Oral cavity disintegration tablet for treating gout and its preparation method

A technology for oral disintegrating tablets and gout, which is applied in the directions of pill delivery, bone diseases, active ingredients of heterocyclic compounds, etc. Improved bioavailability, rapid onset effect

Active Publication Date: 2009-08-19
HAINAN PULIN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, most of the dosage forms of allopurinol in the market have problems such as slow onset of action, low bioavailability, and large gastrointestinal irritation.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Example 1: This example prepares 1000 allopurinol orally disintegrating tablets (specification: 0.25g), using the following ingredients:

[0013] Material name

Feeding amount

Allopurinol

250g

Mannitol

420g

microcrystalline cellulose

150g

Crospovidone

70g

aspartame

20g

mint flavor

10g

silica

20g

Magnesium stearate

5g

[0014] Process steps: mix the active pharmaceutical ingredient allopurinol with the excipients mannitol, microcrystalline cellulose, and crospovidone granules, add aspartame, peppermint essence, silicon dioxide, and magnesium stearate, mix evenly, and place in Compressed into tablets in a tablet press.

[0015] The mouthfeel, oral disintegration time, disintegration time limit and friability of the tablets obtained by the above process were measured.

[0016] Test items

Embodiment 2

[0017] Example 2: This example prepares 1000 allopurinol orally disintegrating tablets (specification: 0.25g), using the following ingredients:

[0018] Material name

Feeding amount

Allopurinol

250g

Sorbitol

400g

glucose

80g

sucrose

70g

Croscarmellose Sodium

60g

Stevioside

25g

Sweet Orange Flavor

10g

silica

20g

Sodium octadecyl fumarate

5g

[0019] Process steps: mix the active ingredient allopurinol with the excipients sorbitol, glucose, sucrose, and croscarmellose sodium, then add stevioside, sweet orange essence, silicon dioxide, and sodium stearyl fumarate , mixed evenly, and then placed in a tablet machine to be compressed into tablets.

[0020] The mouthfeel, oral disintegration time, disintegration time limit and friability of the tablets obtained by the above process were measured.

[0021] Test items

Embodiment 3

[0022] Example 3: This example prepares 1000 allopurinol orally disintegrating tablets (specification: 0.25g), using the following ingredients:

[0023] Material name

Feeding amount

Allopurinol

250g

Mannitol

200g

sucrose

220g

gelatin

50g

Hydroxyethyl cellulose

40g

mint flavor

10g

[0024] Process steps: Dissolve the active ingredient of the drug, allopurinol, and excipients, mannitol, sucrose, gelatin, hydroxyethyl cellulose, and mint flavor in water, mix well, add to the mold and place it in a freeze dryer to freeze at low temperature, and vacuum until the material Dry and pack tightly.

[0025] The tablets obtained in the above steps were tested for mouthfeel, oral disintegration time and disintegration time limit.

[0026] Test items

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PUM

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Abstract

The invention relates to a dosage form of medicine, in particular to an orally disintegrating tablet for treating gout and a preparation method thereof. The orally disintegrating tablet for treating gout of the present invention includes a pharmaceutical active ingredient and auxiliary materials. The pharmaceutical active ingredient is allopurinol, and the auxiliary materials include Disintegrants, soluble polyols, fillers, and penetrating agents, among which allopurinol accounts for 20% to 50% of the tablet weight, disintegrants account for 5% to 15%, and soluble polyols account for 30% to 60%, Fillers account for 10% to 30%, penetrants account for 1% to 5%, lubricants account for 0.5% to 1.5%, sweeteners account for 0.5% to 3%, and flavors account for 0.5% to 3%. Compared with common oral preparations, the present invention has rapid onset of effect because the gastrointestinal tract mucosa is widely covered by the fast-disintegrating medicine. Moreover, the drug can be absorbed through the oral mucosa, eliminating the first-pass effect, improving bioavailability, and reducing irritation to the gastrointestinal tract.

Description

technical field [0001] The invention relates to a dosage form of medicine, in particular to an orally disintegrating tablet for treating gout and a preparation method thereof. Background technique [0002] Gout is a group of heterogeneous diseases caused by excessive blood uric acid and deposition in joints, soft tissues, bone marrow, kidneys, etc. caused by long-term purine metabolism disorders. It is more common in middle-aged, elderly and gastric patients. . The clinical features are: uric acidemia, recurrent episodes of characteristic acute arthritis, uric acid crystals can be found in the white blood cells of the synovial fluid of the joints, tophi formation, and severe cases can lead to joint mobility disorders and deformities, renal uric acid stones and / or gouty Renal parenchymal disease. [0003] Currently, there is no cure for gout. According to the pathogenesis of gout, drugs for the treatment of gout can produce a therapeutic effect by inhibiting the synthesis ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/52A61K9/20A61P19/06
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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