DEVICE FOR DISPENSING SINGLE DROPLETS INTO A CAP OR BODY OF A CAPSULE
20230391486 · 2023-12-07
Assignee
Inventors
Cpc classification
B65B51/10
PERFORMING OPERATIONS; TRANSPORTING
A61J3/072
HUMAN NECESSITIES
International classification
B65B51/02
PERFORMING OPERATIONS; TRANSPORTING
A61J3/07
HUMAN NECESSITIES
B65B7/28
PERFORMING OPERATIONS; TRANSPORTING
B65B51/10
PERFORMING OPERATIONS; TRANSPORTING
Abstract
The present invention relates to a device for dispensing a single droplet of a fluid, for example a single droplet of an adhesive, onto the inside surface of a cap or onto the inside surface of a body of a capsule, this is useful for rendering a closed capsule with a telescopically engaged cap and body more tamperproof, or for fixing a cap or a body or both, which encloses a caplet or tablet or a part thereof, to the caplet or the tablet.
Claims
1.-26. (canceled)
27. A device for dispensing a droplet of a fluid onto an inner surface of a cap or onto an inner surface of a body of a capsule, comprising: a valve comprising an outlet channel with an open end; a fluid dispensing cavity; and a cannula comprising a tube with two ends that are open, wherein the open end of the outlet channel of the valve opens into the fluid dispensing cavity, wherein a first end of the two ends of the cannula dispenses the droplet of the fluid, and a second end of the two ends of the cannula opens into the fluid dispensing cavity, and wherein the device defines a fluid connection from the outlet channel of the valve to the fluid dispensing cavity and from the fluid dispensing cavity to the cannula, and the fluid can flow from the valve to the first end of the cannula via the fluid connection.
28. The device according to claim 27, further comprising: a pin comprising a pin tube and two ends, a first end of the two ends of the pin comprising a pin head, wherein the pin tube receives and contains the cannula, and a portion of the cannula is located in the pin head, the portion of the cannula located in the pin head includes the first end of the cannula.
29. The device according to claim 27, wherein a volume of the fluid dispensing cavity is 5 microliter or smaller.
30. The device according to claim 28, wherein an outer diameter of the pin tube is 15 mm or smaller.
31. The device according to claim 27, wherein an inner diameter of the cannula is 2 mm or smaller.
32. The device according to one or more of claim 28, wherein the portion of the cannula in the pin head comprises a bent portion.
33. The device according to claim 32, wherein the bent portion is bent at a bending angle and the bending angle is 400 to 140°.
34. The device according to claim 27, wherein the device comprises only one cannula.
35. The device according to claim 34, wherein the fluid dispensing cavity has a cross-sectional area perpendicular to a longitudinal axis of the cannula, and the cross-sectional area of the fluid dispensing cavity is different from a cross-sectional area of the cannula.
36. The device according to claim 28, wherein the device comprises a plurality of cannulas.
37. The device according to claim 36, wherein the portion of each of the plurality of cannulas in the pin head comprises a bent portion.
38. The device according to claim 37, wherein the plurality of cannulas are arranged in such a way that openings of the respective first ends, which are located in the pin head, and respective directions of the openings of the first ends are distributed over a circumference of the pin head at the same angle to each other.
39. The device according to claim 38, wherein the plurality of cannulas are two cannulas and the direction of the openings of the first ends, which are located in the pin head, of the two cannulas have an angle of 180° to each other.
40. The device according to claim 38, wherein the plurality of cannulas are four cannulas, and the direction of the openings of the first ends, which are located in the pin head, of the four cannulas have an angle of 90° to each other.
41. The device according to claim 27, wherein the device comprises a means for heating or cooling of the fluid.
42. The device according to claim 28, wherein the device comprises a means for heating or cooling of the pin, the pin head, the cannula, the fluid dispensing cavity, the valve, or of a combination thereof.
43. An apparatus used in a closing process of caps and bodies to form closed capsules or used in an insertion of a tablet or a caplet into a cap or into a body, wherein the apparatus comprises the device of claim 28.
44. The apparatus according to claim 43, wherein the apparatus comprises a device for supplying the fluid into a valve cavity.
45. The apparatus according to claim 43, wherein the apparatus comprises a device for keeping the fluid in a valve cavity under a predefined pressure.
46. The apparatus according to one or more of claim 43, wherein the apparatus comprises a means for heating or cooling of the fluid.
47. The apparatus according to one or more of claim 43, wherein the apparatus comprises a means for heating or cooling of the pin, the pin head, the cannula, the fluid dispensing cavity, the valve, or of a combination thereof.
