GB2591425A

GB2591425A - Food supplement

Info

Publication number: GB2591425A
Application number: GB1905164.8A
Authority: GB
Inventors: Evan Caplin Martyn
Original assignee: Profbiotics Ltd
Current assignee: Profbiotics Ltd
Priority date: 2019-04-11
Filing date: 2019-04-11
Publication date: 2021-08-04
Also published as: GB201905164D0

Abstract

The invention relates to a composition for a food supplement for daily administration, comprising per average daily dose: from approximately 50 mg to approximately 2000 mg of curcuminoids; from approximately 50 mg to approximately 500 mg of omega-3 fatty 5 acids, of omega-6 fatty acids or of a combination of omega-3 and omega-6 fatty acids; from approximately 10 mg to approximately 2000 mg of vitamin C; from approximately 22 mg to approximately 3000 mg of choline; from approximately 15 IU to approximately 150 IU of vitamin E; and from approximately 920 IU to approximately 4000 IU of vitamin D. The use of the composition to treat respiratory diseases is claimed.

Description

Food supplement The present invention relates to compositions for food supplements and in particular, but not exclusively, to compositions for food supplements that may be used to mitigate the risks to health from the ingestion of airborne toxins and pollutants manifesting as respiratory complications or other diseases.

More particularly, the compositions of the present invention are believed to provide protection against airway inflammation caused by air pollution, help protect asthma and chronic obstructive pulmonary disease (COPD) sufferers from the harmful effects of outdoor and indoor air pollution, provide antioxidant protection from air pollutants and generally support a person's health when in a polluted environment.

The World Health Organisation (WHO) released a report in 2014 indicating that 3.7 million premature deaths globally were attributable to ambient air pollution. The majority of outdoor pollutants come from anthropogenic sources such as vehicle emissions, fossil fuel combustion, forest fires and industrial processes including factory outputs. The WHO showed that in urban areas which monitor air pollution levels, greater than 80% of people are exposed to levels of pollution which exceed WHO limits. Primary pollutants can be divided into two groups: particulate matter (PM) and gases (002, CO, NO2, NO, NON, 302).

Secondary pollutants such as ozone are formed from photochemical reactions between the primary pollutants, heat and UV radiation. Other environmental air pollutants of major public concern include polycyclic aromatic hydrocarbons (PAHs) and aryl hydrocarbon receptors (AhR).

There has been increasing research on the effects of ambient pollution on health. Pollution causes damage when it is in contact with the airways and skin. For example, some pollutants can accumulate in the blood and be distributed in digestive organs, purely through inhalation. Pollutants also act on the exterior of the body and have been linked to the progression of inflammatory skin diseases. Many studies have demonstrated the effects of exposure to environmental pollutants via skin, inhalation or ingestion on morbidity and mortality. The lungs rely on filtered air through the nose (with cilia and mucus attempting to filter/trap unwanted particles) or unfiltered air via the mouth. Polluted air contributes to chronic obstructive pulmonary disease (COPD) prevalence and symptom onset. The idea that air pollution can cause exacerbations of pre-existing asthma is supported by an evidence base that has been accumulating for several decades, however it has more recently been suggested that air pollution might cause new-onset asthma as well.

Oxidative stress, resulting from an imbalance between reactive oxidant species and antioxidants, can lead to tissue damage, airway inflammation with increased asthma severity and abnormal immune responses. Evidence increasingly suggests that poor diet, including clinical malnutrition may increase the risk for oxidative stress and chronic diseases. Nutrition is known to play a significant role in the prevention and management of these same chronic diseases.

The present inventor is a co-author of a review paper entitled 'Pollution and respiratory disease: can diet or supplements help? A review' (WHYAND, T. et a/. Respiratory Research. May 2018, Vol. 19, No. 79, ISSN 1465-993X).

The present invention seeks to provide a food supplement which may be used to mitigate the risks to health from the ingestion of airborne toxins and pollutants manifesting as respiratory complications or other diseases.

