Pharmaceutical compositions comprising AZD9291

1. A pharmaceutical composition comprising:

(a) from 2 to 70 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindo-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide;

(b) from 5 to 96 parts of two or more pharmaceutical diluents;

(c) from 2 to 15 parts of one or more pharmaceutical disintegrants;

(d) from 0 to 0.75 parts of one or more pharmaceutical solubilising agents; and

(e) from 0 to 3 parts of one or more pharmaceutical lubricants;

wherein all parts are by weight and the sum of the parts (a)+(b)+(c)+(d)+(e)=100; and

wherein one of the two or more pharmaceutical diluents is microcrystalline cellulose wherein the microcrystalline cellulose makes up from 7 to 30 wt % of the two or more pharmaceutical diluents (b).

2. The pharmaceutical composition according to claim 1 wherein the pharmaceutical composition comprises from 1 to 2.5 parts of the one or more pharmaceutical lubricants (e).

3. The pharmaceutical composition according to claim 2 wherein the one or more pharmaceutical lubricants (e) comprises sodium stearyl fumarate and/or one or more behenate esters of glycerine.

4. The pharmaceutical composition according to claim 3 , wherein the pharmaceutical composition comprises from 2 to 10 parts of the one or more pharmaceutical disintegrants (c).

5. The pharmaceutical composition according to claim 4 wherein the one or more pharmaceutical disintegrants (c) comprises low-substituted hydroxypropyl cellulose.

6. The pharmaceutical composition according to claim 5 , wherein the pharmaceutical composition comprises from 0 to 0.25 parts of one or more pharmaceutical solubilising agents (d).

7. The pharmaceutical composition according to claim 6 , wherein the pharmaceutical composition comprises from 5 to 50 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide.

8. A method of treating cancer in a patient in need thereof, which method comprises the oral administration to the patient of an effective amount of the pharmaceutical composition as claimed in claim 1 .

9. A pharmaceutical tablet comprising the pharmaceutical composition as claimed in claim 1 .

10. A pharmaceutical tablet comprising a tablet core wherein the tablet core comprises the pharmaceutical composition as claimed in claim 1 , wherein the tablet core has a coating.

11. A method of treating cancer in a patient in need thereof, which method comprises the oral administration of an effective number of the pharmaceutical tablet(s), as claimed in claim 9 , to the patient.

12. The method of claim 8 , wherein the cancer is non-small cell lung cancer.

13. The method of claim 11 , wherein the cancer is non-small cell lung cancer.

14. The pharmaceutical composition as claimed in claim 6 , wherein a pharmaceutical solubilising agent (d) is not present.

15. The pharmaceutical composition as claimed in claim 7 , wherein the pharmaceutical composition comprises from 7 to 30 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindo-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide.

16. A pharmaceutical composition as claimed in claim 1 comprising:

(a) from 5 to 50 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide;

(b) from 5to 96 parts of two or more pharmaceutical diluents;

(c) from 2 to 15 parts of one or more pharmaceutical disintegrants;

(d) from 0 to 0.75 parts of one or more pharmaceutical solubilising agents; and

(e) from 0.5 to 3 parts of one or more pharmaceutical lubricants;

wherein all parts are by weight and the sum of the parts (a)+(b)+(c)+(d)+(e)=100;

wherein one of the two or more pharmaceutical diluents is microcrystalline cellulose wherein the microcrystalline cellulose makes up from 7 to 30 wt % of the two or more pharmaceutical diluents (b) and wherein in addition to microcrystalline cellulose, the other pharmaceutical diluent(s) within the two or more pharmaceutical diluents is/are selected from cellulose acetate, erythritol, ethylcellulose, fructose, inulin, isomalt, lactitol, lactose, maltitol, maltodextrin, maltose, mannitol, polydextrose, polyethylene glycol, pullulan, simethicone, sodium chloride, sorbitol, starch, sucrose, trehalose and xylitol; and wherein the one or more pharmaceutical disintegrants (c) comprises low-substituted hydroxypropyl cellulose and wherein the one or more pharmaceutical lubricants (e) comprises sodium stearyl fumarate and/or one or more behenate esters of glycerine.

17. A method of treating cancer in a patient in need thereof, which method comprises the oral administration to the patient of an effective amount of the pharmaceutical composition as claimed in claim 16 .

18. A pharmaceutical tablet comprising the pharmaceutical composition as claimed in claim 16 .

19. A pharmaceutical tablet comprising a tablet core wherein the tablet core comprises the pharmaceutical composition as claimed in claim 16 , wherein the tablet core has a coating.

20. A method of treating cancer in a patient in need thereof, which method comprises the oral administration of an effective number of the pharmaceutical tablet(s), as claimed in claim 19 , to the patient.

21. A pharmaceutical composition according to claim 1 comprising:

(a) from 7 to 25 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide;

(b) from 55 to 85 parts of two pharmaceutical diluents;

(c) from 2 to 8 parts of a pharmaceutical disintegrant; and

(e) from 1.5 to 2.5 parts of a pharmaceutical lubricant;

wherein a pharmaceutical solubilising agent (d) is not present; wherein all parts are by weight and the sum of the parts (a)+(b)+(c)+(e)=100; and wherein one of the two pharmaceutical diluents is microcrystalline cellulose wherein the microcrystalline cellulose makes up from 7 to 30 wt % of the two pharmaceutical diluents (b).

22. A pharmaceutical composition according to claim 21 comprising:

(a) from 7 to 25 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide;

(b) from 55 to 85 parts of two pharmaceutical diluents, wherein the pharmaceutical diluents are microcrystalline cellulose and mannitol;

(c) from 2 to 8 parts of a pharmaceutical disintegrant, wherein the pharmaceutical disintegrant is low-substituted hydroxypropyl cellulose; and

(e) from 1.5 to 2.5 parts of a pharmaceutical lubricant, wherein the pharmaceutical lubricant is sodium stearyl fumarate;

wherein a pharmaceutical solubilising agent (d) is not present; wherein all parts are by weight and the sum of the parts (a)+(b)+(c)+(e)=100; and wherein the microcrystalline cellulose makes up from 7 to 30 wt % of the two pharmaceutical diluents (b).

23. A pharmaceutical composition according to claim 22 comprising:

(a) about 19 parts of the mesylate salt of N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide;

(b) about 59 parts of mannitol;

(c) about 15 parts of microcrystalline cellulose;

(d) about 5 parts of low-substituted hydroxypropyl cellulose; and

(e) about 2 parts of sodium stearyl fumarate.