Combination formulation comprising film coating layer containing active ingredient

A technology of active ingredients and compound preparations, which is applied in the field of preparation of compound preparations, can solve problems such as difficulty in ensuring sufficient efficacy and quality of compound preparations, inability to commercialize preparations, separation or rupture of film coating layers, etc., and achieve high salable product quality, The effect of ensuring bioavailability and increasing convenience

Active Publication Date: 2020-08-18
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] In such a complex preparation comprising a film coating layer containing an active ingredient, if the film coating layer has insufficient tensile strength, the usual impact during storage of the product may cause the film coating layer to separate or rupture, due to the appearance and other changes in properties, which may make it difficult to ensure sufficient efficacy of the combination preparation and maintain the quality of a commercially available product, ultimately resulting in the inability to commercialize the preparation as a product

Method used

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  • Combination formulation comprising film coating layer containing active ingredient
  • Combination formulation comprising film coating layer containing active ingredient
  • Combination formulation comprising film coating layer containing active ingredient

Examples

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preparation example Construction

[0068] In the preparation of the core, the core may be any core that can be used as a core in the pharmaceutical field, for example in the form of a tablet, a hard capsule or a soft capsule. However, the embodiments are not limited thereto. In the preparation of the core, any commercially available preparation that can be used as the core can be used, or the core used in the present invention can be directly prepared. The core can be prepared using known techniques in the pharmaceutical field selected by those of ordinary skill in the art depending on the type of core.

[0069] In preparing the coating solution containing the second active ingredient, the solvent can be any pharmaceutically available solvent that can dissolve the second active ingredient, polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol. For example, the solvent can be water, ethanol, methanol, chloroform, dimethyl sulfoxide (DMSO) or any combination thereof. In some embodiments, t...

Embodiment 1-10

[0074] Examples 1-10: Including tamsulosin hydrochloride gel coated with a film coating layer containing a 5-alpha-reductase inhibitor Preparation of compound formulation of capsule (1)

[0075] A coating solution was prepared by mixing coating materials (Examples 1-10) having different compositions shown in Table 1 with an ethanol-water mixed solution (ethanol:water=1:1 (v / v)), and then By using a pan coater (SFC-30, available from Sejong Co., Ltd.) coated on tamsulosin hydrochloride containing Capsules (available from Hanmi Pharmaceutical Co., Ltd., Korea). The prepared capsules were dried at about 35° C. for about 30 minutes, thereby preparing a composite preparation including a tamsulosin capsule core coated with a film coating layer containing a 5-α-reductase inhibitor.

Embodiment 11 and 12

[0084] Examples 11 and 12: Including Tamsulosin OD Tablets Coated with a Film Coating Containing a 5-alpha-Reductase Inhibitor Preparation of core compound formulations

[0085] A coating solution was prepared by mixing coating materials (Examples 11 and 12) having different compositions shown in Table 2 with an ethanol-water mixed solution (ethanol:water=1:1 (v / v)), and then By using a pan coater (SFC-30, available from Sejong Co., Ltd.) in the mixture containing tamsulosin hydrochloride OD tablets (available from Hanmi Pharmaceutical Co., Ltd., Korea) were coated. The prepared composite tablet was dried at about 35° C. for about 30 minutes, thereby preparing a tablet comprising a film coating layer containing a 5-α-reductase inhibitor. Composite formulation of OD tablet cores.

[0086] [Table 2]

[0087]

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Abstract

Provided is a composite preparation and a preparation method thereof, the composite preparation comprising: a core containing a first active ingredient; and a film coating layer containing a second active ingredient, wherein the film coating layer includes polyvinyl alcohol-polymer Ethylene glycol graft copolymer and polyvinyl alcohol.

Description

technical field [0001] The present invention relates to a composite preparation comprising a film coating layer containing an active ingredient and a preparation method thereof, and more particularly, relates to a composite preparation comprising a film coating layer containing an active ingredient, which can have resistance to general external shocks Stable shape and durability and high dissolution rate of active ingredients, and the preparation method of the compound preparation. Background technique [0002] A healthy young man's prostate is about the size of a walnut and grows progressively with age. Prostatic hypertrophy is a disease in which severe enlargement of the prostate compresses the urethra passing through the prostate to cause various symptoms. [0003] Although not yet clearly identified, the cause of enlarged prostate is known to be a variety of complex factors as in other chronic diseases. The currently recognized cause of prostatic hypertrophy is the agi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K47/32A61K47/30
CPCA61K45/06A61K9/209A61K9/4808A61K31/18A61K31/58A61K31/567A61K2300/00A61K9/20A61K9/4891A61K47/30A61K47/32
Inventor 金炯序赵正贤崔荣根金京洙金辰哲金用镒朴宰贤禹钟守
Owner HANMI PHARMA
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