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Tablets & Capsules July 2019 35 A disadvantage of new co-processed excipients is that they don't have pharmacopeia monographs and require a safety/toxicology assessment. However, if you can demon- strate that no new covalent compound forms, you can bridge this assessment back to the individual components. This is less desirable than being able to simply declare that the excipient is a compendial material, but it's a lot more straightforward than introducing an entirely new chemical excipient (see the following section). The disadvantage of not having a pharmacopeia monograph may be more than offset by the enhanced functionality and performance compared to a new grade of an existing excipient. Development of new chemical excipients. Finding entirely new chemical excipients is the least appealing option for developing excipients for continuous manufac- turing. The uncertainty regarding a new chemical excipi- ent's ultimate regulatory acceptance makes pharmaceuti- cal manufacturers very reluctant to risk a new potential blockbuster drug product on the new chemical excipient. Only five new chemical excipients that have entered the market in the last 30 years or so are currently being used in commercial pharmaceutical products. This trend is likely to continue for the foreseeable future. In the absence of an independent assessment by regulatory authorities, acceptance of a new chemical excipient requires an overwhelming technical need that can't be met by existing excipients. Presently, this doesn't seem likely for continuous manufacturing. Conclusions Formulators need to be aware that differences likely exist in the constraints on excipients between batch and continuous processing in the manufacture of finished drug products. It seems likely that conventional, sin- gle-component excipients and grades won't be able to provide all the answers. Of the alternatives discussed, new co-processed excipients seem to have the most promise to solve some of the challenges of continuous manufacturing, such as metering low-dose components and improved blend-segregation resistance. T&C References 1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evalua- tion and Research (CDER). Draft Guidance for Industry: "Quality Considerations for Continuous Manufactur- ing," February 2019. 2. Delaney et al. "Characterization of synthesized and commercial forms of magnesium stearate using differen- tial scanning calorimetry, thermogravimetric analysis, powder x-ray diffraction and solid-state NMR spectros- copy." J Pharm Sci. 2017; 106(1):338-347. Chris Moreton is partner and vice president of pharmaceutical sciences at FinnBrit Consulting, Waltham, MA (www.fin nbrit.com). Ink Viscosity and Cleaning Systems Available on All Models Printing Inspection Systems SAT's, FAT's, and IQ's/OQ's Machines are FDA and EU Compliant Over 138 Years Experience Manufactured in the USA Global Support & Service TABLET, CAPSULE, AND SOFTGEL PRINTING MACHINES Trusted by Hundreds of Companies in Over 40 Countries Worldwide IBM MACHINE Our high-speed printer's mark your soft-gels, capsules, and tablets with pinpoint precision. With vision inspection to ensu With vision inspection to ensure accuracy, single tablet rejection, and out put rates of up to 500,000 units per hour, identifying your products has never been easier. Contact Us Today! 215-969-9190 info@rwhartnett.com