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Tramadol hydrochloride osmotic pump controlled release tablet

A controlled-release technology of tramadol hydrochloride and osmotic pumps, which can be used in medical preparations of non-active ingredients, organic active ingredients, nervous system diseases, etc., and can solve problems such as release performance decline 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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  • Tramadol hydrochloride osmotic pump controlled release tablet
  • Tramadol hydrochloride osmotic pump controlled release tablet
  • Tramadol hydrochloride osmotic pump controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: Adopt ethyl cellulose+polyethylene glycol to do the comparative embodiment of semi-permeable membrane film-forming material

[0029] 1. Prescription

[0030]1. Tablet core prescription (based on 1000 tablets)

[0031] composition

Dosage

tramadol hydrochloride

100g

sucrose

180g

microcrystalline cellulose

80g

8% povidone K30 in 70% ethanol solution

Appropriate amount

Magnesium stearate

8g

[0032] 2. Semi-permeable membrane prescription

[0033] composition

Dosage

Ethylcellulose N100

30g

polyethylene glycol 4000

21g

water

100ml

ethanol

900ml

[0034] 3. Film coating prescription

[0035] composition

Dosage

Gastric type coating powder

10g

water

100ml

[0036] 2. Preparation process

[0037] 1. Tablet core preparation

[0038] Pass tramadol hydrochloride throu...

Embodiment 2

[0066] Embodiment 2: Adopt cellulose acetate+polyethylene glycol to do the comparative example of semi-permeable membrane film-forming material

[0067] 1. Tablet core prescription: same as Example 1

[0068] 2. Semi-permeable membrane prescription

[0069]

[0070] 3, film coating prescription: with embodiment 1

[0071] 2. Preparation process

[0072] 1. Tablet core preparation: same as Example 1

[0073] 2. Preparation process of semi-permeable membrane coating solution

[0074] Weigh the prescribed amount of polyethylene glycol 4000 and dissolve it in water, add cellulose acetate to the aqueous solution of polyethylene glycol 4000 to disperse, add the prescribed amount of acetone and stir until dissolved, to obtain.

[0075] 3. Packed with semi-permeable membrane

[0076] Put the compressed tablet into a high-efficiency coating machine and wrap it with a semi-permeable membrane, and increase the weight to 9.0%.

[0077] 4, heat treatment: with embodiment 1

[007...

Embodiment 3

[0092] Embodiment 3 The present invention adopts ethyl cellulose+povidone to do the embodiment of semi-permeable membrane film-forming material

[0093] 1. Prescription

[0094] 1. Tablet core prescription: same as Example 1

[0095] 2. Semi-permeable membrane prescription

[0096] prescription

Dosage

Ethylcellulose N100

30g

Povidone K30

18g

ethanol

1000ml

[0097] 3, film coating prescription: with embodiment 1

[0098] 2. Preparation process

[0099] 1. Tablet core preparation: same as Example 1

[0100] 2. Preparation process of semi-permeable membrane coating solution

[0101] Weigh the prescribed amount of ethyl cellulose and add it to ethanol, stir until dissolved, then add the prescribed amount of povidone and stir until completely dissolved, to obtain.

[0102] 3. Packed with semi-permeable membrane

[0103] Put the compressed tablet into a high-efficiency coating machine and wrap it with a semi-permeabl...

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PUM

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Abstract

The invention provides a novel single-chamber tramadol hydrochloride osmotic pump controlled release tablet preparation. A semi-permeable membrane containing ethyl cellulose (EC) and polyvidone (PVP) is coated on the surface of a medicament table core, so that the phenomenon of ageing of the semi-permeable membrane can be avoided, and medicament residues are reduced. The invention further provides a method for improving the anti-ageing performance of a single-chamber tramadol hydrochloride osmotic pump controlled release tablet. The method is characterized in that: ethyl cellulose-polyvidone is taken as a semi-permeable membrane material. Moreover, the invention further provides an application of an ethyl cellulose-polyvidone composition to preparation of a single-chamber tramadol hydrochloride osmotic pump controlled release tablet with anti-ageing performance.

Description

technical field [0001] The invention relates to a tramadol hydrochloride osmotic pump type controlled-release tablet, which belongs to the field of pharmaceutical preparations. Background technique [0002] Tramadol hydrochloride is a central analgesic that exerts an analgesic effect by stimulating the opioid μ receptor and inhibiting the reuptake of central monoaminergic substances (serotonin and norepinephrine). Moderate and severe pain caused by cancer, including cancer pain, fracture or trauma, various postoperative pain, toothache, neuralgia, etc. The basic clinical requirement for this type of drug is that it can control symptoms for a long time. [0003] Tramadol hydrochloride was first marketed as a common preparation, which needs to be taken 2-3 times a day. The blood concentration fluctuates greatly, the peak concentration is too high, and the adverse reactions are serious. The tramadol hydrochloride sustained-release preparations that will be marketed later have...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K31/137A61K47/38A61P25/04
Inventor 姜庆伟黄翠玲狄媛吕玉珠张强刘玉璐衣伟锋梁希葛振中王丽红
Owner 内蒙古天衡医院管理有限公司
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