SPI Pharma has announced the introduction of UltraBurst, an excipient platform intended for flash orally disintegrating tablets (ODTs). According to the manufacturer, the use of the excipient in an ODT facilitates the disintegration of a tablet in under 10 seconds.
Graeme Macleod, global manager of R&D for SPI Pharma, said proper formulation of flash ODTs can be tricky but possibly with the right excipient.
“Achieving content uniformity for low-dose micronized actives requires understanding of the API [active pharmaceutical ingredient] characteristics and how these interact with the excipient platform,” he said. “Larger tablets and tablets with higher drug loadings can be challenging as achieving faster disintegration times becomes more difficult as the tablet size increases or API properties mask the functionality of the excipient platform—fortunately, UltraBurst is designed to overcome these challenges as it relies on multiple mechanisms to promote tablet disintegration.”
According to Macleod, UltraBurst offers excellent flow properties and is suited for direct compression processes. Further, he said, it can be used to generate robust tablets with low friability that withstand further downstream processing, and the resulting tablets do not need specialized protective packaging.
John McInerney, general manager of SPI Pharma’s excipients and drug delivery systems business unit, said UltraBurst performs favorably compared to similar products currently offered by other companies.
“Across a wide range of different API loadings and tablet sizes, we can demonstrate a significant reduction in disintegration time against the current market alternatives,” McInerney said. “We see reductions in disintegration times between 20-40% without loss of tablet hardness or increased friability."
Macleod commented that UltraBurst offers improved disintegration times for both small- and large-format tablets.
“Examples include disintegration times in the 4-9 second range for smaller (50-200mg) tablets, compared with 12-15 seconds,” Macleod reported. “For larger tablets (500mg) we have seen disintegration times reduce from 80-90 secs with conventional ODT platforms to 12 seconds with UltraBurst.”
Macleod added SPI Pharma offers resources to help companies interested in working with UltraBurst or other ODT-geared excipients.
“We have a Pharmasolutions business that is built on our formulation and analytical knowledge and capability; we offer a flexible approach to working with customers and can produce full data packages of new dose forms (eg ODTs, taste masking, softgel capsules, lozenges, etc.) for generic APIs,” he said. “We will also work with customers and partners on proof of concept development, or partial stability and/or formulation projects.”
Orally disintegrating tablets appeal to patients and developers in large part due to various patient-friendly features. They do not require water, accommodate patients with difficulty swallowing, are manageable for pediatric patients, and generally help improve adherence.