Emulsion

Abstract

The invention relates to an orally administrable chewable composition in unit dosage form comprising an oil-in-water emulsion in which the aqueous phase is gelled and in which the oil phase comprises a physiologically tolerable unsaturated fatty acid ester.

Claims

1. An orally administrable chewable composition in unit dosage form comprising a chewable, set, oil-in-water emulsion, in which the aqueous phase is gelled and constitutes about 50% to 60% wt. of the unit dosage form and in which the unit dosage from comprises about 40% wt. of a fish oil, wherein said aqueous phase comprises gelatin in an amount of about 10% to 25% wt. of the aqueous phase, and wherein the unit dosage form has an overall dose unit weight of 0.25 to 3 g, and wherein the composition, upon chewing, remains free of bad odor and taste.

2. The composition as claimed in claim 1 wherein said aqueous phase comprises gelatin and carageenan.

3. The composition as claimed in claim 1 further comprising at least 1% wt. xylitol.

4. The composition as claimed in claim 1 further comprising a citrus flavor.

5. The composition as claimed in claim 1 wherein said aqueous phase comprises a water soluble vitamin.

6. The composition as claimed in claim 1 in animal, doll, vehicle, rod, strip or tube shape.

7. A package comprising an air-tight compartment containing one dose unit of a composition as claimed in claim 1.

8. The package as claimed in claim 7 in the form of a blister pack.

9. A method of treatment of a human by oral administration of an effective amount of an active agent in oil form or dissolved in an oil comprising administering said active agent in a chewable composition according to claim 1.

10. The method as claimed in claim 9 wherein said active agent is an analgesic.

11. The method as claimed in claim 9 wherein said active agent is a triglyceride.

12. The composition as claimed in claim 1, wherein said aqueous phase comprises gelatin in an amount of about 10% wt. of the aqueous phase.

Description

EXAMPLE 1

(1) Chewable Emulsion

(2) Aqueous Phase:

(3) Gelatin: 10% wt. Sorbitol: 50% wt. Lemon flavour: 0.15% wt. Yellow color: 0.1% wt. Water: 100% wt.

(4) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 60 C. under continuous stirring for 45 min. The sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The flavour and color are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles. 0.02% wt. lecithin is added to this solution.

(5) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(6) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 45-50 C. using an ultra turrax. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 30 min at 22 C. The cores are dried to reduce the content of water to approximately 15% wt.

EXAMPLE 2

(7) Chewable Emulsion Shapes

(8) The emulsion is prepared as in Example 1 and filled into an animal shape mould using a syringe. The shapes are then sealed into a blister pack.

EXAMPLE 3

(9) Chewable Emulsion

(10) Aqueous phase:

(11) Gelatin: 10% wt. Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. 50% citric acid: 1% wt Water: to 100% wt.

(12) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 60 C. under continuous stirring for 45 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The acid, flavour and colour are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(13) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(14) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 45-50 C. using an ultra turrax. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 60 min at 22 C. The cores are dried to reduce the content of water to approximately 10% wt

EXAMPLE 4

(15) Chewable Emulsion

(16) Aqueous Phase:

(17) Gelatin: 10% wt. Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. 50% citric acid: 1% wt Water: to 100% wt.

(18) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 60 C. under continuous stirring for 45 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The acid, flavour and colour are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(19) Olive oil (e.g. commercially available Ybarra oil) is mixed with 0.15% wt. lemon flavour.

(20) The oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 45-50 C. using an ultra turrax. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 60 min at 22 C. The cores are dried to reduce the content of water to approximately 10% wt.

EXAMPLE 5

(21) Chewable Emulsion

(22) Aqueous Phase:

(23) Gelatin: 10% wt. Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. 50% citric acid: 1% wt Water: to 100% wt.

(24) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 60 C. under continuous stirring for 45 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The acid, flavour and colour are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(25) Rapeseed oil (Landlord REMA 1000) is mixed with 0.15% wt. lemon flavour.

(26) The oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 45-50 C. using an ultra turrax. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 60 min at 22 C. The cores are dried to reduce the content of water to approximately 10% wt.

EXAMPLE 6

(27) Chewable Emulsion

(28) Aqueous Phase:

(29) Fish gelatin: 10% wt. Kappa-carrageenan: 0.5% wt Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. Water: to 100% wt.

(30) The kappa-carrageenan and fish gelatin is added to the water and allowed to swell for 30 min. The mixture is then heated to 90 C. under continuous stirring for 45 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min at 70 C. The flavour and colour are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(31) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(32) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 45-50 C. using an ultra turrax. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 12 hours at 4 C. The cores are dried at room temperature to reduce the content of water to approximately 10% wt

EXAMPLE 7

(33) Chewable Emulsion

(34) Aqueous Phase:

(35) Gellan: 0.5% wt Xylitol: 36% wt Sorbitol: 14% wt. Water: to 100% wt.

