by Anastasia Zakharyuta, Post-Doctoral Researcher, Boehringer Ingelheim Pharma GMBH Co & KG
This presentation will focus on the development of formulations for pre-clinical studies is attempted in two different forms, namely basic and complex release solid dosage formulations. The former dosage is aimed to provide an alternative to suspensions, as to minimize variability by improving stability and repeatability of the routine formulations.
The latter provides the complex formulations at the early stage of rodent studies, by combining different formulation mechanisms. The different design for such formulations is feasible with regard to the desired release profile and administration route.
Herein, printing procedures are established for solid dosage fabrication, through incorporation of a number of low molecular weight biodegradable polymers via piezo-actuated inkjet printing.
The “mini-pills” of specific dimensions and application-appropriate architecture, suitable for administration via the rodent feeding tubes (≤1-4 mm diameter) or subcutaneous administration, are constructed in a layer-by-layer fashion.
The established protocols are further transferred to a routinely applicable platform, as to facilitate a broad range of structurally different API.
Note: Live translation from English into Italian will be available at the location.
Nota Bene: all’evento sarà disponibile il servizio di traduzione simultanea italiano-inglese, inglese-italiano.
What drives you?
To contribute to the efforts of Pharmaceutical Research, by incorporation of printing technologies in order to improve the quality of routinely used formulations and expending the options available thereof. Routine availability of complex formulation mechanisms at the early stage has a potential of accelerating the translation of the candidate compounds into Development phase.
Why should the delegate attend your presentation?
The insights into the challenges associated with formulations in pre-clinical research will be discussed. Further, benefits and translation possibilities of printing technologies into the Research and Development scenery will be introduced on the example of the developed “mini-pill” formulation.
What emerging technologies/trends do you see as having the greatest potential in the short and long run?
What kind of impact do you expect them to have?
The potential of pharmaceutical printing is widely discussed, particularly within the scope of personalized medicine, ultimately aiming the improved drug effectiveness and reduced side effects. Complex design capability, variable manufacture scale and dosage, compound combination opportunity, release order/rate and polymorphic form control of API and finally the potential possibility of point-of-use production are foreseen to be the benefits of such innovation.
Incorporation of the printing technologies as early as the Research and Development phase will not only facilitate the efforts of the said units, but also form a plausible precedent within the Industry and provide accumulation of experience in the field.
What are the barriers that might stand in the way?
Apart from the obvious infrastructure investment necessity, regulatory issues can be expected to form the biggest challenge in translation of the printing technologies into production of the marketable pharmaceutical products.
About Anastasia Zakharyuta
Anastasia Zakharyuta currently works as a Post-Doctoral Researcher at Boehringer Ingelheim Pharma GMBH Co KG. She obtained her PhD in 2016 at Sabanci University, Biological Sciences and Bioengineering after an MSc in Material Science and Engineering. She holds a BSc in Biochemirsty (Ege University).
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.