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Tamsulosin hydrochloride osmotic pump controlled-release tablet

A technology of tamsulosin hydrochloride and osmotic pump, which is applied in pill delivery, urinary system diseases, pharmaceutical formulations, etc., and can solve problems such as release performance decline and aging

Inactive Publication Date: 2012-09-19
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Osmotic pump-type controlled-release tablets made of currently commonly used semi-permeable membrane materials, such as cellulose acetate + polyethylene glycol, ethyl cellulose + polyethylene glycol, have good release performance within a period of time just after preparation , but after storage for a period of time, its release performance begins to decline, the longer the storage time, the more obvious the decline, often in the second half of the drug's specified validity period, the release performance declines significantly, the popular saying is aging

Method used

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  • Tamsulosin hydrochloride osmotic pump controlled-release tablet
  • Tamsulosin hydrochloride osmotic pump controlled-release tablet
  • Tamsulosin hydrochloride osmotic pump controlled-release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] 1. Prescription

[0066] 1. Tablet core prescription (1000 tablets):

[0067] Drug-containing layer:

[0068]

[0069] Boost layer:

[0070]

[0071]

[0072] 2. Prescription of semi-permeable membrane coating solution

[0073]

[0074] 3. Prescription of film coating solution

[0075] composition

Dosage

Gastric-soluble coating powder

10g

water

100ml

[0076] 2. Detailed preparation process

[0077] 1. Preparation process of tamsulosin hydrochloride tablet core:

[0078] The tablet core is a double-layer tablet, one layer is a drug-containing layer, and the other layer is a booster layer.

[0079] The preparation process is as follows:

[0080] Drug-containing layer:

[0081] (1) Tamsulosin hydrochloride is crushed through a 100-mesh sieve, sodium lauryl sulfate is crushed through a 100-mesh sieve, and sucrose and sodium chloride are crushed through a 80-mesh sieve;

[0082] (2) Take by weighing tamsulosi...

Embodiment 2

[0121] 1. Prescription

[0122] 1. Tablet core prescription: same as Example 1

[0123] 2. Prescription of semi-permeable membrane coating solution:

[0124]

[0125] 3. Prescription of film coating solution: same as Example 1

[0126] 2. Detailed preparation process

[0127] 1. Preparation process of tamsulosin hydrochloride tablet core:

[0128] Same as Example 1

[0129] 2. Preparation process of semi-permeable membrane coating solution

[0130] Weigh the prescribed amount of povidone K30 and ethyl cellulose (N-100), add to ethanol and stir to dissolve completely, to obtain.

[0131] 3. Semi-permeable membrane coating: put the tablet core in a multi-functional coating machine for coating, take a small amount of tablets regularly and weigh them, and calculate the weight gain of the coating.

[0132] The coating weight gain was 10.0% and 12.0%, respectively.

[0133] 4. heat treatment: with embodiment 1

[0134] 5. Laser drilling: same as embodiment 1

[0135] 6. ...

Embodiment 3

[0149] 1. Prescription

[0150] 1. Tablet core prescription: same as Example 1

[0151] 2. Prescription of semi-permeable membrane coating solution

[0152]

[0153] 3. Prescription of film coating solution: same as Example 1

[0154] 2. Detailed preparation process

[0155] 1. Preparation process of tamsulosin hydrochloride tablet core: same as in Example 1

[0156] 2. Preparation process of semi-permeable membrane coating solution

[0157] Weigh the prescribed amount of povidone K30 and ethyl cellulose (N-100), add to ethanol and stir to dissolve completely, to obtain.

[0158] 3. Semi-permeable membrane coating: put the tablet core in a multi-functional coating machine for coating, take a small amount of tablets regularly and weigh them, and calculate the weight gain of the coating.

[0159] Coating weight gain was 12.0%, 15.0%, respectively.

[0160] 4, heat treatment: with embodiment 1.

[0161] 5. Laser drilling: same as embodiment 1.

[0162] 6. Preparation p...

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Abstract

The invention provides a novel tamsulosin hydrochloride osmotic pump controlled-release tablet. Ethyl cellulose and povidone are used as membrane forming materials of a semipermeable membrane, and the asymmetric tablet form is preferably selected, so that the ageing of the semipermeable membrane can be avoided, and the drug residues can be reduced. The invention also provides a method for improving the ageing resistance of the tamsulosin hydrochloride osmotic pump controlled-release tablet, wherein the method is characterized in that the ethyl cellulose-povidone are used as the membrane forming materials of the semipermeable membrane. In addition, the invention also provides applications of the ethyl cellulose-povidone composition in preparing the anti-ageing tamsulosin hydrochloride osmotic pump controlled-release tablet.

Description

technical field [0001] The invention relates to a tamsulosin hydrochloride osmotic pump-type controlled-release tablet, which uses ethyl cellulose-povidone as a semipermeable membrane material and belongs to the field of pharmaceutical preparations. Background technique [0002] Tamsulosin hydrochloride is selective alpha 1A Beta-blockers for the treatment of dysuria associated with benign prostatic hyperplasia. The earliest release of this product was ordinary sustained-release capsules taken once a day, which had serious cardiovascular adverse reactions and poor compliance. Therefore, foreign countries have launched a matrix sustained-release tablet that is taken once a day. [0003] Because tamsulosin hydrochloride sustained-release preparation is a non-constant release drug, the release and absorption rate of the drug is also affected by factors such as the gastrointestinal fluid in the patient's body, so its blood drug concentration still fluctuates greatly, which is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/36A61K31/18A61K47/38A61P13/08
Inventor 姜庆伟刘全志狄媛吕玉珠唐亚坤杨敏衣伟锋梁希葛振中姜静杨勇
Owner 北京天衡药物研究院有限公司
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