Patent ID: 11969413
Assignee: AUROBINDO PHARMA LTD
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 1:
2. An extended release tablet composition comprising,
a) 6-12 mg of Deutetrabenazine with 90% of the particles having size between 360-380 μm
b) 20-30 mg of rate controlling polymers consisting of a combination of hypromellose and xanthan gum in a w/w ration of 1:0.2 to 1:0.70
c) 10-20 mg of povidone as binder
wherein ratio of rate controlling polymer to binder is 1:0.3 to 1:0.7 and the composition contains not more that 2.4% of total impurities by weight relative to Deutetravenazine after storate for 6 months at 40 ° C.±2° C./75% RH±5% RH
and not more than 50% of the Deutetrabenazine dissolves in 1 hour and at least 90% of Deutetrabenazine dissolves within 6 hours in a 500 ml of pH 3.0 acid phthalate buffer at a temperature of 37° C. using a USP apparatus-2 paddle over a disk at a rotation of about 75 rpm, wherein the composition is free of surfactant.