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A kind of packaging material for oral soft capsule preparation containing dutasteride

A soft capsule preparation and packaging material technology, which is applied in the field of packaging materials with storage stability, can solve the problems of reduced solubility of main components and reduced bioavailability, and achieve excellent disintegration stability of preparations and excellent drug dissolution stability.

Inactive Publication Date: 2020-11-17
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, for dutasteride, which is poorly soluble, the solubility of the main component can be reduced due to the penetration of moisture from the gelatin film into the content liquid, thereby reducing the bioavailability, so new methods are needed to improve this problem

Method used

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  • A kind of packaging material for oral soft capsule preparation containing dutasteride
  • A kind of packaging material for oral soft capsule preparation containing dutasteride
  • A kind of packaging material for oral soft capsule preparation containing dutasteride

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0070] Preparation Example 1: Preparation of Soft Capsules Containing Dutasteride

[0071]

[0072] Dutasteride (MSN Laboratories Ltd) was dissolved in MCM oil (Abitech) and the remaining components were sequentially added and dissolved to obtain a self-emulsion.

[0073]

[0074] Using the components and contents shown in Table 1 below, glycerin, glycine and purified water were placed in a gelatin dissolving tank, uniformly suspended with a homomixer, and then wetted with succinic acid gelatin and purified water.

[0075] According to the preparation method of soft capsules in the Korean Pharmacopoeia General Rules of Preparations, the prepared filling contents were filled into soft capsules in the same amount using a soft capsule molding machine (Bochang, BCM-GB) to prepare soft capsule preparations. At this time, the gelatin solid sheet (sheet) before soft capsule formation was adjusted so that the film thickness after molding was 0.8 mm.

[0076] 【Table 1】

[0077]...

Embodiment 1 to 14 and comparative example 1 to 4

[0078] Examples 1 to 14 and Comparative Examples 1 to 4: Measurement of water vapor permeability when soft capsule preparations containing dutasteride are packaged with various packaging materials

[0079] As shown in Table 2 below, use Al-Al, HDPE, PVDC-Al, PCTFE-Al, PVC-Al+Al, LDPE, PP-Al, PVC-Al, and pack them in blisters, bottles, bags, etc. The soft capsule comprising dutasteride prepared in Preparation Example 1.

[0080] Said Al uses TEKNILID 1207 (Tekniplex company), HDPE uses DB161 (Duma company), PVDC uses VDC250-40 (Tekniplex company), PCTFE use VA1060 (Tekniplex), VA10200 (Tekniplex), PVC use 1001C (Tekniplex company), LDPE use VP020 / 002 (Vivek polymer company), PP use PP250 (Tekniplex Corporation).

[0081] In Table 2 below, Example 1 is a medical product packaged in a blister (Blister) with a top plate formed by bonding Al with a thickness of 25.4 μm to a plastic bonding film of PO material with a thickness of 50.8 μm and a base plate formed of Al mate...

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Abstract

The invention provides a packaging material for an oral soft capsule preparation comprising dutasteride, the packaging material has a water vapor permeability (WVTR) of 0.005g / m at 38°C and a relative humidity of 90%. 2 / day to 0.75g / m 2 / sky. Said packaging material, even under the condition that the oral soft capsule preparation comprising dutasteride is stored for a long time, the properties of its preparation do not change, and show excellent preparation disintegration stability and drug dissolution stability, therefore It is very suitable as a packaging material for oral soft capsule preparations containing dutasteride.

Description

technical field [0001] This application claims the benefit of priority based on Korean Patent Application No. 10-2015-0184221 filed on December 22, 2015, and all the contents disclosed in said Korean Patent Application Document are incorporated in this specification as a part of this specification . [0002] The present invention relates to a packaging material for oral soft capsule preparations containing dutasteride, and more specifically, to a packaging material with improved storage stability for soft capsule preparations containing dutasteride. Background technique [0003] Dutasteride represented by the following chemical formula (chemical name: 17β-N-(2,5bis(trifluoromethyl))phenylcarbamate-4-aza-5α-androst-1-ene-3 -ketone), is a dual 5-alpha reductase inhibitor that inhibits the conversion of testosterone to dihydrotestosterone (DHT). This compound is known to be useful in the treatment of benign prostatic hyperplasia, prostate cancer and male pattern baldness (see...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B65D65/02A61K31/58A61K47/14A61K9/48B65D65/38C08L101/00C08L27/06
CPCA61K47/44A61K9/48A61K31/58B65D65/02B65D65/38C08L27/06C08L101/00
Inventor 金载镐金辰哲李炳俊金用镒朴宰贤禹钟守
Owner HANMI PHARMA