Formulation development, optimization and characterization of Pemigatinib-loaded supersaturable self-nanoemulsifying drug delivery systems
نویسندگان
چکیده
Abstract Background Pemigatinib is a small molecule tyrosine kinase inhibitor of fibroblast growth factor receptor inhibitors. The oral bioavailability constricted due to its limited solubility at physiological pH. It essential develop novel formulation improve the intrinsic and reduce pharmacokinetic variability. Self-nanoemulsifying drug delivery system an effective, smart more adequate approach for poorly soluble drugs. Different from conventional self-nanoemulsifying system, supersaturable was prepared by using supersaturation promoter. Results Among all oils, Captex® 300 have shown maximum Pemigatinib. Considering solubilization potential emulsification ability Kolliphor®RH 40 selected as surfactant. Transcutol®HP co-surfactant. composition oil, surfactant co-surfactant identified phase diagrams further adjusted simplex-lattice design. HPMC K4M precipitation 5% concentration resulted in effective supersaturating with increased self-emulsification time. droplet sSNEDDS ranges 166.78 ± 3.14 178.86 1.24 nm PDI 0.212 – 0.256, which significantly smaller than that observed plain SNEDDS. TEM images revealed spherical shape nanodroplets. final optimized formed spontaneous nanoemulsion within 15 secs when added fluids. percent transmittance diluted found be 99.12 0.46. viscosity 574 26 centipoises indicating good flow ability. FTIR DSC studies indicated amorphization drug. dissolution profile faster release compared both pure suspension SNEDDS formulation. rate directly proportional insoluble matrix square root time-dependent Fickian diffusion process. stable transparent pH values 95%. Any kind separation or not different temperatures cycles. No significant difference samples exposed storage conditions. Conclusions This study demonstrated feasibility stabilizing improving in-vitro performance systems incorporating inhibitor.
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ژورنال
عنوان ژورنال: Future Journal of Pharmaceutical Sciences
سال: 2022
ISSN: ['2314-7245', '2314-7253']
DOI: https://doi.org/10.1186/s43094-022-00434-4