WO2011117512A1 - Device and method for forming a solution or a suspension of pharmaceutical or food products - Google Patents

Abstract

The present invention relates to a device for forming a solution or a suspension of products (P) such as medicines and/or foodstuffs, comprising a bottom (2), a body (3) that defines a volume V and is open at at least an upper end (3₂), and a stopper (4) for closing the upper end (3₂) of the body (3). The bottom (2) can be removed from the body (3) and forms a crucible (5) for crushing the product (P) used to form a solution or a suspension, and the stopper (4) comprises a male member (11) having a form complementary to the crucible (5) provided in the removable bottom (2). The bottom (2) and the stopper (4) have complementary connecting and clamping means (7, 8) for connecting and clamping the stopper to the bottom in order to reduce to powder form such a product (P) previously arranged in the crucible (5), and for fastening and clamping the bottom to a lower end (3₁) of the body (3) of the device once said product has been crushed, and fastening and then clamping the stopper (4) to an upper end (3₂) of the body in order to form the solution of suspension and mix the crushed product (P) with a liquid or a mixture of aqueous or non-aqueous liquids.

Description

 Device and method for dissolving or suspending pharmaceutical or food products

 The present invention relates to the technical field of accessories for preparing food and / or drug mixtures in liquid form for oral or enteral administration by a nasogastric or orogastric tube.

 In this field, there are currently manual crushers device type drumsticks, also known in English under the term "pill-crushers" which are used by nurses to crush powdered certain drugs or foods for oral or enteral administration by a probe nasogastric or orogastric. Such crushers are described, for example, in EP-A-0 732 274 or DE 197 06 341 A1.

 These crushers are practical and efficient in their operation, that is to say the reduction of drugs or foods to be administered in powder form.

 However, when the administered products have been crushed by the crushing device, they must then be mixed with a given volume of water or aqueous food solution to be administered orally or enterally by a nasogastric or orogastric tube.

 For these operations, crushing devices are not suitable.

 Indeed, they do not allow a dissolution or direct and effective aqueous suspension of the product after crushing. Traditionally, nurses have to manually transfer the medications or sprays to an ancillary container, after emptying the crushing devices into the container, and then adding a volume of dilution liquid to the container to make an aqueous solution or suspension. They must then fill from this container a feeding syringe either by suction or by manual filling.

This traditional technique for preparing mixtures of drugs or foods for oral administration determines a variability of the concentrations of the solutions or suspensions thus obtained. This variability is detrimental to the quality of therapeutic care since concentration differences of the solutions or suspensions thus obtained do not correspond to the prescribed doses.

 Indeed, the crushed drugs being transferred to a second container to achieve mixing, a portion of the powder mixture persists in the crushing devices, which implies that the entire powder mixture is not transferred to the second container for mixing. As a result, the theoretical amount of product to be administered by the gavage syringe is not completely transferred as soon as the mixture is prepared, so that a concentration error occurs automatically in the mixture.

 Similarly, when nurses then fill gavage syringes, it is common that the entire liquid mixture is not transferred to the syringes, and therefore this is a second cause of variability in the concentration of mixtures administered to patients. since not all prepared mixtures are necessarily distributed to patients.

 The object of the present invention is to provide a device for dissolving or suspending products such as drugs or food in a hospital environment. The device allows easy transfer of food or reduced drugs in the form of powder and dissolved or suspended for oral or enteral administration by a nasogastric or orogastric tube.

 According to the present invention, the object is achieved by means of a device for dissolving or suspending products such as medicaments and / or foods, comprising a bottom, a body having at least one open upper end and defining a volume V solution or suspension of a said product with a liquid or a mixture of aqueous or non-aqueous liquids, and a closure cap of the open upper end of the body, characterized in that:

 the bottom is removable from the body of the device and forms a crucible for crushing the product to be dissolved or suspended, and

the plug comprises a male member of complementary shape of the crucible formed in the removable bottom, and - The bottom and the cap comprise complementary means of connection and clamping allowing, on the one hand, the connection and the clamping of the cap on the bottom to reduce in the form of powder a said product previously disposed in the crucible and allowing, on the other hand, fixing and clamping the bottom on a lower end of the body of the device provided with a thread adapted to its connection to the bottom after crushing said product and fixing and then tightening the cap on an upper end of the body, also provided with a thread adapted to its connection to the plug after filling a volume V of liquid in the body to carry out the dissolution or suspension and the mixture of the crushed product with a liquid or a mixture of aqueous liquids or non-aqueous.

