Preparation device for the use of a live activated probiotic preparation

Abstract

A device (1) is provided for preparing a preparation (2) comprising a powder (21) with probiotics and a diluent (22) of the powder (21); the device (1) includes a chamber (3a) containing powder (21) and diluent (22); and an activator configured to activate and thus make the probiotics immediately usable by maintaining the powder (21) at an activation temperature between 30°C and 40°C for an activation time between 20 minutes and 40 minutes.

Description

[0001] DESCRI PTION

[0002] PREPARATION DEVICE FOR THE USE OF A LIVE ACTIVATED PROBIOTIC

[0003] PREPARATION

[0004] The present invention relates to a preparation device for a probiotic preparation, specifically a preparation containing one or more probiotic strains, as specified in the preamble of the first claim. More specifically, the invention aims to create the conditions for biologically activating such freeze-dried live probiotics through a particular and innovative sequence of phases before their use.

[0005] According to the official FAO and WHO definition, probiotics are live microorganisms that, when applied in adequate amounts, can provide multiple benefits to the body. A first example of the application of probiotic preparations, and thus of a probiotic preparation, is identified in supplements where beneficial effects have been observed on the digestive system, urogenital system, immune function and infection prevention, and in combating cholesterol and blood pressure.

[0006] Another example of application is in the cosmetic field, where these microorganisms promote and support the strengthening of the skin barrier, restoration of the microbiome, maintenance of skin hydration, and regulation of sebum production.

[0007] It is specified that the benefits previously described are not always the result of the combined action of multiple probiotic strains, but can also be due to a single probiotic strain.

[0008] The known technique described includes some important drawbacks.

[0009] A first problem is that live probiotics are ingested / used in their vital state but not efficiently activated at a metabolic level, resulting in a limited action of the probiotic itself, and thus a reduction in the beneficial effects. A second drawback is that probiotics remain viable (in solution or added to matrices such as yogurt, creams, lotions, masks, or muds) for a limited time period, thus necessitating their relatively rapid use / ingestion and reducing their storage time in the aforementioned conditions.

[0010] In fact, these quiescent live organisms, when added to matrices for long periods, may suffer from interaction with the matrices themselves and consequently reduce their viability; or suffer from contamination due to environmental bacteria / fungi that thus alter the composition of the preparation. For these reasons, the use / ingestion, especially topical, of live and biologically activated probiotics is particularly laborious, complex, and not applicable. It is highlighted how these difficulties are greatly limiting the spread and use of probiotics, for example in the cosmetic field, despite their particularly high efficacy.

[0011] In this situation, the technical task underlying the present invention is to devise a preparation device for the use of a live and biologically active probiotic preparation capable of substantially overcoming multiple of the aforementioned drawbacks.

[0012] Within the scope of said technical task, the primary purpose of the invention is to obtain a device that allows simple and practical preparation, and therefore use, of a viable probiotic in its biologically activated state.

[0013] One purpose is therefore to have a device that allows for the correct and completely safe preparation and subsequent use of a preparation containing live probiotics made biologically active even in the domestic environment, in order to optimize the benefits derived from the probiotic charge present in the final product.

[0014] The technical task and the specified purposes are achieved by a preparation device as claimed in the annexed claim 1. Examples of preferred embodiments are described in the dependent claims.

[0015] The characteristics and advantages of the invention are clarified below by the detailed description of preferred embodiments of the invention, with reference to the accompanying drawings, in which:

[0016] Fig. 1 shows an example of a preparation device according to the invention; and

[0017] Fig. 2 presents a schematic diagram of the functioning of the preparation device according to the invention.

[0018] In this document, measurements, values, shapes, and geometric references (such as perpendicularity and parallelism), when associated with words like “approximately” or other similar terms such as “almost” or “substantially,” are to be understood as except for errors of measurement or imprecisions due to production and / or manufacturing errors and, above all, except for a slight departure from the value, measurement, shape, or geometric reference with which it is associated. For example, such terms, if associated with a value, preferably indicate a divergence of no more than 10% of the value itself.

