Orodispersible tablets of erythritol and isomalt

A technology of isomalt and erythritol, which is applied in the directions of pill delivery, medical preparations of non-active ingredients, and pharmaceutical formulations

Inactive Publication Date: 2013-01-30
CARGILL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Tablets and capsules have the disadvantage that water is required when taking them and they are not satisfactorily accepted by the elderly, infants and people with swallowing difficulties

Method used

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  • Orodispersible tablets of erythritol and isomalt
  • Orodispersible tablets of erythritol and isomalt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] The crude erythritol product (Cargill Zerose® 16957) was ground in a Bauermeister turbine mill UTL with a 1 mm sieve to obtain a powder with a volume mean diameter of 25 μm. The volume mean diameter is measured by laser diffraction.

[0071] 400 g of ground erythritol powder was mixed with 100 g of isomalt (Cargill C*lsoMaltidex ?) for 10 seconds of dry mixing.

[0072] Add 30ml of water dropwise at a rate of 5ml / min. After the liquid was added, the blend was continued to mix for 60 seconds.

[0073] The granulated powder was hand wet sieved with a 2 mm sieve.

[0074] The wet sieved granules were dried in a fluidized bed (Aeromatic-Fielder GEA-Strea-1) at a temperature of 60° C. for 30 minutes.

[0075] The dried granules were sieved through a 0.315 mm sieve for 5-10 minutes in a granulator (Erweka (FGS+AR400E)) at 100 rpm.

example 2A

[0076] Example 2A - Comparative Example

[0077] The granulated product obtained from Example 1 was then mixed with 1% magnesium stearate in a Pharmatech apparatus at a speed of 28 rpm.

[0078] The granulated product was compressed in a tablet press (Korsch-PH100) with a compression force varying from 5 kN to 20 kN.

[0079] Tablets have a 1cm 2 The surface of the tablet has a diameter of 11.3mm and its weight is 350mg.

Embodiment 2B

[0081] The granulated product obtained from Example 1 was then (dry) blended in a Pharmatech apparatus at 28 rpm with 2% Ac-di-sol (disintegrant) and 1% magnesium stearate.

[0082] The granulated product was compressed in a tablet press (Korsch-PH100) with a compression force varying from 5 kN to 20 kN.

[0083] Tablets have a 1cm 2 The surface of the tablet has a diameter of 11.3mm and its weight is 350mg.

[0084] Example 3 - Comparative example - according to WO2010 / 025796

[0085]The crude erythritol product (Cargill C*PharmEridex 16956) was ground in a Bauermeister turbine mill UTL with a 1 mm sieve to obtain a powder with a volume mean diameter of 30 μm.

[0086] The volume mean diameter is measured by laser diffraction. Erythritol has 0.40m 2 / g specific surface area.

[0087] 500 g of ground erythritol powder were dry blended for 60 seconds in a high shear mixer (Pro-C-ept-Mi-Pro, chopper: 3000 rpm, and impeller: 1200 rpm).

[0088] 79.17 g of liquid sorbitol (7...

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Abstract

Erythritol is granulated together with at least 10% w / w isomalt. Prior and / or after granulation a disintegrant is added and orodispersible tablets are prepared. The tablet has a disintegration time of less than 100 seconds, less than 90 seconds, preferably less than 80 seconds, more preferably less than 60 seconds and said disintegration time was determined according to the European Pharmacopoeia VI, Test method 2.9.1 by using a pharmaceutical disintegration tester model ZT 73 whereby 6 tablets having a surface of 1 square centimeter and a weight of 350 mg, at a compression force of 20 kN, were analyzed and mean values were calculated. The process for preparing the orodispersible tablet, its use, and the intermediate granulate are described as well.

Description

technical field [0001] The present invention relates to the preparation of orodispersible tablets of erythritol, isomalt and a disintegrant. Background technique [0002] Tablets and capsules have the disadvantage that water is required when taking them, and they are not satisfactorily accepted by the elderly, infants and people who have difficulty swallowing. Dysphagia (dysphagia) has been reported to be common in all age groups, especially in pediatrics, the geriatric population, institutionalized patients, and those with complications of nausea, vomiting, and motion sickness patient. In the last decade, there has been a need for alternative pharmaceutical products and medicaments that can be taken anywhere. One suitable type of formulation is orodispersible or fast dissolving and has the property of dissolving, melting or disintegrating in the oral cavity in the presence of water within seconds. These preparations disintegrate or dissolve quickly when placed in the mou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20
CPCA61K47/26A61K9/2018A61K9/0056
Inventor C.P.L.博曼斯L.M.F.米厄斯
Owner CARGILL INC
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