Osmotic pump type controlled release preparation of tolterodine

A technology of controlled release preparation and osmotic pump, which is applied in the direction of pill delivery, etc., can solve the problems of high difficulty in developing osmotic pump tablets, small therapeutic dose, poor solubility, etc., and achieves the effect of reducing the number of times of medication, improving curative effect, and reducing side effects.

Inactive Publication Date: 2006-09-06
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The therapeutic dose of tolterodine is small, and the release rate needs to be strictly controlled. It is suitable for making osmotic pump tablets. At the same time, its small dose and poor solubility make the development of osmotic pump tablets difficult.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Chip composition:

[0019] Tolterodine 4%

[0020] Sodium Chloride 45.5%

[0021] Gum Arabic 50%

[0022] Magnesium Stearate 0.5%

[0023] Coating composition:

[0024] Cellulose acetate 85%

[0025] Polyethylene Glycol-400 15%

[0026] Solvent composition for dissolving coating material:

[0027] Acetone 90%

[0028] Absolute Ethanol 10%

[0029] The above are expressed by weight percentage, the same below.

[0030] The tablet core is made by the method known in the pharmaceutical industry, and tolterol is customized into a single-layer osmotic pump tablet with film coating technology, and laser drilling or mechanical drilling is performed on one or both sides of the tablet to achieve controlled release. Purpose.

Embodiment 2

[0032] Chip composition:

[0033] Tolterodine 4%

[0034] Gum Arabic 95.5%

[0035] Magnesium Stearate 0.5%

[0036] Coating composition:

[0037] Cellulose acetate 70%

[0038] Polyethylene Glycol-400 30%

[0039] Solvent composition for dissolving coating material:

[0040] Acetone 100%

[0041] The tablet core is made by the method known in the pharmaceutical industry, and tolterol is customized into a single-layer osmotic pump tablet with film coating technology, and laser drilling or mechanical drilling is performed on one or both sides of the tablet to achieve controlled release. Purpose.

Embodiment 3

[0043] Chip composition:

[0044] Tolterodine 2%

[0045] Lactose 57.5%

[0046] Polyoxyethylene 40%

[0047] Magnesium Stearate 0.5%

[0048] Coating composition:

[0049] Ethyl Cellulose 75%

[0050] Hypromellose 15%

[0051] Triethyl Citrate 10%

[0052] Solvent composition for dissolving coating material:

[0053] Ethanol 50%

[0054] Dichloromethane 50%

[0055]The tablet core is made by the method known in the pharmaceutical industry, and the toterol is customized into a single-layer osmotic pump tablet by film coating technology, and the surface of the tablet is laser-drilled or mechanically drilled on one or both sides, with a pore size of 0.2 ~1.2 mm, the purpose of controlled release can be achieved.

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PUM

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Abstract

This invention supplies a Totelode osmosis pump type controlled release formulation, whose constitutes weight percentages are: Totelode 0.5-10.0 percent, findings for controlling release 80.0-99.0 percent and other findings. The type of this invention is osmosis pump troche. Findings for controlling release are separated to controlled release film material and controlled release osmotic pressure active compounds; the other findings contain bond, lubricant and thin film materials that usually used in troche preparation. This Totelode osmosis pump troche can keep effective medicine concentration for a day, advance curative effect and decrease side effect, and its release assumes zeroth-order characteristic in certain period. It is convenient to eat and taking, and it can cut down medicine-taking times. It can used broadly to cure urination frequent, urination urgent, precipitant urine incontinence, and so on caused by bladder pubovesical muscle excess excitation.

Description

technical field [0001] The invention belongs to a pharmaceutical preparation, which relates to a new generation of muscarinic receptor antagonists, which can selectively act on bladder muscarinic receptors, and is used for treating frequent urination, urgency and urgency caused by excessive excitability of the detrusor muscle of the bladder Urinary incontinence, specifically a tolterodine osmotic pump type controlled release preparation. Background technique [0002] Existing common oral preparations of tolterodine have large blood concentration fluctuations, obvious side effects such as dry mouth, and are eliminated rapidly in the body, requiring frequent medication, which is unfavorable for clinical treatment; although the blood concentration fluctuations of its sustained-release tablets are improved after taking, Side effects such as dry mouth are still more obvious, this is because the release of sustained-release tablets belongs to non-zero order release. Osmotic pump-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K9/20
Inventor 王华李士敏吴筱丹梁文权
Owner ZHEJIANG UNIV
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