[0019] Furthermore, when terms like “first,” “second,” “upper,” “lower,” “main,” and “secondary” are used, they do not necessarily identify an order, a priority of relation or relative position, but can simply be used to more clearly distinguish different components from one another.

[0020] Unless otherwise indicated, “perpendicular,” “transverse,” “parallel,” or “normal,” or other terms of geometric positioning between geometric elements (e.g., axes, directions, and lines) are to be understood with reference to their mutual geometric position between corresponding projections. Said projections are defined on a single plane parallel to the lying plane(s) of said geometric elements.

[0021] The measurements and data reported in this text are to be considered, unless otherwise indicated, as performed in the International Standard Atmosphere ICAO (ISO 2533:1975).

[0022] Unless otherwise specified, as reflected in the following discussions, it is considered that terms such as “processing,” “computing,” “determination,” “computation,” or the like, refer to the action and / or processes of a computer or similar electronic computing device that manipulates and / or transforms data represented as physical quantities, such as electronic quantities of records of a computer system and / or memories in other data similarly represented as physical quantities within computer systems, records, or other information storage, transmission, or display devices.

[0023] With reference to the Figures, the preparation device for a live and biologically activated and thus ready-to-use probiotic preparation described in priority as a device for using a probiotic preparation, according to the invention is globally referred to as number 1.

[0024] It should be noted that for clarity the expression “utilization device” used in priority has been replaced here by the expression “preparation device.” Therefore, in this document the "reference preparation device" is to be referred to the "utilization device" in priority. They are actually denoted to in both the priority document and this document by the same number.

[0025] Preparation device 1 is configured to prepare a live biologically activated probiotic product before it is administered and specifically taken by a user either directly (in its pure form, e.g., orally or through the skin) or indirectly (as an added ingredient / integrator, e.g., to yogurt, solutions, beverages, creams, lotions, etc.). Specifically, the device is configured to rehydrate, revitalize, and biologically activate a probiotic preparation 2 and thus make it ready to be immediately taken appropriately directly or indirectly.

[0026] Preparation device 1 shown in Fig. 1 is configured to rehydrate, revitalize and biologically activate a probiotic preparation 2 and thus make it ready to be immediately used by optimizing the benefits from the biologically activated probiotic charge appropriately applied directly or indirectly.

[0027] Specifically, preparation device 1 is configured to perform a series of actions that can rehydrate, revitalize, and biologically activate the live probiotics in powder 21 (as described below).

[0028] The preparation 2 can be configured to perform a treatment on a portion of the body. For example, it can be applied topically and preferably fulfill a cosmetic action such as strengthening the skin barrier, restoring the balance of the skin microbiome, keeping the skin hydrated, and regulating sebum production. Alternatively, preparation 2 can be configured to be taken orally so as to maximize, in this case too, the benefits of using live probiotics in their biologically activated form.

[0029] To summarize, preparation 2 can be a product to be used / applied directly appropriately in its pure form or indirectly and thus be an integrator when added, for example, to a cream, lotion, mask and mud, for cosmetic use, or to a yogurt and beverages for food use.

[0030] The preparation 2 may include a powder 21 and preferably a diluent 22 for suspension of powder 21 .

[0031] Powder 21 can be compressed into tablet form. Alternatively, it is enclosed in a pill that is in a soluble wrapper. Powder 21 includes live probiotics and optionally excipients.

[0032] The live probiotics in powder 21 are appropriately made quiescent (i.e., viable but not biologically activated) in a timely manner by, for example, freeze-drying process. The diluent 22 can be any liquid configured to keep the powder 21 and thus the probiotics in suspension. It can be water; saline solution; buffer solution (such as, for example, phosphate-buffered saline); culture broth, or other medium.

[0033] In addition, diluent 22 must be able to maintain a stable pH appropriately at 7 ± 3.

[0034] The preparation 2 includes one or more sugars (also called glucides, glycides, carbohydrates, or saccharides).

[0035] Said sugars may be in said diluent 22. Alternatively or in addition, sugars can be at a granular aggregate state and thus be mixed with said powder 21 .

[0036] The content of said sugars is optimized to trigger biological activation of the quiescent live probiotics contained in powder 21 .

