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Low dose diclofenac sodium lozenge and its preparation method

A diclofenac sodium and low-dose technology, which is applied in the field of low-dose diclofenac sodium buccal tablets and its preparation, can solve the problems of long-lasting effect and small side effects, and achieve the effects of increased fluidity, small difference in tablet weight, and smooth surface

Inactive Publication Date: 2003-04-30
JIANGSU DURUI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is currently no formulation of diclofenac sodium that is suitable for pain relief after oral diseases such as oral ulcers or toothaches or operations such as tooth extraction or tonsillectomy, with long-lasting effects and small side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1. The preparation of diclofenac sodium buccal tablet

[0029] a. Formulation:

[0030] Diclofenac Sodium 2.0g

[0031] 300g powdered sugar

[0032] Mannitol 300g

[0033] Maltodextrin 200g

[0034] Menthol 4.0g

[0035] 4% Povidone K 30 50% ethanol solution 85g

[0036] Magnesium Stearate 1%

[0037] Makes 1000 pieces

[0038] b. Preparation method: pass sugar powder, mannitol, and maltodextrin through 100 sieves, mix well, dissolve diclofenac sodium, flavoring agent menthol in 4% povidone K 30 50% Z alcohol solution solution binder, uniformly dispersed in diluent, made into soft material, granulated with 18 mesh sieve, dried at 50°C, dry granules plus magnesium stearate lubricant, mixed evenly, 16 mesh sieve Whole grain, compressed tablet. Each tablet contains 2mg of diclofenac sodium.

Embodiment 2

[0039] Embodiment 2. The preparation of diclofenac sodium buccal tablet

[0040] a. Formulation:

[0041] Diclofenac Sodium 20g

[0042] Powdered sugar 3000g

[0043] Mannitol 3000g

[0044] Maltodextrin 2000g

[0045] Menthol 40g

[0046] 4% Povidone K 30 50% ethanol solution 2000ml

[0047] Hydroxypropyl methylcellulose solution 2900ml

[0048] Magnesium Stearate 1%

[0049] Made into 10000 pieces

[0050] b. Preparation method: pass sugar powder, mannitol, and maltodextrin through 100 sieves, mix well, use hydroxypropyl methylcellulose solution as a binder, and granulate into blank granules in one step, diclofenac sodium, flavoring agent Menthol dissolved in 4% Povidone K 30 In 50% ethanol solution, evenly spray on the blank granules to make granules, add magnesium stearate to the dry granules, mix evenly, sieve the granules with 16 mesh, compress into tablets, and each tablet contains 2 mg of diclofenac sodium.

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PUM

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Abstract

A low-dosage lozenge of diclofenac sodium contains diclofenac sodium, sugar powder, mannitol, maltose dextrin, menthol, polyvidone K30 solution and magnesium stearate, and is prepared by solvent dispersing method or particle coating method. It can be used for treating oral inflammation.

Description

technical field [0001] The invention relates to a low-dose diclofenac sodium buccal tablet and a preparation method thereof. Background technique [0002] Diclofenac sodium is a powerful non-steroidal anti-inflammatory analgesic, and its analgesic and anti-inflammatory effects are 2-2.5 times that of indomethacin and 26-50 times that of aspirin. It is clinically used to treat inflammation and pain caused by rheumatism, rheumatoid arthritis, frozen shoulder, tenosynovitis, trauma and surgery, and also has a good effect on fever caused by colds. Although diclofenac sodium is a non-steroidal analgesic with less toxic and side effects, many adverse reactions have also occurred in clinical application. The main clinical adverse reactions are: gastrointestinal reactions such as epigastric discomfort, Nausea, vomiting, severe gastrointestinal bleeding, dizziness, rash, neutropenia, etc. It is now clear that the occurrence of most adverse reactions is related to the dosage used. ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/196A61P29/00
Inventor 傅风华岳志勇蒋王林宋吉伦
Owner JIANGSU DURUI PHARMACEUTICAL CO LTD
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