Novel formulation

Abstract

The present invention relates to a composition for encapsulation in a soft gelatin shell which comprises ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is from 0.1:1 – 0.9:1, the weight ratio of the base to ibuprofen is from 1:6 – 1:20 and the weight ratio of the one or more polyoxysorbitan esters to base is 1:1 – 13:1 and wherein the ibuprofen is present at an amount of 50% – 65% w / w.

Description

The present invention is directed to a composition that comprises ibuprofen. In particular, the present invention is directed to a composition that comprises ibuprofen and is suitable 5 for encapsulation in a soft gelatin capsule. Soft gelatin capsules offer a number of advantages over tablets and caplets as a pharmaceutical dosage form. They are easily digested and dissolve quickly in the stomach thus allowing quicker onset of the desired pharmaceutical effect. Soft gelatin capsules are 10 also very useful for administering poorly soluble or poorly absorbed active pharmaceutical ingredients (API). Soft gelatin capsules are also useful for protecting APIs from light and oxygen thus improving their stability. Soft gelatin capsules which contain a pain killer, such as ibuprofen, are known in the art and 15 are commercially available. These capsules contain the standard dose of 200mg or 400mg of ibuprofen. US 5 376 688 describes soft and hard gelatin capsules containing a fill formulation which comprises a diethylene glycol monoethyl ether and a polyglycerol oleate. US 5 912 011 20 discloses a solvent system for encapsulation in soft and hard gelatin capsules. WO 88 / 02625 discloses a solvent system to enhance the solubility of APIs. WO 2005 / 123133 discloses a solvent system for APIs which comprises 15 - 50 % by weight of polyethylene glycol. However, while the soft gelatin capsules that are currently available are increasingly 25 attractive to consumers one aspect that could be improved is the size of the capsule. A smaller dosage form is easier to swallow and provides a better experience for consumers. The present invention provides a soft-gelatin capsule that is significantly smaller than current capsules but maintains or improves on the therapeutic profile of existing capsules. The soft-gelatin capsule contains a stable highly concentrated solution of ibuprofen that is able to 30 provide an effective dose. 2021275584   25 Jun 2026 According to an aspect of the present invention there is provided a composition for encapsulation in a soft gelatin shell which comprises ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is from 0.4:1 - 0.8:1, the weight ratio of the base to ibuprofen is from 1:8 - 1:15 5 and the weight ratio of the one or more polyoxysorbitan esters to base is 3:1 - 9:1 and wherein the ibuprofen is present at an amount of 50% - 65% w / w. Preferably the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 -0.7:1. 10 Preferably the weight ratio of base to ibuprofen is 1:9 - 1:11.5. Preferably the weight ratio of the one or more polyoxysorbitan esters to base is 5.5:1 - 7.75:1. 15 Preferably the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 -0.7:1, the weight ratio of base to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to base is 5.5:1 - 7.75:1. The composition can comprise ibuprofen, one or more polyoxysorbitan esters and a base 20 wherein the weight ratio of the ibuprofen: the one or more polyoxysorbitan esters:base is about 6 - 20:1 - 13:1. The composition can comprise ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the ibuprofen: the one or more polyoxysorbitan esters:base is 25 about 9 - 12:5 - 8:1. The one or more polyoxysorbitan esters can be selected from the group consisting of polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. A preferred 30 polyoxysorbitan ester is polysorbate 80. 2021275584   25 Jun 2026 The base can be selected from alkali metal hydroxides (i.e. the metals of Group I of the Periodic Table) particularly sodium and potassium, and alkali earth metal hydroxides (i.e. the metals of Group II of the Periodic Table) particularly calcium and magnesium. Preferred hydroxides are sodium hydroxide and potassium hydroxide. A more preferred hydroxide is 5 potassium hydroxide. The base can also be selected from carbonate and bicarbonate salts of the alkali and alkali earth metals, i.e. the metals of Group I or Group II of the periodic table. 10 The base can be selected from amines and amino acids such as ammonia, triethylamine, lysine or arginine. The composition can further comprise polyethylene glycol in an amount from about 2% to about 25% w / w. Preferably the polyethylene glycol is present in an amount from about 5% 15 to about 10% w / w. More preferably the polyethylene glycol is present in an amount from about 6% to about 7% w / w. Typically, the polyethylene glycol is a liquid at room temperature. The polyethylene glycol can have a number average molecular weight (Mn) of up to 1000. The polyethylene glycol 20 can have a number average molecular weight (Mn) of from about 400 to about 800. Preferred polyethylene glycols can have a number average molecular weight (Mn) of 200, 300, 400, 600, 800. Preferred polyethylene glycols can have a number average molecular weight (Mn) of 400 or 600. 25 The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the composition can comprise polysorbate 80 and a polyethylene glycol can have a number 30 average molecular weight (Mn) of 400 or 600 or a combination thereof. 