[0037] The final concentration of said sugars in preparation 2 may be substantially comprised between 0.01 g and 5 g out of 100 mL of said preparation 2.

[0038] The pH of preparation 2 (especially diluent 22 and preferably powder 21 and / or sugars) may be substantially between 3 and 10. Said pH can be nearly equal to 7, appropriately ±2.

[0039] Preparation device 1 may include preparation 2.

[0040] Device 1 includes a container 3 defining a chamber 3a containing at least diluent 22 and specifically preparation 2.

[0041] Container 3 can be, for example, a bottle for cosmetics. It may thus include dispensing means configured to allow the dispensing of the preparation 2 and then its release from the chamber 3, i.e., the powder 21 appropriately diluted in said diluent 22.

[0042] Preferably, the delivery means are configured to allow said preparation 2 to be applied to the skin, for example. Alternatively or additionally, they are configured to allow easy administration of preparation 2.

[0043] Dispensing means are known per se and for simplicity not shown in the figure.

[0044] Container 3 may define an introduction section 3b of said powder 21 into said chamber 3a; and optionally an additional chamber 3c containing powder 21 .

[0045] Possibly, additional chamber 3c is gravitationally superimposed on the introduction section 3b and chamber 3a so as to allow powder to pass from additional chamber 3c to chamber 3a by gravity. In such cases, container 3 may include an enclosing wall of at least part of the section 3b and in detail of the entire section 3b.

[0046] The wall can be configured to allow powder 21 to pass through only in response to a command given by the user. For example, it may be a known breaking wall and thus configured to break for example as a result of pressure applied to it; alternatively, the wall may be movable with respect to section 3c.

[0047] Device 1 includes an activator 4 configured to revitalize and biologically activate the live probiotics of the powder 21 appropriately dissolved and / or suspended in diluent 22 and, precisely, reproduce the optimal conditions as described below, thus making them immediately takeable and usable in their biologically activated form.

[0048] Activator 4 is configured to promote and optimize the revitalization and biological activation of quiescent live probiotics by maintaining at least the probiotics, and in detail the powder 21 , preferably suspended in diluent 22 and then the whole preparation 2 at an activation temperature for an activation time.

[0049] The activation temperature is substantially between 15°C and 45°C. Preferably, it is substantially between 30°C and 40°C, more specifically between 35°C and 40°C, and in detail, substantially equal to 37°C ± 2°C. We specify that the relatively wide range of temperature is justified by the fact that different probiotic species activate at different temperatures. For example, Lactobacillus plantarum is biologically activated at an ideal temperature between 20-25°C, while Bacillus coagulans prefers higher temperatures, between 40 and 45°C.

[0050] Moreover, the exposure time to said temperature, i.e., the activation time, is optimized for the type of probiotic strain(s) contained in powder 21 , strictly dependent on the composition of diluent 22 specific for that strain. For example, in Lactobacillus rhamnosus GG, it has been shown that a time between 1 minute and 10 minutes is sufficient to guarantee its efficient biological activation.

[0051] Therefore, the activation time is substantially between 1 minute and 40 minutes. In first cases, the activation time is substantially between 1 minute and 30 minutes. Preferably, it is substantially between 5 minutes and 40 minutes, specifically between 10 minutes and 25 minutes, in detail between 15 minutes and 25 minutes, and more in detail substantially equal to 20 minutes.

[0052] In second cases, the activation time is substantially less than 40 minutes, specifically substantially between 10 minutes and 40 minutes, in particular between 20 minutes and 40 minutes. Preferably, it is substantially between 25 minutes and 35 minutes, and in detail substantially equal to 30 minutes.

[0053] In third cases, the activation time is substantially between 20 minutes and 40 minutes. Preferably, it is substantially between 25 minutes and 35 minutes, and in detail substantially equal to 30 minutes.

[0054] Activator 4 is thus configured to heat powder 21 and, appropriately, diluent 22 in chamber 3a.

[0055] It may be configured to directly heat powder 21 and, appropriately, diluent 22 in chamber 3a. In this case, activator 4 includes a heat source 41 heating the container 3 such as, for example, an incubator, stove, chemical reaction, or induction plate (Fig. 2).

