High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient

A sildenafil and film-dissolving technology, which is applied in the direction of organic active ingredients, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as difficult production of fast-dissolving film preparations, and achieve masking of bitterness Effect

Active Publication Date: 2014-11-26
SEOUL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is difficult to produce a fast dissolving film form

Method used

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  • High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient
  • High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient
  • High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-27

[0146] As shown in Tables 3 and 4, pharmaceutical compositions for oral film formulations were prepared, and their pH, bitterness score, and film-forming ability were evaluated.

[0147] [table 3]

[0148]

[0149] 1) The proportion of solvent used: the amount of solvent relative to the total solid content (multiple)

[0150] [Table 4]

[0151]

[0152]

[0153] 1) The proportion of solvent used: the amount of solvent relative to the total solid content (multiple)

[0154] As can be seen from the results in Tables 3 and 4, when the pH of the composition was adjusted to 4.41 or more (with a maximum pH of 5.81) using a single alkalizing agent, the bitterness was effectively masked but greatly deteriorated film-forming ability. Therefore, these compositions are not suitable for the production of oral film formulations.

Embodiment 28-40

[0156] As shown in Table 5, pharmaceutical compositions for oral film formulations were prepared, and their pH, bitterness score, and film-forming ability were evaluated.

[0157] [table 5]

[0158]

[0159] 1) The proportion of solvent used: the amount of solvent relative to the total solid content (multiple)

[0160] As can be seen from the results in Table 5, when the combination of magnesium oxide and sodium hydroxide was used as the alkalizing agent, the bitter taste was effectively masked and good film-forming ability was obtained.

Embodiment 41-44

[0162] As shown in Table 6, pharmaceutical compositions for oral film formulations were prepared, and their pH, bitterness score, and film-forming ability were evaluated.

[0163] [Table 6]

[0164]

[0165] 1) The proportion of solvent used: the amount of solvent relative to the total solid content (multiple)

[0166] As can be seen from the results in Table 6, when the combination of magnesium oxide and sodium hydroxide was mixed with Talin MD90 and aspartame in a predetermined ratio as an alkalizing agent, the bitter taste was effectively masked and good results were obtained. film ability and gives a very comfortable feeling when taking it.

[0167] 2. Group B

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PUM

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Abstract

Provided is a fast dissolving film composition comprising a medically active component as an active ingredient, in which the bitter taste of the active ingredient is masked and the fast dissolving film composition has a high content of 50% or higher. More particularly, provided is a pharmaceutical composition which comprises sildenafil or pharmaceutically acceptable salts thereof as an active ingredient, and which comprises a combination of a specific bitter taste masking agent to achieve masking of a bitter taste. Further, provided is a fast dissolving film composition which comprises a combination of a specific plasticizer to mask a bitter taste, and in which the physical properties of the high-content film are excellent.

Description

technical field [0001] The present invention relates to fast dissolving films comprising high doses of sildenafil or a pharmaceutically acceptable salt thereof. More specifically, the present invention relates to rapidly dissolving films comprising per tablet at least 100 mg of sildenafil or a pharmaceutically acceptable salt thereof or 50% by weight of sildenafil or a pharmaceutically acceptable salt thereof relative to the total weight of the film, before This has been considered impossible due to the use of predetermined amounts of specific plasticizers. [0002] The present invention also relates to a fast dissolving film comprising sildenafil or a pharmaceutically acceptable salt thereof as an active ingredient masking its bitter taste. More specifically, the present invention relates to fast dissolving films comprising sildenafil or a pharmaceutically acceptable salt thereof as active ingredient together with specific taste-masking agents. [0003] Finally, the present...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/519A61K47/30A61K47/38
CPCA61K9/7007A61K31/519A61K9/0056A61K47/02A61K47/10A61K47/36A61P15/10A61K9/00A61K9/70A61K47/26
Inventor 郑贤俊长益现金挞根李真厚严镇熹金铉洙郑景泰延圭正朴振奎
Owner SEOUL PHARMA
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