Dexlansoprazole Pharmaceutical Preparations

A technology for dexlansoprazole and medicine, applied in the field of pharmaceutical preparations, can solve the problems of poor acid control effect, non-absorption, inappropriate ratio and the like, and achieves the effects of high drying efficiency, short preparation period and high yield

Active Publication Date: 2021-07-16
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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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 pharmaceutical preparation, in particular to a dexlansoprazole pharmaceutical composition with biphasic drug release behavior and a preparation method thereof. The pharmaceutical composition of the present invention includes enteric-coated quick-release pellets and enteric-coated time-delayed pellets, wherein the time-delay layer of the enteric-coated time-delayed pellets adopts hypromellose phthalate (HPMCP) and methyl Acrylic acid copolymer S100 is mixed in a specific ratio to achieve good acid control effect, stable drug release and long-lasting effect.

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 Patents(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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