Method and System for Conditioning Lipid Compounds for Medicinal Foods and Medicinal Products

Abstract

A method for packaging a lipid compound for ingestion by a human or animal body, comprising the following steps: filling (I) a first part of a prefabricated capsule, previously opened in two parts, with a predetermined volume of a lipid compound; introducing (II) a food-grade lipophilic absorbent into the lipid compound (4) within this first part, so as to produce, after absorption of the lipid compound, a core in the form of a pasty mixture providing for a predetermined dissolution rate, closing (III) the capsule by fitting the second part on the first part containing the core; and coating the capsule thus closed with a polymer, so as to allow subsequent release of the lipid compound at a predetermined release site within said human or animal body.

Claims

1. A method for packaging a lipid compound for ingestion by a human or animal body, comprising the following steps: filling (I) a first part of a prefabricated capsule previously opened in two parts, with a predetermined volume of a lipid compound; inserting (II) a food-grade lipophilic absorbent into the lipid compound within said first part, so as to produce, after absorption of said lipid compound, a core in the form of a pasty mixture providing a predetermined dissolution rate, closing (III) said capsule by fitting the second part on the first part containing said core; and coating (IV) said capsule thus closed, with a polymer, so as to allow subsequent release of the lipid compound at a predetermined releasing site within said human or animal body.

2. The method according to claim 1, wherein the coating step (IV) comprises one or more successive treatments of the capsule, the said treatment(s) comprising the application of a coating polymer on the periphery of said capsule, the number (n) of said treatments determining the thickness of the coating layer and thus the resistance of the capsule to acid attacks.

3. The method according to claim 1, wherein the coating polymer has a dissolution pH of substantially 6, whereby the capsule is provided for releasing the lipid compound substantially in the duodenum of a human or animal body.

4. The method according to claim 1, wherein the coating polymer has a dissolution pH substantially greater than or equal to 7, whereby the capsule is provided for releasing the lipid compound in posterior regions of the digestive tract of a human or animal body.

5. The method according to claim 1, wherein the lipophilic absorbent comprises food clay, so that the mixture thus obtained is thick and provides for a very slow release of the lipid compound.

6. The method according to claim 1, wherein the lipophilic absorbent comprises tapioca, so that the mixture thus obtained is flexible and provides for a rapid release of the lipid compound.

7. The method according to claim 1, wherein the lipid compound comprises a pure essential oil.

8. The method according to claim 1, wherein the lipid compound comprises a mixture of essential oils.

9. A system for packaging a lipid compound intended for ingestion by a human or animal body, carrying out the method according to any one of the foregoing claims, comprising: means for filling a first part of a prefabricated capsule previously opened in two parts, with a predetermined volume of a lipid compound; means for introducing a food-grade lipophilic absorbent into the lipid compound within said first part, so as to provide, upon absorption of said lipid compound, a core in the form of a pasty mixture providing for a predetermined dissolution rate, means for closing said capsule by fitting the second part on the first part containing said core; and means for coating said closed capsule with a polymer provided for releasing the lipid compound at a predetermined release location.

10. The system according to claim 9, wherein the coating means are arranged to carry out one or more successive treatments of the capsule, the said treatment(s) comprising the application of a coating polymer on the periphery of said capsule, the number of said treatments determining the thickness of the coating layer and thus the resistance of the capsule to acid attacks.

11. (canceled)

12. (canceled)

13. A functional food or a medicament, comprising a closed capsule containing a pasty mixture, the pasty mixture consisting in a pure essential oil or a mixture of essential oils absorbed in an absorbent.

14. The functional food or medicament according to claim 13, wherein the absorbent comprises or consists in tapioca.

15. The functional food or medicament according to claim 14, wherein the closed capsule is configured to release the pure essential oil or the mixture of essential oils in the intestine.

16. The functional food or medicament according to claim 13, wherein the absorbent comprises or consists in food clay.

17. The functional food or medicament according to claim 14, wherein the closed capsule is configured to release the pure essential oil or the mixture of essential oils in the intestine.

Description

DESCRIPTION OF THE FIGURES AND EMBODIMENTS

[0050] Other advantages and particularities of the invention will appear after reading the detailed description of the embodiments, with reference to the following attached drawings:

[0051] FIG. 1 is a schematic diagram of the essential steps of the packaging method according to the invention; and

[0052] FIG. 2 schematically illustrates an example of embodiment of the packaging method according to the invention for the production of capsules.

[0053] Now, with reference to FIGS. 1 and 2, the implementation of the packaging method according to the invention, based on specifications established for the design of capsules intended to contain a pure essential oil or a complex of essential oils will be described.

[0054] A first design step A consists in choosing the place of release of the lipid compound in the body of a patient or animal. This choice will determine the nature of the final coating of the capsules. A capsule is then selected (step B) as the future container of the lipid compound.

[0055] Once a capsule 1, previously manufactured according to current industrial standards, has been chosen to contain the lipid compound, it is opened in two parts 10, 11 (step C).

[0056] The following steps for packaging the capsules will now be described with reference to FIGS. 1 and 2.

[0057] The first parts 10.1, 10.2, . . . , 10.i of empty prefabricated capsules, preferably the longest parts of these capsules, are arranged in cylindrical housings 20, 21, . . . , 2i of suitable shape and arranged in a support 2.