In a first aspect of the present invention there is provided a composition for a food supplement for daily administration. The composition comprises per average daily dose: a) from approximately 50 mg to approximately 2,000 mg of curcuminoids; b) from approximately 50 mg to approximately 500 mg of fatty acids selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) from approximately 10 mg to approximately 2,000 mg of vitamin C; d) from approximately 22 mg to approximately 3,000 mg of choline; e) from approximately 15 IU to approximately 150 IU of vitamin E; and f) from approximately 920 IU to approximately 4,000 IU of vitamin D. 30 In one embodiment the composition comprises per average daily dose: a) from approximately 75 mg to approximately 1,000 mg of curcuminoids; b) from approximately 75 mg to approximately 350 mg of fatty acids selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) from approximately 50 mg to approximately 1,000 mg of vitamin C; d) from approximately 22 mg to approximately 1,640 mg of choline; e) from approximately 20 IU to approximately 100 IU of vitamin E; and f) from approximately 920 IU to approximately 2,500 IU of vitamin D. According to the present invention there is also provided a composition for a food supplement, the composition comprising an active component consisting of: a) curcuminoids in an amount of between 23 % and 29 % by mass relative to the total mass of the active component; b) fatty acids in an amount of between 35 % and 42 % by mass relative to the total mass of the active component, wherein the fatty acids are selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) vitamin C in an amount of between 23 % and 28 % by mass relative to the total mass of the active component; d) choline in an amount of between 6 % and 7 % by mass relative to the total mass of the active component; e) vitamin E in an amount of between 4 % and 5 % by mass relative to the total mass of the active component; and f) vitamin D in an amount of between 0.005 % and 0.007 % by mass relative to the total mass of the active component.

The term "active component' as used herein relates to components a) to f) of the composition listed above. Other components of the composition may include other (non-claimed) active components and/or inactive components. These other components may include excipients.

According to the present invention there is also provided a composition for a food supplement, the composition comprising an active component consisting of: a) curcuminoids in an amount of 25.4% by mass plus or minus 7.5% relative to the total mass of the active component; b) fatty acids in an amount of 38.2% by mass plus or minus 7.5% relative to the total mass of the active component, wherein the fatty acids are selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) vitamin C in an amount of 25.4% by mass plus or minus 7.5% relative to the total mass of the active component; d) choline in an amount of 6.4% by mass plus or minus 7.5% relative to the total mass of the active component; e) vitamin E in an amount of 4.6% by mass plus or minus 7.5% relative to the total mass of the active component; and f) vitamin D in an amount of 0.006 % by mass plus or minus 7.5% relative to the total mass of the active component.

The curcuminoids are preferably provided in the form of a turmeric extract powder.

The omega-3 fatty acids may be provided from marine sources (for example) such as fish oil(s) or microalgae. The omega-6 fatty acids may be provided in plant oils (for example). When omega-6 fatty acids are used in combination with omega-3 fatty acids, a greater relative amount of omega-3 fatty acids is present compared to omega-6 fatty acids.

The vitamin D is preferably vitamin 03.

In one embodiment, the composition comprises an average daily dosage of approximately 100 mg of curcuminoids, 150 mg of omega-3, 100 mg of vitamin C, 25 mg of choline, 271U of vitamin E, and 1,000 IU of vitamin D, where IU means International Unit.

In another embodiment, the composition comprises an average daily dosage of approximately 500 mg of turmeric extract powder, 500 mg of fish oils containing approximately 30% omega-3, 103 mg of ascorbic acid, 61 mg of choline bitartrate, 22.32 mg of cholecalciferol (vitamin E), 10 mg of D-alpha-tocopheryl acid succinate (vitamin D3), and 60 mg of rice bran.

Depending on the dosage form and the manufacturing process, the amounts of the ingredients within the composition may vary from the target amount. For example, where the composition is formulated as a capsule using a semi-automatic capsule filling machine, the semi-automatic capsule filling machine will typically fill the capsule to a tolerance of +17.5 %. Accordingly, the amount of each ingredient in the composition may vary from the nominal value by approximately +1-7.5 %.

The composition is preferably formulated as one or more dosage forms, and most preferably as two dosage forms. The dosage forms are preferably capsules. The dosage forms may be two-piece (eg two-piece capsules) and/or may be formed of hydroxypropylmethyl cellulose (HPMC). Tablets, lozenges, pastilles, caplets and pills are also envisaged as dosage forms. The composition is administered orally.

