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A kind of oxybutynin hydrochloride osmotic pump controlled-release tablet and preparation method thereof

A technology of oxybutynin hydrochloride and osmotic pump controlled release, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Obvious differences and other issues to achieve the effect of ensuring stability

Active Publication Date: 2016-06-08
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the sustained-release preparations with this skeleton structure are greatly affected by external environmental factors in the human body, especially the peristaltic rate of the gastrointestinal tract, and individual differences are obvious.

Method used

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  • A kind of oxybutynin hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of oxybutynin hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • A kind of oxybutynin hydrochloride osmotic pump controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0082] The tablet core is composed of: 5g oxybutynin hydrochloride, 11g sodium chloride, 11g lactose, 124g polyoxyethylene (molecular weight: 100000), 6g hypromellose, 1.0g magnesium stearate;

[0083] The composition of the semipermeable film coating layer with drug release channels is: 96g cellulose acetate, 4g polyethylene glycol 6000;

[0084] The moisture-proof clothing layer is: Opadry 295W680000.

[0085] Preparation method:

[0086]Compression of single-layer tablet core: Weigh oxybutynin hydrochloride, polyoxyethylene (molecular weight: 100,000), hypromellose, sodium chloride, and lactose in the formula, pass through 80-mesh sieve, mix evenly, and 90% The soft material is prepared from ethanol solution, sieved and granulated, dried at 40-50°C, sieved and granulated, added with the prescribed amount of magnesium stearate, mixed evenly, pressed into tablets, and the drug tablet core is obtained, ready for use;

[0087] Coating layer with semi-permeable membrane: Disso...

Embodiment 2

[0091] The tablet core is composed of: 5.5g oxybutynin hydrochloride, 11g sodium chloride, 11g lactose, 124g polyoxyethylene (molecular weight: 100000), 6g hypromellose, 1.0g magnesium stearate;

[0092] The composition of the semi-permeable film coating layer with drug release channels is: 96g cellulose acetate, 4g polyethylene glycol 6000;

[0093] The moisture-proof clothing layer is: Opadry 295W680000.

[0094] Preparation method:

[0095] Compression of single-layer tablet cores: Weigh oxybutynin hydrochloride, polyoxyethylene, hypromellose, sodium chloride, and lactose in the prescribed amount, pass through 80 mesh sieves, mix evenly, and make a soft material with 90% ethanol solution , sieve and granulate, dry at 40-50°C, sieve and granulate, add the prescribed amount of magnesium stearate, mix evenly, and press into tablets to obtain drug tablet cores for future use;

[0096] Coating layer with semi-permeable membrane: Dissolve the formulated amount of cellulose acet...

Embodiment 3

[0100] The tablet core is composed of: 5.5g oxybutynin hydrochloride, 16g sodium chloride, 16g lactose, 121.5g polyoxyethylene (molecular weight: 100000), 0.8g magnesium stearate;

[0101] The composition of the semi-permeable film coating layer with drug release channels is: 96g cellulose acetate, 4g polyethylene glycol 6000;

[0102] The moisture-proof clothing layer is: Opadry 295W680000.

[0103] Preparation method:

[0104] Compression of single-layer tablet core: Weigh oxybutynin hydrochloride, polyoxyethylene (molecular weight: 100,000), hypromellose, sodium chloride, and lactose in the formula, pass through 80-mesh sieve, mix evenly, and 90% The soft material is prepared from ethanol solution, sieved and granulated, dried at 40-50°C, sieved and granulated, added with the prescribed amount of magnesium stearate, mixed evenly, pressed into tablets, and the drug tablet core is obtained, ready for use;

[0105] Coating layer with semi-permeable membrane: Dissolve the for...

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Abstract

The invention provides oxybutynin hydrochloride osmotic pump controlled release tablets and a preparation method thereof. The controlled release tablets are stable in drug release speed in release media of different pH values, and the oxybutynin hydrochloride osmotic pump controlled release tablets are released in a gastrointestinal environment at a basically constant rate, so that the blood concentration of oxybutynin hydrochloride is constantly maintained in an effective concentration range for a long time, a peak valley phenomenon is avoided, the toxic and side effects are reduced, and the bioavailability can be improved.

Description

technical field [0001] The present invention relates to the field of pharmaceutical preparations, in particular to an osmotic pump drug delivery preparation containing the active drug oxybutynin hydrochloride and a preparation method thereof, which can release the drug at a constant rate after entering the gastrointestinal tract, reducing the Side effects, reduce the frequency of administration, and increase patient compliance. Background technique [0002] Oxybutynin hydrochloride (oxybutyninchloride, chemical name: α-cyclohexyl-α-hydroxy-phenylacetic acid-4-diethylamino-2-butynyl hydrochloride), is an antispasmodic drug, used for the treatment of Overactive bladder (OAB) with symptoms such as urgency (urgent) urinary incontinence, urgency, and frequency. Oxybutynin hydrochloride has a direct antispasmodic effect on smooth muscle and can inhibit the muscarinic effect of acetylcholine on smooth muscle. Oxybutynin hydrochloride can selectively act on the detrusor muscle of ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/216A61K47/02A61K47/26A61K47/38A61K47/34A61P13/00A61P13/10
Inventor 吴宗好汪贻华何勇李春妮王德海
Owner HEFEI HUAFANG PHARMA SCI & TECH
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