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1. WO2021112795 - ORAL DOSAGE FORMS CONTAINING INDOMETHACIN

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[ EN ]

CLAIMS

1. An oral dosage form; characterized in containing Indomethacin, polyvinyl alcohol and enteric coating.

2. The oral dosage form according to claim 1 , wherein enteric coating comprises one of the group indicated as methacrylic acid - ethyl acrylate copolymer (1 : 1), poly(methaclic acid - co - ethyl acrylate) (1 : 1), hydoxypropyl cellulose - acetate succinate, hydroxypropyl cellulose or mixtures thereof.

3. The oral dosage according to claim 2, wherein enteric coating comprises methacrylic acid - ethyl acrylate copolymer (1 : 1).

4. The oral dosage form according to claim 3, wherein comprising Indomethacin, polyvinyl alcohol , methacrylic acid - ethyl acrylate copolymer (1 : 1) as enteric coating.

5. The oral dosage form according to claim 4, wherein comprising in the range from 40.0 % to 45.0 % by weight Indomethacin, in the range from 10.0 % to 20.0 % polyvinyl alcohol, in the range from 40.0 % to 45.0 % methacrylic acid

- ethyl acrylate copolymer (1 : 1).

6. The oral dosage form according to claim 1 , wherein comprising at least one drug carrying copolymer.

7. The oral dosage form according to claim 6, wherein at least one drug carrying copolymer is selected from the group of as the poly - lactic acid - co

- glycolic acid, polylactic acid, polycaprolactone or mixtures thereof.

8. The oral dosage form according to claim 7, wherein drug carrying copolymer is poly - lactic acid - co - glycolic acid.

9. The oral dosage form according to claim 8, wherein Indomethacin, polyvinyl alcohol comprise poly - lactic acid - co - glycolic acid as drug carrying copolymer and methacrylic acid - ethyl acrylate copolymer (1 : 1) as enteric coating.

10. The oral dosage form according to claim 9, wherein comprising 5.0 % to 10.0 % Indomethacin, 2.5 % to 5.0 % polyvinyl alcohol, 25.0 % to 35.0 % poly - lactic acid - co - glycolic acid, 50.0 % to 67.5 % methacrylic acid - ethyl acrylate copolymer (1 : 1) by weight.

11. An oral dosage form preparation process according to claim 5 or claim 10, wherein the process is achieved by nanoprecipitation technique.

12. The process according to claim 11 , wherein solvents used in the nanoprecipitation technique are selected from a group of acetone, acetonitrile, ethanol, 1 - propanol, 2 - propanol, 1 ,4 - dioxane, methanol or mixtures thereof.