In a second aspect of the present invention, there is provided a composition according to the first aspect for use as medicament. In a preferred embodiment, there is provided a composition according to the first aspect for use in the treatment or prevention of respiratory diseases, for example respiratory diseases arising from air pollution.

In a third aspect of the present invention, there is provided a composition according to the first aspect, for use according to the second aspect, wherein the composition is administered orally, preferably in the form of one or more dosage forms. Most preferably, the composition is administered orally at a dosage of two capsules per day.

Reference will now be made in detail to non-limiting embodiments of the present invention, with examples of the composition according to preferred embodiments being 20 given.

Compositions for food supplements have been developed by the present inventor for use in the treatment and prevention of respiratory diseases arising from increased levels of air pollution.

The present invention is directed to compositions for food supplements comprising the following components: a) curcuminoids; b) fatty acids selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) choline; d) vitamin C; e) vitamin D; and f) vitamin E The amount of curcuminoids present in the composition is between approximately 50 mg and approximately 2,000 mg per average daily dose. More preferably, the amount of curcuminoids present in the composition is between approximately 75 mg and approximately 1,000 mg per average daily dose. Most preferably, the amount of curcuminoids present in the composition is between approximately 92 mg and approximately 108 mg per average daily dose and in one example is approximately 100 mg per average daily dose.

The curcuminoids are preferably provided as a turmeric extract powder. Turmeric extract powders are commonly optimised to enhance the absorption, biodistribution, metabolism, and bioavailability of curcuminoids in the human body. An example of a commercially available optimised turmeric extract powder is CurcuWIN TM. This powder is available from OmniActive Health Technologies, Inc, USA.

The turmeric extract powder preferably comprises approximately 20 % (w/w) of curcuminoids as an active ingredient. The other components in the turmeric extract powder sold under the trade mark CurcuWIN TM are inactive components for the purposes of the present invention.

Accordingly, a preferred embodiment of the composition according to the present invention comprises between approximately 250 mg and approximately 10,000 mg of turmeric extract powder per average daily dose. More preferably, the composition comprises between approximately 375 mg and approximately 5,000 mg of turmeric extract powder per average daily dose. Most preferably, the composition comprises between approximately 460 mg and approximately 540 mg of turmeric extract powder per average daily dose and in one example comprises approximately 500 mg of turmeric extract powder per average daily dose.

Where the composition comprises turmeric extract powder, the composition may be coloured orange.

The total amount of omega-3 and/or omega-6 fatty acids present in the composition is between approximately 50 mg and approximately 500 mg per average daily dose. More preferably, the total amount of omega-3 and/or omega-6 fatty acids present in the composition is between approximately 75 mg and approximately 350 mg per average daily dose. Most preferably, the amount of omega-3 and/or omega-6 fatty acids present in the composition is between approximately 138 mg and approximately 162 mg per average daily dose and in one example is approximately 150 mg per average daily dose.

The omega-3 fatty acids may be one or more of eicosapentaenoic acid (EPA; 20:5,n-3) and docosahexaenoic acid (DHA; 22:6,n-3). The omega-6 fatty acids may be one or more of gamma-linolenic acid (GLA; 18:3,n-6), dihomo-gamma-linolenic acid (DGLA; 20:3,n-6), or arachidonic acid (AA; 20:4,n-6).

The fatty acid is preferably one or more omega-3 fatty acids.

The omega-3 and/or omega-6 fatty acids are preferably provided in a fish oil or combination of fish oils. In a preferred embodiment of the present invention, the composition comprises between approximately 167 mg and approximately 1,667 mg of fish oil(s) per average daily dose. More preferably, the composition comprises between approximately 350 mg and approximately 1,000 mg of fish oil(s) per average daily dose. Most preferably, the composition comprises between approximately 460 mg and approximately 540 mg of fish oil(s) per average daily dose. In one example the composition comprises approximately 500 mg of fish oil(s) including omega-3 fatty acids.

The omega-3 fatty acid may be provided in the form of MEG3TM manufactured by DSM Nutritional Products Inc, USA. MEG-3TM is a powder containing a minimum of 60% fish oil. The fish oil contains about 30% omega-3 in the form of omega-3 eicosapentaenoic acid (EPA) and omega-3 docosahexaenoic acid (DHA). The powder therefore contains a minimum of 18% omega-3 fatty acids. The other components in the product sold under the trade mark MEG-3TM are inactive components for the purposes of the present invention.

