Eureka AIR delivers breakthrough ideas for toughest innovation challenges, trusted by R&D personnel around the world.

Oral compound preparation of enteric-coated metformin tablet coated by vitamin B layer, and preparation method thereof

A technology of enteral and compound preparations of metformin, which is applied to the delivery of medical preparations, coatings, and pills containing active ingredients, and can solve adverse gastrointestinal irritation, reduced drug concentration and bioavailability, and inability to escape enzyme barriers, etc. problems, to achieve the effect of improving drug concentration and bioavailability, reducing drug quantity, and increasing stability

Active Publication Date: 2018-05-01
BEIJING XINDE RUNXING TECH CO LTD
View PDF3 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If administered according to the above three regimens, metformin hydrochloride will be released in the upper gastrointestinal tract after oral administration, but will not be released in the small intestine, and will be enzymatically hydrolyzed in the stomach, unable to escape the enzyme barrier; in addition, vitamin B12 and metformin hydrochloride The two active ingredients are absorbed at the same time, metformin will inhibit the absorption of VB12, and new substances may be generated under acidic pH and pepsin conditions, which will lead to a decrease in local drug concentration and bioavailability
At the same time, metformin hydrochloride also produces adverse stimulation to the gastrointestinal tract.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Oral compound preparation of enteric-coated metformin tablet coated by vitamin B layer, and preparation method thereof
  • Oral compound preparation of enteric-coated metformin tablet coated by vitamin B layer, and preparation method thereof
  • Oral compound preparation of enteric-coated metformin tablet coated by vitamin B layer, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0062] Specifically, the third technical solution of the present invention provides a method for preparing an oral compound preparation, the oral compound preparation is metformin enteric-coated tablets coated with a vitamin B layer, and the vitamin B and metformin are separated step by step at different digestive sites release, the preparation method comprises the following steps:

[0063] First, the metformin tablet core is compressed, and then the metformin tablet core is coated with an isolation coat layer and an enteric coating layer in sequence to obtain a metformin enteric-coated tablet; then, a vitamin B layer is coated on the metformin enteric-coated tablet to obtain an oral compound preparation;

[0064] Wherein the raw material of the metformin tablet core comprises metformin, binding agent, disintegrating agent, filler, lubricant; The raw material of described isolation coat layer comprises hypromellose and lubricant; The raw material of described enteric coating la...

preparation example 1

[0099] 1. General formula of compound medicine

[0100]

[0101] 2. Process flow

[0102] First, the metformin tablet core is compressed, and then the metformin tablet core is coated with an isolation coat layer and an enteric coating layer in sequence to obtain the metformin enteric-coated tablet; then, the metformin enteric-coated tablet is coated with a vitamin B layer to obtain an oral compound preparation.

[0103] 2.1 Preparation of metformin tablet core

[0104] 1) Metformin Tablet Core Formula

[0105] The weight of the tablet is 350mg, and each tablet contains 250mg of metformin. The experimental batch is 200,000 pieces (ie 70kg).

[0106]

[0107] 2) Tablet pressing process and operation

[0108] ① Weighing samples: Weigh each material (except magnesium stearate and micropowder silica gel) according to the proportion. If the material is agglomerated, it needs to pass through a 60-mesh sieve;

[0109] ② Mixing: Mix the above ① materials in a high-speed mixi...

preparation example 2

[0153] The formula and steps from step 2.1 to step 2.3, and the coating process in step 2.4 are the same as those in Preparation Example 1. It's just that the coating does not only contain VB12, but contains VB12 and VB7.

[0154] 2.4 package VB12+VB7 layer

[0155] 1) Formula of VB12+VB7 layer coating solution

[0156] Each metformin tablet should contain 26.5 μg (±5%) of VB12 and 26.5 μg (±5%) of VB7. Because the drug will be lost, the VB12+VB7 layer should be 1.1 times the amount of the following formula, and VB12 and VB7 Raw materials need to be protected from light operation and storage.

[0157]

[0158] 2) Prepare VB12+VB7 layer solution

[0159] The steps are the same as 2) in 2.4, except that VB12+VB7 is added in ②.

[0160] 3. Intermediate control point

[0161] Granule preparation: moisture content of granules (requirement: LOD<3%) and metformin content in granules (requirement: 250mg±5%).

[0162] Tablet compression: monitor actual tablet weight (requireme...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Sheet weightaaaaaaaaaa
Hardnessaaaaaaaaaa
Login to View More

Abstract

The invention relates to a preparation method for an oral compound preparation that is released step by step in different digestive parts of the body, specifically to an oral compound preparation of an enteric-coated metformin tablet coated by a vitamin B layer, and a preparation method thereof.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation method of an oral compound preparation that is gradually released in different digestive parts in the body, in particular to an oral compound preparation of metformin enteric-coated tablets coated with a vitamin B layer and a preparation method thereof. Background technique [0002] Diabetes is a common disease with increasing incidence worldwide in recent years. Drugs commonly used to treat this condition include metformin (primarily known for its antihyperglycemic activity), and metformin hydrochloride (widely used in non-insulin-dependent diabetes). Metformin hydrochloride is widely used clinically and is cheap. It can be produced by many domestic pharmaceutical units and has no patent restrictions. It is currently the most widely used hypoglycemic drug in clinical practice. [0003] Aplastic anemia is a disease with pancytopenia as the main cl...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/36A61K31/714A61K31/155A61P3/10
CPCA61K9/2826A61K9/284A61K9/2866A61K31/155A61K31/714A61K2300/00
Inventor 金拓冯佳吴飞
Owner BEIJING XINDE RUNXING TECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com