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Pharmaceutical composition comprising porous dry matrix

A dry, matrix technology, applied in drug delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc.

Inactive Publication Date: 2012-07-04
株式会社医药处方
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still many problems to be improved, because it is clear that drug efficacy varies with the way the gel is broken when taken (Yakuzaigaku, 60(4), 261-270(2000))

Method used

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  • Pharmaceutical composition comprising porous dry matrix
  • Pharmaceutical composition comprising porous dry matrix
  • Pharmaceutical composition comprising porous dry matrix

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0235] Embodiment 1: the research of heat drying treatment

[0236] A study of heat-drying treatment instead of conventional freeze-drying treatment was performed as follows. First, 1.0 g of sodium carboxymethylcellulose, 5 g of crystalline cellulose, 5 g of medium-chain fatty acid triglycerides, 4 g of white sugar, and 15 g of pure water were mixed and kneaded to obtain a clay-like composition. This composition was elongated and formed into samples having a thickness of about 3 mm and dimensions of about 6.6 cm x about 2.6 cm. With this sample, heat drying was carried out at each temperature shown below.

[0237] When the water activity of the formulation became below 0.55, the sample was allowed to cool down and the porous dry matrix formulation was stored in an airtight container. The resulting porous dry matrix formulation maintained a thickness of about 3 mm. For formulation evaluation of this formulation, the form retention and void content of the formulation were d...

Embodiment 2

[0245] Embodiment 2: the addition amount of composition and porosity

[0246] In order to confirm the essential factors of the composition of Example 1, the composition amounts (grams) listed in Table 2 below were weighed. Mix 1.0 g of sodium carboxymethylcellulose, 5 g of crystalline cellulose, 5 g of medium-chain fatty acid triglycerides, sugars or sugar alcohols (4 g) shown in Table 2 below, and 15 g of pure water at room temperature. Drying by heating yields a porous dry matrix preparation.

[0247] Preparations were produced in the same manner as in Example 1, and the heat treatment was completed when the water activity of the preparations reached below 0.55, or when the moisture content in the preparations reached below 10 w / w%. The porosity and shape retention of the resulting porous dry matrix formulations are shown in Table 2 below. As shown by this result, it was found that the porosity tends to decrease as the amount of the additive increases. It was also found...

Embodiment 3

[0258] Example 3: Addition Effect of Composition Affecting Porosity

[0259] In order to confirm the effect of adding sugar and medium-chain fatty acid triglyceride among the ingredients of Example 2, a sugar-free porous dry matrix preparation (No. 7 in Table 4 below) was newly prepared. The formulation was prepared in the same manner as in Example 2; the porosity and shape retention of the resulting porous dry matrix formulation are shown in Table 4 below.

[0260] [Table 4]

[0261]

[0262] [Note]

[0263] ○: Good, ×: Poor, △: Uncertain.

[0264] From this result, it was confirmed that sugar can significantly improve the feeling of taking as a sweetener. It has also been shown that sugar also contributes significantly to improving the feel of the teeth. On the other hand, it was confirmed that when medium-chain fatty acid triglycerides are used as edible oil / fat, it can mask the ingestion feeling (powdery tooth touch) of excipient ingredients (crystalline cellu...

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Abstract

A new administration form for oral administration is provided. A porous dry matrix preparation comprising at least a polymeric thickener and an excipient ingredient, wherein (1) the content of the polymeric thickener is down to 0.5 w / w% and up to 14 w / w%, (2) the content of the excipient ingredient is down to 30 w / w% and up to 80 w / w%, (3) the void ratio is not less than 20%, and (4) the water activity is not more than 0.55, or water content is not more than 10 w / w%.

Description

[0001] This application is a divisional application of a national phase PCT application with application number 200780051783.4 (the international filing date is December 25, 2007) and the invention title is "porous dry matrix pharmaceutical composition". technical field [0002] The present invention relates to an oral pharmaceutical composition containing a drug in a porous dry matrix comprising at least a polymeric thickener (carboxymethylcellulose salt, etc.) and an excipient. Furthermore, the present invention relates to a method for the manufacture of said oral pharmaceutical composition. Background technique [0003] When administering pharmaceuticals orally, solid preparations such as tablets, granules, powders and the like are generally used. Recently, the development of novel drug delivery systems (DDSs) is underway, among which studies on jelly preparations have been carried out. That is to say, because the jelly-like preparation has a high water content, it h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/00
CPCA61K9/2013A61K9/2054A61K9/2018A61K31/795A61K9/2027A61K47/30A61K47/38A61K47/44A61K47/10A61K47/26
Inventor 石桥贤树小林胜则浜本英利
Owner 株式会社医药处方
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