 According to various preferred features of the dissolution or suspension device of the invention:

 - The connection and clamping means are sealing screw means;

- The bottom and the cap have on their periphery anti-slip elements adapted to facilitate manual tightening of the cap on the bottom to crush a product to be mixed and to facilitate the clamping of the plug and the bottom at each upper and lower end respectively of the body of the device;

 the device comprises a bottom mounting adapter on the lower end of the body of the device, said adapter comprising first fastening and clamping means complementary to those of the bottom and second securing and clamping means complementary to those of the lower end of the body of the device;

 - The first and second fixing means and clamping the adapter are each formed by a clamping ring having an internal or external thread complementary to a thread formed on the bottom and the body of the device respectively.

The dissolution or suspension device of the invention has the advantage of allowing with a single accessory the realization of two functions that are the reduction in powder by crushing the product to put in solution or suspension and its dissolution in solution or in suspension without making any transfer of the product once crushed. Indeed, thanks to the inventive device, to reduce to powder the product, for example a drug, that it is desired to put in solution or suspension by screwing on one another the plug and the bottom of the device, the male element of the plug playing the role of pestle in the bottom crucible and thus crushing the product in said crucible. Subsequently, once the product reduced to powder, it is sufficient to screw on the bottom of the body of the device in place of the cap, to fill the body with a determined volume of dilution liquid and to close the body with the cap for ability to dissolve or suspend without any loss of product.

 The invention furthermore relates in a second object to a process for dissolving a product such as a drug or a food using the device of the invention. This process essentially comprises the following steps:

 depositing a product to be put in solution or in suspension in the crucible delimited inside the bottom of the device,

 the cap of the device is screwed on the bottom by means of their connecting and complementary clamping means, so that the pestle of the cap crushes the product inside the crucible formed in the bottom,

the stopper and the bottom are then unscrewed from each other and a bottom end of the body of the device is screwed on the bottom, possibly via an adapter,

 a volume V of dilution liquid is introduced through the upper end of the body into said body, connected to the bottom of the dissolution or suspension device, so as to mix the reduced powder product present in the crucible with said liquid mixture,

 the cap is screwed onto the upper end of the body of the device after it has been filled with a volume V of liquid,

 the product and the mixing liquid are mixed by manual stirring and / or inverting the device after placing the stopper.

Various other characteristics appear from the description given below with reference to the accompanying drawings which show, by way of non-limiting examples, embodiments of the subject of the invention. In the appended figures:

 - Figure 1 shows an exploded view of the device of the invention in a preferred embodiment;

 FIG. 2 is an exploded view of the bottom and the plug of the device of the invention as shown in FIG. 1 before crushing drugs to be dissolved or suspended,

 FIG. 3 represents a partial sectional view of the device of FIG.

 1 assembled to achieve the dissolution or suspension of reduced products in powder form in the bottom of the device;

 - Figure 4 is a view similar to that of Figure 3 which shows an alternative embodiment of the device of the invention wherein the body of the attachment adapter on the bottom of the device is directly formed at the lower end of the body .

 Figure 1 is an exploded view of the solution device 1 of the present invention in a preferred embodiment.

 This dissolution device 1 essentially comprises a bottom 2, a body 3 and a plug 4 adapted to be screwed to each other as described below.

As is apparent from Figure 2, the bottom 2 has a pin shape consists of two cylindrical sections 2 _lr 2 ₂ of different diameters stacked one on the other, the lower section 2i of greater diameter forming a foot base and the upper section 2 ₂ of smaller diameter a bottom body, the two sections being integral and continuous with each other. The inside of the bottom 2 is hollowed out from the upper surface of the section 2 ₂ so as to form a cylindrical crucible 5 with a conical bottom 5i extending along the longitudinal axis of the bottom 2 in the lower section 2i of said bottom.

