IP Library › Patent Application 15246279
Patent Application
App. No. 15/246,279

SOLID DOSAGE FORMS

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Quick Facts
Patent No.
US None
App. No.
15/246,279
Abstract

The present invention features solid dosage forms comprising two or more different active ingredients. In one embodiment, the present invention features a tablet dosage form comprising a first layer and a second layer, wherein the first layer comprises (1) 200 mg lopinavir, (2) ritonavir, (3) a pharmaceutically acceptable hydrophilic polymer, (4) a pharmaceutically acceptable surfactant, and (5) no more than 0.2% by weight of one or more lubricants, and the second layer comprises another therapeutic agent.

Claims (21)

1 . A tablet dosage form comprising a first layer and a second layer, wherein the first layer comprises (1) from 160 to 200 mg lopinavir, preferably 170 or 180 mg lopinavir, (2) ritonavir, (3) a pharmaceutically acceptable hydrophilic polymer, (4) a pharmaceutically acceptable surfactant and (5) no more than 0.9% by weight of one or more lubricants, and the second layer comprises another therapeutic agent.

2 . The tablet dosage form of claim 1 , wherein the first layer comprises no more than 0.5% by weight of one or more lubricants.

3 . The tablet dosage form of claim 1 , wherein the first layer comprises no more than 0.2% by weight of one or more lubricants.

4 . The tablet dosage form of claim 1 , wherein the first layer comprises no more than 0.1% by weight of one or more lubricants.

5 . The tablet dosage form of claim 3 , wherein the weight ratio of the second layer to the first layer is no more than 1:4.

6 . The tablet dosage form of claim 3 , wherein the weight ratio of the second layer to the first layer is no more than 1:5.

7 . The tablet dosage form of claim 3 , wherein the dosage form is no more than 1.7 g, and the first layer is at least 1 g.

8 . The tablet dosage form of claim 3 , wherein the dosage form is no more than 1.6 g, and the first layer is at least 1 g.

9 . The tablet dosage form of claim 3 , wherein the dosage form is no more than 1.5 g, and the first layer is at least 1 g.

10 . The tablet dosage form of claim 3 , wherein the dosage form is no more than 1.5 g, and the first layer is at least 1.1 g.

11 . The tablet dosage form of claim 10 , wherein the weight ratio of the second layer to the first layer is no more than 1:4.

12 . The tablet dosage form of claim 10 , wherein the weight ratio of the second layer to the first layer is no more than 1:5.

13 . The tablet dosage form of claim 3 , wherein the first layer includes a solid dispersion comprising ritonavir, lopinavir, said hydrophilic polymer and said surfactant.

14 . The tablet dosage form of claim 3 , wherein the first layer includes a solid solution comprising ritonavir, lopinavir, said hydrophilic polymer and said surfactant.

15 . The tablet dosage form of claim 3 , wherein the first layer includes a glassy solution comprising ritonavir, lopinavir, said hydrophilic polymer and said surfactant.

16 . The tablet dosage form of claim 15 , wherein said hydrophilic polymer is copovidone, and said surfactant is sorbitan monolaurate.

17 . The tablet dosage form of claim 16 , wherein said one or more lubricants are sodium stearyl fumarate.

18 . The tablet dosage form of claim 17 , wherein the first layer comprises 50 mg ritonavir.

19 . A pediatric tablet dosage form comprising a first layer and a second layer, wherein the first layer comprises (1) from 80 to 100 mg lopinavir, preferably 85 or 90 mg lopinavir, (2) ritonavir, (3) a pharmaceutically acceptable hydrophilic polymer, (4) a pharmaceutically acceptable surfactant and (5) no more than 0.9% by weight of one or more lubricants, and the second layer comprises another therapeutic agent.

20 . A process of making a tablet dosage form, comprising compressing a first layer and a second layer under a compression force of no more that 30 kN, wherein the first layer comprises (1) from 160 to 200 mg lopinavir, preferably 170 or 180 mg lopinavir, (2) ritonavir, (3) a pharmaceutically acceptable hydrophilic polymer, (4) a pharmaceutically acceptable surfactant and (5) no more than 0.9% by weight of one or more lubricants, and the second layer comprises another therapeutic agent.

21 . A method of treating HIV infection, comprising administering a tablet dosage form of claim 1 to a HIV patient.