Analytical tools to support formulation development are also an important part of innovation. In March 2009, Paraytec (York,
England) introduced ActiPix Dissolution Imager, a quantitative ultraviolet (UV) area imaging system to provide real-time imaging
of pharmaceutical tablet dissolution. The company says that the product offers an alternative to using terahertz spectroscopic
imaging and magnetic resonance imaging to secure data needed to evaluate drug-release processes. The instrument consists of
a specially designed tablet holder that is placed inside the UV imaging system to enable real-time recording and review of
data. When liquid flows over the surface of the formulation, the release of the active ingredient can be quantitatively monitored
directly at the tablet surface. Paraytec is a scientific-instrument company that was formed as a spinout from the chemistry
department at the University of York.
Shaping the excipient landscape
Increased globalization and strategies for securing the supply chain are important issues for excipient producers. The International
Pharmaceutical Excipients Council (IPEC) expanded into China in July 2008 with the formation of IPEC–China. IPEC–China consists
of manufacturers, distributors, and users of excipients. IPEC–China expects to work with China's State Food and Drug Administration
in establishing standards for excipients, according to an IPEC–China 2008 press release.
IPEC is also considering a proposal to create a multiregional body, the IPEC Federation, which will provide advocacy and promote
quality in excipients globally, according to recent information from IPEC Europe. The vision of the IPEC Federation would
be to promote quality, safety, and functionality of excipients and to ensure that new excipients introduced into the market
meet global standards. The federation would also seek to harmonize drug approval, technical, and pharmacopoeial standards
and ensure that safe and effective dosage forms are circulated in the global supply chain. To meet these goals, the proposed
federation would develop, implement, and promote voluntary, harmonized guidance and other programs for the pharmaceutical
industry to ensure that excipients used in finished drug products meet appropriate standards for quality, safety, and functionality
throughout the manufacturing and distribution process. The federation would collaborate with regulatory authorities in adopting
scientifically suitable, risk-based, and global regulatory and compendial standards for excipients (1).
QbD will continue to play an important role in excipient usage. The goal of QbD is to improve process understanding, which
includes the functional effects that excipients have on the drug-manufacturing process as well as understanding the process
variability that may arise with an excipient in a formulation (2). As part of its ongoing Excipient Technical Applications
Initiative, IPEC–Americas formed a working committee, the Quality by Design Product Development Committee, to consider issues
relating to excipients in QbD. Some issues relating to excipients and QbD include the following:
- The proper selection and use of excipient performance tests
- The role of pharmacopeial monographs in meeting changing requirements
- Developing robust formulations according to QbD and process analytical technology
- Reducing barriers to excipient user–supplier collaboration to build on the shared knowledge base.
Nanotechnology is also an emerging issue in formulation development. In March 2009, the US Food and Drug Administration launched
an initiative with the Alliance for NanoHealth (ANH). ANH and FDA cosponsored a scientific workshop, the FDA-ANH Nanotechnology
Initiative Scientific Workshop, to obtain feedback from stakeholders in industry, the federal government, and academia to
identify key scientific and translational challenges in nanoengineered medical product development. A goal of the workshop
was to develop and publish a short list of existing translational gaps and the key elements needed to bridge these gaps, according
to ANH. Member institutions of ANH include the Baylor College of Medicine, the University of Texas M.D. Anderson Cancer Center,
Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A&M Health Science
Center, University of Texas Medical Branch, and the Methodist Hospital Research Institute.
Market growth and segments
As these issues evolve, moderate growth is projected for the global excipient market, which was valued at $3.5 billion in
2006, according to BCC Research (3, 4). The market is expected to increase at a compound annual growth rate (CAGR) of 3.8%
through 2011, when it will reach $4.3 billion. The global excipients market is broken down into three major segments: organic
chemicals, inorganic chemicals, and United States Pharmacopeia (USP) water.
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