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Paroxetine hydrochloride osmotic pump type enteric controlled release tablet

A technology of paroxetine hydrochloride and osmotic pump, which is applied in the directions of non-active ingredients medical preparations, pill delivery, organic active ingredients, etc., can solve the problems of aging and the decline of release performance.

Inactive Publication Date: 2012-09-19
内蒙古天衡医院管理有限公司
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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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  • Paroxetine hydrochloride osmotic pump type enteric controlled release tablet
  • Paroxetine hydrochloride osmotic pump type enteric controlled release tablet
  • Paroxetine hydrochloride osmotic pump type enteric controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] 1. Prescription

[0074] 1. Tablet core prescription (based on 1000 tablets, specification: 25mg, based on paroxetine):

[0075] Drug-containing layer:

[0076]

[0077] Boost layer:

[0078]

[0079] 2. Prescription of semi-permeable membrane coating solution

[0080]

[0081]

[0082] 2. Detailed preparation process

[0083] 1. Preparation process of paroxetine hydrochloride tablet core:

[0084] The tablet core is a double-layer tablet, one layer is a drug-containing layer, and the other layer is a booster layer.

[0085] The preparation process is as follows:

[0086] Drug-containing layer:

[0087] (1) Paroxetine hydrochloride is passed through a 100-mesh sieve, sodium lauryl sulfate is crushed through a 100-mesh sieve, and sodium chloride and sucrose are crushed through a 80-mesh sieve;

[0088] (2) Paroxetine hydrochloride, sucrose, sodium chloride, sodium lauryl sulfate, sodium carboxymethylcellulose, povidone K30 of prescription quantity are ...

Embodiment 2

[0125] 1. Prescription

[0126] 1. Tablet core prescription: same as Example 1

[0127] 2. Prescription of semi-permeable membrane coating solution:

[0128]

[0129] 2. Detailed preparation process

[0130] 1. Preparation process of paroxetine hydrochloride tablet core: same as Example 1

[0131] 2. Preparation process of semi-permeable membrane coating solution

[0132] Weigh the prescribed amount of povidone K30 and ethyl cellulose (N-100), add to ethanol and stir to dissolve completely, to obtain.

[0133] 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.

[0134] The coating weight gain was 10.0% and 12.0%, respectively.

[0135] 4, heat treatment: with embodiment 1

[0136] 5. Laser drilling: same as Example 1

[0137] 3. Release and content determination results

[0138] Release measurement method: wit...

Embodiment 3

[0150] 1. Prescription

[0151] 1. Tablet core prescription: same as Example 1

[0152] 2. Prescription of semi-permeable membrane coating solution

[0153]

[0154] 2. Detailed preparation process

[0155] 1. Preparation process of paroxetine hydrochloride tablet core: same as 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 gains were 12.0%, 14.0%, respectively.

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

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

[0162] 3. Release and content test and results

[0163] Release measurement method: with embo...

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Abstract

The invention provides a novel paroxetine hydrochloride osmotic pump type enteric controlled release tablet. In an osmotic pump type enteric controlled release tablet in an enteric coating, ethyl cellulose and polyvinylpyrrolidone are used as semipermeable membrane formation material, an asymmetric tablet type is preferable, the ageing phenomenon of the semipermeable membrane can be overcome, and the medicine residue is lowered. The invention also provides a method for improving the anti-ageing performance of the paroxetine hydrochloride osmotic pump type enteric controlled release tablet. The method is characterized in that the ethyl cellulose-polyvinylpyrrolidone is adopted to serve as the semipermeable membrane material. In addition, the invention also provides an application of the ethyl cellulose-polyvinylpyrrolidone composite to prepare the paroxetine hydrochloride osmotic pump type enteric controlled release tablet with the anti-ageing performance.

Description

technical field [0001] The invention relates to a paroxetine hydrochloride osmotic pump-type enteric-coated controlled-release tablet, which belongs to the field of pharmaceutical preparations. Background technique [0002] Paroxetine hydrochloride is a selective central nervous system serotonin reuptake inhibitor for the treatment of depression, obsessive-compulsive disorder, panic disorder or social anxiety disorder. [0003] The earliest common preparation of this product on the market has serious adverse reactions in the gastrointestinal tract and poor compliance. Therefore, an enteric-coated sustained-release preparation that is taken once a day has been launched abroad. [0004] Because paroxetine hydrochloride sustained-release preparation is a non-constant release drug, the release and absorption rate of the drug are also affected by factors such as the gastrointestinal fluid in the patient's body, so its blood drug concentration still fluctuates greatly, which is d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/32A61K9/36A61K31/4525A61K47/38A61P25/00A61P25/22A61P25/24
Inventor 姜庆伟刘全志狄媛吕玉珠马春辉衣伟锋梁希姜静孙琪杨勇
Owner 内蒙古天衡医院管理有限公司
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