Rapidly dissolving oral tablet

A technology for intra-oral, fast-disintegrating tablets, which is applied in the fields of non-active ingredient medical preparations, pill delivery, respiratory diseases, etc., to achieve sufficient hardness and excellent intra-oral disintegration effect

Inactive Publication Date: 2014-01-29
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no record about the use of drugs having a bitter taste such as bepotastine or a pharmacologically acceptable salt thereof

Method used

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  • Rapidly dissolving oral tablet

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Experimental program
Comparison scheme
Effect test

Embodiment

[0101] Embodiments of the present invention will be described in detail below based on examples. In addition, the hardness of a tablet, oral disintegration time, and bitterness masking were measured as follows.

[0102] Hardness test method

[0103] The hardness of the orally rapidly disintegrating tablet of the present invention was measured using a tablet hardness meter (model: 8M) manufactured by Schleuniger. The measurement was carried out 3 times, and the average value was taken as the hardness of the tablet.

[0104] Determination of oral disintegration time

[0105] The oral disintegration time of the oral rapidly disintegrating tablet of the present invention is as follows: healthy adult men (3 people) each took one tablet in the mouth without using water for taking it, and placed it in the mouth in a state of standing (without performing Under behaviors such as chewing and vigorously moving the tongue), the time until the tablet was completely disintegrated by ...

Embodiment 1

[0110] (1) 13 g of bepotastine besylate, 65 g of β-cyclodextrin, 288.6 g of D-mannitol, and 11.7 g of hydroxypropylmethylcellulose acetate succinate (grade; HF) were added to polyethylene After mixing in bag making, sieve through Japanese Pharmacopoeia No. 22 sieve (pore size: 710 μm). The obtained sieved product was charged into a fluidized bed granulator (manufactured by Powrex, MP-01 / 03), and granulated while spraying 200 g of purified water at a supply air temperature of 50° C. for about 50 minutes. Drying was carried out until the temperature of the granulated matter reached 35° C. or higher, and all the dried matter passed through a Japanese Pharmacopoeia No. 22 sieve (pore size: 710 μm), thereby obtaining granulated granules.

[0111](2) 5.82 g of the granulated granules of (1) above, 0.12 g of crospovidone, 0.06 g of aspartame, and 0.06 g of sodium stearate fumarate were mixed to obtain granules for tableting. Using the obtained granules for tableting, compression mol...

Embodiment 2

[0113] (1) Add 0.3 g of bepotastine besylate, 3 g of β-cyclodextrin, 5.16 g of D-mannitol, and 0.27 g of hydroxypropylmethylcellulose acetate succinate (grade; HF) in poly After mixing in vinyl bags, sieve through Japanese Pharmacopoeia No. 22 sieve (pore size: 710 μm). After adding 0.5 g of purified water to the obtained sieved product and performing granulation, it was dried in a ventilated box-type dryer at 50°C for 1 hour, and all the dried product passed through a No. Granulated particles are thus obtained.

[0114] (2) 5.82 g of the granulated granules of (1) above, 0.12 g of crospovidone, 0.06 g of aspartame, and 0.06 g of sodium stearate fumarate were mixed to obtain granules for tableting. Using the obtained granules for tableting, compression molding is performed with a tableting analyzer (manufactured by Kikusui Seisakusho, punch: 10mm in diameter, tableting pressure: 300kg / punch) so that the content of each tablet is 303mg, thereby obtaining rapid disintegration i...

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Abstract

Provided is a tablet that dissolves rapidly in the mouth and that contains bepotastine or a pharmacologically acceptable salt thereof, bepotastine being a medicinal component having a bitter taste. The drug formulation masks masks the bitterness, combines excellent dissolving characteristics in the mouth with a sufficient degree of hardness, and can be produced at ordinary tablet production facilities. The present invention relates to a rapidly dissolving oral tablet containing bepotastine or the pharmacologically acceptable salts thereof, menthol or cyclodextrin, water-insoluble polymers, and a solubilizing agent, and, additionally, a production method for the rapidly dissolving oral tablet. This method relates to 1) a step of obtaining granules by mixing and granulating bepotastine or the pharmacologically acceptable salts thereof, the water-insoluble polymers, and, as the case may be, a diluting agent; 2) a step of obtaining granules for tableting by mixing the granules, menthol, and solubilizing agent, and, as the case may be, a lubricating agent and / or sweetening agent; and 3) a step of compressing and forming the granules into tablets.

Description

technical field [0001] The present invention relates to an orally rapidly disintegrating tablet containing bepotastine or a pharmacologically acceptable salt thereof, which masks bitter taste and has sufficient hardness. Background technique [0002] It is considered that the provision of preparations that are easy to take for the elderly and patients who have difficulty swallowing leads to an improvement in the quality of life (Quality of Life) and improvement in medication compliance. In particular, orally disintegrating tablets are not only easy to take, but also have a high possibility of launching new products by demonstrating biological equivalence with approved preparations, so they have been developed in a large number of products. In addition, orally disintegrating tablets also have the advantage of reducing preparation operations such as pulverization and suspension in the clinical field, so it is related to the demand for orally disintegrating tablets. However, p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545A61K9/20A61K47/10A61K47/26A61K47/32A61K47/36A61K47/38A61K47/40
CPCA61K9/2054A61K9/2013A61K9/205A61K31/4545A61K9/2018A61K9/0056A61K9/5042A61P11/02A61P37/08A61P43/00A61K9/20A61K47/10A61K47/26A61K47/32A61K47/40
Inventor 成泽真治杉本昌阳北冈健一大川亚纪子森本甫享
Owner MITSUBISHI TANABE PHARMA CORP
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