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Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method

A technology of acetaminophen and tramadol hydrochloride, which is applied in the field of orally disintegrating tablets containing tramadol hydrochloride and acetaminophen and its preparation, which can solve the problems of not being able to relieve pain in time, not being able to take it in time, and having low bioavailability, etc. question

Active Publication Date: 2008-07-23
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the tramadol hydrochloride / acetaminophen compound tablets currently on the market are ordinary tablets, which need to be swallowed with water when taking them. Once pain occurs, they cannot be taken in time, and the pain cannot be relieved in time. It needs to be excreted through the gastrointestinal tract. Absorption, low bioavailability, large side effects;
[0007] At the same time, it is impossible to form orally disintegrating tablets with tramadol hydrochloride and acetaminophen by conventional methods, because tramadol hydrochloride and / or acetaminophen are extremely bitter drugs, and generally do not make orally disintegrating tablets

Method used

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  • Oral disintegrating tablet containing tramadol hydrochloride and acetaminopher, and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 325mg / 37.5mg paracetamol tramadol / tablet, the formula is shown in Table 1.

[0033] component name

components

Amount added

active ingredient

Acetaminophen

325mg

active ingredient

tramadol hydrochloride

37.5mg

Coating Taste Masking Agent

Acrylic

15mg

Coating Taste Masking Agent

β-cyclodextrin

60mg

Coating Taste Masking Agent

Ethyl cellulose

8mg

flavoring agent

aspartame

10mg

essence

lemon zest

8mg

disintegrant

Crospovidone

50mg

disintegrant

Sodium carboxymethyl starch

20mg

filler

Mannitol

70mg

filler

pregelatinized starch

30mg

lubricant

silica

6.0mg

Adhesive

Polyvinylpyrrolidone

0.5mg

[0034] Preparation Process:

[0035] (1) Mix 10 mg of flavoring agent aspartame and 70 mg of filler mannitol, add 0.5 mg (0.6% of the total mass of flavoring agent and ...

Embodiment 2

[0044] 325mg / 37.5mg paracetamol tramadol / tablet, the formula is shown in Table 2.

[0045] Table 2

[0046] component name

components

Amount added

active ingredient

Acetaminophen

325mg

[0047] active ingredient

tramadol hydrochloride

37.5mg

Coating Taste Masking Agent

Acrylic

8mg

Coating Taste Masking Agent

β-cyclodextrin

110mg

Coating Taste Masking Agent

Ethyl cellulose

15mg

flavoring agent

aspartame

5mg

flavoring agent

ethyl maltol

4mg

essence

lemon zest

13mg

disintegrant

Crospovidone

46 mg

Disintegrant

Sodium dodecyl sulfate

10mg

filler

Mannitol

60mg

lubricant

silica

6.1mg

Adhesive

Polyvinylpyrrolidone

0.4mg

[0048] The preparation process is as follows:

[0049] (1) Mix 5 mg of aspartame as the flavoring agent and 60 mg of the filler mannit...

Embodiment 3

[0058] 325mg / 37.5mg paracetamol tramadol / tablet. The formula is shown in Table 3.

[0059] component name

components

Amount added

active ingredient

Acetaminophen

325mg

active ingredient

tramadol hydrochloride

37.5mg

Coating Taste Masking Agent

Acrylic

12mg

Coating Taste Masking Agent

β-cyclodextrin

100mg

Coating Taste Masking Agent

Ethyl cellulose

15mg

flavoring agent

aspartame

8mg

flavoring agent

ethyl maltol

7mg

[0060] essence

lemon flavor

11mg

disintegrant

Crospovidone

50mg

disintegrant

Sodium carboxymethyl starch

12mg

filler

Mannitol

70mg

filler

pregelatinized starch

30mg

lubricant

silica

6mg

Adhesive

Polyvinylpyrrolidone

0.5mg

[0061] Preparation process is with embodiment 1

[0062] The test results are shown in Table 4.

...

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PUM

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Abstract

The invention provides an orally disintegrating tablet containing tramadol hydrochloride and paracetamol, and the preparing process, wherein tramadol hydrochloride and paracetamol are dressed for mouth cavity use. During the dressing process, right amount of medicinal auxiliary materials are charged.

Description

technical field [0001] The invention relates to a preparation containing tramadol hydrochloride and acetaminophen and a preparation method thereof, in particular to an orally disintegrating tablet containing tramadol hydrochloride and acetaminophen and a preparation method thereof. technical background [0002] Tramadol hydrochloride is a synthetic opioid central analgesic, its spatial structure is similar to the partial structure of endorphin, it can also specifically bind to opioid receptors, stimulate receptors, and produce morphine-like analgesic effects, but without morphine The same serious adverse reactions, under the therapeutic dose, the tolerance is better, the dependence is low, because there is no adrenergic and serotonergic effects, respiratory depression, constipation, dysuria will not occur, and the blood vessels, liver and kidney functions will not be affected. , smooth muscle and striated muscle, etc. There is no adverse effect, the onset is fast and the dur...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/167A61K31/135A61K9/20A61P29/00A61P25/04
Inventor 余伟民郑启兰钱建张冬梅
Owner SHANGHAI SINE PHARMA LAB
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