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Title:
PROCESS FOR ADDITION OF STERILE GASEOUS NITROGEN AND PHARMACOLOGICALLY ACTIVE SUBSTANCES TO SOLID YOGHURT
Document Type and Number:
WIPO Patent Application WO/1997/034496
Kind Code:
A2
Abstract:
A process for addition of sterile or non-sterile nitrogen and of any kind of waterproof controlled release microcapsules of pharmaceutically or nutritionally or biologically active substances to solid yoghurt and to other dairy products and juices is described.

Inventors:
KONTOS ANGELOS (GR)
KONTOS GEORGE (GR)
Application Number:
PCT/GR1997/000009
Publication Date:
September 25, 1997
Filing Date:
March 17, 1997
Export Citation:
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Assignee:
KONTOS ANGELOS (GR)
KONTOS GEORGE (GR)
International Classes:
A23G9/32; A23G9/36; A23G9/40; A61K9/00; A61K9/20; (IPC1-7): A23C/
Domestic Patent References:
WO1994009758A11994-05-11
WO1991009608A11991-07-11
Foreign References:
US4749575A1988-06-07
GB2209936A1989-06-01
US5360614A1994-11-01
GB2160771A1986-01-02
Other References:
DATABASE WPI Week 8531 Derwent Publications Ltd., London, GB; AN 85-185973 XP002020596 & JP 60 112720 A (KOSAKA R.), 19 June 1985 (1985-06-19)
DATABASE WPI Week 9510 Derwent Publications Ltd., London, GB; AN 95-070230 XP002020597 & JP 06 345664 A (TOMITA T.), 20 December 1994 (1994-12-20)
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Claims:
Claims
1. Process for preparation of a confectionery formulation consisting of the known controlled release microcapsules of pharmaceutically active substances enclosed within a matrix, by which the binding mixture used for the formulation is fluid, at a temperature of 1 ° to 0°C at which, under suitable stirring, the addition and homogeneous distribution of the provisionally waterproof capsules is effected, at a precisely predetermined ratio, to said mixture whose composition and viscosity are suitable to enable its very rapid solidification within a special facility of production and kneading of icecream, with simultaneous enclosure, under pressure, within its mass, of approximately 100% by volume (volume/volume) nitrogen or other intert gas, by final cooling to approximately 20°C, in order to create an icecream that constitute a mixture of a major solid icecream phase, a slight possibly liquid phase of a solution of sugar and milk salts, and an abundant gaseous nitrogen phase, as well as of the aforementioned microcapsules, which, upon being warmed inside the mouth, gives the impression of a soft liquid icecream cream of pleasant texture and taste, that melts in a very short period of time, without being chewed, avoiding the risk of damage to the microcapsules that could be caused by chewing or prior heating thereof during the process of preparation of the confectionery formulation, characterised by the fact that said binding mixture for the formulation is liquid stirrable yoghurt .
2. Process for addition of pharmacologically or nutritionally or biologically active substances enclosed within any kind of waterproof controlled release micro capsules, as well as addition of gaseous nitrogen to solid yoghurt, characterised by the fact that the following modifications are brought to the classical production process I) Sterile or non sterile nitrogen is insufflated up to saturation to milk destined for production of solid yoghurt, following deaeration of the former, in order to eliminate the enclosed air and any traces of foreign gases II) The finished sealed recipients of the solid yoghurt are brought back, after having been cooled to 0°C , from the refrigerator of the plant to the packaging station of the plant where a dosemetering filling device injects, by means of a vertically retrograding sterile fine perforating dosemetering needle at the centre of the bottom of each recipient and following perforation of the centre of its thermoplastic cover, an accurately predefined minimal quantity, in comparison with the product contained in the recipient of a concentrated suspension of the microcapsules to be added into solid yoghurt of the same composition and at the same temperature as the contents of the bowl, but with much higher content of solid residues than the latter, in order, on one hand, to ensure the minimum possible mechanical damage to the colloidal jellylike tissue of the solid yoghurt on account of the least possible volume of the added suspension, and on the other hand, to enable the absorption, by the relatively very small mass of the added yoghurt, of the microquantity of serum, on the surface of the colloidal tissue of the yoghurt, that has been displaced by the infused materials on account of unavoidable slight mechanical damage, derived from the decomposed, very rich in enclosed water and nitrogen gelatinized tissue of the packed solid yoghurt III) Following completion of the aforementioned procedure, the cover of the bowl is heatsealed by means of a thermoplastic material, after removal of the needle .
3. Process for addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, as well as for addition of sterile gaseous nitrogen to dirnkable yoghurt or to products of mixing thereof with fruits or juices, characterised by the fact that the following supplementary proceedings are brought to the classical process of preparation I) Following the mixing of the additional materials, such as flavours or fruits, and immediately prior to the packaging of the product in plastic bowls, the waterproof controlled release capsules are added to the finished product and homogenized by stirring, at a temperature of approximately 0°C II) Following completion of the homogenization of the distribution of the microcapsules within the mass of the product, upon continuing the cooling to approximately 0°C and the stirring of the fermented product, sterile gaseous nitrogen is delivered inside the stirring vessel, until saturation of the product which is then hermetically packaged in plastic bowls or carton recipients .
4. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, as well as addition of sterile nitrogen, into yoghurt or products of mixing thereof with fruit or juices.
5. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, and nitrogen into milk or milk of reduced fat content, pasteurised or thermisated.
6. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof controlled release microcapsules, and nitrogen into chocolate milk or cocoa milk, pasteurised or thermisated 7 Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, and nitrogen into kefir.
7. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, and nitrogen into sour milk.
8. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, and nitrogen into sour milk.
9. Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof, controlled release microcapsules, and nitrogen into orange juice containing rich in energy materials 1 1 Process in accordance with the characteristic part of claim 3, for the addition of pharmacologically or nutritionally or biologically active substances, enclosed in any kind of waterproof controlled release microcapsules, and nitrogen into lemon juice containing rich in energy materials 12 Process in accordance with any one of claims 1 11 , characterised by the fact that the controlled release pharmacologically or nutritionally or biologically active microcapsules have been rendered waterproof by means of one or more layers of solid paraffin of fatty acids or fatty acid esters or mixtures thereof of melting point ranging between 32°C and 35°C, in order not to melt even when they remain outside the refrigerator, in a cool place.
Description:
PROCESS FOR ADDITION OF STERILE GASEOUS NITROGEN AND PHARMACEUTICALLY ACTIVE SUBSTANCES TO SOLID YOGHURT

