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Oral disintegrating film formulation containing tadalafil and preparation method therefor

A technology for oral disintegration and tadalafil, which is applied in the field of oral disintegrating film preparation containing tadalafil and its preparation, can solve problems such as low stability, and achieve the effect of excellent stability

Active Publication Date: 2016-05-25
WOOSHIN LABOTTACH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, depending on the structure of the polymer base of the orally disintegrating film preparation, it shows a completely different dissolution pattern of tadalafil and results in low stability

Method used

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  • Oral disintegrating film formulation containing tadalafil and preparation method therefor
  • Oral disintegrating film formulation containing tadalafil and preparation method therefor
  • Oral disintegrating film formulation containing tadalafil and preparation method therefor

Examples

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Embodiment

[0043] Example: Preparation of orally disintegrating film preparation

[0044] Orally disintegrating film preparations containing tadalafil were prepared according to the ingredients and contents in Table 1 below. The content in Table 1 means cut into 7.5cm 2 The content (mg) in the unit preparation of the size.

[0045] Add the ingredients recorded in Table 1 to an aqueous ethanol solution (3:1, weight ratio; about 16 times based on the amount of tadalafil used) and mix well. used tadalafil, used d 90 Raw materials with a particle size of 15 μm. The resulting dispersion was stirred using a paddle under vacuum for about 5 hours, thereby removing air bubbles. The degassed dispersion was coated on a siliconized polyethylene terephthalate film (SKC Polyester Film Co., Ltd.) with a certain thickness, and then dried with hot air. Cut the resulting preparation into 7.5 cm 2 to prepare an orally disintegrating film preparation (thickness: about 120 μm).

[0046] Table 1

[00...

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Abstract

The present invention provides an oral disintegrating film formulation comprising: tadalafil as an active ingredient; and a combination of fluran and polyvinylpyrrolidone as a film forming agent. The oral disintegrating film formulation of the present invention does not exhibit buccal absorption, and can be formulated so as to exhibit bioequivalence to a tadalafil-containing tablet. In addition, the oral disintegrating film formulation of the present invention exhibits good stability.

Description

technical field [0001] The present invention relates to an orally disintegrating film preparation containing tadalafil as an active ingredient. In more detail, the present invention relates to a tadalafil-containing Non-orally disintegrating film preparation and preparation method thereof. Background technique [0002] Erectile dysfunction (erectiledysfunction; ED) is a common disease, and about 10% of adult males suffer from it. Tens of millions, South Korea has 2.5-3 million. The number of patients with erectile dysfunction is rapidly increasing due to the increase in the elderly population due to the aging of society, and the stress and fatigue caused by industrialization and rapid changes in society. It is estimated that by 2020, the number of patients will reach more than 300 million, which will more than triple the current number. [0003] Tadalafil has the following structure and its chemical name is (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexa Hydrogen-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4985A61K47/30
CPCA61K9/70A61K31/4985A61K9/006A61K47/32A61K47/36A61K9/7007A61P15/10A61K47/30
Inventor 南泽秀
Owner WOOSHIN LABOTTACH CO LTD
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