2021275584   25 Jun 2026 The composition can further comprise water in an amount from about 2% w / w to about 10% w / w. The water can be present at a level of from 3% w / w to 5.5% w / w. Typically, the unit dose weight of the formulation can be about 300 - 420mg. More typically, 5 the unit dose weight of the formulation can be about 320 - 400mg. Even more typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 370mg. Typically, the unit dose has a fill volume of from 0.3ml to 0.42ml. 10 Alternatively, the unit dose weight of the formulation can be about 600 - 840mg. The unit dose weight of the formulation can be about 640 - 800mg. The unit dose weight of the formulation can be about 680 - 760mg. The unit dose weight of the formulation can be about 740mg. Typically, the unit dose has a fill volume of from 0.6ml to 0.84ml. 15 The composition can comprise ibuprofen, one or more polyoxysorbitan esters and a hydroxide wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more polyoxysorbitan esters is present at an amount of 30 - 40% w / w, the hydroxide is present at an amount of 3 - 10% w / w, and the weight ratio of the one or more polyoxysorbitan esters 20 to ibuprofen is 0.5:1 - 0.7:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5.5:1 - 7.75:1. The composition can comprise ibuprofen, one or more polyoxysorbitan esters and a hydroxide wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more 25 polyoxysorbitan esters is present at an amount of 30 - 40% w / w, the hydroxide is present at an amount of 4 - 7% w / w, and the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 - 0.7:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5.5:1 - 7.75:1. 30 The composition can comprise ibuprofen, one or more polyoxysorbitan esters, a hydroxide and a polyethylene glycol wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more polyoxysorbitan esters is present at an amount of 20 - 35% w / w, the hydroxide 2021275584   25 Jun 2026 is present at an amount of 3 - 10% w / w, the polyethylene glycol is present as at an amount of 5 - 10% w / w and the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 - 0.6:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5:1 - 6:1. 5 The composition can comprise ibuprofen, one or more polyoxysorbitan esters, a hydroxide and a polyethylene glycol wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more polyoxysorbitan esters is present at an amount of 20 - 35% w / w, the hydroxide is present at an amount of 4 - 7% w / w, the polyethylene glycol is present as at an amount of 10   5 - 10% w / w and the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.4:1 - 0.6:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5:1 - 6:1. According to an aspect of the present invention there is provided a composition consisting 15 essentially of: (a) 50 - 65% w / w ibuprofen; (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water 20 wherein the volume of the unit dose of the composition is from about 0.3ml to about 0.42ml. Preferably, the composition can comprise: (a) 50 - 60% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; 25       (c) 3 - 8% w / w A hydroxide; and (d) Water More preferably, the composition can comprise: (a) 50 - 65% w / w ibuprofen; 30 (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and 2021275584   25 Jun 2026 (e) Water. The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; 5       (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water. The composition can consist essentially of: 10       (a) 52 - 55% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and (d) Water. 15 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and 20       (e) Water. The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; 25       (c) 5 - 8% w / w A hydroxide; (d) 4 - 8% w / w Polyethylene glycol; and (e) Water. The composition can consist essentially of: 30      (a) 50 - 65% w / w ibuprofen; (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and 2021275584   25 Jun 2026 (d) Water wherein the volume of the unit dose of the composition is from about 0.3ml to about 0.42ml. The composition can consist essentially of: 5       (a) 52 - 55% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and (d) Water wherein the volume of the unit dose of the composition is from about 0.3ml to about 0.42ml. 10 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; 15 (d) 5 - 25% w / w Polyethylene glycol; and (e) Water wherein the volume of the unit dose of the composition is from about 0.3ml to about 0.42ml. The composition can consist essentially of: 20       (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; (d) 4 - 8% w / w Polyethylene glycol; and (e) Water 25 wherein the volume of the unit dose of the composition is from about 0.3ml to about 0.42ml. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. 30 2021275584   25 Jun 2026 The polyethylene glycol can be selected from polyethylene glycols having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. 5 The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the composition can comprise polysorbate 80 and a polyethylene glycol can have a number 10 average molecular weight (Mn) of 400 or 600 or a combination thereof. According to an aspect of the present invention there is provided a composition comprising: (a) 50 - 65% w / w ibuprofen; (b) 25 - 45% w / w One or more polyoxysorbitan esters; 15 (c) 3 - 8% w / w      A hydroxide; and (d) Water wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml. Preferably, the composition can comprise: 20 (a) 50 - 60% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w      A hydroxide; and (d) Water. 