Greek Patent 920100490 dated 5-1 1 -1992 entitled «Confectionery delivery systems for pharmaceutically active substances» describes in detail a dairy matrix in the form of any kind of commercially available icecream or commercially available special icecream substitute or other traditional icecream or commercially available icecream with reduced or not reduced nutritional value or commercially available sorbet, suited to accept, at a temperature of 0°C, the addition of any kind of waterproof slow release microcapsules, including pharmaceutically or biologically or nutritionally active substances, and subsequently to form, by further cooling and delivery of nitrogen, a three-phase system composed of the major solid phase of the icecream, a small quantity of eutectic water (A.W. Farall, Engineering for Dairy and Food Products, page 300) containing dissolved amounts of sugar, casein, glucose, milk salts, etc., which does not solidify even at a temperature of -20°C or lower, and of an abundant gaseous phase of enclosed nitrogen or other inert gas. From this teaching of the aforementioned Patent it becomes evident to any expert with normal experience in the branch of foods or of pharmaceuticals that it is possible to add, at a temperature of approximately 0°C, to any liquid dairy product as well as to any kind of drinkable or mixable yogurt or to any kind of dirnkable or mixable yoghurt with juices or with fruit, which is subsequently frozen as icecream, or to no matter how preserved milk or chocolate milk or milk with cocoa or kefir or to sour milk with full or with reduced fat content, that is prepared and packaged in a continuous process (as described in detail in Technologie der Milchverarbeitung von Dr. Ing Edgar Spreer 6, Verb. Auflage VEB Fachbuchverlag Leipzig 1988) which is embodied in the present document by reference, all kinds of the aforementioned waterproof controlled release microcapsules of pharmacologically or nutritionally or biologically active substances, with simultaneous or not simultaneous delivery of N 2 , securing the benefits of European Patent 920100490, i.e. the delay in the initiation of the disintegration thereof, which starts only upon reaching the mouth of the consumer, where the special waterproof coating of the capsule melts, at a body temperature of 37°C, as well as the increased stability of the product, on account of the gaseous nitrogen

