Excipients are an inert substances used along with active ingredient in manufacturing process to aid in handling active ingredient and for long-term stabilization of a drug. It is also useful in facilitating drug absorption, reducing viscosity, and enhancing solubility of a drug. The selection depends upon the dosage form, active ingredient, route of administration, and other factors. It enhances overall safety & functionality of drug during its storage or use and has an ability to alter color, shape, and taste of a drug.
EXCiPACT, an excipient certification organization, has started making their way into China, India, and U.S. markets. It is expanding beyond Europe, where it started three years ago. EXCiPACT is an independent certification body that fulfills needs of pharmaceutical companies to demonstrate GMP compliance of suppliers. It has recently issued first GMP certificate in US. It was the 26th certificate since its inception. Many certificates have been issued for Europe, China, India, Canada, and Saudi Arabia.
Kevin McGlue, head of next phase of its development said, “There is huge interest in markets such as China and India where suppliers are looking to be able to demonstrate that they meet the standards the pharmaceutical industry requires. Having achieved our first certifications in both those countries, EXCiPACT will now be working to promote the scheme and ensure the availability of certification bodies and qualified auditors to meet the demands there.”
The first certifying body has been appointed in China, Bureau Veritas (BV) China, along with excipient market body IPEC China. lain Moore of Croda, former president of EXCiPACT is currently focusing on the technical aspects of EXCiPACT. He was active in development of the standards used by the organization for auditor competency and Good Manufacturing Practice (GMP). McGlue added, “The growth of the certification scheme over the last three years has meant that there is a benefit in splitting the technical and business development roles as it gathers momentum in the EU and overseas.”
Factors affecting the quality of excipients:
1. Concomitant components
The performance of many excipients in the drug formulation relies on the presence of concomitant components. These components aid in improving functionality or solvating drug components. Thus, quality depends upon concomitant composition. Manufacturers need to specify limits of concomitants to ensure safety of patients, regulatory requirements, and customer requirements.
2. Degree of homogeneity
The quality depends upon the degree of homogeneity of solid excipients. The control of all the components in a material is required to assure quality, specifically those supplied in powdered form.
3. Excipient impurities
Impurities need to be present or controlled for safety, toxicological, and other reasons. Furthermore, contaminants occurring due to environmental factors, such as personnel hygiene, equipment failure, contact with packaging, and others should be avoided. The quality is expressed as conformance to GMPs as well as to compendia.
4. Consistent composition
Consistency in composition need to be achieved to improve quality. A consistent composition results into predictable performance in the final drug formulation. Excipient, whose composition profile is known and has tolerable variation with minimum number of concomitant components should be considered in drug formulation.
5. Minimal contamination risk
Usage of dedicated equipment reduces the risk of cross-contamination by the presence of other substances and ensures better quality of excipients. If multi-purpose equipment is used, is should have an ability to detect potential residual contaminants to minimize potential cross-contamination. Choosing an appropriate supplier considering the complexity of supply chain from manufacturing plant to pharmaceutical facilities is important to ensure minimal contamination and better quality.
Analysts studying the industry have discussed a comprehensive information about current market trends and forecasts in research reports. Recently, Allied Market Research has published a report titled, “World Excipient Market - Opportunities and Forecast, 2014 - 2020.” As per the report, the world excipient market is expected to grow at a CAGR of 7.6% from 2015 to 2020 and estimated to reach $6.4 billion by 2020. The report offers an in-depth analysis of key drivers & challenges, detailed segmentation, value chain analysis, and competitive intelligence. Furthermore, the study highlights recent developments, new product launches, and SWOT analysis of prominent manufacturers.
