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CC BY 4.0 · Pharmaceutical Fronts 2023; 05(04): e297-e309
DOI: 10.1055/s-0043-1777043
Original Article

Quality by Design Approach for Development and Characterization of Granisetron Hydrochloride-Loaded Orodispersible Films

Ming-Yan Li   #
1   National Advanced Medical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of China
,
Bing Wang   #
1   National Advanced Medical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of China
,
Jun-Qi Zhang
1   National Advanced Medical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of China
,
Liu-Liu Yang
1   National Advanced Medical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of China
,
Jun-Tao He
2   Research and Development Department, Huanghai Instruments Co., Ltd., Shanghai, People's Republic of China
,
Fang Chen
1   National Advanced Medical Engineering Research Center, China State Institute of Pharmaceutical Industry, Shanghai, People's Republic of China
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Abstract

Granisetron hydrochloride can be used to prevent and treat nausea and vomiting induced by chemotherapy. Its prolonged half-life and reduced dose requirement improve patient acceptance. However, patients undergoing chemotherapy often suffer from dysphagia and drug spitting due to emesis. Hence, the development of a patient-centered formulation of granisetron hydrochloride with simple medication and high compliance is crucial. The current study employed a polymer combination of polyvinylpyrrolidone/polyvinyl alcohol (PVP/PVA) as film-forming materials and Lycoat® RS 780 as a disintegrant to formulate orodispersible films (ODFs) loaded with granisetron hydrochloride. Guided by the concept of quality by design, the quality target product profile and critical quality attributes (CQAs) for the ODF were defined. Through the quality risk assessment, essential factors that have a significant impact on CQAs were identified. The formulation was screened using the Box–Behnken statistical design with three factors and three levels. Our data suggested that all ODF formulations exhibited a disintegration time of less than 60 seconds and complete dissolution within 5 minutes. Furthermore, the formulation displayed appropriate mechanical properties, water residue, and pH values. Thus, the granisetron hydrochloride-loaded ODF is regarded as a patient-friendly formulation that enhances compliance and consequently aids in therapeutic effectiveness.

Keywords

granisetron hydrochloride - orodispersible films - quality by design

# These authors contributed equally to this work.




Publikationsverlauf

Eingereicht: 17. März 2023

Angenommen: 27. Oktober 2023

Artikel online veröffentlicht:
01. Dezember 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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