enclosed within the mass of the aforementioned products, which prevents any oxidative process of dedcomposition, particularly of the microquantities of sensitive odour and flavour imparting substances contained therein The aforementioned A W Farall, Engineering for Dairy and Food Products, embodied herein by reference, indicates on page 14 that extremely low traces of copper, iron or zinc that are occasionally taken up by milk suffice to impart an oxidised odour and that iron may impart a fishy odour to butter It is believed that the presence of the metals acts as catalyst which accelerates the oxidation rate of fats in milk Furthermore, it is known that the presence of dissolved aid influences the degree of action of the metal

In view of the aforementioned Patent 920100490/5-1 1 -92, it is more generally evident to any expert with common experience in the branch of foods and of pharmaceuticals that this addition of the special waterproof controlled release microcapsules of pharmacologically or nutritionally or biologically active substances, together with nitrogen or other inert gas, may be effected in all kinds of other liquid drinkable products, such as for instance fruit juices, lemonade or orange juice without carbonate, or in special combinations thereof in substances that are rich in energy, such as for instance glucose, etc , securing the same beneficial results as regards stability, in view of the gaseous nitrogen enclosed within the product and the delay of the initiation of the disintegration of the controlled release microcapsules in the mouth, similar to the confectionery formulation of Greek Patent 920100490 dated 5-1 1 -1992

Naturally, an indispensable prerequisite for the aforementioned addition to the above products is that the addition of nitrogen and of the waterproof microcapsules should be effected prior to the final packaging and prior to the hermetic sealing of the corresponding product and that, at the time of the addition, the product is in the form of liquid or gel, but may be stirred, and that from the moment of this aforementioned addition to the product up to the date of its consumption it shall never be warmed to temperatures close to body temperature, being usually kept in a refrigerator or in a cool place However, these prerequisites are not met in the case of the preparation of solid yoghurt by the continuous process, where the milk is fermented by cultures of Streptococcus thermophilus and Lactobacillus bulgaπcus at 43-45°C for a period of approximately three hours, at pH 4 5-4 65, within its hermetically sealed package in plastic recipients which are kept totally still up to completion of the fermentation and jellification of the yoghurt In this case, the addition of the gaseous nitrogen to the product to be fermented may of course be carried

out prior to the filling and the hermetic sealing of the product in the plastic recipients, however, on account of the prohibitive temperature of the human body as regards the waterproof oil or wax coating the waterproof controlled release microcapsules may not be added to the product The aim of the present invention is the solution of the problem indicated above The inventors have solved the aforementioned problem as follows

I) By the use, as waterproof coating, of hydrophobic materials such as waxes of melting point ranging from 32°C to 35°C, as well as of a mixture of higher fatty acids among themselves or of higher fatty acids with lower esters thereof, of melting point ranging from 32°C to 35°C, or of paraffin of melting point ranging from 32°C to 35°C, as well as mixtures of the aforementioned materials, in order to coat, with one or more hydrophobic layers, the controlled release microcapsules of pharmacologically or nutritionally or biologically active substances, so as to enable the storage of the product in a cool place, outside the refrigerator, prior to its consumption

II) Saturation, by sterile or non sterile nitrogen, following its deaeration, of the milk destined for lactic fermentation

III) Recycling of the finished sealed product, following its fermentation, in the fermentation chamber and cooling of the product, in a cooling chamber, to approximately 0°C, at the filling station of the plant, where the addition shall be effected successively, by means of a sterile reciprocating three-way needle, of a special dose-metering device whose three-way valve-feeded needle reaches close to the bottom of the recipient, adding at first 0 1 - 5 ml of a suspension of controlled release microcapsules in a content of 0 2% to 5% in stirrable yoghurt, of exactly the same composition and temperature as the manufactured solid yoghurt and, following its removal from the mass of the yoghurt, by supplementary infusion of sterile or not sterile nitrogen in the empty space of the bowl Following the removal of the needle, the aperture is sealed automatically by sealing with the same heat-sealing material of the cover of the bowl, in a well known manner, and the product is brought back to the cooling chamber