The amount of choline present in the composition is between approximately 22 mg and approximately 3,000 mg per average daily dose. More preferably, the composition comprises between approximately 22 mg and approximately 1640 mg of choline per average daily dose. Most preferably, the amount of choline present in the composition is between approximately 22 mg and approximately 28 mg per average daily dose and in one example is approximately 25 mg per average daily dose.

Preferably, the composition comprises choline bitartrate, wherein choline accounts for 41 % by mass of the chemical composition of choline bitartrate. The composition according to the present invention preferably comprises between approximately 53 mg and approximately 7,317 mg of choline bitartrate per average daily dose. More preferably, the composition comprises between approximately 53 mg and approximately 4,000 mg of choline bitartrate per average daily dose. Most preferably, the composition comprises between approximately 53 mg and approximately 66 mg of choline bitartrate per average daily dose and in one example comprises approximately 61 mg of choline bitartrate per average daily dose.

The amount of vitamin C present in the composition is between approximately 10 mg and approximately 2,000 mg per average daily dose. More preferably, the amount of vitamin C present in the composition is between approximately 50 mg and approximately 1,000 mg per average daily dose. Most preferably, the amount of vitamin C present in the composition is between approximately 90 mg and approximately 110 mg per average daily dose and in one example is approximately 100 mg per average daily dose.

The amount of vitamin D present in the composition is between approximately 920 IU and approximately 4,000 IU per average daily dose. More preferably, the amount of vitamin D present in the composition is between approximately 920 IU and approximately 2,500 IU per average daily dose. Most preferably, the amount of vitamin D present in the composition is between approximately 920 IU and approximately 1080 IU per average daily dose and in one example is approximately 1,000 IU per average daily dose.

In a preferred embodiment, the vitamin D component consists of vitamin 03. 1 IU of vitamin 03 equates to a mass of 0.025 pg. Accordingly, the amount of vitamin D3 present in the composition is preferably between approximately 23 pg and approximately 100 pg per average daily dose. More preferably, the amount of vitamin D3 present in the composition is between approximately 23 pg and approximately 75 pg per average daily dose. Most preferably, the amount of vitamin D present in the composition is between approximately 23 pg and approximately 27 pg per average daily dose and in one example is approximately 25 pg per average daily dose.

The amount of vitamin E present in the composition is between approximately 15 IU and approximately 150 IU per average daily dose. More preferably, the amount of vitamin E present in the composition is between approximately 20 IU and approximately 100 IU per average daily dose. Most preferably, the amount of vitamin E present in the composition is between approximately 24 IU and approximately 30 IU per average daily dose and in one example is approximately 27 IU per average daily dose.

In a preferred embodiment, the vitamin E component is a natural form of vitamin E, most preferably D-alpha-tocopheryl acid succinate, wherein 1 IU of vitamin E equates to a mass of 0.67 mg. Accordingly, the amount of vitamin E present in the composition is between approximately 10 mg and approximately 100 mg per average daily dose. More preferably, the amount of vitamin E present in the composition is between approximately mg and approximately 50 mg per average daily dose. Most preferably, the amount of vitamin E present in the composition is between approximately 16 mg and approximately 20 mg per average daily dose and in one example is approximately 18 mg per average daily dose.

Compositions according to the present invention may comprise additional substances for the purpose of formulation of the compositions. For example, in preferred embodiments, the composition additionally comprises a flow excipient. Preferably, the flow excipient comprises rice bran. The amount of rice bran present in the composition is preferably between approximately 110 mg and approximately 130 mg per average daily dose, and more preferably between approximately 115 and approximately 125 mg per average daily dose. Most preferably, the amount of rice bran present in the composition is approximately 120 mg per average daily dose.

Table 1 provides details of compositions according to the present invention.

Table 2 provides details of a preferred composition according to the present invention.

Table 1 -nutritional profile of compositions according to the present invention, per average daily dose.