25 More preferably, the composition can comprise: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; and (d) 5 - 25% w / w Polyethylene glycol. 30 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; 2021275584   25 Jun 2026 (b) 25 - 40% w / w    One or more polyoxysorbitan esters; (c) 3 - 8% w / w      A hydroxide; and (d) Water wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml. 5 The composition can consist essentially of: (a) 52 - 55% w / w (b 35 - 40% w / w (c) 3 - 5% w / w 10          (d) Water ibuprofen; One or more polyoxysorbitan esters; A hydroxide; and wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml. The composition can consist essentially of: 15 (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and (e) Water wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml. 20 The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; 25 (d) 4 - 8% w / w Polyethylene glycol; and (e) Water wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 30 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. 2021275584   25 Jun 2026 The polyethylene glycol can be selected from polyethylene glycols having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. 5 The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the composition can comprise polysorbate 80 and a polyethylene glycol can have a number 10 average molecular weight (Mn) of 400 or 600 or a combination thereof. According to an aspect of the present invention there is provided a composition comprising: (a) 50 - 65% w / w ibuprofen; (b) 25 - 45% w / w One or more polyoxysorbitan esters; 15       (c) 3 - 8% w / w A hydroxide; and (d) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, 20 the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. Preferably, the composition can comprise: (a) 50 - 60% w / w ibuprofen; 25       (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water. The composition can comprise: 30      (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; 2021275584   25 Jun 2026 (d) 5 - 25% w / w Polyethylene glycol; and (e) Water. wherein the unit dose weight of the formulation can be about 300 - 420mg. 5 Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. The composition can consist essentially of: 10       (a) 50 - 65% w / w ibuprofen; (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. 15 Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. 20 Preferably the composition can consist essentially of: (a) 52 - 55% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and (d) Water. 25 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; 30 (d) 5 - 25% w / w Polyethylene glycol; and (e) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. 2021275584   25 Jun 2026 Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. 5 The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; (d) 4 - 8% w / w Polyethylene glycol; and 10      (e) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit 15 dose weight of the formulation can be about 360 - 370mg. The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 25 - 40% w / w One or more polyoxysorbitan esters; 20      (c) 3 - 8% w / w A hydroxide; and (d) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, 25 the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. Preferably,the composition can consist essentially of: (a) 52 - 55% w / w ibuprofen; 30      (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and (d) Water 2021275584   25 Jun 2026 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; 5       (d) 5 - 25% w / w Polyethylene glycol; and (e) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, 10 the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; 15       (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; (d) 4 - 8% w / w Polyethylene glycol; and (e) Water wherein the unit dose weight of the formulation can be about 300 - 420mg. 20 Typically, the unit dose weight of the formulation can be about 320 - 400mg. More typically, the unit dose weight of the formulation can be about 340 - 380mg. Most typically, the unit dose weight of the formulation can be about 360 - 370mg. 25 The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. The polyethylene glycol can be selected from polyethylene glycols having a number average 30 molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. 2021275584   25 Jun 2026 The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the 5 composition can comprise polysorbate 80 and a polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. According to an aspect of the present invention there is provided a composition comprising: (a) 50 - 65% w / w ibuprofen; 10      (b) 25 - 45% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water wherein the unit dose weight of the formulation can be about 600 - 840mg. 15 Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. Preferably, the composition can comprise: 20      (a) 50 - 60% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water. 25 The composition can comprise: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and 30       (e) Water. wherein the unit dose weight of the formulation can be about 600 - 840mg. 2021275584   25 Jun 2026 Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. 