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Oxycodone hydrochloride and ibuprofen compound multilayer tablet, and preparation method thereof

A technology of oxycodone hydrochloride and oxycodone layer, which is applied in the field of oxycodone hydrochloride and ibuprofen compound multi-layer tablet and its preparation, can solve the problems of reducing curative effect and the like, and achieve good anti-adhesion, good stability and quality controllable effect

Inactive Publication Date: 2015-03-25
NHWA PHARMA CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the degradation of the main drug during the storage of pharmaceutical preparations will further reduce the curative effect.

Method used

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  • Oxycodone hydrochloride and ibuprofen compound multilayer tablet, and preparation method thereof
  • Oxycodone hydrochloride and ibuprofen compound multilayer tablet, and preparation method thereof
  • Oxycodone hydrochloride and ibuprofen compound multilayer tablet, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The preparation of double-layer film-coated tablets (Example 1) containing 400 mg ibuprofen and 5 mg oxycodone hydrochloride includes preparing granules containing the following ingredients, uncoated tablets, and film-coated tablets. The addition amount shown in brackets in the following description is an illustration of the prescription shown in Example 1. According to the preparation method, the preparation examples of other double-layer tablets can be prepared by the same method, the difference is that the addition amount needs to be changed according to different prescriptions, and the formulas of each example are detailed in Tables 1-3, Tables 5-6 .

[0047] Preparation:

[0048] Preparation of ibuprofen granules:

[0049] (1) Preparation of binding solution (2% hydroxypropylmethylcellulose aqueous solution)

[0050] Hypromellose (3 g) as a binder was dissolved in pure water (150 g) to obtain a binder solution.

[0051] (2) Granulation of ibuprofen granules

...

Embodiment 2

[0063] The preparation of a three-layer film-coated tablet (Example 2) containing 400 mg ibuprofen and 5 mg oxycodone includes preparing granules containing the following ingredients, uncoated tablet, and film-coated tablet. The addition shown in brackets in the following description is an illustration of the prescription shown in Example 2. According to the preparation method, the preparation examples of other three-layer tablets can be prepared by the same method, the difference is that the addition amount needs to be changed according to different prescriptions, and the formulas of each example are detailed in Tables 1-3, and Tables 5-6 .

[0064] Preparation:

[0065] Preparation of ibuprofen granules:

[0066] (1) Preparation of binding solution (2% hydroxypropylmethylcellulose aqueous solution)

[0067] Hydroxypropylmethylcellulose (3 g) as a binder was dissolved in pure water (150 g) to obtain a binder solution.

[0068] (2) Granulation

[0069] The ibuprofen (400g...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and discloses an oxycodone hydrochloride and ibuprofen compound multilayer tablet, and a preparation method thereof. According to the ibuprofen and oxycodone multilayer tablet, one layer is an ibuprofen layer and comprises ibuprofen and a pharmaceutically acceptable auxiliary material, the other layer is an oxycodone layer and comprises oxycodone and a pharmaceutically acceptable auxiliary material, and the adhesive of the oxycodone layer can not select polyvinylpyrrolidone. According to the present invention, the oxycodone and the ibuprofen are respectively positioned in different layers, are not degraded at the room temperature and the high temperature, and have good stability and good quality controllability. In the prior art, in the general compound tablets, in the presence of the ibuprofen, coexisting of the oxycodone and the adhesive or the oxycodone, the adhesive and the lubricant can cause problems of severe main drug degradation severe and uncontrollable quality, such that the mass production is not easily achieved. With the method of the present invention, the problems in the prior art are avoided.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a compound multilayer tablet of oxycodone hydrochloride and ibuprofen and a preparation method thereof. Background technique [0002] Pain is a common disease, its incidence rate among adults in our country is as high as 40%, and it can occur in various organs of the body, such as dysmenorrhea, headache, migraine, cancer pain, musculoskeletal pain, postoperative pain, burns and scalds pain etc. There are currently two types of analgesic drugs commonly used in clinical practice: one is a narcotic analgesic represented by morphine, and the other is an antipyretic analgesic represented by aspirin. Although the former has high analgesic intensity, its addiction is its fatal weakness, which greatly limits its application; although the latter is not addictive, its analgesic intensity is weak and has serious gastrointestinal effects. Combunox is the first and only fixed-dose c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/485A61K9/24A61P29/00A61K31/192
CPCA61K31/485A61K9/2086A61K9/2866A61K31/192A61K2300/00
Inventor 张涛王佳瑜刘江高梓真
Owner NHWA PHARMA CORPORATION
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