Ingredient Mass per average Active %Active Mass of active ingredient per daily dose Ingredient Ingredient daily dose Min Max Min Max Turmeric extract 250 mg 10,000 Curcuminoids 20 50 mg 2,000 mg powder mg Fish oil 167 mg 1,667 Omega-3 30 50 mg 500 mg mg Choline bitartrate 53 mg 7,317 Choline 41 22 mg 3,000 mg mg Ascorbic acid 10 mg 2,062 Vitamin C 97 10 mg 2,000 mg mg Cholecalciferol 9 mg 40 mg Vitamin D3 0.25 23 pg (920 IU) 100 pg (4,000 IU) D-alpha- 13 mg 124 mg Vitamin E 80.7 10 mg 100 mg tocopheryl acid (151U) (1501U) succinate Rice bran 110 mg 130 mg - - - -Table 2-nutritional profile of a preferred composition according to the present invention, per average daily dose.

Ingredient Mass per Active % Active Mass of active average Ingredient Ingredient ingredient daily dose Turmeric extract powder 500 mg Curcuminoids 20 100 mg Fish oil 500 mg Omega-3 30 150 mg Choline bitartrate 61 mg Choline 41 25 mg Ascorbic acid 103 mg Vitamin C 97 100 mg Cholecalciferol 10 mg Vitamin D3 0.25 25 pg (1000 IU) D-alpha-tocopheryl acid 22.32 mg Vitamin E 80.7 18 mg (27 I U) succinate Rice bran 120 mg Total mass 1316.32 mg - - -Compositions according to the present invention may be provided in any appropriate manner known in the art. Thus, according to the present invention, there is also provided a food supplement dosage form such as a capsule comprising a composition according to the first aspect of the present invention.

Preferably, a composition according to the present invention is provided as one or more dosage forms (eg capsules). The composition may be provided as a single dosage form, or alternatively the composition may be provided as a plurality of dosage forms, wherein each dosage form comprises a proportion of the composition, with the proportion being determined, at least in part, by the average daily dose of the composition.

Preferably, each dosage form is a capsule; more preferably a two-piece capsule.

The capsule may preferably be formed of hydroxypropylmethyl cellulose (HPMC). The capsule is preferably colourless and untinted. Accordingly, where the composition comprises turmeric extract powder, the capsule may be orange in appearance.

A method of manufacturing a composition for a food supplement according to the present invention is now described For each active ingredient of the composition, a raw ingredient comprising a known concentration of the active ingredient is obtained as a powder, and each powder is sampled and analysed prior to being dispensed. The raw ingredient powders are sifted and pre-mixed in the appropriate quantifies to provide a bulk composition powder having the active ingredients in relative quantities according to the desired average daily dose.

Any excipients are added to the bulk composition powder in the appropriate quantities.

The resulting composition is mixed and lubricated ready for encapsulation.

Two-piece capsules are filled with an appropriate amount of the pre-mixed bulk composition powder according to the desired average daily dose. Capsule filling may be carried out using a semi-automatic capsule filler. An example semi-automatic capsule filler which is suitable for use in the manufacture of a food supplement according to the present invention is a Model 10 capsule filling machine manufactured by Schaefer Technologies Inc, USA The capsule bodies are separated from the capsule caps, with the capsule bodies being seated within wells provided in a first turntable and the capsule caps being seated in corresponding wells of a second turntable. The capsule bodies are subsequently filled by discharging the powder from a hopper mounted over the first turntable. The first turntable is rotated to sequentially fill the capsule bodies. The amount of powder to be added to each capsule body may be controlled by adjusting the speed at which the first turntable rotates. The amount of powder to be added to each capsule may additionally be regulated by controlling the speed of an auger conveyor by which the powder is dispensed. The capsule caps are fitted to the capsule bodies by placing the first and second turntables together such that capsules bodies and caps are aligned, and applying pneumatic pressure to the turntables in order to close the capsules Quality control tests are conducted throughout the process to ensure the fill weights remain constant and that the capsules are closed correctly. The closed capsules are polished to remove any surplus powder, inspected and passed through a metal detector before being transferred onward for packaging.

In preferred embodiments, each capsule is filled with an amount of the bulk composition powder which contains half of the average daily dose, such that the average daily dose of the composition consists of two capsules. For example, in the preferred embodiment of Table 2 above, the total mass of the raw ingredients per average daily dose is approximately 1316 mg. Accordingly, each capsule is filled with approximately 658 mg of the bulk composition powder.

