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

Claim 2:
3. An extended release table composition comprising,
a) intra granular portion comprising 2-3% of Deutetrabenazine; 45-50% of mannitol; 3-4% of povidone
b) extra granular portion comprising 8-10% of mannitol; 3-5% of hypromellose; 1-4% of xanthan gum
wherein the composition contains not more than 2.4% of total impurities by weight relative to Deutetrabenazine after storage for 6 months at 40° C.±2° C./75% RH±5% RH
and said dosage form exhibits not more than 50% of the Deutetrabenazine dissolved in 1 hour 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.