Kotobuki pharmaceutical Co., Ltd.

Formulation Developments

What is "Kawara OD Tablets®”?

“Kawara Tablets” can be easily divided by pressing them from above with your fingers, like splitting tiles in karate.

[Karate Chop on Kawaras]

The below Black tile is called “Kawara” in Japanese.
Black belt in Karate practitioners can easily break “Kawara” with their bare hands.

“OD Tablets” are an abbreviation for Orally Disintegrating Tablets, and are tablets that can be taken by quickly dissolving or disintegrating in the mouth.
“Kawara OD Tablets®” are tablets that combine the properties of both ” Kawara Tablets” and “OD Tablets”.
” Kawara Tablets” + “OD Tablet” = “Kawara OD Tablet®
“Kawara OD Tablet®” is a registered trademark of Kotobuki Pharmaceutical Co., Ltd. (Trademark registration number 6475203).
The dividing surface facing the dividing line (split groove) is a unique V-shaped straight line to divide the tablet easily and accurately.

[Value-added Products]

Loop diuretic: Torsemide tablets 4mg/8mg “KO”,
Cancer pain/Chronic pain treatment: Tramadol hydrochloride OD tablets 25mg/50mg “KO”,
Parkinson’s disease treatment (levodopa activator): Zonisamide OD tablets 50mg TRE “KO”

Tramadol hydrochloride OD tablets 50mg “KO”

Zonisamide OD tablets 50mg TRE “KO”

Easy to Swallow Tablets

Learn from the bellows of Japanese swordsmiths
(Use of intermittent pulsating waves)

The wet-drying formulation of fast-disintegrating tablet were launched by an American company in 1997.

In 1999, our main product of Marzulen-S granule, which is unstable in water, transformed “Easy to Swallow” tablet Project started.

How to get the lubricant to adhere to the pestle and mortar?

One company charged the pestle and mortar with static electricity to make the lubricant stick, but this was impossible with larger tablets.

And, we learned from Japanese sword smiths.
They used bellows to send cold air through intermittent pulsating waves to melt iron at high temperatures and create the raw material for Japanese swords.

It may be possible to manufacture “Easy to Swallow” tablets by sending a lubricant with intermittent pulsating waves and tableting in it.

We can succeed to research into spraying lubricant using intermittent pulsating waves, which work in the same way as a used by blacksmiths, and then tableting in the spray to create a thin coating of lubricant on the surface of Marzulen Easy to Swallow tablet.

In 2002, we submitted the formulation patent.
In 2003, we launched first “Easy to Swallow” tablet, Marzulen Easy to Swallow tablet.

Tableting machines for “Easy to Swallow” tablets

Development of an Enteric-coated formulation

An Enteric-coated formulation is a formulation that does not disintegrate in the stomach, but only disintegrates after it is transferred to the intestine. When making tablets of drugs that break down in the stomach or drugs that cause stomach disorders when dissolved in the stomach, Enteric-coated tablets are used when you want to delay the time of action.

Enteric-coated formulations of U.S. Vutaunin (USA) were dominating the global market, and our company decided to process the formulations in Japan. We learned that the Enteric coating technology, which is the key in the manufacturing process of Enteric formulations, is based on the same principle as the manufacturing process of Japan’s “kompeito (Japanese sugar candy).” We independently modified an edible pot used to manufacture “kompeito” created an Enteric coating machine, and successfully formulated the drug.

Kotobuki Pharmaceutical Co., Ltd. became the first in Japan to successfully manufacture and start selling Buformin hydrochloride Enteric-coated tablets 50mg “KO” (formerly known as Zibeton S Enteric-coated tablets) at 1968. At the time, there were no Enteric-coating machines, so we made our own coating machine and were able to formulate the drug in Japan.

In addition, upon hearing this news, the pharmacy department of the Japanese Red Cross Central Hospital in Hiroo, Shibuya Ward, Tokyo, visited our company to observe the manufacturing process of Enteric formulations.