5 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water 10      wherein the unit dose weight of the formulation can be about 600 - 840mg. Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. 15 Preferably the composition can consist essentially of: (a) 52 - 55% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and 20       (d) Water. The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; 25 (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and (e) Water wherein the unit dose weight of the formulation can be about 600 - 840mg. 30 Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. 2021275584   25 Jun 2026 The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; 5       (d) 4 - 8% w / w Polyethylene glycol; and (e) Water wherein the unit dose weight of the formulation can be about 600 - 840mg. Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, 10 the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; 15       (b) 25 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 8% w / w A hydroxide; and (d) Water wherein the unit dose weight of the formulation can be about 600 - 840mg. 20 Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. Preferably,the composition can consist essentially of: 25       (a) 52 - 55% w / w ibuprofen; (b) 35 - 40% w / w One or more polyoxysorbitan esters; (c) 3 - 5% w / w A hydroxide; and (d) Water. 30 The composition can consist essentially of: (a) 50 - 65% w / w ibuprofen; (b) 5 - 35% w / w One or more polyoxysorbitan esters; 2021275584   25 Jun 2026 (c) 5 - 10% w / w A hydroxide; (d) 5 - 25% w / w Polyethylene glycol; and (e) Water. wherein the unit dose weight of the formulation can be about 600 - 840mg. 5 Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit dose weight of the formulation can be about 720 - 740mg. 10 The composition can consist essentially of: (a) 50 - 55% w / w ibuprofen; (b) 30 - 35% w / w One or more polyoxysorbitan esters; (c) 5 - 8% w / w A hydroxide; (d) 4 - 8% w / w Polyethylene glycol; and 15       (e) Water wherein the unit dose weight of the formulation can be about 600 - 840mg. Typically, The unit dose weight of the formulation can be about 640 - 800mg. More typically, the unit dose weight of the formulation can be about 680 - 760mg. Most preferably, the unit 20 dose weight of the formulation can be about 720 - 740mg. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. 25 The polyethylene glycol can be selected from polyethylene glycols having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. 30 The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a 2021275584   25 Jun 2026 number average molecular weight (Mn) of from about 400 to about 800. Preferably the composition can comprise polysorbate 80 and a polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. 5 According to an aspect of the present invention there is provided a soft gelatin capsule which contains a composition as described in any of the previous aspects. According to an aspect of the present invention there is provided a soft gelatin capsule comprising a composition containing ibuprofen as described in the previous aspects wherein 10 the composition allows for less than 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2 . Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH 15 of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised 20 within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 25 According to an aspect of the present invention there is provided a soft gelatin capsule comprising a composition of ibuprofen wherein the composition allows for at least 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2 . 30 Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be 2021275584   25 Jun 2026 solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised 5 within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 10 According to an aspect of the present invention there is provided a composition for a soft-gel capsule which comprises ibuprofen and a solvent system wherein the solvent system comprises: a) from about 60 to about 90% w / w of one or more polyoxysorbitan esters; b) from about 5 to about 25% w / w of potassium hydroxide; and 15       c) water. Typically, the solvent system comprises: a) from about 75 to about 85% w / w of one or more polyoxysorbitan esters; b) from about 10 to about 15% w / w of potassium hydroxide; and 20       c) water. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. 25 Typically, the unit dose weight of the formulation is about 300 - 420mg. More typically, the unit dose weight of the formulation is about 320 - 400mg. Even more typically, the unit dose weight of the formulation is about 340 - 380mg. Most typically, the unit dose weight of the formulation is about 370mg. 30 Typically, the composition has a release rate for ibuprofen of at least 5% in 5mins. More typically, the composition has a release rate of at least 10% in 5mins. 2021275584   25 Jun 2026 Preferably the composition allows for at least 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 5 Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 10 Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric 15 fluid at a pH of 1.2. According to an aspect of the present invention there is provided a soft-gel capsule which contains a composition which can comprise ibuprofen and a solvent system wherein the solvent system comprises: 20      a) from about 60 to about 90% w / w of one or more polyoxysorbitan esters; b) from about 5 to about 25% w / w