Journal of Mazandaran University of Medical Sciences (Oct 2024)
Preparation and Optimization of Effective Parameters for the Controlled Release of Carbamazepine by Nanosilica SBA-16 as a Drug Carrier
Abstract
Background and Purpose: Designing and manufacturing controlled drug release systems can be highly beneficial in improving drug treatment methods. The aim of this study is to synthesize SBA-16 nanosilica and evaluate its use as a drug carrier for carbamazepine. Additionally, this research aims to assess the effects of pH, contact time, temperature, initial drug concentration, and adsorbent amount on the performance efficiency of the drug carrier. Materials and Methods: In this study, carbamazepine (obtained from the Food and Drug Organization of Iran), double-distilled water, 1-butanol, hydrochloric acid, pluronic copolymer F127, tetraethyl orthosilicate, and sodium hydroxide were used. All chemicals were sourced from Sigma-Aldrich and Merck. A dialysis bag manufactured by Sigma-Aldrich (14000 MWCO, 99.99% retention) was used for drug release experiments. The equipment used in this research includes a digital scale (EJ 303), pH meter (ST 2100), oven (Memmert), magnetic stirrer (HOTPLATE STIRRER 81), electric furnace (Shimaz), FT-IR device (Magna-IR Spectrometer 550 Nicolet), X-ray diffraction device (STADIP), scanning electron microscope (MIRA3-LMU), UV-Vis spectrophotometer (DB20-UV), and BET analyzer (NanoSORD92). SBA-16 was synthesized using the sol-gel method. XRD, FTIR, SEM, and EDX analyses were employed to identify and characterize the synthesized adsorbent. The effects of pH, adsorbent amount (nanocarrier), drug concentration, temperature, and contact time were evaluated using the response surface method (RSM) with the central composite design (CCD) in the Design of Experiments software (DOE) to determine optimal conditions and maximum drug loading capacity. Langmuir, Freundlich, and Temkin adsorption isotherms were used for adsorption studies, and thermodynamic and kinetic studies were also conducted. The dialysis method was applied for drug release experiments, providing physical separation and allowing easy sampling at different time intervals. Results: In this study, SBA-16 nanosilica was successfully synthesized, and scanning electron microscope (SEM) images of the SBA-16 surface demonstrated that it had a spherical and homogeneous morphology with particle sizes ranging from 2 to 50 nm. Additionally, the XRD spectrum showed that SBA-16 had a regular structure. Experiment design was used to investigate the effects of key parameters. After conducting the tests, the results were input into the software to generate the best model for evaluating and describing the data. Of the four models (linear, interaction, quadratic, and cubic), the software proposed the quadratic model as the most consistent with the responses. According to the software output, the nanocarrier was able to adsorb 99.87% of carbamazepine under optimal conditions (pH=2, initial drug concentration=20 ppm, drug carrier amount=0.05 g, temperature = 30°C, and contact time=12 minutes). The adsorption data fit the Langmuir isotherm most closely (R²=0.9996). Thermodynamic studies revealed that the adsorption process is spontaneous, exothermic, and physical, following first-order kinetics. The drug release data corresponded with the theoretical kinetic model presented by Zeng et al. (2012) for drug release from mesoporous silica nanoparticles, which assumes an initial burst release in the early hours followed by a slow and steady release. Conclusion: The nanocarrier introduced in this research is a water-insoluble, non-toxic, and highly effective adsorbent for loading the drug carbamazepine. The results demonstrated that, under optimal conditions, the drug loading efficiency reached 99.87%. Additionally, the study showed controlled drug release. The adsorption process followed the Langmuir isotherm with a regression coefficient of 0.9991, while drug release followed the first-order kinetic model with a regression coefficient of 0.9996. Thermodynamic results indicated that the drug loading process is exothermic and spontaneous