Spherical tablet
By designing spherical tablets, the problems of inconvenience and fragility of existing tablets are solved, achieving high drug loading, easy swallowing, and stable compression, making spherical tablets suitable for the pharmaceutical field.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-30
- Publication Date
- 2026-04-07
AI Technical Summary
The existing tablets are shallowly curved, with a small drug loading capacity, making them inconvenient to take and prone to defects such as top cracking and waist cracking. They are also difficult to swallow, especially materials with poor compressibility such as inorganic salts, which are prone to powder sticking and large differences in tablet weight during tableting, affecting coating and other operations.
Design a spherical tablet comprising upper and lower hemispheres and a middle band, the middle band being located in the middle of the spherical tablet. The hemispheres are the same size and shape, and the diameter of the middle band is larger than the diameter of the hemispheres. The ratio of the diameter of the hemispheres of the upper and lower punches of the tableting mold is 0.2 to 0.4:1. The mold design is optimized to be quasi-spherical.
Spherical tablets have reduced size, good flowability, are easy to swallow, have high drug loading capacity, require less dosage, have good hardness, are shock-resistant and wear-resistant, have small tablet weight differences, which is beneficial for coating operations and improves compliance and uniformity of operation.
Smart Images
Figure CN224085713U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to a spherical tablet. BACKGROUND
[0002] At present, the common tablet shape in the market is shallow arc tablet, and the drug loading capacity is small, so many tablets or large tablets need to be taken when the tablet weight is large, and it is not easy to swallow. In addition, for inorganic salt and other materials with poor compressibility, the tablet is prone to top cracking, waist cracking and other problems when it is pressed, and the powder is also prone to sticking to the punch face, so that the tablet surface has defects, the tablet weight difference is large, and the tablet is easy to break, which is not conducive to coating and other problems. SUMMARY
[0003] In order to overcome the problems of the prior art, the utility model provides a spherical tablet, which comprises upper and lower two hemispheres and a middle strip, wherein the middle strip is in the middle of the spherical tablet and is a strip with the same thickness; the upper and lower two hemispheres are located on the two end faces of the middle strip, and the sizes and shapes of the two hemispheres are the same; the diameter of the middle strip is greater than the diameter of the hemisphere, the diameter of the hemisphere of the upper and lower punch dies of the tablet pressing mold used when the spherical tablet is pressed is 6.5-10 mm, and the arc depth / hemisphere diameter ratio is (0.2-0.4):1.
[0004] In a certain scheme of the utility model, the diameter of the middle strip of the spherical tablet is 6.5-9 mm; preferably, the diameter of the middle strip is 6.5-8 mm; more preferably, the diameter of the middle strip is 7 mm.
[0005] In a certain scheme of the utility model, the thickness of the middle strip of the spherical tablet is 1-5 mm; preferably, the thickness of the middle strip is 1.5-4.5 mm; more preferably, the thickness of the middle strip is 2-4 mm.
[0006] In a certain scheme of the utility model, the protruding part of the middle strip of the spherical tablet relative to the hemisphere is an edge, and the cross-sectional width of the edge is 0.1-2 mm; preferably, the cross-sectional width of the edge is 0.1-1 mm; more preferably, the cross-sectional width of the edge is 0.1-0.5 mm.
[0007] In a certain scheme of the utility model, the arc depth of the hemisphere of the spherical tablet is 1-5 mm; preferably, the arc depth is 1.5-4.5 mm; more preferably, the arc depth is 1.8-2.2 mm or the arc depth is 2-4 mm.
[0008] In a certain scheme of the utility model, the arc depth / hemisphere diameter ratio of the upper and lower punch dies of the tablet pressing mold used when the spherical tablet is pressed is (0.2-0.3):1.
[0009] In a certain scheme of the utility model, the spherical tablet is a spherical shape.
[0010] The utility model provides a kind of spherical tablet, the spherical tablet includes two hemispheres of upper and lower and intermediate band, wherein the intermediate band is in the middle of spherical tablet, and it is the same band of thickness;Two hemispheres of upper and lower are located on the two end faces of intermediate band, and the size and shape of two hemispheres are same;The diameter of intermediate band is greater than the diameter of hemisphere;The diameter of hemisphere of upper and lower punch and die of the tablet press die used when the spherical tablet is pressed is 3~9mm, and the ratio of arc depth / diameter of hemisphere is (0.2~0.4):1.
