Upadacitinib formulation
AssigneeIntas Pharmaceuticals Ltd.
InventorsRahul Sudhakar PATIL, Sandip Kumar Manubhai PATEL, Ashutosh JAMLOKI, Ashish SEHGAL
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Abstract
The present invention is related to pharmaceutical composition of upadacitinib comprising upadacitinib or its pharmaceutically acceptable salt thereof, release controlling polymer, pH modifier and one or more pharmaceutical acceptable excipient; wherein the release controlling polymer is hydrophobic polymer.
Claims9
A pharmaceutical composition of upadacitinib comprising upadacitinib or its pharmaceutically acceptable salt thereof, release control polymer, pH modifier and one or more pharmaceutical acceptable excipients;
- wherein the said release control polymer is hydrophobic polymer.
A process for preparation of pharmaceutical composition of upadacitinib comprising upadacitinib or its pharmaceutically acceptable salt thereof, release control polymer, pH modifier and one or more pharmaceutical acceptable excipients, comprising following steps:
- 1) Co-sifting Upadacitinib with pH modifier and diluent and mixing it to obtain a blend.
- 2) The blend of step 1 is granulated with required quantity of purified water.
- 3) The wet granules are wet milled through Co-mill and are dried in Rapid dryer.
- 4) The dried granules of step 3 are passed through Co-mill with suitable screen.
- 5) The extragranular materials i.e., release control polymer and glidant are co-sifted and blended with sized granules.
- 6) Lubricant is added and lubricated the blend of step 5.
- 7) The Lubricated blend of step 6 is compressed into tablets using compression machine with suitable punches.
- 8) The core tablets are coated with coating agent using auto coater.
A pharmaceutical composition of upadacitinib comprising upadacitinib or its pharmaceutically acceptable salt thereof, release control polymer, pH modifier and one or more pharmaceutical acceptable excipients;
- wherein the said release control polymer is hydrophobic polymer selected from the group consisting of glyceryl dibehenate, ethyl cellulose and combinations thereof and the said composition is bioequivalent to innovator product Rinvoq® under both fasting and fed conditions.
Dependencies are inferred from the claim text.