JP3179658B2 - Tablet manufacturing method and device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method and an apparatus for producing wet powder tablets.

[0002]

2. Description of the Related Art Conventionally, tablets are classified into wet tablets and compressed tablets, and have been manufactured by different manufacturing methods. A wet tablet is made by kneading additives such as excipients and binders with the active ingredient, and further adding a lubricant such as water or ethanol to form a wet powder. It is manufactured by molding. There are two molding methods. One is a rubbing method in which the material is rubbed and molded into a certain mold, and the other is a punching method in which a plate-shaped material that has been spread over a spreader is pressed with a certain mold and punched out.
Although wet tablets are excellent in solubility and disintegration, handling of wet powder is difficult, and when wet powder is extruded from the mold, the wet powder sticks to the surface of pins and punches, etc. There are problems in terms of manufacturing, precision and quality, such as the weight of the resulting tablet varies, the surface becomes rough, and the mechanical strength is weak, and it is easy to wear or break,
Currently, it is hardly produced.

[0003] On the other hand, most of the commercially available tablets belong to the compressed tablets. An apparatus for producing such tablets is generally called a tableting machine because it forms dried granules at a relatively high pressure of 100 to several thousand kg / cm ² . This tableting machine is composed of an upper punch, a lower punch, and a die,
By applying force to the upper and lower punches with the granules supplied into the mortar, the granules are pressed and formed at a stretch. A rotary-type tableting machine is usually composed of an upper punch, a lower punch, and a die,
100 sets of punches and dies are mounted on a turntable, and one turn of the turntable can produce tablets as many as the number of mounted punches and dies (some tablets can be made up to 8000 tablets per minute) ). Compressed tablets are suitable for mass production and are superior in precision and quality to wet tablets, but they are inferior to wet tablets in terms of solubility and disintegration due to compression of dried granules at high pressure. I have.

[0004]

As described above, although a compressed tablet is superior in terms of production, a wet tablet having excellent solubility and disintegration properties is difficult for elderly people with poor physical and physiological functions. And suitable for children to take, thus making it possible to make tablets without compromising these properties of a wettablet, easy to take for the elderly and children, and mechanical strength, precision, quality and mass production If effective manufacturing methods are developed, the contribution in the pharmaceutical field will be enormous. An object of the present invention is to solve such a conventional problem, and an object of the present invention is to provide a tablet manufacturing method and a device using a wet powder with high productivity, precision and quality.

[0005]

According to the present invention, a first table having a plurality of filling holes is provided to achieve the above object.
A second table that has a plurality of mold holes and moves relative to the first table by partially contacting the first table; the wet powder is excessively supplied to the filling hole of the first table; The wet powder is pressure-filled into the mold hole of the second table by a filling pin at a position where the filling hole of the first table and the mold hole of the second table overlap, and then the two tables are relatively moved to thereby wet the powder in the mold hole. Tablets are formed by scraping the body.

[0006]

According to the present invention, since the wet powder is pressed and then rubbed off, the handling of the wet powder is facilitated, the productivity is improved, and the porosity, weight, size, etc. of the tablet are not uniform. Tablets with reduced mechanical strength, excellent dissolution and disintegration properties can be produced with high precision and quality.

[0007]

An embodiment of the present invention will be described below.
FIG. 1 is a schematic plan view of a tablet manufacturing apparatus according to one embodiment of the present invention, and FIG. 2 is a schematic front view in the direction of arrows II-II in FIG. On the bed 1, a first table 2 having a small diameter and a second table 3 having a large diameter are overlapped at the position of the station B such that the first table partially contacts and overlaps the second table. It is arranged to be rotatable in the horizontal direction. The first table 2 and the second table 3 are each driven intermittently by a driving device including a motor 4 and two intermittent indexing devices 5 connected to the motor 4 via a chain. The first table 2 is provided with two filling holes 6 each at a position equally divided in the circumferential direction, and the second table 3 is provided with a position equally divided into eight in the circumferential direction. Are provided with two mold holes 7, respectively. The filling hole 6 and the mold hole 7 have the same diameter, and the positions of the first table 2 and the second table 3 are set so that the mold hole 7 overlaps the filling hole 6 at the position of the station B, and is intermittent. The rotation angle is determined by the indexing device 5 and driven.

