SPI Pharma has announced the launch of UltraBurst, an excipient platform for orally disintegrating flash tablets (ODT). According to the manufacturer, the use of the excipient in an ODT facilitates the disintegration of a tablet in less than 10 seconds.
Graeme Macleod, global head of R&D for SPI Pharma, said the proper formulation of flash ODTs can be tricky, but maybe with the right excipient.
“Achieving content consistency for low dose micronized actives requires an understanding of API [active pharmaceutical ingredient] characteristics and how these interact with the platform of excipients“, did he declare. “Larger tablets and tablets with higher drug loadings can be difficult as it becomes more difficult to achieve faster disintegration times as tablet size increases or API properties obscure functionality. of the platform of excipients. Fortunately, UltraBurst is designed to overcome these challenges because it relies on multiple mechanisms. to promote disintegration of tablets. “
According to Macleod, UltraBurst offers excellent flow properties and is suitable for direct compression processes. Additionally, he said, it can be used to generate robust, low friability tablets that withstand further downstream processing, and the resulting tablets do not require specialized protective packaging.
John McInerney, general manager of the excipients and drug delivery systems business unit at SPI Pharma, said UltraBurst performs favorably over similar products currently offered by other companies.
“Over a wide range of API loads and different tablet sizes, we can demonstrate a significant reduction in disintegration time compared to current market alternatives.Said McInerney. “We are seeing reductions in disintegration times between 20 and 40% without loss of tablet hardness or increase in friability. “
Macleod commented that UltraBurst offers improved disintegration times for small and large format tablets.
“Examples include disintegration times on the order of 4-9 seconds for smaller tablets (50-200 mg), compared to 12-15 secondsMacleod reported. “For the larger tablets (500 mg) we have seen the disintegration times go from 80 seconds to 90 seconds with conventional ODT platforms to 12 seconds with UltraBurst.. “
Macleod added that SPI Pharma has resources to help companies interested in working with UltraBurst or other ODT-suitable excipients.
“We have a Pharmasolutions business that relies on our formulation and analytical knowledge and capabilities; we offer a flexible approach to working with clients and can produce full datasets of new dosage forms (e.g. ODT, taste masking, capsules, lozenges, etc.) for generic APIs,” he said. “We will also work with clients and partners on proof of concept, partial stability and / or formulation development projects.. “
Orally disintegrating tablets appeal to patients and developers largely due to various patient friendly features. They do not require water, are suitable for patients with swallowing difficulties, are manageable for pediatric patients, and generally help improve compliance.