of potassium hydroxide; and c) water wherein the composition has a weight of 300 - 420mg and wherein the composition has a release rate for ibuprofen of at least 5% in 5mins. 25 Preferably the composition allows for at least 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 30 Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be 2021275584   25 Jun 2026 solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised 5 within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 10 The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. According to an aspect of the present invention there is provided a composition for a soft-gel 15 capsule contains a composition which comprises ibuprofen and a solvent system wherein the solvent system comprises: a) from about 4 to about 55% w / w polyethylene glycol; b) from about 10 to about 60% w / w of one or more polyoxysorbitan esters; c) from about 4 to about 20% w / w of potassium hydroxide; 20          d) and water. Typically, the solvent system comprises: a) from about 4 to about 8% w / w polyethylene glycol; b) from about 15 to about 20% w / w of one or more polyoxysorbitan esters; 25      c) from about 4 to about 8% w / w of potassium hydroxide; d) and water. Typically, the unit dose weight of the composition is about 300 - 420mg. More typically, the unit dose weight of the composition is about 320 - 400mg. Even more typically, the unit dose 30 weight of the composition is about 340 - 380mg. Most typically, the unit dose weight of the composition is about 370mg. 2021275584   25 Jun 2026 Typically, the composition has a release rate for ibuprofen of at least 5% in 5mins. More typically, the composition has a release rate of at least 10% in 5mins. Preferably the composition allows for at least 5% of the ibuprofen dose to be solubilised 5 within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH 10 of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised 15 within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 20 The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. The polyethylene glycol can be selected from polyethylene glycols having a number average 25 molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 30   80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the 2021275584   25 Jun 2026 composition can comprise polysorbate 80 and a polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. According to an aspect of the present invention there is provided a soft-gel capsule containing 5 a composition which can comprise: (a) 50 - 60% w / w ibuprofen; (b) 25 - 35% w / w of one or more polyoxysorbitan esters; (c) 4 - 6% w / w A hydroxide; (d) 5 - 8% w / w Polyethylene glycol; and 10       (e) Water wherein the composition has a weight of 300 - 420mg and wherein the composition has a release rate for ibuprofen of at least 5% in 5mins. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 15   40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. The polyethylene glycol can be selected from polyethylene glycols having a number average molecular weight (Mn) of from about 400 to about 800. Preferably the polyethylene glycol 20 can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. The composition can comprise a poloxysorbitan ester selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120 and a polyethylene glycol having a 25 number average molecular weight (Mn) of from about 400 to about 800. Preferably the composition can comprise polysorbate 80 and a polyethylene glycol can have a number average molecular weight (Mn) of 400 or 600 or a combination thereof. According to an aspect of the present invention there is provided a soft-gel capsule containing 30 a composition which can comprise: (a) 50 - 60% w / w ibuprofen; (b) 35 - 40% w / w of one or more polyoxysorbitan esters; 2021275584   25 Jun 2026 (c) 3 - 6% w / w a hydroxide; and (d) Water wherein the composition has a weight of 300 - 420mg and wherein the composition has a release rate for ibuprofen of at least 5% in 5mins. 5 Preferably the composition allows for at least 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 10 Preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 10% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. 15 Preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 10 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2. More preferably the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric 20 fluid at a pH of 1.2. The polyoxysorbitan ester can be selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120. Preferably, the polyoxysorbitan ester is polysorbate 80. 25 As used herein the reference to the solubilisation of ibuprofen refers to the release and solubilisation of an amount of the ibuprofen dose in simulated gastric fluid. For example, when the composition allows for the release and solubilisation of 5% of the ibuprofen dose within 5 minutes this means that within 5 minutes of immersion in simulated gastric fluid 5% 30 of the ibuprofen dose is in solution. For example, if the ibuprofen dose is 100mg then 5mg of the ibuprofen will have been both released from the capsule and solubilised. An additional 2021275584   25 Jun 2026 amount may have been released but will not have been solubilised within the 5 minute period following immersion of the gelatin capsule. As used herein the reference to weight ratios refers to the perctange weight of the 5 components in the composition. For example, a composition having a 40% by weight of a first component and 40% by weight of a second component has a weight ratio of 1:1. As used herein the reference to the unit dose weight of the formulation refers to weight of the composition that would be filled into the gelatine shell. The terms ‘formulation’ and 10 ‘composition’ are used interchangeably and have the same meaning. For the avoidance of doubt, in accordance with the present invention it is the compositions which are for encapsulation within a gelatin shell that comprise the ibuprofen, polyoxysorbitan ester, polyethylene glycol and base and not the gelatin shell itself. 