48. A method for dispensing a droplet of a fluid onto an inner surface of a cap or onto an inner surface of a body of a capsule, wherein the droplet is dispensed by the device of claim 27 and the method comprises: providing the valve, the outlet channel of the valve, the fluid dispensing cavity and the cannula of the device filled with the fluid with the valve closed and having the fluid in the valve under a predefined pressure; inserting the pin head into the cavity of the cap or the body; opening and closing the valve for a predefined period of time to dispense a droplet onto the inner surface of cap or the body; and extracting the pin head from the cavity of the cap or the body.
49. The method according to claim 48, wherein the fluid comprises a solvent, the solvent is selected from the group consisting of water, C.sub.1-4 alcohol, C.sub.1-4 ether, C.sub.1-8 ketones, methylenglycol, C.sub.1-4 carboxylic acid C.sub.1-4 ester.
50. The method according to claim 49, wherein the solvent is water, EtOH, isopropanol, or a mixture thereof.
51. The method according to claim 48, wherein the fluid comprises an adhesive agent, the adhesive agent may be selected from a group consisting of polyalkylene, polysaccharide, cellulose and derivatives of cellulose, wax chitosan, carbohydrates including mono-, di-, and poly saccharides, aspartame, glycoside, polyvinylpyrrolidone, gelatin, monofunctional organic acid, polyfunctional organic acid, polymers and copolymers of acrylic acids and methacrylic acids and salts and esters thereof, protein, shellac, rubber, polyvinylacetate, polyuronic acid, poly-hydroxy-alcohol, dialkylphthalate, lower alkyl citrate wherein lower alkyl has 1 to 6 carbon atoms, polyglycol, ester of polyhydroxy-alcohol, reocineoleic acid and esters thereof, long chain fatty acids and long chain esters thereof, wherein long chain fatty acid means 6 to 24 C atoms and long chain ester means an C.sub.6-24 alcohol ester, or phosphoric acid.
52. The method according to claim 48, wherein the method further comprises: after extracting the pin head from the cavity of the cap or the body, telescopically engaging the cap and the body to form a capsule.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0268] The present invention will be described again with reference to the enclosed drawings, wherein:
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0290] The present invention will now be described in more detail with reference to the enclosed figures. Same components and arrangements are denoted in the figures by the same reference numerals and the respective description may be omitted in order to avoid redundancies. Obviously what is depicted as a cap of a capsule in the figures may as well be a body of a capsule.
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[0296] The view 5b shows an enlarged section of the view 5a from a slightly different perspective, shown are the pin tube 3-2 and the pin socket 3-3 into which the pin foot 3-7 is mounted. Also shown is the inner thread 3-3-1 in the pin socket 3-3 with which the valve 5, which is not shown, is mounted by the valve mount 5-4, which is not shown, to the pin socket 3-3 by a screw type connection. Also shown are two cannulas 4 and the fluid dispensing cavity 8; the cannulas 4 extend from the fluid dispensing cavity 8 in a bended way into the pin tube 3-2. The cannulas 4 are mounted to the pin socket 3-3 by the cannula mount 4-4; the cannula mount comprises the fluid dispensing cavity 8.
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[0298] The view 6b shows a cross section of the pin head 3-1 perpendicular to the longitudinal axis of the pin 3, shown by the pin tube 3-2, with two cannulas 4 each with a 900 bend 4-3 and with the opening 4-1 of the cannula facing in opposite directions with respect to each other, the cross section cuts though the end of the cannulas 4 showing the tube like nature of the cannula, also shown is the mount 3-1-2 in the pin head 3-1 for fixing the position of the cannulas 4 and pin head opening 3-4 comprising an open space separating the end of the cannula with its opening 4-1 circumferentially from the wall of the pin head 3-1. Also shown are two pin head gas openings 3-5 which connect the empty pin space 3-6, which is not shown, besides the cannula 4 in the pin 3 with the pin head opening 3-4.