[0011] In a certain scheme of the utility model, the diameter of hemisphere of punch and die is 4~8mm, and the ratio of arc depth / diameter of hemisphere is (0.2~0.4):1;Preferably, the diameter of hemisphere of punch and die is 5~7mm, and the ratio of arc depth / diameter of hemisphere is (0.2~0.3):1.
[0012] In a certain scheme of the utility model, the diameter of intermediate band of the spherical tablet is 4~8mm;Preferably;The diameter of intermediate band is 5~7mm.
[0013] In a certain scheme of the utility model, the thickness of intermediate band of the spherical tablet is 1~5mm;Preferably, the thickness of intermediate band is 1.5~4.5mm;More preferably, the thickness of intermediate band is 2~4mm.
[0014] In a certain scheme of the utility model, the part of intermediate band of the spherical tablet protruding relative to hemispherical body is edge, and the cross-sectional width of the edge is 0.1~2mm;Preferably, the cross-sectional width of the edge is 0.1~1mm;More preferably, the cross-sectional width of the edge is 0.1~0.5mm.
[0015] In a certain scheme of the utility model, the arc depth of hemisphere of the spherical tablet is 1~5mm;Preferably, the arc depth is 1.5~4.5mm;More preferably, the arc depth is 1.8~2.2mm or the arc depth is 2~4mm.
[0016] In a certain scheme of the utility model, the spherical tablet is spheroid.
[0017] The utility model provides a kind of spherical tablet, the spherical tablet includes two hemispheres of upper and lower and intermediate band, wherein the intermediate band is in the middle of spherical tablet, and it is the same band of thickness;Two hemispheres of upper and lower are located on the two end faces of intermediate band, and the size and shape of two hemispheres are same;The diameter of intermediate band is greater than the diameter of hemisphere;The diameter of hemisphere of upper and lower punch and die of the tablet press die used when the spherical tablet is pressed is 6mm, and the ratio of arc depth / diameter of hemisphere is 0.3:1.
[0018] The utility model provides a kind of spherical tablet, the spherical tablet includes two hemispheres of upper, lower and intermediate band, wherein the intermediate band is in the middle of spherical tablet, and it is the same thickness of band shape;The two hemispheres of upper, lower are located on the two end faces of intermediate band, and the size of two hemispheres is same, shape is same;The diameter of intermediate band is greater than the diameter of hemisphere;The diameter of hemisphere of the punch and die of the tablet press die used when the spherical tablet is pressed is 7mm, and the ratio of arc depth / diameter of hemisphere is 0.291:1.
[0019] The utility model terminology definition
[0020] "intermediate band" is the same thickness of band shape in the middle of solid preparation (spherical tablet).
[0021] "hemisphere diameter" is the diameter of hemisphere cross section, if it is similar circular, then it is the maximum diameter of cross section;The diameter of hemisphere of punch is the outermost diameter of punch, i.e. the diameter of intermediate band of spherical tablet.
[0022] "intermediate band thickness" is the longitudinal height of intermediate band.
[0023] "intermediate band diameter" is the diameter of intermediate band cross section, if it is similar circular, then it is the maximum diameter of cross section, i.e. the diameter of hemisphere of punch.
[0024] "arc depth" is the longitudinal depth of hemisphere.
[0025] "edge" is the part of intermediate band protruding to hemisphere.
[0026] "cross section width of edge" is the difference between the diameter of intermediate band and the diameter of hemisphere.
[0027] The utility model has the following positive progress effects:
[0028] (1) compared with conventional tablet, the spherical tablet of the utility model greatly reduces size, and the appearance shape of tablet type design is regular, and fluidity is better, easy to swallow, can solve the problem of difficulty in swallowing, compared with the same diameter ordinary tablet, more easily swallowed, and drug loading is high, and the number of taking is less;And, geometric shape is similar to small candy, can bring certain degree of psychological suggestion to patient, is easily accepted by patient, improves compliance.