At station B where the filling hole 6 and the mold hole 7 are positioned concentrically, a filling and pressurizing device 8 is disposed above the first table 2, and a filling and pressing device 8 is provided below the filling and pressing device 8. A filling pin 9 slightly smaller in diameter than 6 and the mold hole 7 is attached. A filling receiving member 10 is arranged below the second table 3 facing the filling pin 9. At a position of station A on the first table 2 side 180 degrees opposite to station B, a hopper 11 is disposed on the upper portion of the first table 2 and a hopper 11 is disposed on the lower portion of the first table 2 so as to face the hopper 11. A receiving member 12 is arranged.

At the position of station C, which is rotated clockwise by 45 degrees from station B of second table 3,
A release agent applying device 13 is arranged to face the second table 3 via the second table 3. An upper molding device 14 and a lower molding device 15 are arranged at a position of a station D of the second table 3 which is further rotated by 45 degrees from the station C so as to face the second table 3 via the second table 3. An upper punch 16 is attached to the upper molding device 14, and a lower punch 17 is attached to the lower molding device 15. The drying device 18 is arranged above the second table 3 from stations E to F and G, which are further rotated clockwise by 45 degrees from the station D of the second table 3.

Further, the station G of the second table 3
A take-out device 19 is arranged above the second table 3 at a position of the station H rotated clockwise by 45 degrees from the second position, and a take-out pin 20 is attached to a lower portion thereof. Below the second table 3 of the station H, one end of the conveyor 21 is arranged, the other end of the conveyor 21 extends to the side of the bed 1, and a drying device 22 is arranged on the way. The first table 2 and the second table 3 are such that while the first table 2 makes two rotations,
So that it rotates and the filling hole 6 and the mold hole 7
The intermittent indexing device 5 intermittently drives the first table 2 by 90 degrees and the second table 3 by 45 degrees so as to surely stop at each station.

Next, the operation of the above embodiment will be described with reference to FIG. First, in the station A, as shown in FIG. 3A, the wet powder P stored in the hopper 11 is filled and supplied to the filling hole 6 of the first table 2.
Since the hopper receiving member 12 is disposed below the filling hole 6, the wet powder P is reliably supplied into the filling hole 6. At this time, the wet powder P is excessively supplied to the filling hole 6 on the heap. In practice, the upper part of the filling hole 6 is formed in a mortar shape, or the first table 2 is
The wet powder P is formed to be thicker than that of the filling hole 6 or to be thicker than the filling hole 6, so that the wet powder P is supplied more sufficiently than the volume of the mold hole 7 of the second table 3. The filling hole 6 supplied with the wet powder P moves to the station B in two strokes, and another filling hole 6 is located below the hopper 11.

The wet powder P used is 0.0004 to 8
About 0% by weight of active ingredients, excipients, disintegrants, binders,
At least one or more of additives such as acidulants, foaming agents, flavors, lubricants, coloring agents, and sweeteners are added in an amount of about 10 to 80% by weight and about 1 to 25% by weight, preferably 6 to 20
It is a mixed powder consisting of about wt% of a wetting agent. As the wetting agent, water, a pharmaceutically acceptable solvent such as ethanol, propanol, isopropanol or a mixture thereof, or a water-insoluble organic solvent such as hexane can be used.

In the station B, as shown in FIG. 3 (b), the filling hole 6 filled and supplied with the wet powder P is
The lower portion is overlapped with the mold hole 7 of the second table 3 applied by the filling receiving member 10, and the filling pin 9 of the filling pressurizing device 8 descends from above, and the wet powder P in the filling hole 6 is removed. It presses with a certain pressure and pushes it into the mold hole 7 of the second table 3. The pressure at this time is usually 5 to 80 kg
/ Cm ² , preferably about 5-60 kg / cm ² , more preferably about 5-40 kg / cm ² . Since the excess wet powder P is supplied in advance in the filling hole 6 in the previous step, the filling hole 6 is still filled even if the mold hole 7 is filled.
The wet powder P is left in the state.

Next, as shown in FIG. 3 (c), when the second table 3 moves toward the station C, the mold hole 7 filled with the wet powder P and the filling hole 6 come into contact with each other. While moving relative to each other, the wet powder P filled in the mold hole 7 is frayed off at the edges of both holes, and the basic portion of the tablet is formed in the mold hole 7. In the station C, as shown in FIG. 3D, the wet powder P filled in the mold hole 7 of the second table 3 is separated from the nozzles 13a and 13b of the release agent coating device 13 from both sides thereof. A mold agent (also called a lubricant, a substance for preventing sticking) is applied. Since the chamfering molding in the next step is performed using the upper punch and the lower punch directly in contact with the wet powder P, the release agent is applied so that the wet powder P does not adhere to these punches. Things. This is because the wet powder P adheres to the punch and the shape of the tablet collapses due to its inherent stickiness and adhesiveness due to wetting, or causes a manufacturing obstacle due to the solidification of the tablet on the punch.

