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US 12,016,850 B2Granted
Modified release pharmaceutical formulations comprising deferiprone
AssigneesChiesi Farmaceutici S.p.A., Universita' Degli Studi Di Milano
InventorsMarisa Pertile, Andrea Gazzaniga, Matteo Cerea, Micol Cirilli
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Abstract
The disclosure is directed to pharmaceutical compositions for oral administration comprising deferiprone. In particular, the disclosure is also directed to modified release tablets suitable either for twice daily administration or once daily administration. The disclosure is also directed to methods of making and using the same.
Claims17
A delayed release tablet comprising:
- (a) a core comprising about 1000 mg deferiprone, wherein the deferiprone is in an amount of about 85.0% to about 95.0% by weight of the tablet, a modifying release agent comprising glyceryl esters of long fatty acids in an amount of about 1.0% to about 2.0% by weight of the tablet, a lubricant and/or glidant in an amount of about 0 to about 2.0% by weight of the tablet, and additional pharmaceutically acceptable excipients in an amount of about 0 to 13.0% by weight of the tablet;
- and (b) an enteric coating;
- wherein the tablet is suitable for twice a day oral administration;
- and wherein the tablet releases less than about 20% of the deferiprone within 120 minutes when measured by USP Apparatus Type I basket method at 100 rpm in 900 mL at 37° C. and a pH of 1.2 and about 60% or more of the deferiprone within 180 minutes when measured by USP Apparatus Type I basket method at 100 rpm in 900 mL at 37° C. and a pH of 6.8.
1 more element
Dependencies are inferred from the claim text.