[0029] (2) compared with conventional tablet, the spherical tablet of the utility model is good in compressibility, good in hardness, strong in anti-shock and wear resistance, small in tablet weight difference, is favorable to post-coating operation, and uniformity, reproducibility are good. DRAWINGS
[0030] Figure 1 It is the front view of the spherical tablet of the embodiment 1 of the application;
[0031] Figure 2 It is the plan view of the spherical tablet of the embodiment 1 of the application;
[0032] Figure 3 A size specification diagram of the spherical tablet of Example 1.
[0033] Explanation of reference signs:
[0034] Intermediate band 1
[0035] Intermediate band thickness 101
[0036] Intermediate band diameter 102
[0037] Hemisphere 2
[0038] Hemisphere diameter 201
[0039] Arc depth 202
[0040] Edge 3
[0041] Cross-sectional width of edge 301. DETAILED DESCRIPTION
[0042] The embodiments of the present application will be described in detail below with reference to the examples, but those skilled in the art will understand that the following examples are only for illustration of the present application and should not be regarded as limiting the scope of the present application. The specific conditions not mentioned in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments not mentioned by the manufacturer are all conventional products that can be purchased on the market.
[0043] [Example 1]
[0044] The present embodiment discloses a spherical tablet; Figure 1 A front view of the spherical tablet of the present embodiment; Figure 2 A top view of the spherical tablet of the present embodiment; Figure 3 A size specification diagram of the spherical tablet of the present embodiment. The spherical tablet comprises two upper and lower hemispheres 2 and an intermediate band 1, wherein the intermediate band 1 is a band with the same thickness in the middle of the spherical tablet; the two upper and lower hemispheres 2 are located on the two end faces of the intermediate band 1, and the two hemispheres 2 are the same in size and shape;
[0045] The intermediate band diameter 102 of the spherical tablet is 7 mm, the cross-sectional width 301 of the edge 3 is 0.16 mm, the intermediate band thickness 101 is 3 mm, and the arc depth 202 is 2.04 mm.
[0046] The components of the spherical tablet of the present embodiment are shown in Table 1:
[0047] Table 1 Components in the spherical tablet of Example 1
[0048]
[0049] The specific preparation method is as follows:
[0050] Pre-treatment:
[0051] ①Screen the anhydrous sodium sulfate and the anhydrous magnesium sulfate through a screen with a mesh size of 20-40;
[0052] ②Detect the particle size distribution of the anhydrous sodium sulfate;
[0053] ③After the potassium chloride is crushed for 10s by a universal crusher, screen the potassium chloride with a particle size distribution similar to that of the anhydrous sodium sulfate;
[0054] ④After the polyethylene glycol 4000 is crushed for 10s by a universal crusher, pass it through a 60-mesh screen;
[0055] Mixing:
[0056] ①Pour the screened anhydrous sodium sulfate, the anhydrous magnesium sulfate, and the screened potassium chloride into a high-shear mixing granulator and mix for 10 min to obtain mixture I;
[0057] ②Add the polyethylene glycol 4000 and the colloidal silicon dioxide to mixture I and mix for 10 min to obtain mixture II;
[0058] ③Add the dimethicone to mixture II by spraying with a spray gun, granulate, and obtain mixture III;
[0059] ④Pass mixture III through a 0.81-mm screen for sizing and screening;
[0060] ⑤After the sizing is completed, mix the mixture in a conical mixing barrel for 10 min to obtain mixture IV;
[0061] ⑥Check the angle of repose, bulk density, and particle size distribution of mixture IV.
[0062] Tabletting:
[0063] ①Use a tablet press with a semispherical upper and lower punch, a punch semisphere diameter (the diameter of the outermost part of the punch) of 7 mm, and an arc depth / semisphere diameter ratio of 0.291 to press into spherical tablets;
[0064] ②Check for sticking and top cracking defects during tabletting;
[0065] ③Check the friability of the raw tablets, tablet weight variation, and disintegration time.
[0066] Film coating:
[0067] ①Weigh the prescription amount IR, mixed with purified water in a suitable amount to prepare a coating solution. The substrate is kept at 25-35°C, and the coating solution is continuously stirred during the coating process. The coating solution is sprayed onto the spherical tablets to obtain the desired weight gain range, and the coating is stopped once a sufficient film coating is applied, the hot air supply of the inlet air is turned off, and the small spherical tablets are allowed to cool down;
[0068] 2. Check the disintegration time of the tablets.
