DEVICE AND METHOD FOR ORAL ADMINISTRATION OF ACTIVE PRINCIPLES
20200337944 ยท 2020-10-29
Inventors
Cpc classification
A61J1/00
HUMAN NECESSITIES
International classification
Abstract
The present invention concerns a packing device and a method for the preparation and oral administration of an effervescent powder comprising one or more active principles. In particular, the present invention allows to prepare an effervescent powder comprising one or more active principles using storage chambers physically separated from each other.
Claims
1. Packing device (10) for the preparation and oral administration of an effervescent powder comprising one or more active principles (P), wherein said packing device (10) provided with two storage chambers (11a, 11b) physically separated from each other, wherein: a powder comprising one or more active principles (P) and a first excipient (E1) for effervescence is packed in one storage chamber (11a); a powder comprising one or more active principles (P) and a second excipient (E2) for effervescence is packed in another storage chamber (11b).
2. Packing device (10) as in claim 1, wherein it comprises closing welds defining a line of folding and/or tearing around a longitudinal axis (Y) and delimiting said two storage chambers (11a, 11b) physically separated from each other.
3. Packing device (10) as in claim 1, wherein said packing device (10) is a closed stick-pack having only three welds (13a, 13b, 13c) and formed by a pipe (22) of poly-coupled polymer-metal material on which there are two transverse closing welds, upper (13a) and lower (13b), and a central separation weld (13c) defining a folding line (21) around a longitudinal axis (Y), said separation weld (13c) delimiting said two storage chambers (11a, 11b).
4. Packing device (10) as in claim 2, wherein said two storage chambers (11a, 11b) have a common central joining side (16) along said longitudinal axis (Y) and said folding line (21) and two respective external lateral edges (17, 18).
5. Packing device (10) as in claim 3, wherein one or the other of said transverse closing welds, upper (13a) or lower (13b), has a protruding nose welding portion (15) facing toward the inside and disposed centrally in correspondence with said longitudinal axis (Y).
6. Packing device (10) as in claim 2, wherein it comprises a pre-cut (14) disposed along said longitudinal axis (Y) and transverse thereto, and configured to define a tear-off lead-in in order to open said chambers along a tear line (20) transverse to said longitudinal axis (Y).
7. Packing device (10) as in claim 6, wherein said pre-cut (14) is made astride said joining side (16).
8. Packing device (10) as in claim 6, wherein said pre-cut (14) is made as a through incision from side to side through the material of said pipe (22).
9. Packing device (10) as in claim 6, wherein said pre-cut (14) is disposed inside the welding area of one or the other of said transverse closing welds, upper (13a) or lower (13b).
10. Packing device (10) as in claim 6, wherein said pre-cut (14) is provided in said protruding nose welding portion (15).
11. Packing device (10) as in claim 4, wherein said two storage chambers (11a, 11b) can be positioned on top of each other by means of rotation around said folding line (21) along said longitudinal axis (Y), in order to assume an overlapping condition, laterally delimited on one side by a joining edge (19) defined along a common joining line (16) between said two storage chambers (11a, 11b) along the longitudinal axis (Y) and on an opposite side by an overlapping edge of the respective external lateral edges (17, 18) of said two storage chambers (11a, 11b), wherein the overall transverse bulk of said packing device is substantially halved.
12. Packing device (10) as in claim 11, wherein in said overlapping condition said pre-cut (14) is astride said joining edge (19) so that, by tearing said pre-cut (14), the simultaneous opening of both of said two storage chambers (11a, 11b) is determined along said tear line (20).
13. Packing device (10) as in claim 1, wherein said material of said pipe (22) is a polyethylene-aluminum-polyethylene terephthalate (PE-ALU-PET) poly-coupled laminate, wherein the polyethylene constitutes a more internal layer facing toward the inside of said storage chambers (11a, 11b), the aluminum constitutes an intermediate layer and the polyethylene-terephthalate constitutes a more external layer of said material.
14. Packing device (10) as in claim 1, wherein when said first excipient (E1) has a basic nature, said second excipient (E2) has an acidic nature, or vice versa.
