Back to results
US 12,016,851 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
Life of this patent
Estimating the term…
Abstract
The disclosure is directed to pharmaceutical compositions for oral administration in form of coated tablets that exhibit modified release properties when administered as either whole or half tablets. In particular, the disclosure is directed to modified release tablets comprising deferiprone, said tablets being suitable for twice daily oral administration. The disclosure is also directed to methods of making and using the same.
Claims18
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 a hydroxypropylmethylcellulose polymer having a viscosity of 100 cP and optionally a hydroxypropylmethylcellulose polymer having a viscosity of 4000 cP in an amount of about 5.0% to about 10.0% by weight of the tablet, a lubricant and/or glidant in an amount of about 0.2% to about 2.0% by weight of the tablet, and additional pharmaceutically acceptable excipients in an amount of about 0.0 to 5.0% 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.