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
