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Oral disintegrated rupatadine tablet and its preparing method

A technology of orally disintegrating tablets and preparations, applied in the field of rupatad orally disintegrating tablets, can solve problems such as poor compliance and restrictive effects, and achieve the effects of easy promotion and simple preparation process

Inactive Publication Date: 2007-06-27
SHANTOU UNIV MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ordinary tablets need to drink water and swallow to complete the medication process. This dosage form has poor compliance for some elderly, children, and patients who have difficulty swallowing. Its use is restricted (such as lack of drinking water) or the effect is poor in some special conditions.

Method used

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  • Oral disintegrated rupatadine tablet and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Rupatadine Fumarate 5%

[0026] Dextrin 18%

[0027] Mannitol 35%

[0028] Lactose 30%

[0029] Low-substituted hydroxypropyl cellulose (L-HPC) 8%

[0030] Aspartame 2%

[0031] Talc 1.5%

[0032] Magnesium Stearate 0.5%

[0033] The dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by a compression process. The specific preparation method is as follows: aspartame and rupatadine are respectively pulverized through an 80-mesh sieve, weighed according to the prescription amount, mixed evenly, and Pass dextrin, mannitol, lactose, low-substituted hydroxypropyl cellulose, talcum powder, and magnesium stearate through an 80-mesh sieve respectively, weigh them according to the prescription amount, mix them evenly, and then mix them with Lupa mixed with aspartame He decided to mix, sieve and mix evenly, measure the content of the semi-finished product, calculate the tablet weight, compress the tablet, test the hardness of the tablet,...

Embodiment 2

[0036] Rupatadine Fumarate 6%

[0037] Lactose 35%

[0038] Mannitol 40%

[0039] Low-substituted hydroxypropyl cellulose (L-HPC) 8%

[0040] Croscarmellose Sodium (CCNa) 2.5%

[0041] Aspartame 2.5%

[0042] Strawberry flavor 2.0%

[0043] Sweet Orange Flavor 2.0%

[0044] Talc 1.5%

[0045] Magnesium Stearate 0.5%

[0046] The dosage form can be produced by using conventional tablet pharmaceutical equipment and prepared by pressing process. The specific preparation method is as follows: aspartame, strawberry essence, sweet orange essence, and rupatadine are respectively crushed through an 80-mesh sieve. Weigh and mix evenly, and separately pass lactose, mannitol, low-substituted hydroxypropyl cellulose, croscarmellose sodium, and magnesium stearate through an 80-mesh sieve, weigh them according to the prescription amount, mix evenly, and then Mix with rupatadine mixed with aspartame, etc., sieve and mix evenly, measure the content of the semi-finished product, calcul...

Embodiment 3

[0049] Rupatadine Fumarate 8%

[0050] Lactose 40%

[0051] Mannitol 38%

[0052] Sodium Carboxymethyl Starch (CMS-Na) 3%

[0053] Stevioside 3%

[0054] Peppermint Flavor 1.5%

[0055] Strawberry flavor 2.0%

[0056] Sweet Orange Flavor 2.0%

[0057] Talc 1.5%

[0058] Magnesium Stearate 1.0%

[0059]The dosage form can be produced by conventional tablet pharmaceutical equipment and prepared by pressing technology. The specific preparation method is as follows: respectively crush stevioside, strawberry essence, sweet orange essence, mint essence, and rupatadine through an 80-mesh sieve, and press the prescription Weigh and mix evenly, and separately pass lactose, mannitol, sodium carboxymethyl starch, and magnesium stearate through 80 mesh sieves, weigh them according to the prescription amount, mix evenly, and then mix with Lupa mixed with stevioside, etc. He decided to mix, sieve and mix evenly, measure the content of the semi-finished product, calculate the tablet ...

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Abstract

The present invention provides a kind of oral disintegrated rupatadine tablet and its preparation process. The oral disintegrated rupatadine tablet has recipe comprising rupatadine in 5-40 mg each as main medicine component as well as filler, disintegrant, corrective, antioxidant, lubricant, etc. The present invention is used in treating allergic rhinitis, hay fever and other diseases. The medicine of the present invention has simple preparation process, convenient taking, fast acting and obvious curative effect, and is especially suitable for old people, children and patient with dysphagia.

Description

Technical field: [0001] The invention belongs to pharmaceutical preparations, and relates to an orally disintegrating tablet dosage form, in particular to a rupatadine orally disintegrating tablet which is compressed by a direct tableting method and has rapid release. Background technique: [0002] Allergic rhinitis has a great social impact due to its high incidence (10-20%). Including seasonal allergic rhinitis (SAR) and chronic allergic rhinitis (PAR), which are accompanied by complications such as mental weakness and asthma, which have a certain impact on the quality of life. Rupatadine fumarate is an antiallergic drug developed by J Uriach & Cia SA in Spain, which has dual effects of antagonizing histamine and platelet activating factor. It was launched on March 4, 2003 and is suitable for treating perennial allergic rhinitis and hay fever. Clinical and preclinical data suggest that it can be used as a first-line drug option in the treatment of allergic inflammatory di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/351A61K9/20A61P11/02A61P37/08
Inventor 王家权董红梅于晓军徐小虎吕俊耀
Owner SHANTOU UNIV MEDICAL COLLEGE
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