In addition, the outer periphery of the cylindrical section 2 ₂ is provided with its upper surface at the junction with the section 2 ± of a screw thread 6.

The lower section 2 ± is coated on its periphery with anti-slip elements 7. These anti-slip elements 7, for example consisting of grooves or straight beads extending along generatrices section 2 ± the bottom 2 are adapted to facilitate manual tightening of the bottom 2 to the cap 4 or the body 3 as will be described later.

The plug 4 has a shape somewhat similar to that of the bottom 2. In fact, the plug 4 consists of two cylindrical sections 4i, 4 ₂ coaxial and of different diameter conferring on the plug 4 in the form of a counter reversed relative to the bottom 2. The cylindrical section 4i is a cap handle coated on its periphery also anti-slip elements 8 similar to the elements 7 of the bottom 2. On this periphery, the section 4i of the plug 4 also comprises two fins 9 projecting constituting manual grip stops intended to facilitate a clamping or loosening operation of the plug 4 on the body 3 or the bottom 2 of the device 1 of the invention.

 As is also apparent from Figure 1, the inner surface of the section

41 of the plug 4 is threaded with a female thread 10 complementary to the thread 7 of the bottom 2 of the device. Thus, the cap 4 can be screwed and unscrewed easily on the bottom 2.

The plug 4 also comprises an inner section 4 ₂ smaller diameter than the section 4i but of greater height, said inner section

4 ₂ constituting a male member 11 in the form of additional pestle crucible 5 recessed in the bottom 2 of the device. The male member 11 has a conical lower end 11i adapted to fit perfectly abutting in the conical end 5i of the crucible 5 of the bottom when the cap 4 is screwed on the bottom, the outer walls of the male member 11 of the plug then marrying the inner walls of the crucible 5 of the bottom 2.

The body 3 of the device 1 is constituted by a straight cylinder open at its lower and upper ends 3i, 3 ₂ and provided at its lower end 3i with a first thread 12 and at its upper end 3 ₂ with a second thread. 13. The first thread 12 of the body 3 is complementary to the thread 10 of the plug 4 and the second thread 13 of the body is in turn complementary to the thread 6 of the bottom 2 or an adapter 14, 21 as described below. The body 3 defines between its two said ends an internal volume V. The cylinder forming the body 3 is preferably formed of glass or a transparent plastic and quality food or pharmaceutical (for example polyethylene or polyvinyl chloride) and advantageously carries on its periphery a graduated volume scale M engraved or glued along a generatrix of the body 3 in order to measure a volume v of liquid introduced into the body 3 when at least one of the lower and upper ends 3i, 3 ₂ is plugged by the bottom 2 or the cap 4 respectively. The body 3 of the device 1 advantageously has, according to the invention, a minimum height (or length) of 10 cm and a minimum internal diameter of 2.5 cm so as to allow the easy introduction of a gavage syringe by its lower extremities. and upper 3i, 3 ₂ .

The device 1 finally comprises an adapter 14 for sealing the bottom 2 at the lower end 3i of the body 3 of the device 1. This adapter 14 comprises a first clamping ring 15 having an internal thread 16 complementary to the thread 7 formed on the section upper 2 ₂ bottom 2 and a second clamping ring 17 having an internal thread 18 complementary to the thread 13 formed on the lower end 3i of the body 3 respectively.

 The two clamping rings 15, 17 of the adapter 14 are crimped to each other by a third ring 19 in a collar pinching the two clamping rings 15, 17, one on the other, while ensuring a relative mobility of the two clamping rings 15, 17 only in rotation with respect to a common axis, in particular the longitudinal axis ZZ 'of the device 1 as represented in FIG. 1. In addition, in order to guarantee the joint seal between the body 3 of the device 1 and the bottom 2, the adapter 14 comprises at least one O-ring 20 sealing between the two clamping rings 15, 17, preferably at the junction between said rings by the third ring 19 external.

 The two clamping rings 15, 17 are preferably made by molding plastic material, for example polyurethane, and crimped to one another by an aluminum ring 19.

