The US patent filing covers the manufacturing process for a soft chewable product for delivering an API (active pharmaceutical ingredient). Manufacturing of the dosage form is done without extrusion.
“Processes for manufacturing the edible soft chews do not require the use of heat or the addition of water during mixing of active and inactive ingredients, provide stable concentrations of the active ingredient, and produce chews of consistent weight and texture”, Bayer wrote in a US patent filing.
Manufacturing the dosage form without using extrusion allows Bayer to avoid heat generated when using this process. Heat can cause deterioration of the drug’s stability and lead to API degradation.
As such Bayer wrote: “Preferably, the method would be performed without application of any heat above room temperature to the mixture or formed product. It is also desirable that the chews be susceptible to manufacture without use of costly, pharmaceutical grade water as an ingredient.”
The Bayer process cuts out the use of water by adding the ingredients to a mixing vessel capable of blending the material and casting it against the side of the container. Taking this approach cuts the risk of microbial growth – and costs – from the use of pharmaceutical grade water in production.
An oil suspension and liquid ingredients, such as softening agents, are added to the dry materials. After blending the mixture is passed, without compression, into a moulding machine. Bayer thinks the machine could output more than 50,000 units per hour.
Pressing the dosage into this chewable form could increase compliance among people and animals. For humans Bayer envisages using sweet flavourings, such as sugars or molasses, to make it more pleasant to take the medicine.