Glipizide orally disintegrating tablet and preparation method thereof

一种口腔崩解片、格列吡嗪的技术,应用在格列吡嗪口腔崩解片及其制备领域,能够解决工艺复杂、延长崩解时限等问题,达到工艺设备简单、降低成本、口感良好的效果

Inactive Publication Date: 2017-12-01
CHONGQING CONQUER PHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patented prescription uses many excipients and the process is complicated, and the povidone K30 will prolong the disintegration time limit

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030]

[0031]

[0032] Wherein, the amount of binder purified water is 11g, accounting for 26.8% of the total weight of glipizide, mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose with a total addition of 50%.

[0033] A preparation method of glipizide orally disintegrating tablet, is characterized in that, comprises the following steps:

[0034] S1. Mix 5 g of glipizide, 20 g of mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose in a total amount of 50%, and pour it out through a 60-mesh sieve to form mixed powder I;

[0035] S2. Add 11g of purified water to make soft material into the powder mixing I in step S1, pass the soft material through a 30-mesh sieve to make wet granules;

[0036] S3, drying the wet granules, controlling the drying temperature of the wet granules to 80°C until the water content of the granules is lower than 3%, to obtain dry granules;

[0037] S4, the dry g...

Embodiment 2

[0043] prescription:

[0044]

[0045] Wherein, the amount of binder purified water is 16g, accounting for 33.4% of the total weight of glipizide, mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose with a total addition of 50%.

[0046] A preparation method of glipizide orally disintegrating tablet, is characterized in that, comprises the following steps:

[0047] S1. Mix 5 g of glipizide, 33 g of mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose in a total amount of 50%, and pour it out through a 70-mesh sieve to form mixed powder I;

[0048] S2. Add 16g of purified water to make soft material in step S1 mixed powder I, pass the soft material through a 20-mesh sieve to make wet granules;

[0049] S3, drying the wet granules, controlling the drying temperature of the wet granules to 75°C until the water content of the granules is lower than 3%, to obtain dry granules;

[0050] S4, the dry granules are passed thr...

Embodiment 3

[0056] prescription:

[0057]

[0058] Wherein, the amount of binder purified water is 14g, accounting for 34.1% of the total weight of glipizide, mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose with a total addition of 50%.

[0059] A preparation method of glipizide orally disintegrating tablet, is characterized in that, comprises the following steps:

[0060] S1. Mix 5 g of glipizide, 20 g of mannitol, microcrystalline cellulose and low-substituted hydroxypropyl cellulose in a total amount of 50%, and pour it out through a 60-mesh sieve to form mixed powder I;

[0061] S2. Add 14g of purified water to make soft material into the powder mixing I in step S1, pass the soft material through a 30-mesh sieve to make wet granules;

[0062] S3, drying the wet granules, controlling the drying temperature of the wet granules to 80°C until the water content of the granules is lower than 3%, to obtain dry granules;

[0063] S4, the dry granules are ...

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PUM

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Abstract

The invention discloses a glipizide orally disintegrating tablet and a preparation method of the glipizide orally disintegrating tablet. The orally disintegrating tablet comprises glipizide and pharmaceutically acceptable auxiliary materials with effective doses, wherein the pharmaceutically acceptable auxiliary materials comprise a filling agent, a flavoring agent, a disintegrating agent, a lubricant and an adhesive; the filling agent is composed of mannitol and microcrystalline cellulose; the flavoring agent is mannitol; the disintegrating agent is a composition of crospovidone, low-substituted hydroxypropyl cellulose and sodium carboxymethyl starch, and the weight ratio of the crospovidone to the low-substituted hydroxypropyl cellulose to the sodium carboxymethyl starch is (5-20): (5-30): (2-10); the lubricant is magnesium stearate; the adhesive is purified water. The product can rapidly disintegrate in the oral cavity, and is good in taste, easy to swallow, and free of irritation to the oral mucosa. The glipizide orally disintegrating tablet prepared by adopting the preparation method disclosed by the invention is uniform, meanwhile, the production cost is low, and thus large-scale production can be realized.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a glipizide orally disintegrating tablet and a preparation method thereof. Background technique [0002] Glipizide is a second-generation sulfonylurea antidiabetic drug. It is effective for most patients with type II diabetes, and can reduce fasting and postprandial blood sugar. Hypoglycemic drugs are required to be taken before meals. In order to facilitate patients to take the drugs on time under various circumstances, orally disintegrating tablets are an ideal dosage form. Orally disintegrating tablet refers to a tablet that disintegrates or dissolves rapidly in the oral cavity without the need for water. —Generally suitable for small doses of raw materials, often used for patients who have difficulty swallowing or who do not cooperate with medication. [0003] The existing preparation methods of orally disintegrating tablets include: direct powder compression ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/64A61K47/04A61K47/26A61K47/38A61K47/32A61K47/36A61P3/10
CPCA61K9/2009A61K9/0056A61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K9/2077A61K9/2095A61K31/64
Inventor 胡瀚陈用芳杨绪凤赵伟淑胡孝琼张蕾
Owner CHONGQING CONQUER PHARML
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