(36) CaCl2-solution: 15 mM in the water phase

(37) The gellan is added to the water and the mixture is then heated to 95 C. under continuous stirring for 30 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min at 70 C. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(38) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(39) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 60 C. using an ultra turrax. When the emulsion is smooth CaCI2 is added to a final concentration of 15 mM and soft cores are produced by moulding and left to gel for 180 min at 4 C. The cores are dried at room temperature to reduce the content of water to approximately 10% wt.

EXAMPLE 8

(40) Chewable Emulsion

(41) Aqueous Phase:

(42) Gelatin: 7.5% Xylitol: 36% wt Sorbitol: 14% wt. 50% citric acid: 1% wt Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. Water: to 100% wt.

(43) Paracetamol: 125 mg/1.5 g emulsion

(44) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 60 C. under continuous stirring for 45 min. The acid, xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The flavour and colour are then added while stirring. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min. The resultant solution is degassed under vacuum to remove air bubbles.

(45) Olive oil is mixed with 0.15% wt. lemon flavour.

(46) The olive oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 60 C. using an ultra turrax. When the emulsion is smooth paracetamol powder is mixed into the emulsion with a ultra turrax and soft cores are produced by moulding and left to gel for 180 min at 200C. The cores are dried at room temperature to reduce the content of water to approximately 10% wt.

EXAMPLE 9

(47) Chewable Emulsion

(48) Aqueous Phase:

(49) Na-alginate: 0.5% wt Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. Water: to 100% wt. GDL: 30 mM CaCO.sub.3:15 mM

(50) The alginate is added to the water and dissolved under continuous stirring at room temperature for 6 hours. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min at 70 C. The solution is cooled to room temperature and flavour and colour is added. The resultant solution is degassed under vacuum to remove air bubbles.

(51) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(52) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at room temperature using an ultra turrax. When the emulsion is smooth the CaCO.sub.3 and GDL powders are added (one by one) and mixed into the emulsion by the ultra turrax. Soft cores are produced by moulding and left to gel for 24 hours at room temperature. The cores are dried at room temperature to reduce the content of water to approximately 10% wt

EXAMPLE 10

(53) Chewable Emulsion

(54) Aqueous Phase:

(55) Na-alginate: 0.5% wt Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. Water: to 100% wt. Calsiumsulphate (CaSO.sub.42H.sub.2O): 0.3% Tetrasodiumpyrophosphate (Na.sub.4P.sub.2O.sub.7): 0.03%

(56) The alginate is added to the water and dissolved under continuous stirring at room temperature for 6 hours. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min at 70 C. The solution is cooled to room temperature and flavour and colour is added. The resultant solution is degassed under vacuum to remove air bubbles.

(57) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(58) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at room temperature using an ultra turrax. When the emulsion is smooth the CaSO4 and tetrasodiumpyrophosphate powders are added (one by one) and mixed into the emulsion by the ultra turrax. Soft cores are produced by moulding and left to gel for 24 hours at room temperature. The cores are dried at room temperature to reduce the content of water to approximately 10% wt.

EXAMPLE 11

(59) Chewable Emulsion

(60) Aqueous Phase:

(61) Gelatin: 10% wt. Xylitol: 36% wt Sorbitol: 14% wt. Lemon flavour: 0.15% wt. Yellow colour: 0.1% wt. 50% citric acid: 1% wt Water: to 100% wt. Vitamin C (ascorbic acid): 10 g

(62) The gelatin is added to the water and allowed to swell for 30 min. The gelatin solution is then heated to 70 C. under continuous stirring for 45 min. The xylitol and sorbitol is then added to the solution and allowed to dissolve under stirring for 30-60 min. The acid, flavour and colour are then added while stirring. The temperature is lowered to 50 C. and the vitamin C powder is added to the solution. The solution is mixed for 30 min before stirring is stopped and the solution is left for 30 min.

(63) Marine oil (e.g. commercially available fish liver oil) is mixed with 0.15% wt. lemon flavour.

(64) The marine oil and the aqueous solution are emulsified in a weight ratio of 1:2 at 40-45 C. using an ultra turrax. The resultant emulsion is degassed under vacuum to remove air bubbles. When the emulsion is smooth, soft cores are produced by moulding and left to gel for 60 min at 22 C. The cores are dried to reduce the content of water to approximately 10% wt.

EXAMPLE 12

(65) Blister Packs

(66) The emulsion cores of Examples 1, 2 and 4 to 11 are filled into plastic blister pack trays over which a plastic/metal foil laminate is heat sealed.

EXAMPLE 13

(67) Chewable Strips

(68) Before setting, the emulsions of Examples 1, 2 and 4 to 12 are extruded into strips which are then sealed into individual plastic/metal foil laminate envelopes.