15 For the avoidance of doubt, the compositions described in the present specification are in the form of a liquid. Embodiments of the invention will now be described by way of example only with reference 20 to the accompanying Figures in which: Figures 1 & 2 illustrate release profiles for ibuprofen from compositions of the present invention and current commercially available soft gelatin capsules. 25 Tables 1 & 2 illustrate examples of the composition of the present invention. 2021275584   25 Jun 2026 Component Example 1 (%w / w) Example 2 (%w / w) Example 3 (%w / w) Ibuprofen 54.23 54.23 61.98 Polysorbate 80 37.63 35.93 28.73 KOH pellets 4.88 5.90 5.58 Purified water 3.26 3.94 3.71 Total 100 100.00 100.00 Table 1 Component Example 4 (% w / w) Example 5 (% w / w) Ibuprofen 54.23 61.98 Polysorbate 80 30.57 20.63 PEG 400 6.25 6.545 KOH Pellets 5.37 6.505 Water 3.58 4.34 Total 100.00 100.00 Table 2 10 The formulation can be made using standard techniques known to the person of ordinary skill in the art. The polysorbate is initially heated to a temperature of 550C. When polyethylene glycol is used the two materials are mixed together while heating to the same temperature. A portion of ibuprofen is added followed by a portion of aqueous potassium hydroxide 15 solution while maintaining the heating. Once a homogenous solution has been achieved, the remaining ibuprofen and aqueous potassium hydroxide solution are added with continued heating. The resulting mixture is then stirred until a clear solution is obtained. The resulting solution can be stored until required for encapsulation in a gelatin capsule. 20 Similarly, the formulation can be encapsulated using standard soft gelatin encapsulation techniques well-known to the person skilled in the art. For example, the composition of the present invention can be deposited between two opposing ribbons of a gel composition. The composition of the ribbons may include gelatin and plasticisers such as glycerine and sorbitol and mixtures thereof. For example, a suitable gel composition can comprise about 35 - 50% 2021275584   25 Jun 2026 by weight of gelatin, 20 - 40% by weight of a plasticiser and 25 - 50% by weight of water. The opposing ribbons are then run between two die rollers having die pockets thereon the surface of which corresponds to the configuration of the desired soft capsule. The composition is sealed within the fused casing. 5 The soft gelatin capsules were filled with compositions containing the standard dose of 200mg of ibuprofen, i.e. in the examples above the amount of ibuprofen is 200mg. As can be seen from Figure 1 and Table 3 below, the compositions of Examples 1 - 3 release 10 the ibuprofen unexpectedly and significantly quicker than a current commercial product tested under the same conditions. As can be seen from Figure 2 and Table 4 below, the compositions of Examples 4 and 5 release the ibuprofen at a rate that matches that of a current commercial example. Time Example 1 Example 2 Example 3 Commercial Example 0.0 0.0 0.0 0.0 0.0 5.0 14.8 3.9 4.9 1.43 10.0 18.6 8.3 6.3 3.1 15.0 21 10.1 6.6 4.5 20.0 22.1 11.2 7.4 5.87 30.0 23.3 11.9 8 6.63 45.0 24.6 13.0 9.7 7.6 60.0 26 13.3 11.3 9.23 Table 3 15 Time Example 4 Example 5 Commercial Example 0.0 0.0 0.0 0.0 5.0 3.0 3.5 1.43 10.0 4.4 5.0 3.1 15.0 5.1 5.4 4.5 20.0 5.7 5.7 5.87 30.0 6.8 6.5 6.63 45.0 7.6 7.3 7.6 60.0 8.3 7.5 9.23 Table 4 2021275584   25 Jun 2026 The release rate of the compositions of the present invention were determined by immersing the compositions in a gelatin capsule in simulated gastic fluid. The compositions were immersed into a beaker / container containing 900ml of the simulatied gastric fluid at a temperature of 370C. The pH of the simulated gastric fluid was 1.2. 5 An advantage of the present invention is that there is provided a stable ibuprofen-containing composition which is suitable for encapsulation in a soft gelatin capsule and which releases the ibuprofen in a more solubilisable form than standard ibuprofen-containing soft gelatin capsules. A further advantage is provided with the ability to use a lower amount of base 10 within the formulation whilst improving the solubilisation of the ibuprofen in simulated gastric fluid. Further modifications can be made without departing from the scope of the invention described herein. 15 The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that such prior art forms part of the common general knowledge. 20 It will be understood that the terms “comprise” and “include” and any of their derivatives (e.g. comprises, comprising, includes, including) as used in this specification, and the claims that follow, is to be taken to be inclusive of features to which the term refers, and is not meant to exclude the presence of any additional features unless otherwise stated or implied. 25

