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Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor

A technology of tramadol hydrochloride and orally disintegrating tablets, which is applied in the field of tramadol hydrochloride orally disintegrating tablets and its preparation, can solve the problems of not fully meeting the needs of patients for medication and difficulty in taking medication, and achieve improved bioavailability, Good adhesion and good taste

Active Publication Date: 2006-10-18
CSPC OUYI PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The dosage forms of tramadol hydrochloride currently clinically used include tablets and injections. The injections must be used by medical staff, and the tablets need to be taken with water. It will be difficult for patients with swallowing difficulties or inconvenient water intake; so these dosage forms cannot be used. Fully meet the patient's medication needs

Method used

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  • Tramadol hydrochloride oral disintegration tablets, and prepn. method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1: Preparation of Tramadol Hydrochloride Orally Disintegrating Tablets

[0045] components

weight

weight percentage

tramadol hydrochloride

Mannitol

sodium saccharin

microcrystalline cellulose

L-HPC

citric acid

sodium bicarbonate

Talc powder

Menthol

50g

100 g

1 g

96 grams

12.6 grams

6 grams

2 grams

2.7 grams

0.4 grams

18.47％

36.94％

0.37％

35.46％

4.65％

2.22％

0.74％

1.00％

0.15％

Gross weight:

270.7 grams

[0046] Preparation Process:

[0047]Weigh tramadol hydrochloride, mannitol, sodium saccharin, citric acid, and part of microcrystalline cellulose according to the prescription amount, put them into a mixer and mix them evenly, add 50% ethanol solution as a wetting agent, stir for 5 minutes, and use 40 mesh Sieve granulation, ventilate and dry at 50°C±5°C, pass dry granules through a 40-mesh sieve f...

Embodiment 2

[0048] Embodiment 2: Preparation of Tramadol Hydrochloride Orally Disintegrating Tablets

[0049] components

weight

weight percentage

tramadol hydrochloride

Erythritol

sodium saccharin

microcrystalline cellulose

Croscarmellose Sodium

citric acid

sodium bicarbonate

Magnesium stearate

Menthol

50g

50g

1 g

85.4 grams

20 grams

9 grams

3 grams

2.2 grams

0.4 grams

22.62％

22.62％

0.45％

38.64％

9.05％

4.07％

1.36％

1.00％

0.18％

Gross weight:

221 grams

[0050] Preparation Process:

[0051] Weigh tramadol hydrochloride, erythritol, sodium saccharin, citric acid, and part of microcrystalline cellulose according to the prescription amount, put them into a mixer and mix them evenly, add an appropriate amount of 5% povidone, 95% ethanol solution, and stir for 5 minutes, use a 40-mesh sieve to granulate, ventilate and dry at 50°C±5...

Embodiment 3

[0052] Embodiment 3: Preparation of Tramadol Hydrochloride Orally Disintegrating Tablets

[0053] components

weight

weight percentage

tramadol hydrochloride

Erythritol

sodium saccharin

microcrystalline cellulose

L-HPC

citric acid

sodium bicarbonate

Talc powder

Magnesium stearate

Menthol

50g

81.8 grams

2 grams

95.4 grams

10.6 grams

9 grams

3 grams

1 g

1 g

0.5 grams

19.66％

32.17％

0.79％

37.51％

4.17％

3.54％

1.18％

0.39％

0.39％

0.20％

Gross weight:

254.3 grams

[0054] Preparation Process:

[0055] Weigh tramadol hydrochloride, erythritol, sodium saccharin, citric acid, and part of microcrystalline cellulose according to the prescription, put them into a mixer and mix them evenly, add 50% ethanol solution as a wetting agent, stir for 5 minutes, and use Granulate with a 40-mesh sieve, ventilate and dry at 5...

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PUM

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Abstract

The invention relates to a tramadol hydrochloride orally disintegrating tablet and a preparation method thereof, which comprises an effective amount of tramadol hydrochloride and a pharmaceutically acceptable excipient that can disintegrate rapidly in the oral cavity to release the drug, and the pharmaceutically acceptable excipient There are water-soluble fillers, disintegrants, lubricants, and wetting agents or binders. The tablet disintegrates quickly and takes effect quickly; the intestinal residue is small, the absorption is sufficient, and the side effects are low; it is convenient to use and has a good taste .

Description

technical field [0001] The invention relates to a tramadol hydrochloride orally disintegrating tablet and a preparation method thereof. technical background [0002] Tramadol hydrochloride is a synthetic non-morphine central nervous analgesic. It is a racemic mixture. The reuptake of adrenaline increases the concentration of serotonin outside the neurons, thereby affecting the pain transmission and producing analgesic effect. There are morphine-like effects such as analgesia and antitussive, but no respiratory depression, no constipation. No significant effect on cardiovascular and liver and kidney functions. No euphoric, hallucinatory or histamine-releasing effects. Does not cause miosis or sphincter spasm. The generation of tolerance and addiction is slow and weak, and it is a safe and effective analgesic. [0003] The structural formula of tramadol hydrochloride is as follows: [0004] [0005] The dosage forms of tramadol hydrochloride curre...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/137A61K9/20A61P25/04
Inventor 刘振涛周桂荣张莉郭文敏闫随朝李云立
Owner CSPC OUYI PHARM CO LTD
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