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Lurasidone sublingual tablet as well as preparation method and application thereof

A technology for lurasidone and sublingual tablets, applied in the field of lurasidone sublingual tablets and its preparation, can solve problems such as difficulty in swallowing, poor dissolution rate, difficult quality control, etc., and achieve simple molding process and transmembrane absorption Good effect with few types of excipients

Inactive Publication Date: 2017-09-08
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the particularity of the patient population, patients have difficulty in swallowing solid oral dosage forms. These dosage forms such as tablets and capsules have poor dissolution rate in the gastrointestinal tract, low bioavailability, and are not suitable for swallowing
However, injections and films usually have the disadvantages of high production costs, inconvenient transportation and storage, etc., which cannot be mass-produced well, and quality control is relatively difficult.

Method used

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  • Lurasidone sublingual tablet as well as preparation method and application thereof
  • Lurasidone sublingual tablet as well as preparation method and application thereof
  • Lurasidone sublingual tablet as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 Preparation of sublingual tablet of the present invention

[0026] 【prescription】

[0027] Lurasidone 0.04g

[0028] Pregelatinized starch 4.5g

[0029] Sodium starch glycolate 3.1g

[0030] Microcrystalline Cellulose 1.2g

[0031] Aspartame 0.1g

[0032] Proper amount of povidone

[0033] [Preparation method] First mix the raw drug lurasidone and 35% prescription amount of the disintegrating agent microcrystalline cellulose evenly, then add the filler pregelatinized starch and carboxymethyl starch sodium by equal addition method, and mix evenly. Add an appropriate amount of binder povidone to make the prepared soft material "lightly hold into a ball, and it will disperse when pressed", pass through a 20-mesh sieve, and dry the obtained wet granules. After sizing, add the remaining 65% of disintegrant The solution is obtained by pressing into tablets.

Embodiment 2

[0034] Embodiment 2 Preparation of sublingual tablet of the present invention

[0035] 【prescription】

[0036] Lurasidone 0.08g

[0037] Pregelatinized starch 4.5g

[0038] Sodium starch glycolate 3.1g

[0039] Microcrystalline Cellulose 1.2g

[0040] Aspartame 0.1g

[0041] Proper amount of povidone

[0042] 【Preparation】

[0043] First, mix the raw drug lurasidone and 35% prescription amount of the disintegrating agent microcrystalline cellulose evenly, then add the filler pregelatinized starch and carboxymethyl starch sodium by the equal amount incremental method, and mix evenly, add an appropriate amount of adhesive Povidone is used to make the prepared soft material "lightly hold into agglomerate, and it will disperse when pressed", pass through a 20-mesh sieve, dry the obtained wet granules, after sizing, add the remaining 65% disintegrant, press Slice and serve.

Embodiment 1-2 and comparative Embodiment 1-3

[0079] Embodiment 1-2 and comparative example 1-3 influence factor test detects related substances (%)

[0080]

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PUM

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Abstract

The invention provides a lurasidone sublingual tablet. The invention also provides a preparation method and an application of the sublingual tablet. The sublingual tablet provided by the invention is less in variety of adjuvants, relatively high in drug content, high in disintegrating speed and good in transdermal absorption, and the sublingual tablet is effectively applicable to sublingual administration; in addition, after compatibility of raw materials and the adjuvants, treatment by a special dispersion technology is omitted, so that the preparation method is simpler and more convenient in forming process, lower in production cost and conducive to industrial production.

Description

technical field [0001] The invention relates to a lurasidone sublingual tablet, a preparation method and application thereof. Background technique [0002] Lurasidone (lurasidone) is a new type of atypical antipsychotic drug, which was approved by the US Food and Drug Administration (FDA) on October 28, 2010. Its trade name is Latuda, and it is used for the treatment of schizophrenia. [0003] English name: Lurasidone [0004] English alias: (3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl ]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione;4-{[(1R,2R)-2-{[4-(2$l^{4}-thia-6 -azatricyclo[5.4.0.0^{2,6}]undeca-1(11),2,4,7,9-pentaen-5-yl)piperazin-1-yl]Methyl}cyclohexyl]Methyl}-4-azatricyclo [5.2.1.0^{2,6}] deca-1(9),2(6),7-triene-3,5-dione [0005] Mechanism of action: Lurasidone is an atypical antipsychotic drug, and its exact mechanism for treating schizophrenia is still not very clear like other atypical antipsychotic drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P25/18
CPCA61K9/2059A61K9/006A61K31/496
Inventor 严洁
Owner TIANJIN HANKANG PHARMA BIOTECH