Stability test of mesoporous particles of SBA-15 loaded with albendazole

ADROVER, MARÍA ESPERANZA; BONNE MAGALÍ; JUAN FRANCISCO PEÑA; BUCALÁ VERÓNICA; GALLO LOREANA

Congreso; 7ma Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2023); 2023

The loading of mesoporous silica particles with poorly water-soluble drugs has been explored as a strategy to enhance the solubility and dissolution rate of this drugs.1 In particular, the mesoporous material SBA-15 have arisen as a promise carrier due to several advantageous characteristics such as large pore size (4.6-10 nm) and high surface area (630 - 1040 m2/g).2 While various methods have been investigated for loading poorly water-soluble drugs into SBA-15, the stability of the drug in SBA-15 carrier has not been extensively examined. In this context, the aim of the present work was evaluated the stability of SBA-15/albendazole powders comparing the drug dissolution profile immediately after the drug loading procedure (initial time) and after storage at room temperature (25 ºC) and 60 % RH for 12 months. The antiparasitic drug albendazole (ABZ) was selected as the model compound due to its low water solubility.3ABZ was loaded into SBA-15 by immersion method at different loading conditions following an experimental design. Seventeen ABZ/SBA-15 powders were produced (P1 to P17)4. X-ray powder diffraction (XRPD) was used to evaluate the structure of the loaded drug into SBA-15. Dissolution profiles of ABZ from SBA-15/ABZ powders were assayed with a dissolution apparatus II (initial time). The dissolution efficiency (DE, %) was employed to study the dissolution performance of ABZ. To evaluate the stability of the drug in the carrier, the powders (P1-P17) were stored in sealed polypropylene containers at room temperature (25 ºC) and 60 % RH for 12 months. Then, the dissolution test was repeated to analyze the variations in the dissolution behavior of ABZ. The similarity factor (f2) was used to compare the dissolution profile of ABZ for each powder at initial time and after 12 months.5 The DE% for all the SBA-15/ABZ powders were noticeably higher than 29.5%, which is the corresponding value for pure crystalline ABZ. The XRPD pattern of the powders showed an amorphous state of ABZ, being the consequence of the increase of drug dissolution rate in comparison to pure ABZ3. Twelve of the total seventeen powders showed f2 value higher than 50 indicating similarity between most of the compared dissolution profiles. The sample that showed a more visible difference between the dissolution profile at initial time and after 12 months exhibited peaks in their XRPD pattern after 12 months revealing signs of crystallinity. On the other hand, for most samples, the XRPD patterns did no exhibit noticeable change with time. Therefore, this work demonstrated that SBA-15 allows the change of ABZ from a crystalline to an amorphous state and also conserves its stability during storage.References:1 Seljak et al., J Drug Deliv Sci Technol 2020; 59. https://doi.org/10.1016/j.jddst.2020.101906.2 Vavsari et al., RSC Adv 2015; 5:91686–707. https://doi.org/10.1039/c5ra17780d.3 Adrover et al., Saudi Pharm J 2020; 28:15–24. https://doi.org/10.1016/j.jsps.2019.11.002.4 Adrover et al., In: Proceedings of the 6ta Reun. Int. Ciencias Farm. (RICiFa 2020+1), 20215 Shuma et al., Dissolution Technol 2021; 28:30–5. https://doi.org/10.14227/DT280221P30.