JP6096726B2 - Wet tablet forming equipment - Google Patents

Description

  The present invention relates to a wet tablet forming apparatus for forming a wet raw material into a tablet.

  As a tablet molding apparatus for molding raw materials into tablets, upper and lower punches capable of reciprocating vertically in through-holes formed in a vertical direction are arranged so that the material supplied from the material supply means into the through-holes from above and below. A tableting machine that forms a tablet by compressing at a high pressure is known (for example, see Patent Document 1). A rotary tableting machine that compresses and molds raw materials in two stages using a two-side turntable is known (see, for example, Patent Document 2). Furthermore, a method for producing a preparation is known in which a wet raw material in which a drug or a drug-containing particle is kneaded with a binder solution is molded at low pressure. (For example, refer to Patent Document 3).

JP 2001-47294 A Japanese Patent No. 3187657 Japanese Patent No. 5513936

  By the way, as raw materials to be formed by the tablet molding apparatus, in addition to dried raw materials (dry raw materials), raw materials (moisture raw materials) containing moisture and / or organic solvents are known. Since tablets formed using a moist raw material tend to have a larger gap in the preparation than ordinary tablets, water such as saliva can easily penetrate and become an orally disintegrating tablet. Orally disintegrating tablets are softly shaped to dissolve in a small amount of water such as saliva in the oral cavity and dissolve quickly in the oral cavity. It is a tablet that is easy to take even for patients who are ill.

  However, when an orally disintegrating tablet is formed from a moist raw material using a tableting machine as described above, the moist raw material is contained in the material supply means due to the viscosity derived from the raw material or drug contained in the moist raw material. There was a problem in that the wet raw material stuck to the upper and lower ridges and a tablet with a clean surface could not be obtained.

  In addition, tablets must ensure the uniformity of weight and content, due to the difficulty of weighing the moist raw material to a certain amount, or because the moist raw material sticks to the upper and lower bowls, There existed a problem that there existed a possibility that precision, such as the uniformity of the weight of a molded formulation and a content, may not be ensured.

  Furthermore, the tableting machine described in Patent Document 2 must be provided with a two-sided turntable in order to form tablets with high precision by two-stage compression, and the device size of the tableting machine tends to increase. There was a problem of being.

  In addition, there has been no molding apparatus that realizes a method for producing a preparation that accurately molds a wet raw material as described in Patent Document 3 at a low pressure.

  Therefore, a technical problem to be solved in order to form a tablet efficiently ensuring the weight and content uniformity of the moist raw material while ensuring easy solubility or easy disintegration arises, and the present invention The purpose is to solve this problem.

  The present invention is proposed in order to achieve the above object, and the invention according to claim 1 is a wet tablet forming apparatus for forming a wet raw material uniformly wetted with water and / or an organic solvent into a tablet. A raw material feed mechanism having a screw for feeding the wet raw material in the horizontal direction, and a molding for pressing the predetermined amount of the wet raw material supplied from the raw material feed mechanism from the horizontal direction to form the tablet A first molding part provided on the downstream side of the raw material feeding mechanism, the molding mechanism having a first molding surface formed according to the shape of one side surface of the tablet; An ejector part capable of reciprocating the first molding surface in a horizontal direction with respect to the first mold part, and a second molding surface formed according to the shape of the other side surface of the tablet, A second mold part arranged to face the first mold; One side surface of the tablet is formed by the raw material feeding mechanism filling the first molding surface with the wet raw material, and the other side surface of the tablet is formed by the ejector portion being the first molding. Provided is a wet tablet molding apparatus in which a surface is brought close to the second molding surface and the wet raw material is molded in a horizontal direction with a press pressure corresponding to the tablet hardness of the tablet.

  According to this configuration, the screw forcibly feeds the moist raw material in the horizontal direction, so that sticking due to the viscosity of the moist raw material is reduced as compared with a conventional tableting machine in which the moist raw material falls by its own weight. Therefore, the wet raw material can be efficiently formed into a tablet.

  In addition, when compressing the wet raw material by bringing the first molding surface and the second molding surface close to each other, a soft tablet is formed by adjusting the pressing pressure of the eject portion according to the tablet hardness of the tablet. Since it is possible, a tablet having easy solubility or easy disintegration can be formed.