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[0309] In the view 16b a schematic and perspective view of a mount 3-1-2 of a pin head 3-1 with four cannulas 4 is shown. Also shown are three droplets 7 positioned on the inside of a cap 6, but without showing the cap itself. The four cannulas 4 pass through the pin head mount 3-1-2 which comprises also the four pin head gas openings 3-5 in form of bores in the pin head mount 3-1-2. The pin head 3-1 is closed by the pin head closure cap 3-1-1. Again the end of each cannula 4 with its opening 4-1 is located in the pin head opening 3-4 comprising an open space separating the end of each cannula 4 with its opening 4-1 circumferentially from the wall of the pin head 3-1
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[0311] The view 17b shows a schematic cross section of a side view of the assembled pin head 3-1 with four cannulas 4, the cross section is again as in view 17a done through a plane perpendicular to the surface of the pin 3 and along the longitudinal axis of the pin 3 cutting through the middle of the pin head 3-1. View 17b shows two droplets 7 positioned on the inside of a cap 6, but without showing the cap 6 itself. The pin head 3-1 comprises the pin head closure cap 3-1-1 fixed to and abutting the mount 3-1-2 in the pin head, the mount 3-1-2 is fixed on and abutting the pin tube 3-2. The mount 3-1-2 fixes the position of the four cannulas 4, of which one is shown in a cross cut display with its opening 4-1 at its end, further two cannulas 4 with their bending 4-3 are shown passing through the pin head mount on the back side of the one cannula shown in cross cut display, and of the fourth cannula 4 only the cross cut section of the end of the cannula 4 is shown which extends to the back of the pin head 3-1. One of pin head gas opening 3-5 is shown as a cross cut through the respective bore and thereby connecting the empty pin space 3-6 with the pin head openings 3-4. The two cannulas which are shown with their bending 4-3 end in their respective pin head openings 3-4 which are shown in a cross cut display comprising an open space separating the end of the cannula 4 with its opening 4-1 circumferentially from the wall of the pin head 3-1.
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[0314] The gas inlet channel 9-2, the gas inlet splitter 9-3, the opening 3-3-2-1 in the foot 3-3-2 of the pin socket 3-3, the opening 3-7-1 in the pin foot 3-7 and the empty pin space 3-6 are in fluid connection, gas with the desired temperature can pass through.
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[0316] The spring 9-3-1- of the gas inlet splitter 9-3 holds the gas inlet splitter in SPLITTERBYPASS. The gas inlet channel 9-2, the gas inlet splitter 9-3 and the gas bypass outlet channel 9-4 are in fluid connection via an opening 9-3-2 which connects the gas inlet channel with the gas bypass outlet channel when the gas inlet splitter is in SPLITTERBYPASS, gas with the desired temperature can pass through. The pin socket 3-3-2 does not abut the gas inlet splitter 9-3, but is moved a certain distance upwards away from the gas inlet splitter 9-3.
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[0318] The empty space 3-6, the pin head gas openings 3-5, the pin head opening 3-4 and the gas tempering outlet channel are in fluid connection, gas with the desired temperature can pass through.
EXAMPLES
[0319] Materials and dimensions [0320] Capsules The capsules used had an essentially hollow-cylindrical shape with dome shaped closed ends and consists of two parts, a cap and a body, which telescopically engage with each other for closing the capsule. The telescopic engagement of the cap and the body when the capsule is closed, is realized in form of an overlap of a part of the cap over a part of the body. In this region of overlap there may be a snap fit ring in the cap, which is located in the cylindrical part of the cap and is located at a certain distance from the edge of the open end of the cap.
[0321] Dimensions of parts of the filling machine were (if not stated expressly otherwise in an example): [0322] Cannula OD: 0.413 mm, ID: 0.21 mm [0323] pin tube OD 4.0 mm, ID 3.0 mm, thickness of the wall of the pin tube is 0.5 mm [0324] Pressure FLU in the valve cavity was under pressure of 1.5 bar [0325] V-OUTLETCHAN 0.07 microliter [0326] V-CAV 0.18 microliter [0327] Plantcaps® capsules produced from tapioca pullulan; Capsugel, now Lonza Ltd, Morristown, New Jersey, USA [0328] Vcaps® capsules made from HPMC; Capsugel, now Lonza Ltd, Morristown, New Jersey, USA [0329] Vcaps® Enteric Two-piece hard capsule manufactured with pharmaceutical-grade cellulosic derivatives (HPMCAS, HPMC); Capsugel, now Lonza Ltd, Morristown, New Jersey, USA [0330] Vcaps® Plus immediate release capsule for pharmaceutical products in HPMC; Capsugel, now Lonza Ltd, Morristown, New Jersey, USA
Example 1
[0331] Vcaps® Plus size 0 capsule are used. On a filling machine two droplets of a 75 wt % ethanol/25 wt % de-ionized water mixture 23° C. are dispensed on the inner surface of the cap of each capsule using two cannulas per pin tube. The droplets of 0.15 microliter (valve opening time: 2 msec) are dispensed 180° from each other in between the snap fit ring and the cap edge. In a next step the filling machine inserts the body into the cap up to a fully closed position. As a result the mixture is spread-out and local sealing zones are formed between the cap and the body. The seal zones increase the pull-apart force compared to the baseline with a factor 5 without any visual outer defects.