[0056] Alternatively, activator 4 can be configured to indirectly heat powder 21 and, appropriately, diluent 22 in chamber 3a. In this case, it includes, in addition to said heat source 41 , a tank containing a hot liquid, e.g., water, suitably brought to said activation temperature by said heat source 41.

[0057] Device 1 may include an agitator 5 configured to mix powder 21 with diluent 22 appropriately in chamber 3a.

[0058] Agitator 5 can be configured to mix powder 21 with diluent 22 by agitation of at least diluent 22 for at least a mixing time.

[0059] The mixing time is substantially between 1 minute and 40 minutes.

[0060] In said first cases, the mixing time can be between 1 minute and 30 minutes. Preferably, it is substantially between 10 minutes and 25 minutes, specifically between 15 minutes and 25 minutes, and more specifically substantially equal to 20 minutes.

[0061] In said second cases, the activation time is substantially less than 40 minutes, specifically substantially between 10 minutes and 40 minutes, in particular between 20 minutes and 40 minutes. Preferably, it is substantially between 25 minutes and 35 minutes, and in detail substantially equal to 30 minutes.

[0062] In said third cases, the mixing time can be substantially less than 30 minutes, specifically substantially between 5 and 20 minutes, and specifically between 10 and 15 minutes.

[0063] The mixing time can be substantially equal to the activation time.

[0064] Agitator 5 can perform direct agitation and thus include a whisk configured to be at least submerged in said diluent 22 and agitate it, favoring mixing between powder 21 and diluent 22.

[0065] Alternatively, agitator 5 can indirect agitate (Fig. 2) and thus it can be configured to rock / vibrate chamber 3a and specifically container 3. It includes a homogenizer (e.g., rotary or ultrasonic); an oscillator; or a magnetic stirrer.

[0066] Preparation device 1 may include a control unit 6 of the device itself.

[0067] Unit 6 is in data connection with activator 4 and, if present, agitator 5.

[0068] Unit 6 may include an electronic board 61 comprising a software defining the operation of the device and thus the process introduced below.

[0069] Unit 6 may include a clock 62 measuring the passing of time so as to command biological activation for said activation time and / or said agitation for said agitation time.

[0070] Unit 6 may include at least one sensor 63 measuring the temperature of diluent 22 (thus preparation 2) and / or of chamber 3a.

[0071] The operation of preparation device 1 defines a new preparation process 100 for preparing a probiotic preparation 2.

[0072] It should be noted that for the sake of clarity the expression “utilization process 100" used in priority has been replaced here by the expression “preparation process 100”. Therefore, in this document reference to “preparation process 100" is to be referred to the “utilization process 100" in priority. They are actually denoted in both the priority document and this document by the same number. The execution of the new preparation process 100 for a preparation 2 is controllable by an operator, for example, through an interface proper to said unit 6.

[0073] Process 100 is configured to make preparation 2 immediately usable at the end of process 100. Therefore, it is preferably implemented before preparation 2 is administered and specifically taken by a user either directly (in its pure form, e.g., orally or through the skin) or indirectly (as an added ingredient, e.g., to yogurt, beverages, creams, lotions, etc.).

[0074] Process 100, schematized in Fig. 2, is configured to rehydrate, revitalize, and biologically activate the live and appropriately quiescent probiotics present in powder 21 (preferably resuspended in diluent 22), thereby increasing and optimizing the action of preparation 2.

[0075] Process 100 includes a dispersion step 110 of powder 21 in diluent 22 wherein powder 21 is introduced and then dispersed in diluent 22. Consequently, in dispersion step 110, powder 21 is rehydrated.

[0076] In this step 110, powder 21 is fed into container 3 and specifically into chamber 3a containing diluent 22. In detail, powder 21 passes from additional chamber 3c to chamber 3a conveniently through introduction section 3b. Alternatively, dispersion step 110 can occur by passing diluent 22 directly from chamber 3a to chamber 3c containing powder 21.

[0077] It is shown that if present at the end of this step, the sugars are also in suspension / dissolved together with powder 21 in diluent 22.

