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Claims for Patent: 9,089,534

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Claims for Patent: 9,089,534

Title:Pharmaceutical semi-solid composition of isotretinoin
Abstract: An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.
Inventor(s): Vanderbist; Francis (Rhode-Saint-Genese, BE), Servais; Cecile (Mehaigne, BE), Baudier; Philippe (Brussels, BE)
Assignee: Galephar Pharmaceutical Research, Inc. (Puerto Rico 00777, unknown)
Application Number:13/713,897
Patent Claims: 1. An oral pharmaceutical composition of isotretinoin in the form of a capsule comprising about 16 mg of isotretinoin and one or more excipients in the form of a semi-solid paste contained within the capsule, the paste consisting essentially of an oil and a glyceroyl macrogolglyceride of HLB of at least 10 to improve the bioavailability of the isotretinoin, wherein the composition exhibits a total amount of isotretinoin absorbed that is bioequivalent to a commercially available capsule composition containing 20 mg of isotretinoin (Roaccutane) upon administration to a human subject, wherein the bioequivalence of the total amount of isotretinoin absorbed is established by a 90% confidence interval for AUC.sub.0-.infin. which is between 80% and 125% upon administration with food.

2. The oral pharmaceutical composition of claim 1, wherein the oil is selected from the group consisting of vegetable oils, medium chain triglycerides, fatty acid esters, glycerol oleate and mixtures thereof.

3. The oral pharmaceutical composition of claim 1, wherein the glyceroyl macrogolglyceride comprises between 20% to 80% w/w of the composition and the oil comprises between 5% to 70% w/w of the composition.

4. The oral pharmaceutical composition of claim 1, wherein the glycerol macrogolglyceride has a HLB value of at least 12.

5. The oral pharmaceutical composition of claim 4, wherein the glycerol macrogolglyceride has a HLB value of at least 13.

6. The oral pharmaceutical composition of claim 1, wherein the composition comprises a semi-solid paste at a body temperature of about 37.degree. C.

7. The oral pharmaceutical composition of claim 6, wherein the composition is a suspension of isotretinoin.

8. The oral pharmaceutical composition of claim 6, wherein the composition is a solution of isotretinoin.

9. The oral pharmaceutical composition of claim 1, which further comprises at least one surfactant.

10. The oral pharmaceutical composition of claim 9, wherein the surfactant is selected from the group consisting of sorbitan fatty acid esters, polysorbate compounds, polyoxyethylene sorbitan fatty acids esters, sodium lauryl sulphate, compounds of lecithin, propylene glycol esters, fatty acid esters of propylene glycol, fatty acid esters of glycerol, and mixtures thereof.

11. The oral pharmaceutical composition of claim 9, wherein the surfactant comprises between 1% to 15% w/w of the composition.

12. The oral pharmaceutical composition of claim 1, which further comprises at least one disintegrant.

13. The oral pharmaceutical composition of claim 12, wherein the disintegrant is selected from the group consisting of crospovidone, sodium croscarmellose, and mixtures thereof.

14. An oral pharmaceutical composition of isotretinoin in the form of a capsule comprising isotretinoin and one or more excipients in the form of a semi-solid paste contained within the capsule, the paste consisting essentially of an oil and a glyceroyl macrogolglyceride of HLB of at least 10 to improve the bioavailability of the isotretinoin, wherein the composition exhibits an AUC.sub.0-.infin. 90% confidence interval comprised between 100% and 150% when compared to the same dosage strength of isotretinoin from a commercially available capsule composition containing isotretinoin under the commercial name of Roaccutane after administration with food, wherein the composition is in a capsule and is characterized by in a form of a paste at a body temperature of about 37.degree. C.

15. The oral pharmaceutical composition of claim 14, wherein the oil is selected from the group consisting of vegetable oils, medium chain triglycerides, fatty acid esters, glycerol oleate and mixtures thereof.

16. The oral pharmaceutical composition of claim 14, wherein the glyceroyl macrogolglyceride comprises between 20% to 80% w/w of the composition and the oil comprises between 5% to 70% w/w of the composition.

17. The oral pharmaceutical composition of claim 14, wherein the glyceroyl macrogolglyceride has a HLB value of at least 12.

18. The oral pharmaceutical composition of claim 14, wherein the glyceroyl macrogolglyceride has a HLB value of at least 13.

19. The oral pharmaceutical composition of claim 14, wherein the isotretinoin is partly in suspension and partly in solution.

20. The oral pharmaceutical composition of claim 14, wherein the isotretinoin is in suspension.

21. The oral pharmaceutical composition of claim 14, wherein the isotretinoin is in solution.

22. The oral pharmaceutical composition of claim 14, which further comprises at least one surfactant.

23. The oral pharmaceutical composition of claim 22, wherein the surfactant is selected from the group consisting of sorbitan fatty acid esters, polysorbate compounds, polyoxyethylene sorbitan fatty acids esters, sodium lauryl sulphate, compounds of lecithin, propylene glycol esters, fatty acid esters of propylene glycol, fatty acid esters of glycerol, and mixtures thereof.

24. The oral pharmaceutical composition of claim 22, wherein the surfactant comprises between 1% to 15% w/w of the composition.

25. The oral pharmaceutical composition of claim 14, which further comprises at least one disintegrant.

26. The oral pharmaceutical composition of claim 25, wherein the disintegrant is selected from the group consisting of crospovidone, sodium croscarmellose, and mixtures thereof.

27. The oral pharmaceutical composition of claim 14, wherein the composition comprises from about 10 mg to 20 mg of isotretinoin.

28. The oral pharmaceutical composition of claim 6 wherein the isotretinoin is partly in suspension and partly in solution.

29. The oral pharmaceutical composition of claim 1, wherein the composition comprises a semi-solid and is characterized by being a paste at a body temperature of about 37.degree. C.

30. The oral pharmaceutical composition of claim 29, wherein the isotretinoin is in suspension.

31. The oral pharmaceutical composition of claim 29 wherein the isotretinoin is in solution.

32. The oral pharmaceutical composition of claim 31 wherein the isotretinoin is partly in suspension and partly in solution.

33. The oral pharmaceutical composition of claim 1, wherein the food comprises a continental breakfast.

34. The oral pharmaceutical composition of claim 14, wherein the food comprises a continental breakfast.

35. An oral pharmaceutical composition of isotretinoin in the form of a capsule comprising isotretinoin and one or more excipients in the form of a semi-solid paste contained within the capsule, the paste consisting essentially of an oil and a glyceroyl macrogolglyceride of HLB of at least 10 to improve the bioavailability of the isotretinoin, wherein about 16 mg of isotretinoin in the composition exhibits a total amount of isotretinoin absorbed that is bioequivalent to a commercially available capsule composition containing 20 mg of isotretinoin (Roaccutane) upon administration to a human subject, wherein the bioequivalence of the total amount of isotretinoin absorbed is established by a 90% confidence interval for AUC.sub.0-.infin. which is between 80% and 125% upon administration with food, the composition is characterized as being a paste at a body temperature of about 37.degree. C., and at least a portion of the isotretinoin in the composition is in solution within the composition.
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