US 11,980,622 B1
Oxcarbazepine extended release dosage form
Krishna Hari Bhandari, Brampton (CA); Sandeep Patel, Brampton (CA); Navin Vaya, Woodbridge (CA); Bernard Charles Sherman, Toronto (CA); and Arunprasath Kaliaperumal, Weston, FL (US)
Assigned to Apotex Inc., Toronto (CA)
Filed by Apotex Inc., Toronto (CA)
Filed on Mar. 16, 2022, as Appl. No. 17/695,881.
Application 17/695,881 is a continuation of application No. 17/217,178, filed on Mar. 30, 2021, abandoned.
Claims priority of provisional application 63/040,014, filed on Jun. 17, 2020.
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/28 (2006.01); A61K 9/00 (2006.01); A61K 9/20 (2006.01); A61K 31/55 (2006.01)
CPC A61K 31/55 (2013.01) [A61K 9/0053 (2013.01); A61K 9/2054 (2013.01); A61K 9/2095 (2013.01)] 23 Claims
 
1. An extended-release dosage form of oxcarbazepine for oral administration comprising oxcarbazepine, hydroxypropyl methylcellulose (HPMC) that has a viscosity ranging from about 50 to about 500 cP, and one or more additional pharmaceutically acceptable excipients,
wherein the dosage form is substantially free, or free of, a release promoting agent(s) and/or a polymer(s) having pH-dependent solubility,
wherein the weight percentage of HPMC is from about 20% to about 65% based upon total weight of the dosage form, and
wherein the dosage form has Cmax and AUCT ratios in the range of 80% to 125%, relative to an oxcarbazepine extended-release dosage form comprising a polymer having pH-dependent solubility and having a similar total amount of oxcarbazepine.