15. Packing device (10) as in claim 1, wherein said storage chambers (11a, 11b) are physically separated from each other by an intermediate sealing strip (12).
16. Packing device (10) as in claim 1, wherein said active principles (P) comprise one or more of pharmacological substances, vitamins, minerals, probiotics, amino acids, trace elements, antioxidants and plant extracts.
17. Packing device (10) as in claim 1, wherein the excipients (E1 or E2) of a basic nature comprise carbonates and/or bicarbonates of sodium, magnesium, potassium.
18. Packing device (10) as in claim 1, wherein the excipients (E1 or E2) of an acidic nature comprise citric acid, malic acid, tartaric acid, ascorbic acid, fumaric acid, adipic acid.
19. Packing device (10) as in claim 1, wherein said storage chambers (11a, 11b) are in a controlled environment.
20. Packing device (10) as in claim 1 wherein said two storage chambers (11a, 11b) are made in a single sachet (23).
21. Packing device (10) as in claim 20, wherein said two storage chambers (11a, 11b) are separated by a transverse division or membrane (24) inside said sachet (23).
22. Packing device (10) as in claim 20, wherein it comprises a single sachet (23).
23. Packing device (10) as in claim 20, wherein it comprises two or more sachets (23) connected to each other by a tear line (21a).
24. Method to prepare an effervescent powder comprising one or more active principles (P) using storage chambers (11a, 11b) physically separated from each other, said method comprising making available a packing device as in claim 1, wherein in one storage chamber (11a) there is a powder comprising said active principles (P) and a first excipient (E1) for effervescence and in another storage chamber (11b) there is a powder comprising said active principles (P) and a second excipient (E2) for effervescence; with the condition that when said first excipient (E1) has a basic nature, said second excipient (E2) has an acidic nature, or vice versa.
25. Method as in claim 24, wherein the ratio in weight between said excipient with an acidic nature and said excipient with a basic nature is comprised between 1.0 and 2.2.
26. Method as in claim 25, wherein the grain size of said powders contained in said storage chambers (11a, 11b) is comprised between 75 and 800 m.
27. Method to prepare a solution comprising one or more active principles (P) using a packing device (10) with storage chambers (11a, 11b) physically separated from each other as in claim 1, wherein: in one storage chamber (11a) there is a powder comprising said active principles (P) and a first excipient (E1) for effervescence; in another storage chamber (11b) there is a powder comprising said active principles (P) and a second excipient (E2) for effervescence; said method comprising: opening said storage chambers (11a, 11b) and mixing in water the powders contained in said storage chambers (11a, 11b) with consequent development of effervescence due to the reaction between said first excipient (E1) and said second excipient (E2); obtaining a solution of said active principles (P) in water suitable for oral administration.
28. Method for packaging an effervescent powder comprising one or more active ingredients (P), wherein said method provides to: make available a poly-coupled polymer-metal material; make closing welds defining a folding line around a longitudinal axis (Y) and delimiting two storage chambers (11a, 11b) physically separated from each other; introduce into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a first excipient (E1) for effervescence; introduce into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a second excipient (E2) for effervescence; make a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
29. Method to package an effervescent powder comprising one or more active principles (P), wherein said method provides to: make available a pipe (22) made of poly-coupled polymer-metal material; make a first lower transverse closing weld (13b) and a second central separation weld (13c) defining a folding line around a longitudinal axis (Y) delimiting two physically separated storage chambers (11a, 11b); introduce into a storage chamber (11a) a powder comprising one or more active principles (P) and a first excipient (E1) for effervescence; introduce into another storage chamber (11b) a powder comprising one or more active principles (P) and a second excipient (E2) for effervescence; make a third upper transverse closing weld (13a) to close said two storage chambers (11a, 11b) and obtain a closed multi-chamber stick-pack.
30. Packaging method as in claim 28, wherein it comprises making a pre-cut (14) disposed along said longitudinal axis (Y) and transverse thereto, and configured to define a tear-off lead-in, to open said storage chambers (11a, 11b) along a tear line (20) transverse to said longitudinal axis (Y).
