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Doxofyline osmotic pump controlled releasing preparation and its production

A technology of doxofylline and controlled-release preparations, applied in the field of medicine, can solve the problems of large dosage and no sustained-release preparations, etc., and achieve the effects of stable blood drug concentration, reducing toxic and side effects, and reducing peak-to-valley phenomenon.

Inactive Publication Date: 2004-12-08
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It was first listed in Italy in 1988, and it has been successfully developed in China. There are several pharmaceutical factories producing it, but clinical application shows that there are obvious individual differences in its dose, blood concentration and drug effect, and the dosage is relatively large, and there is no delay. The advent of controlled release formulations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Tablet core preparation: respectively pulverize the drug, diluent and penetration enhancer, sieve, mix evenly, granulate the drug-containing layer powder with acetone / isopropanol (1:1) 16-mesh sieve, dry at room temperature for 24 hours, and granulate with 12 For granulation, add an appropriate amount of lubricant and press it into a loose tablet with a small pressure, then mix the push-pull layer powder and fill it directly, and press it into a double-layer tablet with an appropriate pressure, that is, 1000 tablet cores.

[0062] 12-hour controlled release tablet coating solution

24-hour controlled release tablet coating solution

CA (2% acetone solution) 80mL

PEG6000 (2% acetone / chloroform 1:4 solution) 20mL

Coating film thickness 0.13~0.14mm

CA (2% acetone solution) 90mL

PEG6000 (2% acetone / chloroform 1:4 solution) 10mL

Coating film thickness 0.16~0.17mm

[0063] (The concentrations of CA and PEG6000 in the table are bo...

Embodiment 2

[0067] Tablet core preparation: same as Example 1.

[0068] Coating liquid prescription: with embodiment 1.

[0069] Coating process: with embodiment 1.

Embodiment 3

[0072] Tablet core preparation: same as Example 1.

[0073] Coating liquid prescription: with embodiment 1.

[0074] Coating process: with embodiment 1.

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PUM

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Abstract

An osmotic pump type release controlled doxofylline tablet is composed of the core consisting of the medicine layer prepared from doxofylline, osmosis-promoting polymer, osmosis promoter, diluent and lubricant and the push-pull layer prepared from osmosis promoter, coloring agent and lubricant, and the coated layer prepared from cellulose acetate, polyethanediol and acetone or chloroform. Its preparing process is also disclosed. Its advantages are long release controlling time (12-24 hr), and low by-effect.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a new drug dosage form of doxofylline-doxofylline osmotic pump type controlled-release preparation and a preparation method thereof. Background technique: [0002] Doxofylline is a new type of theophylline anti-asthma drug developed in recent years. It is used as a phosphodiesterase inhibitor to treat chronic obstructive pulmonary disease with bronchial asthma combined with bronchospasm. The drug is slightly soluble in water and can be quickly absorbed into the blood and tissues. Compared with theophylline, it has the remarkable characteristics of low toxicity and high activity. It was first listed in Italy in 1988, and has been successfully developed in China. There are several pharmaceutical factories producing it, but clinical application shows that there are obvious individual differences in its dosage, blood drug concentration and drug effect. Controlled-release formulati...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/522A61P11/00A61P11/06
Inventor 何仲贵郭晓蕾唐星潘卫三
Owner SHENYANG PHARMA UNIVERSITY
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