  According to a second aspect of the present invention, in addition to the configuration of the first aspect of the invention, the raw material feeding mechanism includes a casing that houses the screw, a screw drive unit that drives the screw within the casing, A screw control unit that controls the screw drive unit, and a pressure detection unit that detects a pressure acting on the screw, wherein the screw control unit sets the pressure detected by the pressure detection unit to a preset limit pressure. A wet tableting device is provided that, when reached, stops the screw.

  According to this configuration, when the pressure detection unit detects that the pressure acting on the screw has reached the limit pressure according to the filling amount of the wet raw material supplied to the first mold part, the screw control unit Since the density of the moist raw material per tablet is kept constant, the uniformity of the tablet weight and content is ensured.

  According to a third aspect of the present invention, in addition to the configuration of the second aspect of the invention, when the pressure detected by the detection unit reaches the limit pressure, the screw control unit stops after reversely rotating the screw. A wet tablet forming apparatus is provided.

  According to this configuration, by reducing the pressure acting on the moist raw material filled in the first mold part, the tablet weight varies due to the excessively high pressure acting on the moist raw material, Since abnormal shapes are suppressed, uniform quality tablets can be obtained efficiently.

  According to a fourth aspect of the present invention, in addition to the configuration of the second or third aspect of the present invention, the limit pressure provides a wet tablet forming apparatus that can be arbitrarily changed according to the weight of the tablet.

  According to this configuration, since the weight control unit can change the weight of the wet raw material supplied to the molding mechanism simply by increasing or decreasing the limit pressure value at which the screw is stopped, it is compatible with various tablets. be able to.

  In the present invention, since the screw forcibly feeds the moist raw material in the horizontal direction, sticking due to the viscosity of the moist raw material is suppressed, so that the moist raw material can be efficiently formed into a tablet. Moreover, since a soft tablet can be shape | molded by adjusting the press pressure of an eject part, the tablet which has easy solubility or easy disintegration can be shape | molded.

The schematic diagram which shows the shaping | molding line using the wet tablet shaping | molding apparatus which concerns on one Example of this invention. The front view which shows the wet tablet-molding apparatus of FIG. The side view which shows the wet tablet-molding apparatus of FIG. The figure which shows the turntable of a wet tableting apparatus. It is a schematic diagram which shows the procedure which shape | molds a moist raw material into a tablet, (a) is a figure which shows the state before filling with a moist raw material, (b) has shape | molded one side of the tablet. It is a figure which shows a state, (c) is a figure which shows the state which made the 1st shaping | molding die part and the 2nd shaping | molding die part oppose, (d) is shape | molding the other side surface of a tablet. (E) is a figure which shows the state which released the tablet.

  The present invention achieves the object of providing a wet tablet molding apparatus for molding into tablets that efficiently ensure the weight and content uniformity of a moist raw material while ensuring easy solubility or easy disintegration. And / or a wet tableting device for forming a wet raw material uniformly moistened with an organic solvent into a tablet, which is supplied from a raw material feed mechanism having a screw for feeding the wet raw material in a horizontal direction and the raw material feed mechanism A predetermined amount of the moist raw material to be pressed from the horizontal direction and formed into a tablet, and the forming mechanism includes a first molding surface formed according to the shape of one side surface of the tablet, The first mold part disposed on the downstream side of the raw material feeding mechanism, the ejector part capable of reciprocating the first molding surface in the horizontal direction with respect to the first mold part, and the shape of the other side surface of the tablet And a second molding surface formed in accordance with the first molding die And a second mold part disposed so as to face each other, and one side surface of the tablet is molded by a raw material feeding mechanism filling the first molding surface with a wet raw material, and the other side surface of the tablet is This was realized by forming the ejector portion by causing the first molding surface to approach the second molding surface and compressing the wet raw material in the horizontal direction with a press pressure corresponding to the tablet hardness of the tablet.

  First, the molding line 1 using the wet tablet molding apparatus 100 which is one Example of this invention is demonstrated based on FIG.

  The molding line 1 includes a wet tablet molding device 100, a surface dryer 2 that heat-drys the surface of the tablet, a main dryer 3 that heat-drys the inside of the tablet, and a weight sorter 4.

  The wet tablet forming apparatus 100 forms a raw material (hereinafter referred to as “moist raw material”) uniformly wetted with water and / or an organic solvent into a tablet. The tablets are discharged from the lower part of the wet tablet forming apparatus 100 and fall on the belt conveyor 22 of the surface dryer 2. Details of the wet tablet forming apparatus 100 will be described later.