In an alternative embodiment shown in Figure 4, the adapter 14 of the device 1 of the invention, shown in Figures 1 and 3, is replaced by an adapter 21 integral with the body 3, formed directly at the lower end 3i thereof, and more precisely consists of a clamping ring 22 embedded in a groove 23 formed in the thickness of the border 3 ₃ forming the lower end 3i of the body. This clamping ring 22 comprises an internal thread 24 complementary to the external thread 7 of the bottom 2 of the device 1, so as to allow rapid sealing of the body 3 on said bottom 2 in order to carry out the dissolution or suspension of a product P according to the method described below.

 The device 1 of the invention is intended to carry out the dissolution or suspension of a product P such as tablet drugs, powders, granules for oral or enteral administration by a nasogastric or orogastric tube. For this purpose, the device 1 of the invention makes it possible to perform both the reduction by crushing of the tablets P in powder form in the crucible 5 formed in the bottom 2 of the device 1, then the dissolution in solution or in suspension of powders, granules or compressed tablets using the body 3 of the device 1 fixed on the bottom 2 and filled with a determined volume v of water or a food-grade aqueous solution or a mixture of liquids aqueous or non-aqueous.

 As is particularly apparent from Figure 2, the cap 4 and the bottom 2 of the device 1 of the invention form a pestle-crucible assembly adapted to perform the crushing of tablets P placed in the bottom 5i of the crucible 5 in the bottom 2.

 It suffices, in order to carry out the crushing of the tablets P in the crucible 5, to insert the male member 11 forming the pestle of the plug 4 into said crucible 5, then to screw the plug 4 onto the bottom 2 via the threads 6 , 10 complementary bottom and cap respectively, this screwing is easily done manually through the anti-sliding elements 7, 8 and fins 9 of the cap 4. Under the effect of screwing the cap 4, the organ male 11 crushes the tablets P in the crucible 5 and reduces them to the state of powder.

Once the tablets P crushed, it is then sufficient, to achieve the dissolution or suspension of this powder, to unscrew the cap 4 of the bottom 2 and then fix the lower end 3i of the body 3 of the device on the bottom 2 by through the adapter 14, 21 as shown in Figures 3 and 4. The connection of the adapter 14, 21 on the cap 2 is easily done by screwing the clamping ring 15, 22 of the adapter 14 , 21 on the upper section 2 ₂ threaded 2. In the example of FIG. 3 using an adapter 14 with double rings 15, 17 for clamping, it is also necessary to link the adapter 14 to the lower end 3i of the body 3 by screwing the second clamping ring 17 on said threaded lower end 3i.

A volume v of dilution liquid of the drug powder P located in the bottom 5i of the crucible 5 is then introduced through the open upper end 3 ₂ of the body 3. This volume v can easily be measured by means of the volumetric scale M on the body 3.

It is sufficient finally to close said upper end 3 ₂ by screwing the plug 4 thereon and shake the device 1 thus closed to achieve the dissolution or suspension of the drug P in the volume v of liquid without losing a single part and thus guaranteeing the realization of a solution or suspension of drug concentration chosen and verifiable.

 Once the solution or suspension is well homogenized after a few moments of stirring in the device 1, it is then sufficient to remove the cap 4 by unscrewing it and then pump the prepared solution directly into the body of the device 1 by introducing into it by the upper end opens a feeding syringe. The body 3 of the device having a minimum length of 10 cm and a minimum internal diameter of 2.5 cm, a feeding syringe can be introduced integrally over its entire length and to the bottom 5i of the crucible 5 of the bottom in the body 3 and the bottom 2, so as to suck up the entire prepared solution. This avoids losing a certainly small amount of solution or suspension but not negligible as to the treatment dosage of the patient to whom the solution must be administered.

 Once filled the feeding syringe, just unscrew the various elements of the device 1 to rinse with clear water and dry for the further preparation of a new solution. The device 1 can also be considered as a single-use device, made of glass or preferably of plastic material, and will then optionally be eliminated after the first use.

 The invention is not limited to the examples described and shown because various modifications can be made without departing from its scope.

