By Herman Mitchell
Whether generic or branded, in the high-stakes race to bring a therapeutic drug to market, manufacturers are engaged in two simultaneous challenges. The first is against the clock — a race to market approval; the second — to contain development and manufacturing costs.
A manufacturer will invest years and millions of dollars to optimize a formulation and process. In the case of oral solid dosage forms, the manufacturer needs to perfect the finalized drug for safety, efficacy, and desired tablet properties. With respect to tabletability and cost per unit dose, the final formulation and manufacturing process are equally important to the development of the final drug. The drug manufacturer must formulate using a suitable, cost-effective process. This all adds up to speed to market. The speed and efficiency with which a drug maker formulates, develops a scalable manufacturing process, and gains regulatory approval is key to succeeding in today’s economic climate.
Using A Formulation Knowledge Base
For drug manufacturers who are tasking their organizations to improve time to market while reducing development and manufacturing costs, there are now innovative and cost-effective options available to streamline formulation development and manufacturing processes. By collaborating with experts in the supply chain, such as excipient manufacturers who have developed a wide range of solutions to meet formulation challenges, drug makers have greater access to novel coprocessed excipients and innovative drug delivery systems. These coprocessed, or high-functionality excipients (HFEs), are engineered particles which interact at a subparticle level to provide enhanced functionality and tableting performance that may, for example, enable direct compression of difficult-to-formulate active pharmaceutical ingredients (APIs). This allows the drug maker to focus resources on its core competencies rather than on inventing new processes.
These collaborations between excipient suppliers, contract service suppliers, and the pharmaceutical firm’s research and development specialists have proven their effectiveness in developing solutions that maximize speed to market while enabling the regulatory compliance sometimes associated with the use of HFEs and new technology in general.
Flexible Formulation Development Using High- Functionality Excipients
Many marketed therapeutics have formulations that incorporate HFEs, in which a single excipient fulfills two or more functions (e.g. as a binder, filler, and disintegrant). Using HFEs can improve content uniformity and in many cases will allow manufacturers to eliminate time-consuming processes like wet granulation. Manufacturers can take advantage of well-established techniques and procedures for creating simplified formulations with challenging APIs. Additionally, HFEs can significantly reduce development time and costs by enabling products to get into clinical trials sooner and out to market faster.
Leveraging their own R&D resources, capabilities, and spending, some leading-edge pharmaceutical manufacturers are cultivating innovative approaches to product development and manufacturing. Working in partnership with excipient suppliers and formulation specialists, drug manufacturers have created new platforms that utilize HFEs in their formulations. Best of all, HFEs with a well-defined design space help drug manufacturers implement quality by design (QbD) initiatives to develop robust, scalable formulations and manufacturing processes, again reducing time to market.
HFEs, in addition to increasing speed to market, provide benefits to the drug manufacturer for years after the product launch. HFEs can produce significant gains in productivity, due to simplified processes, and higher throughput with fewer tablets rejected. In addition, reductions in cycle times and inventory turnover increases can also be achieved. These are all advantages that can improve a manufacturer’s bottom line from the day the product is launched until far into the future.
Herman Mitchell is the global director of marketing for Mallinckrodt Baker, which is a business unit of Covidien, a global provider of healthcare products. Mitchell has more than 33 years of experience in the pharmaceutical industry, where he’s had commercial responsibility for performance chemistries supporting both pharmaceutical research and manufacturing worldwide.