Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Roflumilast tablet and preparation method thereof

A technology of roflumilast tablets and excipients, which is applied in the field of roflumilast tablets and its preparation, can solve problems such as poor content uniformity of tablets, and achieve high product yield, easy industrialization, The effect of simple preparation process

Inactive Publication Date: 2014-10-22
SHANDONG TAITIAN NEW MEDICINE DEV
View PDF4 Cites 6 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The hypromellose solution is a hydrophilic gel solution, and the raw drug roflumilast cannot be dissolved in it and can only be in a suspension state. The suspension solution is used as a binder, which may easily lead to poor content uniformity of the tablet

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
  • Roflumilast tablet and preparation method thereof
  • Roflumilast tablet and preparation method thereof
  • Roflumilast tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The roflumilast pharmaceutical composition described in every 100 tablets, its formula composition is as shown in table 1 and table 2:

[0041] Table 1

[0042] .

[0043] Table 2

[0044] .

[0045] Process operation:

[0046] (1) Dissolve the raw material drug with absolute ethanol to form a raw material drug solution;

[0047] (2) PVP-K90 is crushed through a 100-mesh sieve, starch, lactose, and pregelatinized starch are passed through a 80-mesh sieve, the above four excipients are mixed evenly, and the ethanol solution of the raw material drug is added to make granules, dried, and granulated;

[0048] (3) Add magnesium stearate, mix evenly, and test the intermediate;

[0049] (4) According to the test data of the intermediate, determine the weight of the tablet, press the tablet, and the hardness of the tablet is greater than 12N;

[0050] (5) Coat the film with water-soluble water-containing material, and control the weight gain of the film coat to 2.5-3....

Embodiment 2

[0052] The roflumilast pharmaceutical composition described in every 100, its formula composition is as shown in table 3 and table 4:

[0053] table 3

[0054] .

[0055] Table 4

[0056] .

[0057] Process operation:

[0058] (1) Dissolve the raw material drug with absolute ethanol to form a raw material drug solution;

[0059](2) PVP-K90 is crushed through a 100-mesh sieve, starch, lactose, and pregelatinized starch are passed through a 80-mesh sieve, the above four excipients are mixed evenly, and the ethanol solution of the raw material drug is added to make granules, dried, and granulated;

[0060] (3) Add magnesium stearate, mix evenly, and test the intermediate;

[0061] (4) According to the test data of the intermediate, determine the weight of the tablet, press the tablet, and the hardness of the tablet is greater than 12N;

[0062] (5) Coat the film with water-soluble water-containing material, and control the weight gain of the film coat to 2.5-3.5%.

Embodiment 3

[0064] The roflumilast pharmaceutical composition described in every 100 tablets, its formula composition is as shown in table 5 and table 6:

[0065] table 5

[0066] .

[0067] Table 6

[0068] .

[0069] Process operation:

[0070] (1) Dissolve the raw material drug with absolute ethanol to form a raw material drug solution;

[0071] (2) PVP-K90 is crushed through a 100-mesh sieve, starch, lactose, and pregelatinized starch are passed through a 80-mesh sieve, the above four excipients are mixed evenly, and the ethanol solution of the raw material drug is added to make granules, dried, and granulated;

[0072] (3) Add magnesium stearate, mix evenly, and test the intermediate;

[0073] (4) According to the test data of the intermediate, determine the weight of the tablet, press the tablet, and the hardness of the tablet is greater than 12N;

[0074] (5) Coat the film with water-soluble water-containing material, and control the weight gain of the film coat to 2.5-3....

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
Hardnessaaaaaaaaaa
Login to View More

Abstract

The invention discloses a roflumilast tablet and a preparation method thereof. The roflumilast tablet is composed of roflumilast, starch, pregelatinized starch, lactose, PVP-K90 and magnesium stearate. According to the preparation method, roflumilast is dissolved in anhydrous ethanol, so that the bulk drug is dispersed in an excipient in a solution form; and the release rate of the tablet in four media with different pH is regulated by specific proportions of the starch to the pregelatinized starch, so that the roflumilast tablet has good release curve and good content uniformity in the four media. The preparation method is simple and convenient in process; the bulk drug is in no need of micronization treatment; and the preparation method is in no need of special equipment, can be industrialized easily, is high in product yield, and has obvious advantages.

Description

Technical field [0001] The present invention involves the field of pharmaceutical preparation technology, especially a Robfluste agent and its preparation method. Background technique [0002] Chronic obstructive lung disease (COPD) is one of the main diseases that cause high incidence and mortality in the world. The incidence of incidence will be increased year by year. It is expected that by 2020, it will become the third largest common cause of death in the world.Among patients with medium -weight COPD, acute aggravation is often related to the decline in lung function, decline in quality of life, and rising mortality.Roblustel, Phosphodiese 4 Inhibitor, is the latest study that can be used as a new type of anti -inflammatory drugs that can be used in the target of intracellular.Gravity cells and hypertrophic cells.This medicine can specially act on a certain enzyme that participates in smooth muscle contraction, which can prevent CAMP degradation, thereby blocking the transmi...

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): A61K9/20A61K9/30A61K31/44A61K47/36A61P11/00
Inventor 窦春水汪海洋刘腾孙鹏齐瑗晶石秀娟
Owner SHANDONG TAITIAN NEW MEDICINE DEV
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap 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