebutolol Hydrochloride Capsules
Aceclofenac Instant Granules
Acetaminophen and Diphenhydramine Hydrochloride Hot Therapy Sachet
Acetaminophen Capsules 500 mg
Acetaminophen, Doxylamine, and Caffeine Effervescent
Acetaminophen Instant Granules
Acetaminophen, Pseudoephedrine Hydrochloride, Chlorpheniramine Hot Therapy Sachet
Acetaminophen, Pseudoephedrine Hydrochloride Hot Therapy Sachet
Acetaminophen Swallow Capsules
Acetazolamide Sustained-Release Capsules
Acetylcysteine Sachets
Acitretin Capsules
Acrivastine and Pseudoephedrine Hydrochloride Capsules
Acyclovir Capsules
Adenosine Monophosphate Topical Powder
Aluminum Acetate Powder
Aluminum Hydroxide and Magnesium Carbonate Dry Syrup
Aminosalicylic Acid Granules
Amlodipine Besylate and Benazepril Hydrochloride Capsules
Amlodipine Besylate Capsules
Amoxicillin and Bromhexine Hydrochloride Capsules
Amoxicillin and Clavulanic Acid Powder for Suspension, 125 mg and 31.25 mg per 5 ml
Amoxicillin and Clavulanate Potassium for Suspension
Amoxicillin Powder for Suspension 125 and 250 mg
Amoxicillin Trihydrate Capsules 250 and 500 mg
Ampicillin Powder for Suspension
Ampicillin Trihydrate Capsules
Ampicillin Trihydrate Capsules for Suspension
Ampicillin Trihydrate Powder for Suspension
Antibacterial and Bacterial Culture Capsules
Antifungal Foot Powder
Aspartame Granules in Sachet
Aspartame Powder in Sachet
Aspirin and Chlorpheniramine Powder
Aspirin and Phenylpropanolamine Powder
Aspirin Microencapsulated Sustained-Release Capsules
Aspirin, Salicylamide, and Caffeine Powder
Azithromycin Capsules
Azithromycin Capsules and Oral Suspension
Azithromycin for Oral Suspension
Azithromycin Sachet for Oral Suspension
Balsalazide Disodium Capsules
Benazepril Hydrochloride and Amlodipine Besylate Capsules
Bisacodyl Colonic Delivery Capsules
Brompheniramine and Pseudoephedrine Capsules
Budesonide Capsules
Budesonide Inhalation Powder
Butalbital and Acetaminophen Capsules
Calcitonin (Salmon) Capsules
Calcitriol Capsules
Calcium Carbonate Microencapsulated Sustained-Release Capsules
Camptothecin Capsules
Carbamazepine Extended-Release Capsules
Cefaclor Capsules
Cefdinir Capsules and Oral Suspension
Cefixime for Oral Suspension
Cefpodoxime Proxetil for Oral Suspension
Cefprozil for Oral Suspension
Ceftibuten Capsules and Oral Suspension
Ceftibutin for Oral Suspension
Cefuroxime for Oral Suspension
Celecoxib Capsules
Cellulose Triacetate Liquefiable Topical Powder
Cephalexin Capsules
Cephalexin Powder for Oral Suspension
Cephradine Capsules
Cephradine Powder for Suspension
Cevimeline Capsules
Chlordiazepoxide Hydrochloride Capsules
Chloroxylenol and Chlorhexidine Topical Powder
Chlorpromazine Sustained-Release Capsules
Cimetidine Microencapsulated Sustained-Release Capsules
Citrate Effervescent Powder
Clindamycin Capsules 150 mg
Clofibrate Capsules
Clonidine Sustained-Release Capsules
Clorazepate Dipotassium Capsules
Cyclosporin A Capsules
.....and more (d - z)

Index