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Release controlled Tuoteluoding Tartrate and its preparing process

A technology of tolterodine tartrate and tartaric acid, which is applied in the field of controlled-release preparations of tolterodine tartrate and its preparation, can solve the problems of uncontrollable drug release, easy blockage of membrane pores, unfavorable drug release, etc., and achieve a release surface rate Easy to control, simple process, simple and feasible operation

Inactive Publication Date: 2002-10-09
NANJING MEIRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Membrane-controlled sustained-release preparations rely on the membrane to control the release rate. Because chyme is easy to block the membrane pores, it is not conducive to the release of drugs after water infiltration, and the thickness of the membrane and the size of the membrane pores also affect the release of drugs.
In addition, Pharmacia and Upjohn's controlled-release preparations use membrane-controlled spheres, which have a large surface area and are not easy to control the release of drugs.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] The controlled-release formulation of tolterodine tartrate contains the following substances per 1000 tablets:

[0053] Tolterodine Tartrate 4g

[0054] Mannitol 20g

[0055] Hypromellose (K4MCR) 30g

[0056] Dextrin 80g

[0057] PVP 40g

[0058] Magnesium Stearate 2g

[0059] For the preparation of the adhesive, accurately weigh the PVP, prepare a solution with 95% ethanol, and set aside.

[0060] Core preparation

[0061] Take tolterodine tartrate, mannitol, hypromellose microcells, and dextrin and pass through a 80-mesh sieve to fully mix, add an appropriate amount of PVP, and make a soft material with moderate dryness and wetness as usual, pass through a 20-mesh sieve, and granulate. Dry at 50°C for 30-40 minutes, granulate into 20 meshes, add magnesium stearate, mix well, and press into tablets.

[0062] Take the above-mentioned plain tablets and put them in a sugar-coating pot, the pot speed is 10-20 rpm, the temperature in the pot is 40-50°C, spray the coa...

Embodiment 2

[0066] The controlled-release formulation of tolterodine tartrate contains the following substances per 1000 tablets:

[0067] Tolterodine Tartrate 4g

[0068] Mannitol 40g

[0069] Hypromellose (K4MCR) 40g

[0070] Dextrin 100g

[0071] PVP 40g

[0072] Magnesium Stearate 2.3g

[0073] According to the above prescription, take tolterodine tartrate, mix well with mannitol, hypromellose, dextrin, etc., pass through a 80-mesh sieve, add PVP to make a soft material with moderate dryness and wetness, granulate with a 20-mesh sieve, 50 Dry at ℃ for 30-40 minutes, granulate into 20 meshes, add magnesium stearate and mix thoroughly, compress into tablets and coat.

[0074] The release range of the controlled-release formulation release of tolterodine tartrate is 20-50% of the labeled amount in 2 hours, i.e. 0.8-2 mg; the released drug amount is 45-75% of the labeled amount in 6 hours, That is, 1.8-3 mg; the amount of drug released within 8 hours is greater than 75% of the marke...

Embodiment 3

[0076] The controlled-release formulation of tolterodine tartrate contains the following substances per 1000 tablets:

[0077] Tolterodine Tartrate 4g

[0078] Mannitol 80g

[0079] Hypromellose Micron 80g

[0080] Dextrin 100g

[0081] PVP 300g

[0082] Magnesium Stearate 3.6g

[0083] According to the above prescription, take tolterodine tartrate, mannitol, hypromellose (K4MCR), PVP, and dextrin, mix thoroughly, pass through an 80-mesh sieve, add PVP, and make a soft material with moderate dryness and wetness, and use a 20-mesh sieve Granulate, dry at 50°C for 30-40 minutes, granulate into 20 meshes, add magnesium stearate, mix thoroughly, compress into tablets, and coat.

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PUM

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Abstract

A release-controlled Tuoteluoding tartrate for treating vesical disease is prepared from Tuoteluoding tartrate, C3-C20 aliphatic carboxylic acid or glycol, cellulose and its derivative, dextrin and polyvidone through mixing and granulating or tabletting. Its advantages are effective release control within 24 hr, simple preparing process and low cost.

Description

field of invention [0001] The invention relates to a preparation and a preparation method thereof for reducing daily taking times, reducing side effects, and controlling drug release, in particular to a tolterodine tartrate slow-controlled release preparation that patients only need to take once a day and a preparation method thereof. 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, Swedish Pharmacia and Upjohn have developed a controlled-release drug formulation of tolterodine tartrate. In addition to the drug compound tolterodine, the formulation of this patent application is mainly c...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/52A61K31/135A61P13/10
Inventor 曹德善刘正和
Owner NANJING MEIRUI PHARMA CO LTD
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