received by the International Bureau on 27 May 2019 (27.05.2019)

1. An oral immediate release pharmaceutical composition in a single unit dosage form comprising diclofenac or a pharmaceutically acceptable salt thereof, famotidine or a pharmaceutically acceptable salt thereof and a carbonate; wherein famotidine is in an amount of 20 to 55% based on the weight of diclofenac,

- wherein at least 60% of famotidine and 60% of diclofenac are released within 20 minutes when subjected to an in vitro dissolution test at about 50 rpm in a solution volume of 900 mL at a pH of 6.8 to 7.4 and at 37.0°C. ± 0.5°C, and/or,

- wherein at least 60% of famotidine and 60 % of diclofenac are released within 20 minutes when subjected to an in vitro dissolution test at about 50 rpm in a solution volume of 900 mL at a pH of 4.5 and at 37.0°C. ± 0.5°C.

2. The pharmaceutical composition according to claim 1, wherein diclofenac is in an amount of from 12.5 to 100 mg.

3. The pharmaceutical composition according to claim 2, wherein diclofenac is in an amount of from 25 to 55 mg.

4. The pharmaceutical composition according to any one of claims 2 to 3, wherein diclofenac is diclofenac sodium or diclofenac potassium.

5. The pharmaceutical composition according to any one of claims 1 to 4, wherein famotidine is in an amount of from 15 to 30 mg.

6. The pharmaceutical composition according to any one of claims 1 to 5, wherein the carbonate is in an amount of from 5 to 200 mg.

7. The pharmaceutical composition according to claim 6, wherein the carbonate is sodium carbonate, sodium bicarbonate, calcium carbonate, calcium bicarbonate, magnesium carbonate, ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate, sodium glycine carbonate, disodium glycine carbonate, arginine carbonate, arginine bicarbonate, lysine carbonate or derivatives thereof.

8. The pharmaceutical composition according to claim 7, wherein the carbonate is sodium bicarbonate or potassium bicarbonate.

9. The pharmaceutical composition according to any one of the preceding claims, wherein the single unit dosage form is selected from tablet, capsule, granule or powder form.

10. The pharmaceutical composition according to any one of the preceding claims, further comprising one or more excipients selected from the group consisting of diluents, binders, lubricants, glidants, disintegrating agents, surfactants, sweetening agents, coloring agents and coating agents.

11. The pharmaceutical composition according to claim 10, wherein the lubricant is selected from the group consisting of metallic stearates, metallic lauryl sulfates, fatty acids, fatty acid esters, fatty alcohols, paraffins, hydrogenated vegetable oils, polyethylene glycols, boric acid, sodium benzoate, sodium acetate, sodium chloride and talk.

12. The pharmaceutical composition according to claim 10, wherein the lubricant is a metallic stearate.

13. The pharmaceutical composition according to claim 12, wherein the lubricant is magnesium stearate.

14. The pharmaceutical composition according to any one of claims 10 to 13, wherein the glidant is colloidal silicon dioxide.

15. The pharmaceutical composition according to any one of the preceding claims, wherein the glidant or lubricant is present in an amount of from 3 to 30% by weight of famotidine.

16. The pharmaceutical composition according to claim 15, wherein the glidant or the lubricant are present in an amount of from 3 to 20% by weight of famotidine.

17. The pharmaceutical composition according to any preceding claims for use in a method for the treatment of pain and inflammation.

18. The pharmaceutical composition for use according to claim 17, wherein the method is for the treatment of osteoarthritis, rheumatoid arthritis, acute musculoskeletal pain, dysmenorrhea, headache, toothache, fever, muscular pain, back pain, shoulder pain, bursitis, tendinitis, epicondylitis ichronic polyarthritis, ankylosing spondilytis, gout attacks, extra-articular rheumatism, post-traumatic and postoperative pain.

19. The pharmaceutical composition for use according to claims 17 or 18, wherein the pharmaceutical composition is administered 2 to 4 times a day.

25