[0078] Process 100 includes an activation step 120 wherein the probiotics in powder 21 , appropriately dispersed in diluent 22, are revitalized, biologically activated, and made immediately usable and thus takeable directly or indirectly. Activation step 120 is subsequent to dispersion step 110. Alternatively, step 120 is prior to step 110. As a further alternative, step 120 is performed simultaneously / parallel to step 110.

[0079] In activation step 120, powder 21 and particularly diluent 22 (and possibly sugars) can be brought to the above activation temperature and then held at said activation temperature for the above introduced activation time.

[0080] Such step 120 is preferably performed at controlled pH.

[0081] In detail, in step 120, activator 4 and in particular heat source 41 heat container 3 and in detail chamber 3a, bringing it and its contents (i.e. , powder 21 and diluent 22 and thus preparation 2 possibly with added sugars, appropriately pH controlled) to the activation temperature, which is then maintained for the activation time.

[0082] Once the activation step is completed, preparation 1 a is ready to be used / applied directly or indirectly.

[0083] Finally, process 100 may include a mixing step 130 of preparation 2 and specifically of powder 21 and diluent 22 and possibly sugars, promoting the retention of powder and any sugars in suspension in diluent 22. The mixing step 130 can also be performed before use.

[0084] Mixing step 130 is subsequent to dispersion step 110 and preferably before activation step 120. Alternatively, steps 120 and 130 can be performed simultaneously / in parallel.

[0085] In mixing step 130, agitator 5 mixes powder 21 with diluent 22 (possibly added with sugars) for the above mixing time.

[0086] Finally, process 100 includes a preparation step of the preparation at the end of the activation step. At this point, preparation 2 can be used directly, for example, ingested or applied without being added to another product. Alternatively, it can be used indirectly and thus be added to a product, for example, a cosmetic product (such as a cream, lotion, mask, or mud) or a food product (such as yogurt, drink).

[0087] Steps 110, 120, and, if present, 130 are performed before intake / use of preparation 2.

[0088] Accordingly, process 100 can be part of a utilization process including, at the end of process 100, a utilization step (also described in priority) of preparation at the end of the activation step. In said utilization step, preparation 2 can be used directly and, for example, ingested or applied without being added to another product. Alternatively, it can be used indirectly and thus be added to a product, for example, a cosmetic product (such as a cream, lotion, mask, or mud) or a food product (such as yogurt, drink).

[0089] Device 1 and consequently process 100 according to the invention achieve important advantages.

[0090] A first advantage is that device 1 and as a consequence process 100, by performing a rehydration, revitalization, and biological activation of live quiescent probiotics contained in powder 21 , allow any live probiotic to be used in its biologically activated form.

[0091] Another advantage is that device 1 and consequently process 100, by reproducing in a controlled and stable manner the optimal conditions for efficient biological activation of the probiotics, allow maximizing the beneficial effects derived from the probiotic charge present in preparation 2.

[0092] An important advantage lies in the fact that device 1 and consequently process 100 allow the user, i.e. , the general public, the possibility to use, without the need for specific technical expertise in the pre-intake / use phase, namely in the preparation, any live probiotic product in its best state of biological activation.

[0093] A not secondary advantage is that device 1 and consequently process 100 allow a preparation of preparation 2 at the time of its use or intake, minimizing any possible undesirable effects of the matrices on the preservation of the probiotics and, at the same time, optimizing the concentration of vital and biologically activated probiotics. Furthermore, device 1 and consequently process 100 allow a preparation of preparation 2 at the time of its use, thus making it less sensitive to potential contaminations that can cause the degradation of the probiotic charge. Consequently, preparation 2, thanks to device 1 , is usable / takeable without safety risks and problems and in full compliance with regulatory requirements.

[0094] Therefore, device 1 and process 100 allow obtaining, in a simple and rapid manner and with complete safety, a live non-quiescent probiotic preparation 2 that is easily administered, correctly, efficiently, and almost fully activated.