Example 2
[0332] Vcaps® Enteric size 0 capsules are used. On a filling machine two droplets of 99 wt % ethanol of 23° C. are dispensed on the inner surface of the cap of each capsule using two cannulas per pin tube. The droplets of 0.1 microliter (valve opening time 1 msec) are dispensed 180° degrees from each other in between the snap fit ring and the cap edge. In a next step the filling machine inserts the body into the cap up to a fully locked position. As a result the mixture is spread-out and local sealing zones are formed between the cap and the body. The seal zones increase the pull-apart force compared to the baseline with a factor 10 without any visual outer defects.
Example 3
[0333] Plantcaps® size 0 capsules are used. On a filling machine four droplets of a 25 wt % ethanol/75 wt % de-ionized water mixture of 23° C. are dispensed on the inner surface of the cap of each capsule using two cannulas per pin tube. The droplets of 0.05 microliter (valve opening time 1 msec) are dispensed 180° from each other in between the snap fit ring and the cap edge. In a next step the filling machine inserts the body into the cap up to a fully locked position. As a result of the formulation point-seals are formed between the cap and the body. The point-seals increase the pull-apart force compared to the baseline with a factor 8 without any visual outer defects.
Example 4
[0334] Hard gelatin size 0 capsules are used. On a filling machine four droplets of de-ionized water of 70° C. are dispensed on the inner surface of the cap of each capsule using four cannulas per pin tube. The droplets of 0.25 microliter (valve opening time 2 msec) are dispensed 90° from each other in between the snap fit ring and the cap edge. In a next step the filling machine inserts the body into the cap up to a fully locked position. As a result the mixture is spread-out and local sealing zones are formed between the cap and the body. The point-seal increases the pull-apart force compared to the baseline with a factor 4 without any visual outer defects.
Example 5
[0335] Vcaps® size 0 capsules are used.
[0336] On a filling machine four droplets of de-ionized water of ca. 65° C. are dispensed on the inner surface of the cap of each capsule using four cannulas per pin tube. The droplets of 0.2 microliter (valve opening time 2 msec) are dispensed 90° from each other in between the snap fit ring and the cap edge. In a next step the filling machine inserts the body into the cap up to a fully locked position. As a result of the formulation point-seals are formed between the cap and the body. The point-seals increase the pull-apart force compared to the baseline with a factor 5 without any visual outer defects.
LIST OF REFERENCE NUMERALS
[0337] 1 APP [0338] 1-1 holder for holding a cap or a body of a capsule [0339] 1-2 ring of holders [0340] 2 array of pins [0341] 2-1 mounting plate of the array of pins for mounting the pins in the array of pins [0342] 3 pin [0343] 3-1 pin head [0344] 3-1-1 pin head closure cap [0345] 3-1-1-1 holding means of the pin head closure cap for fixing the ends of the four cannulas 4 in the correct position in the pin head [0346] 3-1-2 mount in the pin head for fixing the position of the cannula [0347] 3-2 pin tube which forms the pin [0348] 3-3 pin socket in which the pin is mounted [0349] 3-3-1 inner thread in the pin socket with which the valve is mounted by the valve mount to the pin socket by a screw type connection [0350] 3-3-2 foot of the pin socket [0351] 3-3-2-1 opening in the foot of the pin socket [0352] 3-4 pin head opening comprising an open space separating the end of the cannula with its opening circumferentially from the wall of the pin head [0353] 3-5 pin head gas opening [0354] 3-6 empty pin space [0355] 3-7 pin foot [0356] 3-7-1 opening in the pin foot [0357] 4 cannula [0358] 4-1 opening of the cannula at the end of the cannula for ejecting the droplet [0359] 4-2 opening of the cannula which is opening into the fluid dispensing cavity [0360] 4-3 bending of the cannula [0361] 4-4 cannula mount [0362] 5 valve [0363] 5-1 outlet channel of the valve ending in the fluid dispensing cavity [0364] 5-2 valve ball [0365] 5-3 valve seat [0366] 5-4 valve mount for mounting the valve to the pin socket [0367] 5-5 valve cavity containing FLU under pressure [0368] 6 cap of a capsule shell [0369] 7 droplet of FLU [0370] 8 fluid dispensing cavity [0371] 9 tempering system [0372] 9-1 device for supplying tempered gas [0373] 9-2 gas inlet channel [0374] 9-3 gas inlet splitter [0375] 9-3-1 spring of the gas inlet splitter [0376] 9-3-2 opening which connects the gas inlet channel with the gas bypass outlet channel when the gas inlet splitter is in SPLITTERBYPASS [0377] 9-4 gas bypass outlet channel [0378] 9-5 gas tempering outlet channel