Since the release agent is applied directly to the wet powder P to be turned into tablets, it is harmless to the human body. For example, stearic acid, calcium stearate, magnesium stearate, talc, cellulose sugars, starches such as constarch, silicic anhydrides, those used as lubricating agents for pharmaceuticals such as silicon oil, and the like can be mentioned. Not limited. Particularly, starches such as stearic acid, calcium stearate, magnesium stearate, and constarch potato starch are preferable. Of course, these substances can be mixed and used.

In the station D, as shown in FIG. 3 (e), the wet powder P in the mold hole 7 coated with the release agent on both sides is supplied to the upper punch 16 and the lower molding device of the upper molding device 14. The lower punch 17 is formed from above and below, and both upper and lower surfaces are formed along the chamfered shapes formed on the end surfaces of the upper punch 16 and the lower punch 17. Since the release agent is applied to the wet powder P, the wet powder P does not adhere to these punches 16 and 17. In addition, this chamfering is for taking a corner of the tablet to make it easy to drink, and in this specification, not only chamfering by a flat surface but also rounding by a spherical surface is included in the chamfering. When the chamfer molding is not performed, the release agent application in the previous step is not required. Further, molding for marking a score line, a product mark, or the like may be performed together with the chamfer molding.

Next, in stations E, F and G, as shown in FIG. 3 (f), the wet powder P formed in the mold hole 7 is dried and solidified by the drying device 18, and It becomes a tablet. Then, at the station H shown in FIG. 3 (g), the wet powder P solidified in the mold hole 7 is pushed downward by the lowering of the takeout pin 20 of the takeout device 19, and the belt of the rotating conveyor 21 is rotated. Fall on. The dropped wet powder P is further dried by the drying device 22 and then discharged to a predetermined tray. A lubricant application step can be provided before the discharging step.

As described above, according to the above embodiment, after the wet powder P supplied to the filling hole 6 of the first table 2 is filled into the mold hole 7 of the second table 3 with the filling pin 9 under pressure,
By relatively moving the first table 2 and the second table 3, the wet powder P in the mold hole 7 is abraded and formed into a tablet shape, so that it is easy to manufacture and mass production is possible. Variations in porosity, weight, dimensions, and the like of the tablets are reduced, and the mechanical strength is increased, so that the accuracy and quality of the product are improved.

In the above embodiment, instead of directly applying the release agent to the wet powder P in the pre-chamfering step of FIG. As shown in FIG. 3, after the release agent is applied to the end surfaces of the upper punch 16 and the lower punch 17 which are in contact with the wet powder P, the chamfering step shown in FIG. 3E may be performed.

Further, as shown in FIG.
By closing the lower portion of the mold hole 7 with a slide pin 23 having an upper surface formed into a chamfered shape, and by configuring the slide pin 23 to be able to move up and down by a rail 24,
The filling receiving member 10, the hopper receiving member 12, the lower punch 17, the takeout pin 20, and the like become unnecessary. In this case, it is necessary to apply a release agent to the upper end surface of the slide pin 23 in advance. After the tablet is extracted by raising the slide pin 23, the tablet can be moved onto the belt conveyor 21 by another means such as a gripper.

Further, as shown in FIG. 6, instead of the mold hole 7 of the second table 3, the bottom is closed and the air hole 25 is closed.
Are formed and the mold hole 26 is formed with a chamfered corner, so that the filling receiving member 10, the hopper receiving member 12, the lower punch 17 and the take-out pin 20 are similarly formed.
Etc. become unnecessary. In this case, air is supplied to the air hole 25 to take out the tablet. However, since the taken-out product has a residue of wet powder in a portion corresponding to the air hole 25, it is necessary to remove the residue. There is.

[0022]

As described above, according to the present invention, the wet powder supplied to the filling hole of the first table by using the first table and the second table which are relatively moved in contact with each other. At a position where the filling hole of the first table and the molding hole of the second table overlap with each other, using a filling pin to press-fill the mold hole of the second table. Tablets are formed by moving and rubbing, which facilitates handling of wet powder and improves productivity, reduces variance in porosity, weight, dimensions, etc. of tablets, and increases mechanical strength. , Tablets having high dissolution and disintegration properties can be produced with high precision and quality.

