Utilization of the Drug–Polymer Solid Dispersion Obtained by Ball Milling as a Taste Masking Method in the Development of Orodispersible Minitablets with Hydrocortisone in Pediatric Doses
Monika Trofimiuk,
Katarzyna Olechno,
Emil Trofimiuk,
Anna Czajkowska-Kośnik,
Patrycja Ciosek-Skibińska,
Klaudia Głowacz,
Joanna Lenik,
Anna Basa,
Halina Car,
Katarzyna Winnicka
Affiliations
Monika Trofimiuk
Department of Clinical Pharmacy, Medical University of Bialystok, Mickiewicza 2a, 15-222 Bialystok, Poland
Katarzyna Olechno
Department of Pharmaceutical Technology, Medical University of Bialystok, Mickiewicza 2c, 15-222 Bialystok, Poland
Emil Trofimiuk
Department of Clinical Pharmacology, Medical University of Bialystok, Waszyngtona 15a, 15-274 Bialystok, Poland
Anna Czajkowska-Kośnik
Department of Pharmaceutical Technology, Medical University of Bialystok, Mickiewicza 2c, 15-222 Bialystok, Poland
Patrycja Ciosek-Skibińska
Chair of Medical Biotechnology, Faculty of Chemistry, Warsaw University of Technology, Noakowskiego 3, 00-664 Warsaw, Poland
Klaudia Głowacz
Chair of Medical Biotechnology, Faculty of Chemistry, Warsaw University of Technology, Noakowskiego 3, 00-664 Warsaw, Poland
Joanna Lenik
Department of Analytical Chemistry, Institute of Chemical Sciences, Faculty of Chemistry, Maria Curie Sklodowska University, Maria Curie-Sklodowska Square 3, 20-031 Lublin, Poland
Anna Basa
Faculty of Chemistry, University of Białystok, Ciołkowskiego 1K, 15-245 Białystok, Poland
Halina Car
Department of Clinical Pharmacology, Medical University of Bialystok, Waszyngtona 15a, 15-274 Bialystok, Poland
Katarzyna Winnicka
Department of Pharmaceutical Technology, Medical University of Bialystok, Mickiewicza 2c, 15-222 Bialystok, Poland
The objective of the conducted research was to design 2 mm orodispersible minitablets of pediatric doses of hydrocortisone (0.5 mg; 1.0 mg) with desirable pharmaceutical properties and eliminate the sensation of a bitter taste using preparation of solid dispersion by ball mill. Hydrocortisone was selected as the model substance, as it is widely utilized in the pediatric population. ODMTs were prepared by compression (preceded by granulation) in a traditional single-punch tablet machine and evaluated using pharmacopoeial tests, DSC, and FTIR analysis. The methods used to evaluate the effectiveness of the taste-masking effect included in vivo participation of healthy volunteers, in vitro drug dissolution and utilization of an analytical device—“electronic tongue”. The research employed a preclinical animal model to preliminary investigate the bioequivalence of the designed drug dosage form in comparison to reference products. The study confirmed the possibility of manufacturing good-quality hydrocortisone ODMTs with a taste-masking effect owing to the incorporation of a solid dispersion in the tablet mass.
