© Sandra Hallinger / Fotoagentur Wild & Team
Bion®3 three-layer tablets: It takes special know-how to combine three layers in a very tiny space
It’s amazing to think about what you can consume with a glass of water: Bion®3 is the name of a diet product — a tablet whose tremendous spectrum of health activation features compacted into such a tiny space was only made possible by patents and special manufacturing processes.
“The tablet consists of three layers,” says Klaus Raunegger, Managing Director of the Merck plant in Spittal, in the Austrian state of Carinthia, whose office provides a view of the magnificent mountains of the eastern Alps. Many people are already familiar with two-layered structures that can be found in dishwashing tablets, although these are much larger than Raunegger’s products. Combining three precisely defined layers into an extremely small space requires special expertise, however — and the people in Spittal possess this knowledge. This is why they may soon achieve a manufacturing milestone: delivering one billion Bion®3 tablets a year.
Bacteria must reach the intestines alive
So why three layers? As the chemist who manages pharmaceutical production operations in Spittal, Dr. Gerald Schwarzenbacher knows the answer. “Our goal is to make the broadest possible contribution to improving health with the use of just one tablet,” Schwarzenbacher explains. “The idea is to get vitamins, minerals, and probiotic bacteria for strengthening the body’s immune system into the intestines with just one application.”
The bacteria used here are imported alive and freeze-dried from Japan. They need to be carefully handled by the formulation scientists, which is the technical term used to describe experts in the development of dosage forms. “The bacteria are sensitive to moisture and acids, which can form from some of the vitamins included in the tablets. And there can be as many as 12 vitamins, depending on the target markets,” says Schwarzenbacher. Moisture kills the bacteria, thus preventing them from having their immune-strengthening effect across the intestinal mucosa, which can cover an area of up to 400 square meters.
To ensure that all three components interact properly in a single tablet, the Merck facility in Darmstadt developed not only the tablet formula but also the process for transferring the product from the lab to large-scale production operations. Dr. Markus Rudolph from Merck headquarters is responsible for this. “My job is to define the technological concept used for a new product,” Rudolph explains. The Austrians, in turn, handle the details for concept execution, as does an additional plant in Mexico.
Raunegger explains the production process during a tour of the production facility: “We mix the substances for the vitamin and mineral layer in accordance with the formula; the basic raw substances undergo strict quality control beforehand.” A giant mixing machine can handle several hundred kilograms of materials, whose contents are repeatedly pre-mixed, broken down into small pieces, sifted, and then remixed to ensure that the subsequent main mixture is a truly homogenous mass. This process is conducted separately for each of the three layers. In this system, an eight-hour factory shift can press, coat, and package one million tablets.
The Bion®3 manufacturing process