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Pharmaceutical capsule composite formulation comprising tadalafil and tamsulosin

A compound preparation, the technology of tadalafil, is applied in the directions of pharmaceutical combinations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. Problems such as poor stability and difficulty in developing fixed compound formulations to achieve the effects of excellent product stability, high productivity, and excellent dissolution rate

Active Publication Date: 2016-02-17
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, when the amount of active ingredients to be combined is too large or too small, it may be difficult to prepare a composition of suitable quality
Third, in the preparation of combination drugs, the dissolution rate and stability of the compound formulation may be deteriorated due to the interaction between the different active ingredients of the compound formulation, therefore, it makes it difficult to develop a drug for administration in a physicochemically stable form fixed compound preparation
However, the above method will require special manufacturing equipment (e.g. tablet presses) for bi- or tri-layer tablets, and interactions between ingredients in adjacent regions of the tablet may also occur
In contemporary technology, it is not yet possible to establish a perfect separation between components

Method used

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  • Pharmaceutical capsule composite formulation comprising tadalafil and tamsulosin
  • Pharmaceutical capsule composite formulation comprising tadalafil and tamsulosin
  • Pharmaceutical capsule composite formulation comprising tadalafil and tamsulosin

Examples

Experimental program
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Effect test

Embodiment 1

[0050] Embodiment 1: Capsule compound preparation I

[0051]

[0052]

[0053]

[0054]

[0055]

[0056] The ingredients in powder form corresponding to individual fractions of tadalafil were mixed and the mixture was compressed into tablets by a round punch with a diameter of 5.5 mm. The tadalafil tablet of gained is coated with solution (that is, Yellow (Colorcon Ltd.) solution in purified water) for coating.

[0057] In addition, ingredients corresponding to separate parts of tamsulosin were mixed in powder form, and the mixture was prepared into granules. The resulting tamsulosin granules are coated with an inner coating solution (i.e., a solution of povidone, propylene glycol and polyvinyl acetate in water), and then coated with an outer coating solution (i.e., methacrylate-ethyl acrylate copolymer and triacetin in water) for further coating.

[0058] The thus coated tadalafil tablets and tamsulosin granules were filled into hard capsule No.1 having hypr...

Embodiment 2

[0059] Embodiment 2: capsule compound preparation II

[0060] A capsule compound formulation containing 5 mg of tadalafil and 0.2 mg of tamsulosin hydrochloride was prepared in the same manner as in Example 1, except that the hard capsule used had pullulan as the capsule material.

Embodiment 3

[0061] Embodiment 3: capsule compound preparation III

[0062] A capsule composite formulation containing 5 mg of tadalafil and 0.2 mg of tamsulosin hydrochloride was prepared in the same manner as in Example 1, except that the hard capsule used had gelatin as the capsule material.

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Abstract

Disclosed are a capsule composite formulation for preventing or treating erectile dysfunction and benign prostatic hyperplasia comprising tadalafil and tamsulosin, and a method of preparing the same. The capsule composite formulation of the present invention enables the complete separation of the two pharmaceutically active ingredients and minimizes reactivity between the active ingredients, and thus provides excellent product stability over time, thereby maximizing the therapeutic effects thereof.

Description

technical field [0001] The present invention generally relates to a capsule composite formulation comprising tadalafil and tamsulosin for preventing or treating erectile dysfunction and benign prostatic hyperplasia and a preparation method thereof. Background technique [0002] Erectile dysfunction and benign prostatic hyperplasia are common conditions among men aged 50 and over. Erectile dysfunction is a sexual dysfunction characterized by the inability to develop or maintain a penile erection during sexual activity due to a variety of causes including cardiovascular disease, diabetes, hormone deficiencies, and others. Benign prostatic hyperplasia is an increase in the size of the prostate which causes difficulty urinating with accompanying or subsequent complications such as urinary tract infection, urinary stones, hematuria, kidney failure, etc. [0003] Tadalafil is a substance belonging to the class of phosphodiesterase 5 (PDE5) inhibitors such as sildenafil and varden...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4985A61K31/18A61P13/08
CPCA61K9/48A61K31/18A61K31/4985A61P13/08A61K9/2054A61K9/209A61K9/4808A61K9/5026A61K9/5073A61K9/5084A61K2300/00A61K9/0053A61K9/16A61K9/28A61K9/2833A61K9/2886A61K9/2893A61K47/00
Inventor 朴炯玟金用镒朴宰贤禹锺守尹英洙
Owner HANMI PHARMA
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