Thus the addition of the suspension of the microcapsules in stirrable yoghurt is effected in a small volume, only close to the bottom of the bowl where the needle stops in order to carry out the addition of the suspension and subsequently the needle is withdrawn until it is removed from the mass of the solid yoghurt, eventually sucking up the air in the empty space of the bowl and deltveπng sterile nitrogen for the removal of any eventually remaining oxygen

residues, from the air that is expelled by the insufflation of the nitrogen, in the liquid contents of the bowl, prior to the sealing and prior to the initiation of the fermentation.

Ilia) In accordance with a variation of the above process, the addition of the aforementioned suspension may be carried out in a continuous manner, in one retrograde movement of the needle, from the moment of its entry into the mass of the solid yoghurt, during its movement in the direction of the bottom, continuously up to its exit from the mass of the yoghurt, after the end of its regrograde movement. Thus, a small diameter column of the added suspension of microcapsules is formed inside the yoghurt under stirring, from the bottom up to the filling surface of the bowl with yoghurt, which may also have a higher content of solid matter in comparison with the manufactured solid yoghurt, in order to absorb any possibly locally leaking serum, on account of mechanical damage of the tissue of the solid yoghurt caused by the aforementioned addition.

Illb) In accordance with another variation of the process, the addition of the suspension may be carried out by spraying the surface of the solid yoghurt with a perforating spraying nozzle without mechanical damage of the jellylike tissue of the yoghurt. Naturally, the specialist technicians in this sector may also apply different variations, modifications, alterations and combinations of the aforementioned products and processes without digressing from the spirit of the present invention, as defined in the attached claims.

In order to give a better insight of the invention, some examples are given below indicatively with regard to the application thereof, which should however in no case be considered as limiting the extent of the invention that, in any case, is laid down in the attached claims.

Example 1 Preparation of solid traditional yoghurt with addition of waterproof controlled release microcapsules of vitamin C and nitrogen.

Ten kilograms of traditional yoghurt are prepared, in a non continuous manner, by insufflating sterile nitrogen to the milk that has been deaerated under vacuum, and by fermentation by means of a suitable special culture of Streptococcus Thermophilus and Lactobacillus Bulgaricus, at 43-45°C, for approximately three hours, until a pH of 4.5-4.65 is attained within the product that has been hermetically packed in 50 plastic recipients each of capacity two

hundred grams, that are kept still up to completion of the fermentaiton and jellification of the yoghurt. The recipients are subsequently transferred, as finished product, into a refrigerator. When the recipients are cooled to 0°C they are brought back, by a transporting device, to the installation of filling and sealing of the recipients where a dose-metering device injects, through a vertical retrograding sterile fine perforating dose-metering needle, a volume of 0.2 ml suspension of waterproof controlled release microcapsules of vitamin C, of 1 % content, into liquid yoghurt under stirring. Following the exit of the needle, the aperture is heat-sealed.

Example 2 Preparation of chocolate milk with addition of waterproof controlled release microcapsules of vitamin C and nitrogen

Nitrogen is delivered into 10 kg chocolate milk under stirring at a temperature of approximately 10°C, 0.1 grams waterproof controlled release vitamin C microcapsules are added and the product is filled in carton boxes of 300 cubic centimeters capacity.

Example 3 Preparation of peach juice with addition of water proof controlled release vitamin C and nitrogen microcapsules.

Nitrogen is delivered to 10 kg peach juice, under stirring, at a temperature of approximately 10°C, 0.1 grams waterproof controlled release vitamin C microcapsules are added and the product is filled in carton boxes of three hundred cubic centimeters capacity.

Example 4 Preparation of icecream from stirrable yoghurt with fruit, with addition of waterproof controlled release vitamin C microcapsules and nitrogen. Proceed in accordance with claim 1 of the present patent application using 10 kg stirrable yoghurt containing 10% fresh or sugar-treated finely chopped fruits and 0.1 grams waterproof controlled release vitamin C microcapsules.