Claims

1. A composition for encapsulation in a soft gelatin shell which comprises ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is from 0.4:1 - 0.8:1, the weight ratio of the base to ibuprofen is from 1:8 - 1:15 and the weight ratio of the one or more polyoxysorbitan esters to base is 3:1 - 9:1 and wherein the ibuprofen is present at an amount of 50% - 65% w / w.

2. A composition as claimed in Claim 1, wherein the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 - 0.7:1.

3. A composition as claimed in Claim 1 or Claim 2, wherein the weight ratio of base to ibuprofen is 1:9 - 1:11.5.

4. A composition as claimed in any one of the preceding Claims, wherein the weight ratio of the one or more polyoxysorbitan esters to base is 5.5:1 - 7.75:1.

5. A composition as claimed in any one of the preceding Claims, wherein the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 - 0.7:1, the weight ratio of base to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to base is 5.5:1 - 7.75:1.

6. A composition as claimed in any one of the preceding Claims, wherein the composition comprises ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the ibuprofen: the one or more polyoxysorbitan esters:base is about 6 - 20:1 - 13:1.

7. A composition as claimed in Claim 6, wherein the composition comprises ibuprofen, one or more polyoxysorbitan esters and a base wherein the weight ratio of the ibuprofen: the one or more polyoxysorbitan esters:base is about 9 - 12:5 - 8:1.

8. A composition as claimed in any one of the preceding Claims, wherein the composition further comprises water in an amount from about 2% w / w to about 10% w / w.2021275584   25 Jun 20269. A composition as claimed in any one of the preceding Claims, wherein the composition comprises ibuprofen, one or more polyoxysorbitan esters and a hydroxide wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more polyoxysorbitan esters is present at an amount of 30 - 40% w / w, the hydroxide is present at an amount of 3 - 10% w / w, and the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 - 0.7:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5.5:1 -7.75:1.

