Palatability of a novel oral formulation of prednisone in healthy young adults.

Autor: Bai S; Arkansas Children's Research Institute, Little Rock, AR, USA.; Biostatistics Program, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Dormer N; Orbis Biosciences, Inc., Lenexa, KS, USA., Shoults C; Orbis Biosciences, Inc., Lenexa, KS, USA., Meyer A; Orbis Biosciences, Inc., Lenexa, KS, USA., Pierce CD; Arkansas Children's Research Institute, Little Rock, AR, USA.; Section of Pediatric Clinical Pharmacology and Toxicology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Neville KA; Arkansas Children's Research Institute, Little Rock, AR, USA.; Section of Pediatric Clinical Pharmacology and Toxicology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Kearns GL; Arkansas Children's Research Institute, Little Rock, AR, USA.; Section of Pediatric Clinical Pharmacology and Toxicology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Jazyk: angličtina
Zdroj: The Journal of pharmacy and pharmacology [J Pharm Pharmacol] 2017 Apr; Vol. 69 (4), pp. 489-496. Date of Electronic Publication: 2017 Mar 08.
DOI: 10.1111/jphp.12710
Abstrakt: Objectives: Prednisone is a widely used anti-inflammatory for a variety of conditions. While oral liquid formulations of prednisone enable weight-based dosing, children frequently find them to be objectionable due to bitter taste. This limitation of prednisone can adversely impact patient acceptance and may result in non-compliance. Efforts to mask flavours often result in poorly controlled, heterogeneous particle distributions and can provide ineffective taste masking. The present work utilized a novel drug delivery technology developed by Orbis Biosciences, Inc., to create an oral taste-masked formulation of prednisone.
Methods: The study examined the palatability of Orbis' microsphere prednisone formulation in healthy young adults (n = 24). Four test articles were used in the study including a reference formulation (Roxanne Laboratories), a control and the test formulation (Orbis) prepared in two different ways. Study participants were randomized in a crossover design.
Key Findings: Results indicated that the test prednisone formulation was indistinguishable from the control, and both were preferable to the reference formulation in every category of palatability assessed using a validated 9-point Hedonic Scale. The data also suggested that preparing the microsphere suspension immediately before administration results in the most ideal palatability properties.
Conclusions: In conclusion, the novel microsphere formulation technology was effective in taste-masking prednisone.
(© 2017 Royal Pharmaceutical Society.)
Databáze: MEDLINE
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