Pharmaceutical Excipients for Oral Formulations - Market Research

Pharmaceutical Excipients for Oral Formulations
Product Type: Market Research Report
Published by Kalorama Information
Published on January 2005
Product Code: R566-0104
Price: $3500
Abstract
Pharmaceutical Excipients, especially those for solid oral dosage forms, have very much been taken for granted and, until recently, have been largely ignored by chemical excipient suppliers, as well as by pharmaceutical formulating companies and end-users. The traditional view of an excipient as just an inert material still permeated throughout the various supplier/end-user industries. However, new developments in regulation, compliance, testing, and innovation have forced the pharmaceutical excipient industry to pay more attention to these materials, especially since many pharmaceutical excipients are also used as food ingredients.
The U.S. government is currently considering counter-bioterrorism and FDA- proposed good manufacturing (GMP) rules for dietary supplements, and these proposals?if implemented?will have a serious impact on the way that excipient manufacturers and their customers conduct business, especially toward the inexpensive offshore sources of pharmaceutical excipients.
Most formulations (70%-80%) contain excipients at a higher concentration than the active drug. Consequently, the excipients contribute significantly to a formulation?s functionality and processability, and issues such as purity, safety, and standardization become increasingly important, as excipients are critical to delivering drug actives.
The search for new excipients has traditionally been market-driven, i.e. excipients were developed in response to market demand, and growth has been relatively slow, due to the high cost involved in excipient discovery and development. A plausible solution is for excipient and pharmaceutical manufacturers to develop drug products jointly, during which a new excipient becomes an integral part of the eventual new drug application.
Growth of the pharmaceutical excipient industry?and the search for new excipients-- is poised for substantial growth, due to demands for ideal binder-filler combinations, increased tableting machinery speeds?which necessitate excipients to maintain good compressibility, shortcomings of existing excipients, the lack of excipients that address the needs of a particular population group, such as those with diabetes, hypertension, and lactose intolerances.
Excipients with improved functionality can be obtained by developing (1) new excipients, (2) new grades of existing materials, and (3) new combinations of existing materials. The last development shows great promise and market potential with the development of high-functionality and multifunctional co-processed excipients. In addition, new synthetic excipients are being developed which exhibit improved functionality.
This report addresses all these issues and provides a comprehensive overview of the fine chemical/excipient industry, the pharmaceutical formulators industry, and the pharmaceutical finished drug industry, including market sizings, forecasts, and competitive analysis.
Table of Contents
Chapter One: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
The Total Market by Major Product Categories
Trends Influencing the Market and Future Directions
Market Forecasts through 2008
Business Opportunities for Chemical and Pharmaceutical Suppliers
Chapter Two: PHARMACEUTICAL EXCIPIENTS
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
Chapter Three: 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
Chapter Four: INDUSTRY PROFILE
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 (International Pharmaceutical Excipients Council) Monographs
Participating Companies
Research and Development
Marketing and Distribution
Pricing and Reimbursement
Corporate Strategies/SWOT Analysis
Chapter Five: ORAL EXCIPIENTS: MARKETS AND PRODUCTS
(For each of the following market segments there will be a discussion of the major products, the current market, competitive analysis by major suppliers with their market shares, and future directions/market forecast)
Anti-caking Agents
Magnesium Carbonate
Mannitol
Silica
Talc
Binders and Fillers
Microcrystalline Cellulose (MCC)
Hydrolyzed Gelatin
Alginic Acid
Dextrin
Glucose (liquid)
Lactose
Dibasic Calcium Phosphate (DCP)
Coatings
Enteric Coatings
Polymer Coatings (acrylics, etc)
Cellulosics
Carbohydrates
Microcrystalline cellulose
Other
Disintegrants
Starches
Corn 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
Other (i.e. emulsifiers, oleochemicals, colorants and dyes, etc.)