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Slow released tolterodine tartrate microcapsule and its prepn process

A technology of tolterol tartrate and sustained-release pellets, which is applied in the fields of pharmaceutical formulation, drug delivery, urinary system diseases, etc., can solve the problems of complicated process and sustained-release tablets, and achieve simple process, short production cycle and good economic benefits Effect

Inactive Publication Date: 2007-03-21
珠海天翼医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved in the present invention is to study the formulation and process of using domestically produced auxiliary materials to prepare sustained-release pellets of tolterodine tartrate, so that it not only retains the advantages of the pellets, but also overcomes the shortcomings of complex processes in the CN1287484A patent and patents. Defects in sustained-release tablets in 021125120

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1 Every 1000 tolterodine tartrate sustained-release pellet capsules contain the following materials:

[0018] Tolterodine Tartrate 4g

[0019] Sucrose 20g

[0020] Hypromellose (E5) 30g

[0021] Starch 80g

[0022] Acrylic resin (EUDRAGIT RS) 40g

[0023] Microcrystalline Cellulose 20g

[0024] For the preparation of the adhesive, accurately weigh hypromellose (E5), prepare a solution with water, and set aside.

[0025] Preparation of Micropills Take tolterodine tartrate, sucrose, starch, and acrylic resin through an 80-mesh sieve and mix thoroughly, add an appropriate amount of hypromellose (E5) solution, and make a soft material with moderate dryness and wetness according to routine. Extrusion-spheronization to make pellets.

[0026] The release range of the sustained-release pellets of tolterodine tartrate is 5-20% of the labeled amount released within 1 hour; 40-70% of the labeled amount released within 3 hours; released within 7 hours The dose is ...

Embodiment 2

[0027] Embodiment 2: the controlled-release formulation of every 1000 tolterodine tartrate contains the following substances:

[0028] Tolterodine Tartrate 4g

[0029] Sucrose 60g

[0030] Hypromellose (E5) 30g

[0031] Starch 20g

[0032] Acrylic resin (EUDRAGIT RS) 40g

[0033] Microcrystalline Cellulose 30g

[0034] The method of making is the same as above.

[0035] The release range of the sustained-release pellets of tolterodine tartrate is 5-20% of the labeled amount released within 1 hour; 40-70% of the labeled amount released within 3 hours; released within 7 hours The dose is greater than 75% of the labeled amount.

Embodiment 3

[0036] Embodiment 3: the controlled-release formulation of every 1000 tolterodine tartrate contains the following substances:

[0037] Tolterodine Tartrate 4g

[0038] Sucrose 55g

[0039] Hypromellose (E5) 30g

[0040] Starch 20g

[0041] Acrylic resin (EUDRAGIT RS) 25g

[0042] Microcrystalline Cellulose 30g

[0043] Stearic acid 10g

[0044] The method of making is the same as above.

[0045] The release range of the sustained-release pellets of tolterodine tartrate is 5-20% of the labeled amount released within 1 hour; 40-70% of the labeled amount released within 3 hours; released within 7 hours The dose is greater than 75% of the labeled amount.

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PUM

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Abstract

The slow released tolterodine tartate microcapsule preparation with homogeneous medicine release is one kind of slow release capsule with slow released microcapsule as main component, and the slow released microcapsule contains tolterodine tartate as the active component, slow releasing material and medicinal supplementary material in the weight ratio of 1-5 to 1-30 to 100-380. The preparation process of the slow released microcapsule includes the steps of mixing the main medicine component and the supplementary material, preparing the mixture into soft material, extruding and rounding. The slow released preparation can prolong the in vivo residence time of medicine, control the release of medicine, reduce medicine -taking times, lower the toxic side effect and raise curative effect.

Description

field of invention [0001] The invention relates to a micropill for reducing the number of daily doses, reducing side effects, and controlling drug release and a preparation method thereof, specifically referring to the tolterodine tartrate sustained-release micropill preparation and its preparation that patients only need to take once a day method. Background of the invention [0002] Tolterodine tartrate is a modified muscarinic receptor antagonist, which is a drug with good efficacy in the treatment of unstable or overactive bladder. Common tablets of tolterodine tartrate are commercially available. Common tablets of tolterodine tartrate need to be taken twice a day, and its side effects such as dry mouth are obvious. In order to alleviate the side effects of tolterodine tartrate, Sweden's Pharmacia and Upjohn have developed a sustained-release drug formulation of tolterodine tartrate. In addition to the drug compound tolterodine, the formula of this patent application ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/52A61P13/10
Inventor 张晓明
Owner 珠海天翼医药技术开发有限公司
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