Dexlansoprazole medicinal preparation

A dexlansoprazole and drug technology, applied in the field of pharmaceutical preparations, can solve the problems of inappropriate proportion, non-absorption, poor acid control effect, etc., and achieve the effects of stable drug release, long maintenance time, and reduced dosage

Active Publication Date: 2018-02-02
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The time-delay layer materials of the above-mentioned patent documents all use methacrylic acid copolymers, which have the following problems: 1. The proportion of methacrylic acid copolymer S100 and methacrylic acid copolymers in the prescription is not suitable, and there is a problem of non-absorption in the body; 2. When using methacrylic acid copolymer alone in the coating scale-up process, the acid control effect is poor, and more coating weight is needed to achieve the controlled release effect. Therefore, it is urgent to develop a drug with good acid control effect and more stable drug release. , Dexlansoprazole preparations with longer duration

Method used

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  • Dexlansoprazole medicinal preparation
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  • Dexlansoprazole medicinal preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Embodiment 1: A kind of dexlansoprazole delayed capsule composition and preparation method thereof

[0088] Enteric-coated immediate-release pellets:

[0089]

[0090] Delayed pellet prescription composition:

[0091]

[0092] The preparation process of enteric-coated quick-release pellets: (1) Weigh the prescription amount of dexlansoprazole, sucrose, heavy magnesium carbonate, and hypromellose, mix them evenly, place them in the feed funnel, and place the medicinal sucrose pellet cores in the In a coating granulator, 2% (w / w) hydroxypropyl cellulose aqueous solution is used as a binder, and the drug-containing pellets are prepared by centrifugal granulation. Dry the drug-containing pellets at 35°C±5°C until the water content is less than 5%, and sieve the pellets between 18 mesh and 24 mesh for use.

[0093] (2) Place the drug-containing pellets in a fluidized bed, preheat to the material temperature, adopt the Hüttlin bottom spray fluidized bed coating techno...

Embodiment 2

[0098] Embodiment 2: A kind of dexlansoprazole delayed capsule composition and preparation method thereof

[0099] Enteric-coated immediate-release pellets:

[0100]

[0101]

[0102] Delayed pellet prescription composition:

[0103]

[0104] The preparation process of enteric-coated quick-release pellets: (1) Weigh the prescription amount of dexlansoprazole, sucrose, heavy magnesium carbonate, and hypromellose, mix them evenly, place them in the feed funnel, and place the medicinal sucrose pellet cores in the In a coating granulator, 2% (w / w) hydroxypropyl cellulose aqueous solution is used as a binder, and the drug-containing pellets are prepared by centrifugal granulation. Dry the drug-containing pellets at 35°C±5°C until the water content is less than 5%, and sieve the pellets between 18 mesh and 24 mesh for use.

[0105] (2) Place the drug-containing pellets in a fluidized bed, preheat to the material temperature, adopt the Hüttlin bottom spray fluidized bed co...

Embodiment 3

[0110] Embodiment 3: A kind of dexlansoprazole delayed capsule composition and preparation method thereof

[0111] Enteric-coated immediate-release pellets:

[0112]

[0113] Delayed pellet prescription composition:

[0114]

[0115]

[0116] The preparation process of enteric-coated quick-release pellets: (1) Weigh the prescription amount of dexlansoprazole, sucrose, heavy magnesium carbonate, and hypromellose, mix them evenly, place them in the feed funnel, and place the medicinal sucrose pellet cores in the In a coating granulator, 2% (w / w) hydroxypropyl cellulose aqueous solution is used as a binder, and the drug-containing pellets are prepared by centrifugal granulation. Dry the drug-containing pellets at 35°C±5°C until the water content is less than 5%, and sieve the pellets between 18 mesh and 24 mesh for use.

[0117] (2) Place the drug-containing pellets in a fluidized bed, preheat to the material temperature, adopt the Hüttlin bottom spray fluidized bed coat...

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Abstract

The invention discloses a dexlansoprazole medicinal preparation, and in particular relates to a dexlansoprazole medicinal composition having a bi-phase drug release behavior and a preparation method of the medicinal composition. The medicinal composition consists of enteric quick release pellets and enteric delay pellets, wherein delay layers of the enteric delay pellets are prepared by mixing hydroxypropyl methylcellulose phthalate (HPMCP) and methacrylic acid copolymers S100 according to specific proportions. Effects of a good acid control effect, stable drug release and long holding time are achieved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of dexlansoprazole and a preparation method thereof. Background technique [0002] The chemical name of dexlansoprazole is (+)-2-[3-methyl-4-(2,2,2-trifluoroethyl)pyridin-2-yl]methyl}sulfinyl]-1H -benzimidazole, its chemical structural formula is as follows: [0003] [0004] Dexlansoprazole is a PPI proton pump inhibitor, which can efficiently and rapidly inhibit H+ / K+-ATP, and achieve the effect of inhibiting gastric acid secretion. The "Dexilant" developed and marketed by Takeda in 2009 is a dual control agent of dexlansoprazole, which contains two kinds of time-delayed granules with different coatings inside, releases the drug twice, and has two absorption peaks in the body. Studies have shown that this biphasic time-delay capsule has a higher cure rate for non-erosive or erosive gastroesophageal reflux disease. [0005] The prepar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/52A61K47/32A61K47/38A61P1/04
CPCA61K9/5026A61K9/5042A61K31/4439
Inventor 王蕊瑞黄玉超袁恒立孙运栋
Owner JIANGSU HANSOH PHARMA CO LTD
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