[0069] Example 2
[0070] The spherical tablet of the present embodiment comprises an upper half-sphere 2 and a lower half-sphere 2 and a middle band 1, wherein the middle band is a band with the same thickness in the middle of the spherical tablet; the upper and lower half-spheres 2 are located on the two end faces of the middle band 1, and the two half-spheres 2 are the same in size and shape.
[0071] The diameter 102 of the middle band of the spherical tablet is 6 mm, the cross-sectional width of the edge 3 is 0.20 mm, the thickness 101 of the middle band is 2.50 mm, and the arc depth 202 is 1.80 mm.
[0072] The components of the spherical tablet of the present embodiment are shown in Table 2:
[0073] Table 2 Components in the spherical tablet of Example 2
[0074]
[0075] The spherical tablet is prepared by a direct compression method, comprising the following steps:
[0076] Pre-treatment:
[0077] Screen the anhydrous sodium sulfate, anhydrous magnesium sulfate, and potassium chloride through a 20-40 mesh screen.
[0078] Mixing:
[0079] ①Mix the sieved anhydrous sodium sulfate, anhydrous magnesium sulfate, and potassium chloride with polyethylene glycol 4000, pour them into a high-shear mixing granulator in turn, mix for 20 min, and obtain mixture I;
[0080] ②Mix colloidal silicon dioxide with dimethicone to obtain mixture II;
[0081] ③Mix mixture I with mixture II to obtain mixture III;
[0082] ④Add sodium caprylate to mixture III, mix for 20 min, and obtain mixture IV;
[0083] ⑤Check the angle of repose, bulk density, and particle size distribution of mixture IV.
[0084] Tabletting:
[0085] ① In the tablet press, using the upper and lower punch of the tabletting die as a hemispherical shape, the punch with a hemispherical diameter of 6 mm and an arc depth / hemispherical diameter ratio of 0.3, the mixture IV is pressed into tablets;
[0086] ② Check whether there are sticking and top cracking process defects in the tabletting process;
[0087] ③ Check the friability of the raw tablets, tablet weight difference, and disintegration time.
[0088] Film coating:
[0089] ① Weigh the prescribed amount IR, mix with an appropriate amount of purified water to prepare a coating solution. Keep the raw tablets at 25-35°C and continue to stir the coating solution during the coating process. Spray the coating solution onto the spherical tablets to obtain the desired weight gain range. Once sufficient film coating is applied, stop the coating, turn off the hot air supply of the inlet air, and cool the small spherical tablets;
[0090] ② Check the disintegration time of the tablets.
[0091]
Comparative Example 1
[0092] Using the same prescription as Example 1, 7 mm ordinary tablets are pressed using a shallow arc-shaped punch die.
[0093]
Comparative Example 2
[0094] Using the same prescription as Example 1, 17*10 mm ordinary tablets are pressed using a shallow arc-shaped punch die.
[0095]
Comparative Example 3
[0096] Using the same prescription as Example 2, 6 mm ordinary tablets are pressed using a shallow arc-shaped punch die.
[0097]
Comparative Example 4
[0098] Using the same prescription as Example 2, 17*10 mm ordinary tablets are pressed using a shallow arc-shaped punch die.
[0099] Effect Example
[0100] 1. Tabletting and friability test
[0101] Observe the sticking and top cracking during the tabletting process.
[0102] Take several pieces of preparation (corresponding to the material for checking the friability in the preparation steps of the examples and comparative examples), and make the total weight about 6.5g. Blow off the powder falling off from the preparation with a hair dryer, and accurately weigh the total weight as the weight before rolling. Then, put it in the cylinder of the friability tester (model: FT-2000AE) and roll for 100 times. Take it out, blow off the powder falling off from the preparation with a hair dryer, and accurately weigh the total weight as the weight after rolling.
[0103] Friability = (weight before rolling - weight after rolling) / weight before rolling x 100%.
[0104] The experimental results show that the tablets prepared by using the ordinary tablet punch (comparative examples 1-4) of the same prescription have defects of sticking and capping, whether large or small in size. In addition, the friability is significantly increased (more than 1%), which cannot meet the subsequent coating requirements. The spherical tablets (examples 1-2) of the utility model can be stably and completely compressed and formed under the condition of the same tablet diameter and tablet weight, and the friability is good (less than 0.5%), which is beneficial to the subsequent coating process and transportation and storage of the finished product.
