Composite preparation comprising active-ingredient-containing film coating layer

A technology for composite preparations and active ingredients, which is applied in the field of composite preparations including a film coating layer containing active ingredients, can solve the problems of separation or rupture of the film coating layer, difficulty in ensuring sufficient efficacy of the composite preparation and the quality of commercially available products, and the like, Achieve increased convenience, high marketable product quality, and improved compliance

Active Publication Date: 2017-05-10
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, if the film coating layer has insufficient tensile strength, the film coating layer may be separated or ruptured by the usual impact during storage of the product, making it difficult to ensure sufficient efficacy of the compound formulation due to changes in appearance and other properties and maintaining the quality of a commercially viable product, ultimately resulting in the inability to commercialize the formulation as a product

Method used

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  • Composite preparation comprising active-ingredient-containing film coating layer
  • Composite preparation comprising active-ingredient-containing film coating layer
  • Composite preparation comprising active-ingredient-containing film coating layer

Examples

Experimental program
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preparation example Construction

[0090] 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.

[0091] Coating of the core can be performed using any available film coating methods used in the pharmaceutical field, such as pan coating, fluidized bed coating or press coating. However, the embodiments are not limited thereto.

[0092] When the 5-alpha-reductase inhibitor is finasteride (classic 5-alpha-reductase inhibitors known to be teratogenic), a separate independent production line is required to pr...

Embodiment 1-10 and comparative example 1-8

[0095] Examples 1-10 and Comparative Examples 1-8: Preparation of Composite Preparations Comprising Finasteride-Containing Film Coating Layers

[0096]Coating solutions were prepared by mixing corresponding coating materials with organic solvent-water mixed solvents at various mixing ratios according to various compositions shown in Tables 1 to 3, and then by using a pan coating machine (SFC-30, available from SejongPharmatech Co., Ltd.) was coated on a tadalafil-containing tablet core (mass of unit dose: 160 mg). Tablet cores containing tadalafil are prepared by mixing tadalafil with mannitol, pregelatinized starch, hydroxypropyl cellulose, sodium lauryl sulfate and sodium starch glycolate, granulating the resulting mixture, and The resulting granules are obtained by tableting. The tablet cores coated with a pan coater were dried at about 35° C. for about 30 minutes, thereby preparing a composite comprising a tadalafil-containing tablet core coated with a finasteride-conta...

Embodiment 12-21

[0133] Examples 12-21: Including tamsulosin hydrochloride coated with a film coating layer containing a 5-alpha-reductase inhibitor Preparation of compound preparation of capsule core

[0134] A coating solution was prepared by mixing coating materials (Examples 12 to 21) having different compositions as shown in Table 7 with an ethanol-water mixed solution (ethanol:water=1:1 (v / v)), Then by using a pan coater (SFC-30, available from Sejong Pharmatech Co., Ltd.) coated on the 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.

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Abstract

Provided are a composite preparation and a method for producing same, the composite preparation comprising: a core containing a first active ingredient; and a film coating layer containing a 5-alpha-reductase inhibitor, wherein the film coating layer is coated with a film coating solution which is a mixed solvent of water and organic solvent with a ratio of 30-80 wt% of the latter, and in which film coating material dissolved.

Description

technical field [0001] The present invention relates to a kind of composite preparation comprising the film coating layer containing 5-alpha-reductase inhibitor and its preparation method, more particularly, relate to a kind of comprising the film coating layer containing 5-alpha-reductase inhibitor A composite preparation that can have improved content uniformity and high dissolution rate of active ingredients and can maintain a stable shape against usual external impacts, and a method for preparing the composite 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 recogn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/48A61K47/32A61K47/30
CPCA61K45/06A61K9/209A61K9/4808A61K31/18A61K31/58A61K31/567A61K2300/00A61K9/20A61K9/4891A61K47/30A61K47/32
Inventor 金炯序赵正贤金辰哲金用镒朴宰贤禹钟守
Owner HANMI PHARMA
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