Anna Kluk

Title: Development and evaluation of nanofibrous oral strips-new drug delivery system for poorly soluble drugs

Anna Kluk

Zentiva k.s., Czech Republic

Biography

Anna Kluk Ph.D. is a graduate of the Faculty of Pharmacy, Medical University in Gdansk, Poland.

Her 5-year studies have been dedicated to the design, development and evaluation of modern pediatric drug forms and evaluation of their acceptability in pediatric population during clinical trials. During her Ph.D. studies she was a grant researcher in research projects of Ministry of Science and Higher Education and teacher of pharmaceutical technology and biopharmacy to pharmacy students and postgraduates working in pharmacies and in the pharmaceutical industry. In her current role, she is working in the pharmaceutical industry on the position of Formulation Scientist Junior in Zentiva k.s., Sanofi Company Group, being responsible for the design and development of generic drugs.

 

Abstract

Orodispersible films (ODFs) have recently gained much attention as a very beneficial formulation for pediatric and geriatric patients, where the difficulty of swallowing of the standard solid drug forms needs to be eliminated. Orodispersible films either disintegrate quickly in the oral cavity to be swallowed easily or stay in the particular place in the mouth due to their mucoadhesive properties. Thus ODFs are used as rapid release products and as buccoadhesive or swallowed controlled drug release systems.

                One of the most recent method of ODF production is electrospinning - a process, where polymer nanofibers (diameter from few nanometers to several micrometers) can be produced using an electrostatically driven jet of the polymer solution or melt. The main advantage of nanofibrous oral strips is an increased bioavailability of poorly soluble drugs as a result of API conversion from crystalline to amorphous form, incorporated into polymeric nanofibers. Additionally, due to the porous structure of polymeric nanofibers, obtained ODFs (in comparison with products obtained by casting method) demonstrate favorable properties, including homogeneity of thickness and assay, faster disintegration and immediate dissolution.

                However, one of the most important requirements of electrospinning is to prepare the final formulation in the form of solution. When using water-soluble polymers water can be applied as solvent in the electrospinning process, however, it is not sufficient to dissolve poorly soluble drugs. The present study relates to the composition of the solution used for electrospinning process in order to prepare orodispersible films as well as the composition of ODFs, comprising poorly soluble therapeutic agents. Preparation of the stable solution, stabilization procedures and effective taste masking have also been proposed.

Takeaway Notes

•Familiarization with the requirements and details of the new potential production method for oral drug forms

•Example of innovation and “out of box” thinking in the design of drug delivery systems

•Example of  an effective taste masking method and amorphization technique of poorly soluble drugs