31. Method for packaging an effervescent powder comprising one or more active ingredients (P), wherein said method provides to: make available a poly-coupled polymer-metal material and a division or membrane (24); make closing welds to define at least one sachet (23) delimiting internally two storage chambers (11a, 11b) physically separated from each other by said division or membrane (24) transversely inside said sachet (23); introduce into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a first excipient (E1) for effervescence; introduce into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a second excipient (E2) for effervescence; make a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
32. Packing device (10) for the preparation and oral administration of a powder composition comprising one or more active principles (P), wherein said packing device (10) is provided with two storage chambers (11a, 11b) physically separated from each other, in which: in one storage chamber (11a) a powder is packaged comprising one or more active ingredients (P) and a possible first excipient (E1); in another storage chamber (11b) a powder is packaged comprising one or more active ingredients (P) and a possible second excipient (E2).
33. Packing device (10) for the preparation and oral administration of a powdered composition comprising one or more active principles (P), wherein said packing device (10) is a closed stick-pack having only three welds (13a, 13b, 13c) and formed by a pipe (22) made of poly-coupled polymer-metal material on which there are two transverse closing welds, upper (13a) and lower (13b), and a central separation weld (13c) defining a folding line (21) around a longitudinal axis (Y), said separation weld (13c) delimiting two storage chambers (11a, 11b) physically separated from each other, in which: in one storage chamber (11a) a powder is packaged comprising one or more active principles (P) and a possible first excipient (E1); in another storage chamber (11b) a powder is packaged comprising one or more active principles (P) and a possible second excipient (E2).
34. Packing device (10) as in claim 32, wherein said storage chambers (11a, 11b) are in a controlled atmosphere.
35. Packing device (10) as in claim 32, wherein it comprises closing welds defining a line of folding and/or tearing around a longitudinal axis (Y) and delimiting said two storage chambers (11a, 11b) physically separated from each other.
36. Packing device (10) as in claim 32, wherein said two storage chambers (11a, 11b) are made in a single sachet (23).
37. Packing device (10) as in claim 36, wherein said two storage chambers (11a, 11b) are separated by a transverse division or membrane (24) inside said sachet (23).
38. Packing device (10) as in claim 36, wherein it comprises a single sachet (23).
39. Packing device (10) as in claim 36 wherein it comprises two or more sachets (23) connected to each other by a tear line (21a).
40. Method for packaging a powder composition comprising one or more active principles (P), wherein said method provides to: make available a polymer-metal polymeric material; make closing welds defining a folding and/or tear line around a longitudinal axis (Y) and delimiting two storage chambers (11a, 11b) physically separated from each other; introduce into one storage chamber (11a) a powder comprising one or more active principles (P) and a possible first excipient (E1); introduce into another storage chamber (11b) a powder comprising one or more active principles (P) and a second excipient (E2); make a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
41. Method to package a powdered composition comprising one or more active principles (P), wherein said method provides to: make available a pipe (22) of poly-coupled polymer-metal material; make a first lower transverse closing weld (13b) and a second central separation weld (13c) defining a folding and/or tearing line around a longitudinal axis (Y) delimiting two physically separated storage chambers (11a, 11b); introduce into a storage chamber (11a) a powder comprising one or more active principles (P) and a possible first excipient (E1); introduce into another storage chamber (11b) a powder comprising one or more active principles (P) and a possible second excipient (E2); make a third upper transverse closing weld (13a) to close said two storage chambers (11a, 11b) and obtain a closed multi-chamber stick-pack.
42. Method for packaging an effervescent powder comprising one or more active principles (P), wherein said method provides to: make available a poly-coupled polymer-metal material and a division or membrane (24); make closing welds to define at least one sachet (23) internally delimiting two storage chambers (11a, 11b) physically separated from each other by said division or membrane (24) transversely inside said sachet (23); introduce into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a first excipient (E1); introduce into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a second excipient (E2); make a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
43. Packaging method as in claim 40, wherein it comprises making a transverse pre-cut (14) configured to define a tear-off lead-in, to open said storage chambers (11a, 11b) along a transverse tear line (20).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0086] These and other characteristics of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:
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[0095] To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can conveniently be incorporated into other embodiments without further clarifications.