[0105] 2. Tablet weight difference experiment
[0106] Randomly take 20 tablets (corresponding to the material for checking the tablet weight difference in the preparation steps of the examples and comparative examples), accurately weigh the total weight, obtain the average tablet weight, and then accurately weigh the weight of each tablet. Compare the weight of each tablet with the average tablet weight.
[0107] Lower limit of tablet weight difference = (minimum weight in 20 tablets - average tablet weight) / average tablet weight x 100%;
[0108] Upper limit of tablet weight difference = (maximum weight in 20 tablets - average tablet weight) / average tablet weight x 100%;
[0109] The experimental results show that the tablets prepared by using the ordinary tablet punch (comparative examples 1-4) of the same prescription have defects of sticking and capping, whether large or small in size. In addition, the friability is significantly increased (more than 1%), which cannot meet the subsequent coating requirements. The spherical tablets (examples 1-2) of the utility model can be stably and completely compressed and formed under the condition of the same tablet diameter and tablet weight, and the friability is good (less than 0.5%), which is beneficial to the subsequent coating process and transportation and storage of the finished product.
Claims
1. A spherical tablet, characterized in that, The spherical tablet comprises upper and lower hemispheres and a middle band, wherein the middle band is located in the middle of the spherical tablet and is a band of the same thickness; the upper and lower hemispheres are located on the two end faces of the middle band, and the two hemispheres are the same size and shape; the diameter of the middle band is larger than the diameter of the hemispheres; the hemisphere diameter of the upper and lower punches of the tableting mold used in tableting is 4~8mm, and the arc depth / hemisphere diameter ratio is (0.2~0.4):
1.
2. The spherical tablet as described in claim 1, characterized in that, The spherical tablets satisfy one or more of the following conditions: ①The thickness of the middle band of the spherical tablet is 1~5mm; ②The part of the middle band of the spherical tablet that protrudes relative to the hemisphere is the edge, and the cross-sectional width of the edge is 0.1~2mm; ③ The arc depth of the hemisphere of the spherical tablet is 1~5mm; ④ The spherical tablets are quasi-spherical.
3. The spherical tablet as described in claim 1, characterized in that, The spherical tablets satisfy one or more of the following conditions: ① The diameter of the central band of the spherical tablet is 4~8mm; ② The thickness of the middle band of the spherical tablet is 1.5~4.5mm; ③ The part of the middle band of the spherical tablet that protrudes relative to the hemisphere is the edge, and the cross-sectional width of the edge is 0.1~1mm; ④ The arc depth of the hemisphere of the spherical tablet is 1.5~4.5mm.
4. The spherical tablet as described in claim 1, characterized in that, The spherical tablets satisfy one or more of the following conditions: ① The diameter of the hemisphere of the die is 5~7mm, and the ratio of arc depth to hemisphere diameter is (0.2~0.3):1; ②The diameter of the central band of the spherical tablet is 5~7mm; ③ The thickness of the middle band of the spherical tablet is 2~4mm; ④ The portion of the spherical tablet that protrudes from the hemisphere in the middle is the edge, and the cross-sectional width of the edge is 0.1~0.5mm; ⑤ The arc depth of the hemisphere of the spherical tablet is 1.8~2.2mm or 2~4mm.
5. A spherical tablet, characterized in that, The spherical tablet comprises upper and lower hemispheres and a middle band, wherein the middle band is located in the middle of the spherical tablet and is a band of the same thickness; the upper and lower hemispheres are located on the two end faces of the middle band, and the two hemispheres are the same size and shape; the diameter of the middle band is larger than the diameter of the hemispheres; the tableting mold used for tableting has a hemisphere diameter of 6mm for the upper and lower punches, and an arc depth / hemisphere diameter ratio of 0.3:
1.
6. A spherical tablet, characterized in that, The spherical tablet comprises upper and lower hemispheres and a middle band, wherein the middle band is located in the middle of the spherical tablet and is a band of the same thickness; the upper and lower hemispheres are located on the two end faces of the middle band, and the two hemispheres are the same size and shape; the diameter of the middle band is larger than the diameter of the hemispheres; the tableting mold used for tableting has a hemisphere diameter of 7mm for the upper and lower punches, and an arc depth / hemisphere diameter ratio of 0.291:1.