Claims

1 - Device (1) for dissolution or suspension of products (P) such as drugs and / or food, comprising a bottom (2), a body (3) having at least an upper open end (3 _Î ) and defining a volume V for dissolving or suspending a said product with a liquid or a mixture of aqueous or non-aqueous liquid, and a plug (4) for closing the open upper end (3 ₂ ) of the body (3), characterized in that:  the bottom (2) is removable from the body (3) of the device and forms a crucible (5) for crushing the product (P) to be dissolved or suspended, and - The cap (4) comprises a male member (11) of complementary shape of the crucible (5) formed in the bottom (2) removable, and - The bottom (2) and the cap (4) comprise means (6, 10) complementary connection and clamping, on the one hand, the connection and the clamping of the cap on the bottom to reduce to the state of powder a said product (P) previously disposed in the crucible (5), and allowing, on the other hand, the attachment and clamping of the bottom on a lower end (3i) of the body (3) of the device provided with a thread (13) adapted to its connection to the bottom (2) after crushing said product and fixing and tightening the plug (4) on the open upper end (3 ₂ ) of the body, also provided with a thread (12) adapted to its connection to the plug (4) for effecting the dissolution or suspension and mixing of the product (P) crushed with a liquid or a mixture of aqueous or non-aqueous liquids.  2 - dissolution or suspension device according to claim 1, characterized in that the means (6, 10) complementary connection and clamping are sealed screw means. 3 - dissolution or suspension device according to claim 1 or 2, characterized in that the bottom (2) and the cap (3) have on their periphery elements (7, 8) anti-slip adapted to facilitate a manual clamping of the cap on the bottom to crush a product to be mixed and to facilitate the clamping of the bottom and the cap at the lower and upper ends (3i, 3 ₂ ) respectively of the body (3) of the device. 4 - dissolution or suspension device according to one of claims 2 or 3, characterized in that it comprises an adapter (14, 21) for mounting the bottom (2) on the lower end (3i) of the body (3), said adapter comprising first attachment and clamping means complementary to those of the bottom (2) and second securing and clamping means complementary to those of the lower end (3i) of the body (3).  5 - dissolution or suspension device according to claim 4, characterized in that the first and second fixing and clamping means are each formed by a clamping ring (15, 17) having an internal thread (16, 18 ) or external complementary to a thread (6, 13) formed on the bottom and the lower end (3i) of the body (3) respectively.  6 - dissolution or suspension device according to claim 4, characterized in that the clamping rings (15, 17) of the adapter (14) are crimped to one another by a ring (19) ensuring relative mobility of the two clamping rings only in rotation.  7 - dissolution or suspension device according to one of claims 4 to 6, characterized in that the adapter (14) comprises at least one O-ring (20) sealing between the two clamping rings (15). , 17).  8 - dissolution or suspension device according to one of the preceding claims, characterized in that the body (3) has a minimum height of 10 cm and a minimum internal diameter of 2.5 cm.  9 - dissolution or suspension device according to one of claims 1 to 8, characterized in that the body (3) is made of glass or a transparent plastic material of food grade or pharmaceutical.  10 - Process for dissolving or suspending a product (P) such as a drug or a food using a device (1) as described in claims 1 to 9, characterized in that: - depositing a product (P) to be dissolved or suspended in the crucible (5) defined inside the bottom (2) of the device, the cap (4) of the device is screwed onto the bottom (2), so that the male member (11) of the plug (4) crushes the product inside the crucible (5) formed in the background,  the cap (4) and the bottom (2) are then unscrewed from each other and a lower end (3i) of the body of the device is fixed on the bottom (2), where appropriate by the intermediate of an adapter (14, 21), - introducing a volume v of fluid at the upper end (3 _Î) of the body into said body (3), linked to the base (2) so as to mix the product (P) powdered and present in the crucible ( 5) with said liquid, - is screwed cap (4) on the upper end (3 _Î) of the body (3) of the device after filling thereof with the volume v of the liquid,  the product and the liquid are mixed by manual stirring and / or inverting the device after placing the stopper (4).