As mentioned above, the semi-automatic capsule filling machine will typically fill the capsule to a tolerance of approximately +/-7.5 %. Accordingly, the amount of each ingredient in the composition may vary from the nominal value by approximately +/-7.5 %.

It will be appreciated that capsule filling may alternatively be carried out using other semi-automatic capsule filling machines, fully automatic filling machines or by any other appropriate means.

The present invention provides a composition which may be used as a medicament, in particular for the treatment and/or prevention of respiratory diseases. A preferred dosage regime comprises oral administration of a daily dose of the composition once daily. The daily dose of the composition may be formulated a single dosage form, and thus the dosage regime comprises oral administration of one dosage form per day. However, in a preferred embodiment, the daily dose of the composition is formulated as two dosage forms, and thus the dosage regiment comprises oral administration of two dosage forms per day.

The invention has been described above with reference to specific embodiments, given by way of example only. It will be appreciated that variations of the disclosed embodiments are possible, which fall within the scope of the appended claims.

Claims

Claims 1. A composition for a food supplement for daily administration, comprising per average daily dose: a) from approximately 50 mg to approximately 2000 mg of curcuminoids; b) from approximately 50 mg to approximately 500 mg of fatty acids selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) from approximately 10 mg to approximately 2000 mg of vitamin C; d) from approximately 22 mg to approximately 3000 mg of choline; e) from approximately 15 IU to approximately 150 IU of vitamin E; and f) from approximately 920 IU to approximately 4000 IU of vitamin D.
2. A composition according to claim 1, comprising per average daily dose: a) from approximately 75 mg to approximately 1000 mg of curcuminoids; b) from approximately 75 mg to approximately 350 mg of fatty acids selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) from approximately 50 mg to approximately 1000 mg of vitamin C; d) from approximately 22 mg to approximately 1640 mg of choline; e) from approximately 20 IU to approximately 100 IU of vitamin E; and f) from approximately 920 IU to approximately 2500 IU of vitamin D.
3. A composition for a food supplement, the composition comprising an active component which comprises: a) curcuminoids in an amount of between 23 % and 29 % by mass relative to the total mass of the active component; b) fatty acids in an amount of between 35 To and 42 c/o by mass relative to the total mass of the active component, wherein the fatty acids are selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) vitamin C in an amount of between 23 % and 28 % by mass relative to the total mass of the active component; d) choline in an amount of between 6 % and 7 % by mass relative to the total mass of the active component; e) vitamin E in an amount of between 4 % and 5 cro by mass relative to the total mass of the active component; and f) vitamin D in an amount of between 0.005 % and 0.007 % by mass relative to the total mass of the active component. 5
4. A composition for a food supplement according to claim 1 or claim 2, the composition comprising an active component which comprises: a) curcuminoids in an amount of between 23 % and 29 % by mass relative to the total mass of the active component; b) fatty acids in an amount of between 35 % and 42 % by mass relative to the total mass of the active component, wherein the fatty acids are selected from the group consisting of omega-3 fatty acids, omega-6 fatty acids and mixtures thereof; c) vitamin C in an amount of between 23 % and 28 % by mass relative to the total mass of the active component; d) choline in an amount of between 6 % and 7 % by mass relative to the total mass of the active component; e) vitamin E in an amount of between 4 % and 5 % by mass relative to the total mass of the active component; and f) vitamin D in an amount of between 0.005 % and 0.007 % by mass relative to the total mass of the active component.
5. A composition according to any preceding claim, wherein the fatty acids are provided from marine sources and/or plant sources.
6. A composition according to any preceding claim, further comprising one or more excipients.
7. A composition according to any preceding claim, wherein the curcuminoids are provided in the form of turmeric extract powder.
8. A composition according to any preceding claim, wherein the vitamin D is vitamin D3.
9. A composition according to any preceding claim, wherein the composition is formulated as one or more dosage forms, optionally being in the form of one or more capsules.
10. A composition according to claim 9, wherein the composition is formulated as two dosage forms.
11. A composition according to any one of claims 1 to 10 for use as medicament.
12. A composition according to any one of claims 1 to 10 for use in the treatment or prevention of respiratory diseases.
13. A composition according to any one of claims 1 to 10, for use according to claim 11 or 12, wherein the composition is administered orally.