DETAILED DESCRIPTION OF SOME EMBODIMENTS
[0096] We will now refer in detail to the various embodiments of the invention, of which one or more examples are shown in the attached drawings. Each example is supplied by way of illustration of the invention and shall not be understood as a limitation thereof. For example, the characteristics shown or described insomuch as they are part of one embodiment can be adopted on, or in association with, other embodiments to produce another embodiment. It is understood that the present invention shall comprise all such modifications and variants.
[0097] Before describing these embodiments, we must also clarify that the present description is not limited in its application to details of the construction and disposition of the components as described in the following description using the attached drawings. The present description can provide other embodiments and can be obtained or executed in various other ways. We must also clarify that the phraseology and terminology used here is for the purposes of description only, and cannot be considered as limitative.
[0098] We must point out that, in the embodiments described here, the term effervescent refers to mixtures of solid substances, generally based on sodium bicarbonate or other suitable basic compounds and a substance with an acidic character, which in contact with water cause an instantaneous development of gas, generally carbon dioxide.
[0099]
[0100] In particular,
[0101] In embodiments described using
[0102] In embodiments described using
[0103] Below we describe alternative embodiments of the present description, which can be combined and applied to the embodiments described using
[0104] In possible embodiments, combinable and applicable to the embodiments described using
[0105] In possible embodiments in which an effervescent formulation is provided, the excipients (E1) or (E2) with an acidic nature can comprise, by way of non-restrictive example, citric acid, malic acid, tartaric acid, ascorbic acid, fumaric acid or adipic acid. Other possible acids can be, for example, cream of tartar or acid phosphate.
[0106] As regards the weight ratio between the powders of the excipients with an acidic nature and those with a basic nature, this is generally between 1.0 and 2.2, preferably between 1.4 and 2.0.
[0107] The excipients functional to effervescence (E1), (E2) are inserted in the powdered preparation with percentages from 14% to 100% in weight for the carbonates and from 16% to 100% in weight for the acids, which must be calibrated as a function of the desired greater or lesser effervescent effect.
[0108] In the embodiments where it is provided to use the packing device 10 for non-effervescent formulations as described above, the excipients E1, E2 can be of another nature, suitable for the specific purpose for which the formulation is provided.
[0109] On the contrary, the content of the active principles (P) in the embodiments described in
[0110] With regard to the grain size of the powdered substances (P, E1, E2) inserted inside the storage chambers (11a, 11b), this is generally comprised between 75 and 800 m. However, for powders of excipients E1, E2 with effervescent effect, it is preferred to use a slightly lower particle size comprised between 75 and 500 m.
[0111] In some particular formulations, such as the preparation of magnesium-based supplements, magnesium carbonate, besides having the function of active principle (P), helps to generate the effervescence effect in contact with water, as it is simultaneously an excipient substance (E1 or E2) with a basic character.
[0112] An analogous case concerns the preparation of vitamin C supplements, in which the ascorbic acid, in addition to having the function of active principle (P), helps to generate effervescence when put in contact in water, as it is simultaneously an excipient substance (E1 or E2) with acidic character.
[0113]
[0114] The packing device (10) described using
[0115] To this purpose, with reference to the embodiments described using
[0116] Advantageously, moreover, the packaging can be carried out in a controlled atmosphere, so as not to contaminate or alter the state of the ingredients of the composition. In particular, packaging in a controlled atmosphere is such that the residual oxygen content in the package is less than 1%, thus limiting the oxidative effect on the substances present.
[0117] As explained, the packing device (10) made in accordance with the present description is suitable to be used in a method for the preparation and oral administration of a powder comprising one or more active principles (P).