[0058] A first packaging step (I) consists in partially filling the first parts of capsule 10.1, 10.2, . . . , 10i with a determined quantity of essential oil or lipid compound 4 poured from a filling device 3 movably controlled above support 2 in an automated version of the packaging system according to the invention. As a non-limiting example, a mass of one gram of oil can be poured into the first parts 10.1, 10.2, . . . , 10i of the open capsules.

[0059] In a second packaging step (II), a lipophilic agent 6 is poured from a motion-controlled pouring device 5 into the first part 10.1 of a capsule until the oil or lipid compound 4 already present is saturated.

[0060] Slow filling ensures that the oil is absorbed without overflowing the container. As a non-limiting example, the capsule finally reaches a mass of about 1.5 grams.

[0061] By mixing lipid compound 4 and lipophilic agent 5, a pasty substance is obtained with a variable dissolution rate depending on the type of lipophilic agent chosen.

[0062] This is followed by a step (III) during which the capsules thus filled are closed by means of their respective second closing parts 11.1, 11.2, . . . , 11.i which are fitted to in their respective first parts 10.1, 10.2, . . . , 10.i.

[0063] Given the high concentration of the oils used, which ensures their therapeutic effect, the capsule must then undergo a coating treatment in order to strengthen the protection of the envelope and ensure optimal and durable imperviousness, which ensures commercial feasibility.

[0064] After filling the capsule with the essential oil/absorbent mixture and closing it, a peripheral coating of the capsule will ensure its imperviousness over time, hermeticity and mechanical strength. This coating also allows the dissolution rate to be chosen, and therefore also the place of dissolution within the digestive tract.

[0065] The capsules thus filled and closed are subjected, during a coating (IV) step, either to several (n) successive dips in a bath filled with a polymer component in the liquid phase, or to several contacts with these polymers, for example, and as a non-limiting example, by spraying, in order to externally coat the capsule, which will provide an adjustable function of releasing the active principle contained in the capsule according to the pH of the surrounding environment. It is thus possible to predetermine, within the human or animal body ingesting this capsule, the place where the lipid compounds will be released.

[0066] At the end of this coating step (IV), capsules that are now operational have been obtained, which will then be packaged in packages 100 adapted to their distribution (step V).

[0067] The selection of the different components used in the packaging method according to the invention will now be described in more detail.

[0068] To make the capsule shell for the concentrated and stabilized oil preparations, in practice, empty capsules already manufactured and marketed by specialized laboratories can be chosen. The capsules are enteric and preferably of white color and opaque to avoid deterioration over time by prolonged exposure to light. The size of these capsules must allow them to be filled with a volume corresponding to one gram of oil plus the retained lipophilic stabilizing agent. The size chosen is therefore of the known type 000, which corresponds to an inner volume of 1.37 ml.

[0069] Elements involved in the choice of the food-grade lipophilic absorbent agent will now be considered. This choice will depend on the objective for a more or less rapid release and absorption rate, in a context of packaging and coating one gram of oil or lipid compound to be slowly dissolved in the digestive tract

[0070] As a non-limiting example, two food absorbents were used: food-grade clay and tapioca.

[0071] Food-grade clay is gastroresistant. It ensures the production of a thick mixture with a slow dissolution rate. The mixture of clay and oils so obtained is thus released very slowly and will therefore allow release in the posterior or terminal part of the intestinal tract.

[0072] Tapioca is a starch used in cooking, produced from the roots of cassava, dried and then pulverized. It ensures the production of a softer mixture with a faster dissolution rate. The tapioca and oil mixture so obtained is thus released more quickly and will therefore allow release in the anterior part of the intestinal tract.

[0073] The coating of the capsule previously filled with the absorbent+oil mixture and closed again can be done, for example, with a specific polymer such as EUDRAGIT marketed by EVONIK INDUSTRIES. Different products of this type allow the dissolution site of the capsule according to a pH level that triggers the dissolution of the coating to be adjusted.

[0074] The chemical composition of these products is that of copolymers of methacrylic acid and ester of this acid. Three derivatives are particularly well known: EUDRAGIT L, S and L30D. They differ by their content in methacrylic groups.

[0075] Hence, EUDRAGIT L is rich in these groups: its dissolution pH is 6. It is therefore more suitable for coating formulations that must release the active ingredient at the level of the duodenum.

[0076] On the contrary, EUDRAGIT S contains few of such groups. This product only dissolves at pH 7 and above. It is therefore chosen for forms that are expected to act at posterior levels of the digestive tract.

[0077] The more baths in this coating polymer, the thicker the coating layer is and the more resistant the capsule is to acid attack.

[0078] Since these embodiments are in no way limiting, it will be possible to consider variants of the invention comprising only a selection of characteristics described or illustrated, subsequently isolated from the other characteristics described or illustrated (even if this selection is isolated within a sentence comprising these other characteristics), if this selection of characteristics is sufficient to confer a technical advantage or distinguish the invention from the prior art. This selection shall include at least one characteristic which is preferably functional without structural details, and/or with only part of the structural details if this part alone is sufficient to confer a technical advantage or differentiate the invention from the prior art.

[0079] Of course, the invention is not limited to the examples just described and many adjustments can be made to these examples without going beyond the scope of the invention.

[0080] Of course, the different characteristics, forms, variants and embodiments of the invention may be associated with each other in various combinations to the extent that they are not incompatible with or exclusive of one another. In particular, all the variants and embodiments described above can be combined with each other.