10. A composition as claimed in Claim 9, wherein the composition comprises ibuprofen, one or more polyoxysorbitan esters and a hydroxide wherein ibuprofen is present at an amount of 50 - 65% w / w, the one or more polyoxysorbitan esters is present at an amount of 30 - 40% w / w, the hydroxide is present at an amount of 4 - 7% w / w, and the weight ratio of the one or more polyoxysorbitan esters to ibuprofen is 0.5:1 -0.7:1, the weight ratio of hydroxide to ibuprofen is 1:9 - 1:11.5 and the weight ratio of the one or more polyoxysorbitan esters to hydroxide is 5.5:1 - 7.75:1.

11. A composition as claimed in any one of the preceding Claims, wherein the unit dose weight of the composition is about 300 - 420mg.E12. A composition as claimed in Claim 11, wherein the unit dose weight of the composition is about 340 - 380mg13. A composition as claimed in any one of Claims 1 - 10, wherein the unit dose has a fill volume of from 0.3ml to 0.42ml.

14. A composition as claimed in any one of Claims 1 - 10, wherein the unit dose weight of the formulation is about 600 - 840mg.

15. A composition as claimed in Claim 14, wherein the unit dose weight of the formulation is about 680 - 760mg.2021275584   25 Jun 202616. A composition as claimed in any one of Claim 1 - 10, wherein the unit dose has a fill volume of from 0.6ml to 0.84ml.

17. A composition consisting essentially of:(a)    50 - 65% w / w ibuprofen;(b)    25 - 40% w / w One or more polyoxysorbitan esters;(c)    3 - 8% w / w A hydroxide; and(d)    Waterwherein the volume of the unit dose of the composition is from about 0.3ml to about0.42ml.

18. A composition as claimed in Claim 17, wherein the composition consists essentially of:(a)    52 - 55% w / w ibuprofen;(b)    35 - 40% w / w One or more polyoxysorbitan esters;(c)    3 - 5% w / w A hydroxide; and(d)    Waterwherein the volume of the unit dose of the composition is from about 0.3ml to about0.42ml.

19. A composition consisting essentially of:(a) 50 - 65% w / w ibuprofen;(b) 25 - 40% w / w One or more polyoxysorbitan esters;(c) 3 - 8% w / w      A hydroxide; and(d) Waterwherein the volume of the unit dose of the composition is from about 0.6ml to about0.84ml.

20. A composition as claimed in Claim 19, wherein the composition consists essentially of:(a) 52 - 55% w / w(b 35 - 40% w / w(c) 3 - 5% w / wibuprofen;One or more polyoxysorbitan esters;A hydroxide; and(d) Water2021275584   25 Jun 2026wherein the volume of the unit dose of the composition is from about 0.6ml to about 0.84ml.

21. A composition as claimed in any one of Claims 1 - 20, wherein the composition has a release rate for ibuprofen of at least 5% in 5mins.

22. A composition as claimed in Claim 21, wherein the composition has a release rate of at least 10% in 5 mins.

23. A soft gelatin capsule which contains a composition as claimed in any one of Claims 1 - 22.

24. A soft gelatin capsule comprising a composition as claimed in Claim 23, wherein the composition allows for at least 5% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2.

25. A soft gelatin capsule as claimed in Claim 23 or Claim 24, wherein the composition allows for at least 15% of the ibuprofen dose to be solubilised within 5 minutes of immersion of the soft gelatine capsule in simulated gastric fluid at a pH of 1.2.

26. A composition as claimed in any one of Claims 1 - 22 or a soft-gel capsule as claimed in any one of Claims 23 - 25, wherein the polyoxysorbitan ester is selected from polysorbate 20, polysorbate 21, polysorbate 40, polysorbate 60, polysorbate 61, polysorbate 65, polysorbate 80, polysorbate 81, polysorbate 85 or polysorbate 120.

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