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Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer

A technology of vinylpyrrolidone and polyethylene glycol, which is applied in the field of film preparation and its preparation, can solve problems such as layer separation and uneven active ingredients, and achieve the effect of reducing the amount of bubbles

Active Publication Date: 2015-12-30
CTC BIO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] When tadalafil is manufactured in an insufficiently dissolved state or in a dispersed or suspended state, it may cause layer separation of the film for preparing the solution and unevenness of the active ingredient due to strong water repellency

Method used

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  • Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer
  • Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer
  • Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer

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preparation example Construction

[0047] Preparation of film formulation containing tadalafil free base >

[0048] A film formulation containing tadalafil free base was prepared as follows. Plasticizers, additives, sweeteners, surfactants, and dispersion stabilizers are added to purified water, stirred until dissolved or dispersed in the purified water, and tadalafil free base is added thereto. Subsequently, homogenization was performed using a homogenizer (Ultraturrax T-25, IKA). Add polymer to it and homogenize with the same homogenizer. Then, the gas was removed from the film preparation solution under vacuum at 45° C., and after cooling to room temperature, it was coated with a polyethylene (PE) film of the most suitable thickness. Then, drying was performed at 80°C to prepare a film formulation containing tadalafil free base.

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Abstract

The present invention relates to a film preparation for oral administration, containing tadalafil free base, and a preparation method therefor. The invention provides a film. It is possible to: maximize the dispersion stability of tadalafil free base in the film by using a small amount of a dispersion stabilizer without inducing a specific odor or taste which can occur when using other dispersion stabilizers known in the relevant art; provide a film having an extremely low rate of tadalafil free base particle reaggregation; and remarkably reduce the amount of bubbles during a preparation process.

Description

Technical field [0001] The present disclosure relates to a film preparation containing tadalafil free base (tadalafilfreebase) as an active ingredient and a preparation method thereof. More specifically, the present disclosure relates to a film containing tadalafil free base with content uniformity and dispersion uniformity, and a method for preparing tadalafil free base with content uniformity and dispersion uniformity Of the membrane method. [0002] This application claims the priority of Korean Patent Application No. 10-2013-0040084 filed in Korea on April 11, 2013, and the disclosure of the patent application is incorporated herein by reference in its entirety. Background technique [0003] The active ingredient of Tadalafil (Tadalafil) has been used to treat male erectile dysfunction. The prescription information for this product describes this product as an almond-shaped oral drug coated with a film containing tadalafil, and records the following inactive ingredients: cro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/38A61K47/30
CPCA61K47/38A61K9/7007A61K47/10A61K9/006A61K47/36A61K9/0056A61K31/4985A61K47/32A61P15/10A61K47/34
Inventor 全泓烈权度又李凤相朴秀晙车奉根金准基韩知姈吉明哲
Owner CTC BIO INC
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