[Brief description of the drawings]

FIG. 1 is a schematic plan view of a tablet manufacturing apparatus according to one embodiment of the present invention.

FIG. 2 is a schematic front view of the tablet manufacturing apparatus in the direction of arrows II-II in FIG.

FIG. 3 is a schematic view showing steps of a tablet manufacturing method according to one embodiment of the present invention.

FIG. 4 is a schematic view showing a main part of another embodiment of the present invention.

FIG. 5 is a schematic view showing a main part of another embodiment of the present invention.

FIG. 6 is a schematic view showing a main part of another embodiment of the present invention.

[Description of Signs] 1 Bed 2 First Table 3 Second Table 4 Motor 5 Intermittent Indexing Device 6 Filling Hole 7 Mold Hole 8 Filling Pressing Device 9 Filling Pin 10 Filling Receiving Member 11 Hopper 12 Hopper Receiving Member 13 Release Agent Coating device 14 Upper forming device 15 Lower forming device 16 Upper punch 17 Lower punch 18 Drying device 19 Extraction device 20 Extraction pin 21 Conveyor 22 Drying device

──────────────────────────────────────────────────続 き Continued on the front page (72) Masaharu Nakajima, Inventor 315 Yoshidabayashi, Kodama-cho, Kodama-gun, Saitama (72) Inventor Yutaka Morita 510-59, Kitahori, Honjo, Saitama (56) References JP-A-6-218028 ( JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61J 3/10 B30B 11/08-11/10

Claims (12)

(57) [Claims] A first table having a plurality of filling holes;
A second table having a plurality of mold holes and partially moving relative to the first table by partially contacting the first table, excessively supplying wet powder to the filling holes of the first table, The supplied wet powder is pressure-filled into the mold hole of the second table by a filling pin at a position where the filling hole of the first table and the mold hole of the second table overlap, and then the two tables are relatively moved. A tablet manufacturing method comprising rubbing off wet powder in the mold hole. 2. The tablet manufacturing method according to claim 1, further comprising chamfering circumferential portions of upper and lower surfaces of the wet powder in the mold hole. 3. The tablet manufacturing method according to claim 2, further comprising applying a release agent to the surface on the chamfered side of the wet powder before chamfering. 4. The tablet manufacturing method according to claim 2, further comprising applying a release agent to an end face of the forming die to be chamfered before chamfering. 5. The tablet manufacturing method according to claim 1, further comprising drying the wet powder in the mold hole. 6. The pressure during filling under pressure is 5 to 80 kg / cm ^2.
The tablet manufacturing method according to claim 5, which is: 7. A first table having a plurality of filling holes to which a wet powder is sequentially supplied, and partially overlapped with the first table and positioned concentrically with the filling holes at positions overlapping each other. A second table having a plurality of mold holes to be formed, means for pressurizing and filling the mold holes with the filling pin with the wet powder in the filling holes at the mutually overlapping positions, and the first table and the second table. A tablet manufacturing apparatus comprising: means for relative movement. 8. The tablet manufacturing apparatus according to claim 7, further comprising means for chamfering the upper and lower corners of the upper and lower surfaces of the wet powder in the mold hole with an upper punch and a lower punch. 9. The tablet manufacturing apparatus according to claim 8, further comprising means for applying a release agent to the surface on the chamfered side of the wet powder before chamfering. 10. The tablet manufacturing apparatus according to claim 8, further comprising means for applying a release agent to an end face of the punch which performs chamfering before chamfering. 11. The tablet manufacturing apparatus according to claim 7, further comprising means for drying the wet powder in the mold hole. A hopper for accommodating the 12. wet powder, a first table having a plurality of filling holes which are sequentially supplied with moist powder from said hopper are circumferentially spaced, said first A second table partially overlapping the table and having a plurality of circumferentially spaced mold holes positioned concentrically with the filling holes at the overlapping positions thereof; and A filling and pressurizing device having a filling pin for pressurizing and filling the moist powder in the filling hole into the mold hole, and a releasing agent for applying a release agent to both surfaces of the wet powder pressurized and filled into the mold hole. A mold applying device, a molding device having an upper punch and a lower punch for chamfering both corners of the wet powder coated with the release agent, and a take-out having a take-out pin for extruding the wet powder from the mold hole Equipment and A tablet manufacturing apparatus comprising: a driving device that drives the first table and the second table to intermittently rotate in synchronization.