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

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