  The surface dryer 2 includes a chamber 21 that heats and drys the tablet surface, and a belt conveyor 22 that is disposed in the chamber 21 and that transports the tablets sent from the wet tablet forming apparatus 100 to the main dryer 3. . When the tablet passes through the chamber 21 over a predetermined time (for example, 5 minutes), the surface of the tablet is dried.

  The dryer 3 includes a chamber 31 that heats and drys the inside of the tablet, and a turntable 32 that is arranged in the chamber 31 and rotates clockwise one time over a predetermined time (for example, 3 hours). Yes. On the turntable 32, six containers 33 for storing tablets are arranged. When the main drying is finished, the container 33 is reversed and the tablets are transferred to the bucket conveyor 34.

  The weight sorter 4 measures the weight of the tablet conveyed from the main dryer 3 via the bucket conveyor 34. The tablets whose weight is within the allowable range are collected as non-defective products in the non-defective product collecting container 42 on the turntable 41. In addition, tablets whose weight is outside the allowable range are distinguished from non-defective products as defective products and collected in the defective product collection container 43.

  Next, the wet tablet forming apparatus 100 will be described with reference to FIGS. 2 is a front view of the wet tablet forming apparatus 100, FIG. 3 is a right side view of the wet tablet forming apparatus 100 in which the ejector portion 132 is omitted, and FIG. 4 is a first forming on the turntable 134. It is a figure which shows the arrangement | positioning relationship of the mold part.

  The wet raw material formed into a tablet using the wet tablet forming apparatus 100 is, for example, a drug or functional fine particles containing a drug, such as mannitol, lactose, a cellulose sugar excipient, a starch disintegrant. Is prepared by wet-kneading a binder prepared with water and / or an organic solvent, and is more viscous than dry materials. The term “functional fine particles” refers to a drug or a drug-containing fine particle having a particle size of 400 μm or less coated with a functional film such as bitterness masking, sustained release and enteric properties.

  The wet tablet forming apparatus 100 includes a hopper 110 that accommodates a wet raw material that has been mixed with stirring in advance, a raw material feed mechanism 120 that is connected to the lower end of the hopper 110 and feeds the wet raw material in the horizontal direction H, and a raw material feed mechanism 120. And a forming mechanism 130 for forming the supplied raw material into a tablet. Reference numeral 101 denotes a cover that accommodates the wet tablet molding apparatus 100.

  The hopper 110 is disposed on the outer peripheral side of the screw 112 and rotates in the direction opposite to the rotation direction of the screw 112. The casing 111 accommodates the moist raw material, the screw 112 that sends the moist raw material downward in the vertical direction V. And a rotary blade 113. While the screw 112 and the rotary blade 113 rotate in opposite directions, the wet raw material is sent to the lower side in the vertical direction V, whereby sticking of the wet raw material with viscosity to the casing 111 is suppressed. The wet raw material is input from the input port 110 a of the hopper 110 and is sent to the raw material feeding mechanism 120 from the discharge port 110 b of the hopper 110. Reference numeral 114 denotes a motor that rotates the screw 112, reference numeral 115 denotes a motor that rotates the rotary blade 113, and reference numeral 116 denotes a cover that can be opened and closed to close the insertion port 110a.

  The raw material feed mechanism 120 includes a casing 121 that houses the wet raw material, a screw 122 that sends the wet raw material in the horizontal direction H in the casing 121, a servo motor 123 that serves as a screw drive unit that drives the screw 122, and a servo motor A screw control unit 124 that controls 123 and a pressure detection unit 125 that detects a pressure acting on the screw 122 are provided. The wet raw material sent from the hopper 110 is sent in the horizontal direction H in the casing 121. The servo motor 123 is controlled to operate synchronously with the motors 114 and 115 and a turntable motor 134 described later.

  The molding mechanism 130 includes a first mold part 131, an ejector part 132, and a second mold part 133.

