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Pramipexole dihydrochloride osmotic pump type controlled release tablets

A technology of pramipexole hydrochloride and osmotic pump, which is applied in the field of pramipexole hydrochloride osmotic pump type controlled-release tablets, which can solve the problems of decreased release performance and aging

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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  • Pramipexole dihydrochloride osmotic pump type controlled release tablets
  • Pramipexole dihydrochloride osmotic pump type controlled release tablets
  • Pramipexole dihydrochloride osmotic pump type controlled release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] 1. Prescription

[0068] 1. Tablet core prescription (based on 1000 tablets, specification: 1.5mg):

[0069] Drug-containing layer:

[0070]

[0071] Boost layer:

[0072]

[0073]

[0074] 2. Prescription of semi-permeable membrane coating solution

[0075]

[0076] 3. Prescription of film coating solution

[0077] composition

Dosage

Gastric type coating powder

10g

water

100ml

[0078] 2. Detailed preparation process

[0079] 1. Preparation process of pramipexole hydrochloride tablet core:

[0080] The tablet core is a double-layer tablet, one layer is a drug-containing layer, and the other layer is a booster layer.

[0081] The preparation process is as follows:

[0082] Drug-containing layer:

[0083] (1) Pramipexole hydrochloride is crushed through a 100-mesh sieve, sodium lauryl sulfate is crushed through a 100-mesh sieve, and sodium chloride is crushed through an 80-mesh sieve;

[0084] (2) Take pra...

Embodiment 2

[0122] 1. Prescription

[0123] 1. Tablet core prescription: same as Example 1

[0124] 2. Prescription of semi-permeable membrane coating solution:

[0125]

[0126] 3. Prescription of film coating solution: same as Example 1

[0127] 2. Detailed preparation process

[0128] 1. Preparation process of pramipexole hydrochloride tablet core: same as in 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 12.0% and 14.0%, respectively.

[0133] 4, heat treatment: with embodiment 1

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

[0135] 6. Preparati...

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

[0155] 2. Detailed preparation process

[0156] 1. Preparation process of pramipexole hydrochloride tablet core: same as in Example 1

[0157] 2. Preparation process of semi-permeable membrane coating solution

[0158] Take by weighing povidone K30 and ethyl cellulose (N-100) of recipe quantity, add in ethanol and stir to dissolve completely, to obtain final product

[0159] 3. Coating with semi-permeable membrane: 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.

[0160] Coating weight gain was 15.0%, 18.0%, respectively.

[0161] 4, heat treatment: with embodiment 1.

[0162] 5. Laser drilling: same as embodiment 1.

...

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Abstract

The invention provides novel pramipexole dihydrochloride osmotic pump type controlled release tablets. Ethyl cellulose and povidone are used as semi-permeable membrane forming materials; and preferably, the tablets have asymmetrical tablet form, so that the aging phenomenon of a semi-permeable membrane can be eliminated, and medicinal residue is reduced. The invention also provides a method for improving the anti-aging performance of the pramipexole dihydrochloride osmotic pump type controlled release tablets. Moreover, the invention also provides application of an ethyl cellulose and povidone composition in preparation of the pramipexole dihydrochloride osmotic pump type controlled release tablets with the anti-aging performance.

Description

technical field [0001] The invention relates to a pramipexole 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] Pramipexole hydrochloride is a non-ergot dopamine agonist used in the treatment of Parkinson's disease. [0003] This product was first marketed as a common preparation that was taken 3 times a day. Due to the difficulty in taking the medicine, the patient's compliance was poor. In addition, continuous stimulation of dopamine receptors for long-term relief of symptoms is a basic requirement for the treatment of Parkinson's disease. Therefore, a common sustained-release preparation that is taken once a day has been launched abroad. [0004] Since pramipexole hydrochloride sustained-release preparation is a non-constant release drug, the release and absorption rate of the drug is also affected by fa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K9/36A61K31/428A61K47/38A61P25/16
Inventor 姜庆伟刘全志狄媛吕玉珠唐亚坤李帅衣伟锋梁希葛振中王丽红刘伟孙琪
Owner 内蒙古天衡医院管理有限公司
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