[0118] To perform the oral administration of the active principles (P) it is necessary to open the storage chambers (11a, 11b) in order to extract the powders contained therein, and then pour them into a small quantity of water in order to obtain a solution of the powders in water. Mixing the powders in water will promote their solution, together with the effect of effervescence generated by the reaction between the excipients with a basic and acidic nature.
[0119] Therefore, other embodiments, combinable and applicable to the embodiments described using
[0120] disposing in a storage chamber (11a) a powder comprising the active principles (P) and a first excipient (E1) for effervescence;
[0121] disposing in a storage chamber (11b) a powder comprising the active principles (P) and a second excipient (E2) for effervescence;
[0122] mixing in water the powders contained in the storage chambers (11a, 11b) with consequent development of effervescence due to the reaction between the first excipient (E1) and the second excipient (E2);
[0123] obtaining a solution of the active principles (P) in water suitable for oral administration.
[0124]
[0125] in one storage chamber (11a) a powder is packaged comprising one or more active principles (P) and a first excipient (E1) for effervescence;
[0126] in another storage chamber (11b) a powder is packaged comprising one or more active principles (P) and a second excipient (E2) for effervescence.
[0127] In particular, the packing device (10) according to the embodiments described here using
[0128] Again, once it has been closed with the two transverse closing welds or seals, upper (13a) and lower (13b), the packing device (10) according to the embodiments described here using
[0129] In some embodiments, the two storage chambers (11a, 11b) have a common central joining side (16) along the longitudinal axis (Y) and the folding line (21) and two respective external lateral edges (17, 18).
[0130] In some embodiments, one or the other of the transverse closing welds or seals, upper (13a) or lower (13b), has a protruding nose welding portion (15) facing toward the inside and disposed centrally in correspondence with the longitudinal axis (Y).
[0131] In some embodiments, combinable with all the embodiments described using
[0132] In possible implementations, the pre-cut (14) is made astride the joining side (16) (see
[0133] In some embodiments, the pre-cut (14) is made as an incision passing from side to side through the material of the pipe (22).
[0134] In some embodiments, the pre-cut (14) is disposed inside the welding region of one or the other of the transverse closing welds, upper (13a) or lower (13b) (see
[0135] In some embodiments, the pre-cut (14) is provided in the protruding nose welding portion (15) (see
[0136] In some embodiments, combinable with all the embodiments described using FIGS. from 1 to 5, the two storage chambers (11a, 11b) can be reciprocally overlapped by rotation around the folding line (21) along the longitudinal axis (Y) to assume an overlapping condition (see
[0137] In some embodiments, in the overlapping condition (see
[0138] In some embodiments, combinable and applicable to all the embodiments described here, the material of the pipe (22) is a polyethylene-aluminum-polyethylene terephthalate (PE-ALU-PET) poly-coupled laminate, in which the polyethylene constitutes an innermost layer facing toward the inside of the storage chambers (11a, 11b), the aluminum constitutes an intermediate layer and the polyethylene terephthalate constitutes an outermost layer of the material. This material is advantageously non-transparent, so as to protect the contents from light radiations which could damage or ruin them.
[0139] In embodiments, a method is also provided for packaging an effervescent powder comprising one or more active ingredients (P). The method provides to:
[0140] make available a poly-coupled polymer-metal material;
[0141] make closing welds defining a fold and/or tear line around a longitudinal axis (Y) and delimiting two storage chambers (11a, 11b) physically separated from each other;
[0142] introduce into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a first excipient (E1) for effervescence;
[0143] introduce into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a second excipient (E2) for effervescence;
[0144] make a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
[0145]
[0146] make available a pipe (22) made of poly-coupled polymer-metal laminated material (see
[0147] make a first lower transverse closing weld, or seal, (13b) (see
[0148] introduce into a storage chamber (11a) a powder comprising one or more active principles (P) and a first excipient (E1) for effervescence (as indicated by the arrow F1 in
[0149] introduce into another storage chamber (11b) a powder comprising one or more active principles (P) and a second excipient (E2) for effervescence (as indicated by the arrow F2 in
[0150] make a third upper transverse closing weld, or seal (13a) to close the two storage chambers (11a, 11b) and obtain a closed multi-chamber stick-pack (see
[0151] In other embodiments, the method comprises making a pre-cut (14) disposed along the longitudinal axis (Y) and transverse thereto and configured to define a tear-off lead-in to open the storage chambers (11a, 11b) along a tear line (20) transverse to the longitudinal axis (Y) (see
[0152] In some embodiments, which can be combined and applied to the embodiments described using
[0153] In other embodiments, the packing device (10) can also be used for the preparation and oral administration of a powdered composition comprising one or more active principles (P), which is not necessarily of the effervescent type, as described above (see
[0154] in one storage chamber (11a) a powder is packaged comprising one or more active principles (P) and a possible first excipient (E1);
[0155] in another storage chamber (11b) a powder is packaged comprising one or more active principles (P) and a possible second excipient (E2).