  A plurality of first mold parts 131 are installed on the turntable 134. In the present embodiment, six first mold parts 131 are arranged together to form a first mold part group G. Then, six first mold part groups G are arranged at equal intervals on the periphery of the turntable 134. The turntable 134 can be rotated around a rotation shaft 134b by a turntable motor 134a, and the first mold part group G is filled with a wet raw material at the uppermost end by rotating the turntable 134. Arrangement (P1), arrangement (P2) for cleaning the second mold part 133 and applying a mold release agent, arrangement (P3) for forming a wet raw material into tablets at the bottom end, arrangement for releasing the tablets (P4), an arrangement (P5) for cleaning the first mold part 131 and an arrangement (P6) for applying a release agent to the first mold part 131 are repeated in order. A small amount of a release agent that does not affect the tablet such as silicone and liquid paraffin is used.

  In the arrangement (P1) in which the wet raw material is filled, the first mold part 131 is arranged to face the opening 121a of the casing 121, and the wet raw material sent by the screw 122 is the casing 121. And is filled in the first mold part 131.

  The ejector portion 132 can be reciprocated in the horizontal direction H by an air cylinder (not shown), and is connected to a first forming surface 131a described later.

  The second mold part 133 is disposed so as to face the first mold part 131 at the lowermost end of the turntable 134. The second mold part 133 is attached so as to be swingable around the shaft part 135.

  Next, the operation of the forming mechanism 130 will be described with reference to FIG. FIG. 5 shows a forming mechanism 130 with a simplified configuration.

  FIG. 5A shows a state where the first mold part 131 is located at the uppermost end of the turntable 134. At this time, the first mold part 131 faces the opening 121 a of the casing 121. The first mold part 131 includes a first forming surface 131 a connected to the ejector part 132.

  When the screw 121 feeds the wet raw material toward the downstream side in the horizontal direction H, that is, toward the right side of the sheet of FIG. 5, and the wet raw material starts to be filled in the first mold part 131, the screw pushes out the wet raw material. In response to the pressure 122, the ejector section 132 slides to the right in FIG.

  FIG. 5B shows a state where the wet raw material is filled in the first mold part 131. The wet raw material is filled in the first forming mold portion 131, whereby the one side surface s1 of the tablet t is formed into a shape corresponding to the first forming surface 131a.

  When the wet raw material is filled in the first mold part 131, the pressure detection unit 125 detects that the pressure acting on the screw 121 has reached a preset limit pressure, and the screw control unit 124 The screw 121 is rotated in the reverse direction slightly to release the pressure acting on the wet raw material, and then the rotation of the screw 121 is stopped. Thereby, a predetermined amount of wet raw material can be supplied into the first mold part 131. Further, by releasing the pressure acting on the moist raw material, when the first mold part 131 moves in the shearing direction with respect to the casing 121, the tablet t is rubbed against the casing 121 and roughened on the surface of the tablet t. Variations in tablet weight and abnormal shapes due to shaving and occurrence are suppressed. In addition, the limit pressure can be arbitrarily changed according to the weight of the tablet, and thereby, it can correspond to various tablets. After the rotation of the screw 121 stops, the turntable 134 rotates and the first mold part 131 moves with respect to the casing 121 in the shearing direction, that is, in the direction perpendicular to the paper surface of FIG.

  FIG. 5C shows a state where the first mold part 131 is located at the lowermost end of the turntable 134. When the first mold part 131 moves to the lowermost end of the turntable 134, the first mold part 131 and the second mold part 133 approach each other. The second mold part 133 includes a second forming surface 133a. The second forming surface 133a is attached to the second forming mold portion 133 via the screw portion 133b.

  FIG.5 (d) shows the state which is forming the tablet t. In a state where the first mold part 131 and the second mold part 133 are in close contact with each other, the ejector part 132 slides in the horizontal direction H so that the first molding surface 131a approaches the second molding surface 133a. Thus, the other side surface s2 of the tablet t is molded into a shape corresponding to the second molding surface. At this time, the press pressure of the ejector part 132 is arbitrarily set within a range in which the easy solubility or easy disintegration of the tablet is ensured. Moreover, the thickness of the tablet t can be adjusted by adjusting the stroke amount of the ejector part 132.

  FIG. 5E shows a state where the tablet t is released. The second mold part 133 is separated from the first mold part 131, and the ejector part 132 is further slid in the horizontal direction H, whereby the tablet t is released from the first mold part 131.

