JPS59199627A - Method for stabilizing tablet - Google Patents

Abstract

PURPOSE:To obtain easily stable tablets, by forming an additive and a chemical causing chemical reaction in contact in the state of powder separately into tablets to make them present in one dose package of divided packaging. CONSTITUTION:An additive and a chemical, e.g. an effervescent tablet, consisting of aspirin and an antacid, vitamin C and an antacid, an organic acid and a bicarbonate, causing chemical reaction in contact in the state of powder are separately formed into tablets, made present in one dose unit (in one dose package) of divided packaging and stabilized. The above-mentioned method is applicable to the method for tableting all the additives and chemicals causing chemical reactions by mutual contact. The additives and chemicals can be taken out at the same time for use due to the presence in one dose package, and the same effect of use as in two- or three-layer tablets, etc. can be expected. The method can be applied to all the industrial fields, e.g. medicines, foods, agricultural chemicals, fertilizers, etc.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a method for stabilizing tablets containing two or more additives and/or pharmacologically active substances (drugs) that cause a chemical reaction when brought into contact in powder form.

When tablets containing two or more drugs and/or additives are stored, chemical reactions due to mutual contact may cause discoloration or embossment.

To prevent such decomposition during storage, for example, in tablets containing aspirin and antacids, aspirin (
In order to prevent chemical reactions between antacids (acidic substances) and antacids (basic substances), double-layer tablets or double-layered tablets are used to stabilize the drug.

However, these methods require special processing techniques and equipment, and have problems in terms of manufacturing costs.

Therefore, the present inventors have conducted intensive studies on a method for stabilizing tablets that cause chemical reactions when two or more drugs and/or additives are mixed together. The present inventors have discovered that stabilization can be achieved by making tablets and coexisting them in one dosage unit (in one package) in divided packaging, and have completed the present invention.

According to the present invention, no special processing technology or equipment is required in the production of tablets, and the present invention can be applied to tabletting all drugs and additives that cause chemical reactions when they come into contact with each other. It can now be applied to drugs and additives that had previously been abandoned due to the difficulty of forming them into tablets such as triple-layer tablets and double-layered tablets, which were the standard means of stabilizing drugs.

In other words, the present invention eliminates the need for special processing such as triple-layer tablets and double-layer tablets, which have been the standard means of stabilizing tablets of this type, and instead uses substances that cause chemical reactions upon mutual contact in combination with the packaging form. Separate tablets, each packaged in one dose unit (
It has become possible to easily produce stable tablets by simply coexisting in the same package (in one package).

As for the packaging form of the powder, any packaging form may be used as long as it is a separate package and allows tablets to coexist in one dosage unit (in one package). In addition, there are no particular limitations on the packaging material.
Depending on the substance used, moisture-proof packaging materials or light-shielding packaging materials may be used.

The drugs and additives used in the powder method are not particularly limited, and the powder method can be applied to any substance that causes a chemical change upon contact with the powder.

Examples include a combination of aspirin and an antacid, a combination of an unstable enzyme component and an antacid, and a combination of vitamin C and an antacid.

The applicable fields of the law include all industrial fields such as pharmaceuticals, foods, agricultural chemicals, and fertilizers.

In the case of powdered tablets, additives and drugs that cause chemical reactions when they come into contact with each other are made into tablets separately, but they coexist in one dosage unit (one package), so they are taken out and used at the same time. Therefore, it is expected to have the same effect of use as triple-layer tablets, double-layer tablets, etc.

As described above, according to the present invention, it is possible to stabilize a tablet containing two or more drugs and/or additives that cause a chemical reaction when brought into contact in a powdered state.

Examples will be described next, but the present invention is not limited thereto.

Example 1 (1) Tablet containing aspirin Aspirin 200Wv Corn starch 36■ Tal
After mixing aspirin and corn starch in the above amounts, granules are produced by dry granulation.

After mixing talc with the granules in the above amount, tablets each having a weight of 240 mm and a diameter of 9 mm were made using a tablet machine.

(2) Tablet containing antacid Magnesium carbonate 200 ■ Corn starch 889 Magnesium stearate 2 ■ Magnesium carbonate and corn starch were mixed in the above amounts, and then granules were produced by dry granulation. After mixing magnesium stearate with granules, by tablet machine/tablet weight 240I
Tablets with a diameter of 9 gourds were prepared.

(3) Discounted tablets One tablet containing aspirin and one tablet containing an antacid were filled into a parent packaging device package made of glassine and polyethylene to prepare a packaged preparation.

Comparative example 1 Aspirin 200q Magnesium carbonate 2 (10■ Corn starch 74q Tarri)
4 η Magnesium stearate 2 ■ Add aspirin and JjJ to the above amount. Magnesium and corn starch were mixed to form tablets with a diameter of 12 mm and each tablet weighing 480 ~.

A sachet containing one tablet was prepared using the packaging material of Example 1.

As a result of storing the sachets of Example 1 and Comparative Example 1 under the conditions of 40°C and 75% relative humidity for one month, no change was observed in Example 1, but no color change was observed in Comparative Example 1. and an acetic acid odor was observed.

Claims (1)

[Claims] It is characterized in that the additives and/or pharmacologically active substances that cause a chemical reaction when they come into contact with each other in powder form are made into tablets separately and then coexisted in one dosage unit (in one package) in a separate package. Tablet stabilization method.