[0156] A method for packaging a powder composition comprising one or more active ingredients (P) is also provided. The method provides to:
[0157] make available a poly-coupled polymer-metal material;
[0158] make closing welds defining a fold and/or tear line around a longitudinal axis (Y) and delimiting two storage chambers (11a, 1 lb) physically separated from each other;
[0159] introduce into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a possible first excipient (E1);
[0160] introduce into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a possible second excipient (E2);
[0161] make out a closing weld to close said two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
[0162] A method is also provided for packaging a powdered composition comprising one or more active principles (P), which is not necessarily of the effervescent type (see
[0163] make available a pipe (22) made of poly-coupled polymer-metal laminated material;
[0164] make a first lower transverse closing weld, or seal (13b) and a second central separation weld, or seal (13c) defining a folding line around a longitudinal axis (Y) delimiting two storage chambers (11a, 11b) physically separated from each other;
[0165] introduce into a storage chamber (11a) a powder comprising one or more active principles (P) and a possible first excipient (E1);
[0166] introduce into another storage chamber (11b) a powder comprising one or more active principles (P) and a possible second excipient (E2);
[0167] make a third upper transverse closing weld, or seal (13a) to close the two storage chambers (11a, 11b) and obtain a closed multi-chamber stick-pack.
[0168] In accordance with other embodiments described using
[0169] In possible implementations, the two storage chambers (11a, 11b) made in a single sachet (23) are separated by a transverse division or membrane (24) inside the sachet (23). The division or membrane (24) is configured to keep the active ingredients (P) and the first excipient (E1) and the second excipient (E2) separated. By opening the upper part of the sachet (23) by tearing, the upper part of the division or membrane (24) is also automatically torn, so that it is possible to deliver the contents of the two storage chambers (11a, 11b).
[0170] According to a possible variant embodiment, described using
[0171] According to another variant embodiment, described using
[0172] In some embodiments, therefore, a method can be provided for packaging an effervescent powder comprising one or more active ingredients (P), which comprises:
[0173] making available a poly-coupled polymer-metal material and a division or membrane (24);
[0174] making closing welds to define at least one sachet (23) delimiting internally two storage chambers (11a, 11b) physically separated from each other by the division or membrane (24) transversely inside said sachet (23);
[0175] introducing into one storage chamber (11a) a powder comprising one or more active ingredients (P) and a first excipient (E1) for effervescence;
[0176] introducing into another storage chamber (11b) a powder comprising one or more active ingredients (P) and a second excipient (E2) for effervescence;
[0177] making a closing weld to close the two storage chambers (11a, 11b), obtaining a closed multi-chamber package.
[0178] As described above, the embodiments described using
[0179] It is clear that, although the packing device (10) and the method for the preparation and oral administration of a powder according to the present invention have been described with reference to the embodiments described in the attached figures, a person of skill in the art shall certainly be able to make many other equivalent forms of the packing device (10) having the characteristics set forth in the claims, and hence all coming within the field of protection defined thereby.
[0180] In the following claims, the sole purpose of the references in brackets is to facilitate reading: they must not be considered as restrictive factors with regard to the field of protection claimed in the specific claims.