Development of pharmaceutical products

Developing a finished product is an interdisciplinary process involving many Krka experts (some projects involve more than 50 experts). Our products are the result of extensive and thorough chemical, technological, analytical, preclinical and bioequivalence research. This integration of know-how from different fields allows us to develop and pursue a common objective effectively – the finished product in line with the highest quality, safety, and efficacy standards.

At Krka, we develop different pharmaceutical forms, but our most common products are immediate-release tablets or capsules. We also develop and produce advanced pharmaceutical forms such as prolonged-release tablets, matrix tablets, and tablets employing the osmotic-controlled release oral delivery system. We are one of the leading companies developing and producing pellets contained in capsules. We have been expanding our range of bilayer tablets by developing products containing combinations of two or more APIs. We were among the first generic companies to obtain marketing authorisation for a new generation of orodispersible tablets and lozenges. Apart from the above, we also develop liquid oral dosage forms (syrups, solutions, suspensions) and sterile dosage forms.

From raw materials to finished products

We study new and innovative approaches and look for non-infringing product solutions. We conduct carefully planned experiments to determine the composition of each product. One tablet can contain more than ten excipients that may impact the release and stability of the API.

The selection of excipients is essential to developing the technological procedure used to produce the medicinal product. Sometimes target properties cannot be achieved through standard technological procedures (e.g. tabletting, dry or wet granulation). In those cases, we can achieve them by developing and using more complex procedures (e.g. extrusion, hot-melt extrusion, spray drying, etc.). We also use in-process analytical techniques to monitor and analyse the obtained process data, gaining additional insight into the microenvironment of individual technological experiments. That knowledge is then effectively used to develop robust technologies for use in the industry.

Appropriate packaging is selected for each product to ensure its protection and stability.

Analytical methods are developed in parallel to the development of pharmaceutical forms and used, in combination with different research approaches tailored to each experiment, to evaluate and guide the development of each product (towards its set objective).

Stability and BEQ studies are key milestones on the path from prototype to product for which safety and efficacy have been confirmed. Stability studies serve to confirm product quality throughout its entire life cycle, while BEQ studies serve to demonstrate that Krka’s products are bioequivalent to reference products and are thus of comparable safety and efficacy.