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Published by: Kalorama Information
Published: Feb. 1, 2008 - 131 Pages
Table of Contents
I. INTRODUCTION
Study Rationale
Study Goals
Scope and Structure
Methodology
Target Audience
II. PHARMACEUTICAL EXCIPIENTS: EXECUTIVE SUMMARY
Global Excipient Market: Background
Market Size and growth
Future market trends
Leading Players
Industry Structure, Margins and business models
Future prospects
III. PHARMACEUTICAL EXCIPIENTS: INDUSTRY OVERVIEW
Industry Overview
The Pharmaceutical Industry
The Chemical/Excipient Industry
Industry Trends
Issues
Challenges
Constraints
Trends (especially outsourcing and offshore manufacturing)
Business Opportunities
Excipient Regulations
CGMP Practices
FDA/CDER (Center for Drug Evaluation and Research) Regulations, USP (U.S. Pharmacopoeia) and IPEC v(International Pharmaceutical Excipients Council) Monographs
Excipient Safety Regulations
Participating Companies
Research and Development
Marketing and Distribution
Pricing and Reimbursement
Corporate Strategies/SWOT Analysis
IV. PHARMACEUTICAL EXCIPIENTS: TECHNICAL PERSPECTIVES
Definition and Applications
Oral delivery (Tablets, etc)
Topical delivery (ointments and creams)
Vaginal and Rectal delivery (suppositories)
Excipient Formulations
Tablets and Powders
Capsules and Gels
Liquid and Aqueous
Excipient Drug Dissolution Types and Properties
Immediate (fast-melt/quick dissolving)
Time-released (sustained/extended release)
Excipient Manufacturing Methods/Technologies
Direct-compression/spray drying
Freeze-drying
Direct Granulation (wet/dry)
Molding
Sublimation
Cotton-candy Process
Major End-Uses
Tablets/Caplets
Aspirin
Acetaminophen
Ibuprofen
Anti-acids
Analgesics
Vitamins
Other
Capsules
Vitamins
Anti-oxidants
Other
Liquid/Aqueous Preparations
Cough Medications
Anti-Acids
Other
V. ORAL EXCIPIENTS: MARKETS AND PRODUCTS
Global Excipient Market size, share, growth by segment (2007-2012)
Fillers
Emollients
Vehicles
Coatings
Disintegrants
Flavorants
Osmotic agents
Colorants
Anti-caking Agents
Magnesium Carbonate
Mannitol
Sorbitol
Silica
Talc
Erythritol
Isomalt
Maltitol
Tagatose
Trehalose
Xylitol
Binders and Fillers
Microcrystalline Cellulose (MCC)
Hydrolyzed Gelatin
Alginic Acid
Dextrin
Glucose (liquid)
Lactose
Sucrose
Dibasic Calcium Phosphate (DCP)
Coatings
Enteric Coatings
Polymer Coatings (acrylics, etc)
Cellulosics
Carbohydrates
Microcrystalline cellulose
Other
Disintegrants
Starches
Corn Starch
Dried Starch
Modified Starch
Gelatin
Pregelatinized Starch
Modified Cellulose
Gums
Guar Gum
Xanthan Gum
Polymers
Acrylic Polymers
Matrix (controlled-release) Polymers
Alginates
Other
Enzymes
Pepsin
Trypsin
Multifunctional Excipients (Co-processed Adjuvants)
Synthetic Excipients
Artificial Sweeteners
Acesulfame-Potassium
Aspartame
Neotame
Saccharin
Sucralose
Povidone
Mineral Hydrocarbons
Petrolatum
Mineral Waxes
Mineral Oils
Colorants
EDTA
Flavors
Glycine and Glycylglycine
Vinyl Polymers
Silicones
Miscellaneous Synthetic Petrochemicals
Oleochemicals
Fatty Alcohols
Glycerin
Metal Stearate
Others
Natural Waxes
Beeswax
Candelilla Wax
Carnauba Wax
Cocoa and Shea Butters
Lanolin
Others
Aroma agents
Binders
Buffers
Chelating agents
Glidants
Humectants
Lubricants
Plasticizers
Thickeners
VI. COMPANY PROFILES
BASF Corporation
Baxter Healthcare Corporation
Chr Hansen
Colorcon
Cargill
Degussa Corporation Rohm Pharma
Dow Chemical Company
Eastman Chemical Company
FMC Corporation
Fuji Chemical Industries
Gattefosse Corporation
International Specialty Products (ISP)
JRS Pharma LP
Mallinckrodt Group, Inc.
Mutchler, Inc. Pharmaceutical Ingredients
National Starch & Chemical Company
Noviant, Inc
Particle Dynamics
Purac America
Pharmaceutical Sourcing Group Americas (Janssen)
Rhodia, Inc.
Roquette America, Inc.
Ruger Chemical Company
SPI Pharma
TIC Gums
Tomita Pharmaceuticals
Univar Company
Wright Chemical Company
AbstractPharmaceutical excipients are substances, other than the pharmacologically active drug or prodrug, which are included in the manufacturing process or are contained in the finished pharmaceutical product dosage form. Excipients provide enhanced functionality to the pharmaceuticals, aid the innovations in the drug development and help improve patent life as well. Excipients make the products more functional at a lower cost, a benefit much desired by the pharmaceutical industry that is inundated with pressures to reduce costs.
All in all, excipients play a wide variety of functional roles in pharmaceutical dosage forms, including:
- Modulating the solubility and bioavailability of active pharmaceutical ingredients (APIs).
- Increasing the stability of active ingredients in dosage forms.
- Helping active ingredients maintain preferred polymorphic forms or conformations.
- Maintaining the pH and/or osmolarity of liquid formulations.
- Acting as antioxidants, emulsifying agents, aerosol propellants, tablet binders, and tablet disintegrants.
- Preventing aggregation or dissociation (e.g., of protein and polysaccharide actives).
- Modulating immunogenic responses of active ingredients (e.g., adjuvants).
Excipient market comprises of five key segments including binders/fillers, coating agents, disintegrants, lubricants, sweeteners.
This report will address all the current trends in the sector that are reshaping the industry and making it more efficient from profitability perspective. This report will provide a comprehensive overview of the fine chemical/excipient industry, the pharmaceutical formulators industry, and the pharmaceutical finished drug industry. Based on the information, analysis provided in this report, the managers will be able to estimate the market size, forecasts, and prepare their development plans, budgets, and plan marketing, competitive strategies to improve their market power in the segments of their interest. As such, this report will be of particular interest and value to business, i.e. marketing managers, product managers, strategic planners, technical personnel, and R & D personnel.
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