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

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 se...

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Bibliographic Details
Published in:Pharmaceutics 2024-08, Vol.16 (8), p.1041
Main Authors: Trofimiuk, Monika, Olechno, Katarzyna, Trofimiuk, Emil, Czajkowska-Kośnik, Anna, Ciosek-Skibińska, Patrycja, Głowacz, Klaudia, Lenik, Joanna, Basa, Anna, Car, Halina, Winnicka, Katarzyna
Format: Article
Language:English
Subjects:
Adults
Age groups
ball milling
Cellulose
Children & youth
Drug dosages
Drug therapy
hydrocortisone
hypromellose
minitablets
Patients
Pediatrics
Pharmaceutical sciences
Pharmacokinetics
Polymers
solid dispersion
Swallowing
taste masking
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Summary: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.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics16081041