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Anion exchange resin-containing tablets

A technology of exchange resin and anion, which is applied in the field of cholesterol inhibitors, preparation of said tablets and coated tablets, and high-stability coated tablets, which can solve the problems of large number of tablets, etc.

Inactive Publication Date: 2003-06-18
HISAMITSU PHARM CO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets containing a compound represented by the general formula (II) and a large amount of carriers (in order to reduce the bitter taste of the compound) are also problematic in that the number of tablets to be taken at one time is large
Specifically, non-crosslinked anion exchange resins with an average degree of polymerization represented by general formula (I) greater than 10,000 have strong hygroscopicity, and therefore, the existing tableting methods that require a predetermined amount of water cannot be directly applied

Method used

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  • Anion exchange resin-containing tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] (1) Mixing steps:

[0054] The components were mixed using the following mixing apparatus.

[0055] Mixing device: V-type mixer, FMV100 (POWREX).

[0056] (1-1) Mixing method:

[0057] As the mixture formulation mentioned below, 1000 grams of crystalline cellulose and 50 grams of light silicic anhydride were weighed, put into a mixer and mixed therein for 5 minutes.

[0058] Poly(acryloyloxyethyl-N, N-dimethyl-N-benzyl ammonium chloride) with an average degree of polymerization of 12000 (as shown in general formula (I), wherein X is a chloride ion, the compound Hereinafter referred to as "Compound 1") was divided into 4 portions and each portion was added to the mixture separately with 5 minutes between additions of one portion and another portion was added with continuous mixing.

[0059] Next, weigh 50 grams of magnesium stearate, add it to the mixture, and continue mixing for 1 minute.

[0060] (1-2) Mixture formula (10 kg)

[0061] Compound 1 8900 g

[006...

Embodiment 2

[0086] (1) Mixing steps:

[0087] The components were mixed using the following mixing apparatus.

[0088] Mixing device: V-type mixer, FMV100 (POWREX).

[0089] (1-1) Mixing method:

[0090] As the mixture formulation mentioned below, 2000 grams of crystalline cellulose and 50 grams of light silicic anhydride were weighed, put into a mixer and mixed therein for 5 minutes.

[0091] Compound 1 was divided into 4 portions and each portion was added to the mixture separately with continuous mixing, with 5 minutes between the addition of one portion and the addition of the other portion.

[0092] Next, weigh 50 grams of magnesium stearate, add it to the mixture, and continue mixing for 1 minute.

[0093] (1-2) Mixture formula (10 kg)

[0094] Compound 1 7900 g

[0095] Crystalline cellulose 1000g

[0096] (The market name is Avicel PH-310 (average particle size is 40 microns)

[0097] Magnesium Stearate 50g

[0098] Light Silicic Acid 50g

[0099] ...

Embodiment 3

[0103] (1) Mixing steps:

[0104] The components were mixed using the following mixing apparatus.

[0105] Mixing device: V-type mixer, FMV100 (POWREX).

[0106] (1-1) Mixing method:

[0107] For the mixture formulation mentioned below, 1000 grams of crystalline cellulose, 550 grams of lactose and 50 grams of light silicic anhydride were weighed, put into a mixer and mixed therein for 5 minutes.

[0108] Compound 1 was divided into 4 portions and each portion was added to the mixture separately with continuous mixing, with 5 minutes between the addition of one portion and the addition of the other portion.

[0109] Next, weigh 50 grams of magnesium stearate, add it to the mixture, and continue mixing for 1 minute.

[0110] (1-2) Mixture formula (10 kg)

[0111] Compound 1 8350 g

[0112] Crystalline cellulose 1000g

[0113] (The market name is Avicel PH-F20 (average particle size is 17 microns)

[0114] Lactose 550g

[0115] Magnesium Stearate 50g ...

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Abstract

Disclosed are cholesterol-depressant, coated or non-coated tablets for oral administration, which comprise an anion exchange resin of formula (I):wherein X represents a physiologically-acceptable counter ion; and p represents an average degree of polymerization, and is larger than 10,000,silicon dioxide and crystalline cellulose, but not containing water. The non-coated tablets are preferably coated with cellulosic substances. The tablets are easy to take, as being not bitter. The dose of the tablets can be decreased, since the tablets can contain a large amount of the active ingredient. The mixture comprising the constituent components can be directly tabletted in the absence of water.

Description

technical field [0001] The present invention relates to tablets and coated tablets containing anion exchange resins, in particular non-crosslinked anion exchange resins of formula I hereinafter, which are useful as cholesterol suppressants. In particular, the present invention relates to coated tablets having high stability, in which the content of active ingredients is increased, so that they can be administered easily and the frequency of administration can be reduced. [0002] In addition, the present invention also relates to processes for the preparation of said tablets and coated tablets. Background technique [0003] The cross-linked cholestasis is a traditional cholesterol inhibitor, and its problem is that its dosage is large (8-16 g / day), and it must be administered in the form of a suspension. Therefore, a great deal of research has heretofore been conducted to prepare tablets and coated tablets of anion exchange resins. For example, a method of coating solid ch...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/20A61K31/785A61K47/38A61P3/06C08F20/34
CPCA61K31/785A61K9/2054A61K9/2009A61P3/06
Inventor 后藤武目野龙也
Owner HISAMITSU PHARM CO INC
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