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Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation

A technology for solid preparations and coating agents, which is applied in the fields of coating agents for pharmaceutical solid preparations, film preparations for pharmaceuticals and coating solid pharmaceutical preparations, can solve problems such as bad odor and discoloration of medicines, and can prevent deterioration and provide excellent gas barrier properties. Excellent performance and disintegrability

Active Publication Date: 2013-05-01
TORAY IND INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is because if these substances diffuse, there will be problems such as producing a bad smell or discoloring other medicines when made into a package.

Method used

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  • Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation
  • Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation
  • Coating agent for pharmaceutical solid preparation, pharmaceutical film formulation, and coated pharmaceutical solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1）

[0110] Add 10.5 parts by mass of PEG (Macrogel 6000 (average molecular weight 7300 to 9300); NOF), 544.4 parts by mass of 4.5% BT solution and 3.5 parts by mass of Span20 in 445.1 parts by mass of water, and pass through a homogenizer (Polytonon (registered trademark) Model KR) was stirred to obtain a coating agent (hereinafter referred to as "Example 1 coating agent"). It should be noted that, as a 4.5% BT solution, the following solution was used: 45 parts by mass of BT (クニピア-F (cation exchange capacity: 115meq / 100g); Kunimine Industry) was added to 955 parts by mass of stirred water, and the solution was passed through homogenization. The filtrate was obtained by centrifugal separation after the homogeneous dispersion in the dehumidifier, and the supernatant was suction-filtered with filter paper.

[0111] 50g of sodium valproate tablets (デパケン (registered trademark) tablets 200mg; Kyowa Hakko Kirin Corporation) and 200g of blank control tablets ( ) (for increasing the vol...

Embodiment 2）

[0114] Add 20g of montelukast sodium tablets (Singley (registered trademark) tablets 10mg; Wanwu Pharmaceutical) and 230g of blank control tablets (for increasing volume) into a coating pan (DRC-200; Example 1 The coating agent coated montelukast sodium tablets until the thickness of the film reached 60-80 μm. The thus-obtained coated montelukast sodium tablets were stored at 40° C. and a relative humidity of 75% for one week, and the dissolution profile and moisture absorption increase before and after storage were studied.

Embodiment 3）

[0116] Add 5.25 parts by mass of PEG (Macrogol 6000; NOF) and 382.8 parts by mass of 3.2% BT solution to 111.95 parts by mass of water, and stir with a homogenizer to obtain a coating agent (hereinafter referred to as "Example 3 coating agent"). It should be noted that, as the 3.2% BT solution, the following solution was used: 32 parts by mass of BT (クニピア-F; Kunimine Industry) was added to 968 parts by mass of stirred water, uniformly dispersed with a homogenizer, and then centrifuged. The filtrate obtained by suction-filtering the supernatant with filter paper.

[0117] Thereafter, the coating agent of Example 3 was sprayed onto the back of the polypropylene balance pan, and immediately dried with hot air from a drier. After repeating these operations several times, the entire balance pan was left to dry overnight in an oven at 50°C, and the film was peeled off from the balance pan to measure its water vapor transmission rate. In addition, the haze value of the coating agen...

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Abstract

The purpose of the present invention is to provide a coating agent which imparts superior gas barrier properties, equivalent to those of a PTP sheet, to an unpacked pharmaceutical solid preparation without affecting the disintegration properties of the pharmaceutical solid preparation. The coating agent of the present invention comprises polyethylene glycol having an average molecular weight of 950 to 25,000, and swelling clay, and the mass ratio of polyethylene glycol and swelling clay is 2:8 to 6:4.

Description

technical field [0001] The present invention relates to a coating agent for medicine solid preparation, a medicine film preparation and a coated medicine solid preparation. Background technique [0002] Since most drugs are unstable to oxygen and water vapor, most of the commercially available drugs, especially solid drug preparations, are packaged with packaging materials such as PTP (press through pack) sheets to protect them from the effects of oxygen and water vapor. [0003] On the other hand, in the medical field and the dispensing pharmacy, in order to prevent forgetting to take prescribed medicines and taking wrong dosages, multiple medicines taken at one time are taken out of packages such as PTP sheets and collected into 1 One-pack dispensing, which is provided in a single bag, is gaining popularity. Furthermore, in Europe and the United States, it is often the case that patients take out medicines taken out of packages such as PTP sheets into small portions and p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/34A61K9/32A61K9/70A61K47/02A61K47/04A61K47/14
CPCA61K9/2853A61K9/2813A61K9/7007A61K9/70A61K47/14A61K47/02A61K9/28A61K47/10
Inventor 藤崎由记吉井良二高木卓
Owner TORAY IND INC
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