Quick disintegrating tablet in buccal cavity and production process thereof

a technology of disintegrating tablets and buccal cavity, which is applied in the direction of securing communication, digital transmission, star/tree networks, etc., can solve the problems of small strength, inability to take over the preparation of ptp, and some problems with the dosage form

Inactive Publication Date: 2005-05-12
ASTELLAS PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0029]FIG. 1 shows the stability of the tablet strength in the present invention. In the fi...

Problems solved by technology

However, these dosage forms will have some issues if a patient takes them.
For instance, regarding a tablet or a capsule, if the patient is a person of advanced age or a child, there are some cases that they dislike to take the pharmaceutical preparation because it is difficult for them to swallow it or the preparation will stick in the throat or the esophagus of them.
In addition, regarding a granule or a powder, in some cases they dislike to take the preparation under the reason that it is dif...

Method used

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  • Quick disintegrating tablet in buccal cavity and production process thereof

Examples

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example 1

[0031] Mannitol 602 g and lactose 602 g were mixed. This was passed through a sieve (14 mesh). 433 g of glucose solution (15 w / v %) was used as a binding agent for this mixture, and the mixture was granulated in a fluidized-bed granulator. Up to 157 g of the solution was used to coat the above mixture at a spray pressure of 2.5 kg / cm2. Afterwards, it was granulated with spray pressure 1.5 kg / cm2. After drying the granule, peppermint flavor 10g, stearic acid 12g, magnesium stearate 10g were combined. Rotary tablet machine was used to manufacture tablets which were 540 mg per one tablet (tablet hardness 1.4 kp (n=5)). Next, this tablet was humidified and heated for 20 minutes in a thermo-hygrostat at 35° C., 85% RH. Afterwards, it was dried for 15 minutes at 50° C. (humidity 30%), and the tablet of the present invention was achieved. The obtained tablet had hardness of 9.1 kp, and buccal cavity disintegrating time of 17 seconds.

example 2

[0032] 175 g of a lactose solution (10 w / v %) was a binding agent for 350 g of lactose (Domo milk Corp.). This was granulated in a fluidized-bed granulator (Ohkawara Seisakusho). Up to 70 g of the previous solution was used to coat the lactose with a spray pressure of 2.5 kg / cm2. Afterwards, it was granulated with a spray pressure 1 kg / cm2. After drying the granule, 0.5% magnesium stearate was mixed with the granule. Tablets ((phi 10 mm, 10 mmR), tablet hardness 2.3 kp (n=5)) of 300 mg per tablet were produced using a rotary tablet machine. Next, the tablet was stored under heated humidified conditions of 25° C. / 70% RH for 19 hours, using a thermo-hygrostat (Tabiespec Corp., PR-35C). Afterwards it was dried for 2 hours at 25° C. (humidity 50%). The tablet of the present invention was obtained. The obtained tablet had a hardness of 4.1 kp (n=5) and a buccal cavity disintegration time of 20 seconds.

example 3

[0033] 378 g of mannitol (Towa Chemical Industry Corp.) was passed through a sieve (20 mesh). Afterwards, this was granulated in a fluidized bed granulator (Ohkawara Seisakusho) with 133 g of an aqueous solution of hydrated crystalline glucose (Nippon Shokuhin Kako Corp.) (15 w / v %) as a binding agent. Up to 50 g of the previous solution was used to coat the mannitol with a spray pressure of 2.5 kg / cm2. Afterwards, it was granulated with a spray pressure 1.5 kg / cm2. At this time, the disappearance of the absorption peak derived from glucose crystals (i.e. glucose is amorphous) was confirmed using a differential scanning calorimeter (DSC for short). 0.5% magnesium stearate was mixed with the granule. Tablets ((phi 8 mm, 9.6 mmR), tablet hardness 2.0 kp (n=5)) of 150 mg per tablet were produced using a rotary tablet machine with a compression pressure of approximately 0.18 ton / punch. Next, the tablet was stored under heated humidified conditions of 25° C. / 70% RH for 24 hours, using a ...

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Abstract

The present invention relates to a quick disintegrating tablet in buccal cavity, comprising: a mixture, comprising a drug, a sugar (A), and an amorphous sugar (B), and after it is forming a tablet, it is humidified and dried. In particularly, the present invention relates to a quick disintegrating tablet in buccal cavity comprising: a mixture; comprising a drug, a sugar (A), and an amorphous sugar (B) which an amorphous-forming sugar in crystalline state is dissolved in a medicinally permitted solvent, the amorphous sugar is obtained from this solution by removing the solvent, and after it is forming a tablet, and it is humidified and dried. The tablet in the present invention is to provide stability against moisture at preserved, because the amorphous sugar changed to the crystalline state in a nonreversible reaction after it is humidified and dried in a manufacturing process. The tablet in the present invention is to further provide a design for the pharmaceutical preparation with respect to the stability of a drug, because the tablet is manufactured by one kind of a sugar and an amorphous sugar. Furthermore, the tablet in the present invention is to provide a production process by utilizing a common granulating machine and by utilizing a common tablet machine.

Description

TECHNICAL FEILD [0001] The present invention relates to a quick disintegrating tablet in buccal cavity and production process thereof. BACKGROUND OF THE INVENTION [0002] As for the pharmaceutical dosage forms for oral use, a tablet, a capsule, a granule, a powder and the like are mentioned. However, these dosage forms will have some issues if a patient takes them. For instance, regarding a tablet or a capsule, if the patient is a person of advanced age or a child, there are some cases that they dislike to take the pharmaceutical preparation because it is difficult for them to swallow it or the preparation will stick in the throat or the esophagus of them. In addition, regarding a granule or a powder, in some cases they dislike to take the preparation under the reason that it is difficult for them to swallow it with its remaining in buccal cavity or the reason that they will choke when taking the dosage. Since a compliance to take the pharmaceutical preparation is caused to fall in t...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/20A61K47/26A61K47/36H04L12/44H04L29/06H04L29/08
CPCA61K9/0056A61K9/2018A61K9/2095H04L12/44H04L69/329H04L67/26H04L67/12H04L69/08H04L29/06H04L67/55A61K9/20H04L9/40
Inventor MIZUMOTO, TAKAOMASUDA, YOSHINORIKAJIYAMA, ATSUSHIYANAGISAWA, MASAHIRONYSHADHAM, JANAKI RAM
Owner ASTELLAS PHARMA INC
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