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Generated: December 13, 2017

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Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: VELOXIS PHARMACEUTICALS A/S (Copenhagen, DK)
Filing Date:Sep 16, 2015
Application Number:14/855,624
Claims:1. A solid pharmaceutical composition comprising: (a) tacrolimus; (b) hydroxypropyl methylcellulose; (c) lactose; (d) polyethylene glycol 6000; (e) poloxamer 188; and (f) magnesium stearate.

2. The solid pharmaceutical composition of claim 1, wherein less than 20% w/w of the tacrolimus is released from the solid pharmaceutical composition within 0.5 hours, when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium.

3. The solid pharmaceutical composition of claim 1, wherein less than 20% w/w of the tacrolimus is released from the solid pharmaceutical composition within 3 hours, when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium.

4. The solid pharmaceutical composition of claim 2, wherein the weight ratio of polyethylene glycol 6000 to poloxamer 188 is between 1:3 and 10:1.

5. The solid pharmaceutical composition of claim 2, wherein the dosage form is a tablet.

6. The solid pharmaceutical composition of claim 1, wherein the composition releases at most 62% of the tacrolimus in the composition within 15 hours when subjected to an in vitro dissolution test using USP Paddle method at a rotation speed of 50 rpm in a 900 mL aqueous dissolution medium with 0.005% hydroxypropylcellulose which has been adjusted to pH 4.5.

7. The solid pharmaceutical composition of claim 1, wherein the dosage form is a tablet.

8. The solid pharmaceutical composition of claim 3, wherein the dosage form is a tablet.
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