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Oral disintegrative tablet of sildenafil citrate and preparation method thereof

A technology for sildenafil citrate and orally disintegrating tablets is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc. and quality issues

Inactive Publication Date: 2010-03-31
张晓芳
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The orally disintegrating tablet either adopts a powder coating process, the preparation process is complicated, or the contradiction between the hygroscopicity and quality of the orally disintegrating tablet is not resolved

Method used

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  • Oral disintegrative tablet of sildenafil citrate and preparation method thereof
  • Oral disintegrative tablet of sildenafil citrate and preparation method thereof
  • Oral disintegrative tablet of sildenafil citrate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation prescription is: sildenafil citrate 250g, mannitol 500g, chitosan 500g, low-substituted hydroxypropyl cellulose 50g, magnesium stearate 10g, aspartame 5g, povidone K30 1g.

Embodiment 2

[0041] The preparation prescription is: 500 g of sildenafil citrate, 750 g of lactose, 750 g of chitosan, 70 g of croscarmellose sodium, 12 g of magnesium stearate, 6 g of mint essence, and 2 g of povidone K30.

Embodiment 3

[0043] The preparation prescription is: sildenafil citrate 1000g, mannitol 500g, lactose 500g, chitosan 1000g, cross-linked polyvinylpyrrolidone 100g, sodium lauryl sulfate 20g, aspartame 6g, mint essence 4g, Povidone K30 2g.

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PUM

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Abstract

The invention belongs to the technical field of pharmacy, in particular to an oral disintegrative tablet for treating male erection dysfunction by using sildenafil citrate as an active component and apreparation method thereof. The oral disintegrative tablet of sildenafil citrate comprises the following components in parts by weight: 2.5-10 sildenafil citrate, 10-20 diluent, 0.5-1 disintegrant, 0.1-0.2 lubricant, 0.05-0.1 taste modifier and 0.01-0.02 bonder (accounted by povidone K30), wherein the diluent is a compound jointly formed by chitosan and one or two of lactose and mannitol. The oral disintegrative tablet remarkably improves the humidity resistance and is beneficial to improving the stability of the preparation and ensuring the quality in the production and storage processes.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and more specifically relates to an orally disintegrating tablet for treating male erectile dysfunction with sildenafil citrate as an active ingredient and a preparation method thereof. Background technique [0002] Oral medication is the simplest and most acceptable treatment for erectile dysfunction. [0003] Sildenafil is an effective drug for the treatment of erectile dysfunction caused by objective and subjective reasons. It was approved by the FDA as a prescription drug in the United States in March 1997. Sildenafil is a highly selective phosphodiesterase 5 (PDE5 ) inhibitor, PDE5 is highly expressed in the corpus cavernosum, while its expression is low in other tissues (including platelets, blood vessels, visceral smooth muscle, and skeletal muscle). Sildenafil selectively inhibits PDE5, enhances the nitric oxide (NO)-cGMP pathway, and increases the level of cGMP to cause the relaxation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/519A61P15/10
Inventor 张晓芳
Owner 张晓芳
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