Next, the uniformity of the weight of the tablet formed using the wet tablet forming apparatus 100 will be described. Table 1 shows the weight (unit: g) of the tablet molded by the wet tablet molding apparatus 100 including four molds (molds 1 to 4). In addition, the weight shown in Table 1 is the value which measured the tablet shape | molded with the wet tablet shaping | molding apparatus 100 in the wet state. Table 2 shows the variation in weight of 100 tablets in Table 1.
The raw material of the tablet is layered with ambroxol hydrochloride on the core of crystalline cellulose (trade name: SELPHYA CP102, manufactured by Asahi Kasei Chemicals Co., Ltd.) using a binder, and gradually released into the resulting drug-containing fine particle core Spray coating of water / organic solvent mixed system liquid with plasticizer added to ethyl cellulose for rolling using a tumbling fluidized bed granulator / dryer (trade name: MP-01, manufactured by POWREC Co., Ltd.) Then, ambroxol hydrochloride-containing fine particles (drug content: 20%) were obtained, and 1 part of PVP 30% aqueous solution was added to 6 parts of the fine particles and kneaded.

  As shown in Tables 1 and 2, 100 tablets formed by the wet tablet forming apparatus 100 had a weight variation of 3.24%, and it was confirmed that sufficiently good accuracy was obtained. Moreover, the disintegration time of the tablet thus produced with high accuracy was measured according to the disintegration test method of the Japanese Pharmacopoeia, and was easily disintegrable as 19 to 24 seconds.

  In this way, the wet tablet molding apparatus 100 according to the present invention suppresses sticking due to the viscosity of the moist raw material by the screw 122 forcibly sending the moist raw material in the horizontal direction H. The raw material can be efficiently formed into a tablet. Further, when compressing the wet raw material by bringing the first molding surface 131a and the second molding surface 133a close to each other, the press pressure of the ejecting portion 132 is adjusted according to the tablet hardness of the tablet, thereby making the soft material soft. Since a tablet can be formed, a tablet having easy solubility or easy disintegration can be formed.

  The present invention can be variously modified without departing from the spirit of the present invention, and the present invention naturally extends to the modified ones.

DESCRIPTION OF SYMBOLS 1 ... Molding line 2 ... Surface dryer 3 ... Main dryer 4 ... Weight sorter 100 ... Wet tablet molding apparatus 101 ... Cover 110 ... Hopper 111 ... Casing 112 ... Screw (of hopper) 113 ... Rotor blade 120 ... Raw material feed mechanism 121 ... Casing 122 ... (raw material feed mechanism) screw 123 ... Servo motor (screw drive)
124 ... Screw control unit 125 ... Pressure detection unit 130 ... Molding mechanism 131 ... First molding die 131a ... First molding surface 132 ... Ejector unit 133 ... First Two mold parts 133a ... second molding surface 134 ... turntable

Claims (4)

In a wet tablet forming apparatus for forming a wet raw material uniformly wetted with water and / or an organic solvent into tablets,
A raw material feed mechanism including a screw for feeding the raw material in a horizontal direction;
A molding mechanism for pressing a predetermined amount of the moist raw material supplied from the raw material feed mechanism from the horizontal direction into the tablet;
With
The molding mechanism is
A first molding die provided with a first molding surface formed according to the shape of one side surface of the tablet, and disposed on the downstream side of the raw material feeding mechanism;
An ejector part capable of reciprocating the first molding surface in a horizontal direction with respect to the first mold part;
A second mold part provided with a second molding surface formed according to the shape of the other side surface of the tablet, and disposed so as to be opposed to the first mold;
With
One side of the tablet is formed by the raw material feeding mechanism filling the first raw material with the wet raw material,
The other side surface of the tablet is compressed in the horizontal direction with the ejector portion causing the first molding surface to approach the second molding surface and the wet raw material at a press pressure corresponding to the tablet hardness of the tablet. A wet tablet molding apparatus characterized by being molded by The raw material feeding mechanism is
A casing for housing the screw;
A screw drive section for driving the screw in the casing;
A screw control unit for controlling the screw drive unit;
A pressure detector for detecting pressure acting on the screw;
With
The wet tablet molding apparatus according to claim 1, wherein the screw control unit stops the screw when the pressure detected by the pressure detection unit reaches a preset limit pressure.   3. The wet tablet molding apparatus according to claim 2, wherein when the pressure detected by the detection unit reaches the limit pressure, the screw control unit stops the screw after rotating it backward. 4. The threshold pressure is wet tableting apparatus according to claim 2 or 3, wherein the possible arbitrarily changed according to the weight of the tablet.