[0095] It is emphasized how, in the cosmetic field, some of the mentioned advantages are particularly relevant. In fact, unlike what has happened until today, the innovative device 1 allows, through process 100, to prepare and use in complete safety a preparation 2 containing any live and activated probiotic, avoiding potential interferences from excipients or other substances present in known cosmetic formulations, which could cause a reduction in the total probiotic charge. In particular, preparation 2, comprising probiotics activated exclusively immediately before their use / application, can be added, for example, to muds / masks with the advantage of maximizing the charge of activated probiotics in the time interval. In addition, device 1 allows through process 100 to reduce the toxicity effects deriving from any excipients / matrices towards the probiotics, as the period of mutual contact probiotics-matrices is only limited to the moment of application / use compared to any other matrix in which preparation 2 is mixed at the time of industrial production. The invention is susceptible to variations within the scope of the inventive concept defined by the claims. In this context, all the details can be replaced by equivalent elements, and the materials, shapes, and dimensions can be any.

Claims

CLAI MS1. The device (1 ) for preparing a preparation (2) configured to make said preparation (2) ready to use; said preparation (2) being characterized by comprising:- powder (21 ) comprising added live quiescent probiotics;- sugars; and- a diluent (22) of suspension of said powder (21 ); and said device (1 ) being characterised by comprising- a chamber (3a) containing said powder (21 ) and said diluent (22);- an activator (4) configured to bring said powder (21 ) in said diluent (22) to an activation temperature substantially between 15°C and 45°C and to maintain said activation temperature for an activation time between 1 minute and 40 minutes so as to biologically activate said probiotics in said powder (21 ) and thereby render said live activated probiotics in said powder (21 ) immediately usable and takeable when suspended in said diluent (22).

2. The device (1 ) according to claim 1 , wherein said activation temperature is substantially between 30°C and 40°C.

3. The device (1 ) according to claim 2, wherein said activation temperature is substantially equal to 37°C ± 2°C and said activation time is substantially equal to 25 ± 5 minutes.

4. A device (1 ) according to at least one preceding claim, comprising an agitator (5) configured to mix said powder (21 ) with said diluent (22) in said chamber (4a) for a mixing time substantially between 10 minutes and 15 minutes.

5. A device (1 ) according to at least one preceding claim, wherein the concentration of said sugars in said preparation (2) is substantially between 0.01 gand 5 g per 100 mL of said preparation (2).

6. A device (1 ) according to at least one preceding claim, wherein said sugars is dissolved in said diluent.

7. The device (1 ) according to the preceding claim, wherein said preparation (2) is a cosmetic, nutraceutical, food, agricultural, veterinary, industrial, pharmaceutical preparation.

8. The device (1 ) according to the preceding claim, wherein said preparation (2) has a pH substantially equal to 7 ± 2.

9. The process (100) for preparing a preparation (2) configured to make said preparation (2) ready to use; said preparation (2) comprising:- powder (21 ) comprising probiotics; and- a diluent (22) of suspension of said powder (21 ); and said process (100) being characterised by comprising- a dispersion step (110) of said powder (21 ) in said diluent (22);- an activation step (120) in which said probiotics in said powder (21 ), suspended in said diluent (22), are activated and rendered immediately usable and then takeable by bringing said powder (21 ) to an activation temperature between 15°C and 45°C and maintaining said powder (21 ) and then said diluent (22) at said activation temperature for an activation time substantially between 1 minute and 40 minutes.

10. The process (100) according to the preceding claim, wherein said activation temperature is substantially equal to 37°C ± 2°C and said activation time is substantially equal to 25 ± 5 minutes.

11. A process (100) according to at least one claim 9-10, comprising a mixing step (130) wherein said powder (21 ) and said diluent (22) are agitated so as topromote the maintenance in suspension of said powder (21 ) in said diluent (22); wherein said mixing step (130) is performed for a mixing time substantially between 1 minute and 40 minutes; and wherein said mixing step (130) is subsequent to said dispersion step (110) and to said activation step (120).

12. The process (100) according to the preceding claim, wherein said mixing time is substantially equal to said activation time.

13. A process (100) according to at least one claim 11 -12, wherein said mixing time is substantially between 10 minutes and 15 minutes.

14. A process (100) according to at least one claim 11 -13, wherein said mixing step (130) is prior to said activation step (120).

15. A process (100) according to at least one claim 11 -13, wherein said mixing step (130) is performed in parallel with said activation step (120).

Images