OPTIMIZATION AND CHARACTERIZATION OF MICROSPHERES OF BERBERINE HYDROCHLORIDE USING BOX-BEHNKEN DESIGN

GAUTAM KUMAR; NARENDRA KUMAR PANDEY; VIJAY MISHRA; SURAJ PAL VERMA; JITENDER SINGH; BIMLESH KUMAR; SACHIN KUMAR SINGH; DILEEP SINGH BAGHEL; KALVATALA SUDHAKAR; SAURABH SINGH

doi:10.22159/ijap.2024v16i1.49254

Authors

GAUTAM KUMAR School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India. Lord Shiva College of Pharmacy, Sirsa-125055, Haryana, India https://orcid.org/0009-0000-1307-8729
NARENDRA KUMAR PANDEY School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0003-0821-7653
VIJAY MISHRA School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India
SURAJ PAL VERMA School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, Delhi, India https://orcid.org/0000-0002-4357-2995
JITENDER SINGH Lord Shiva College of Pharmacy, Sirsa-125055, Haryana, India
BIMLESH KUMAR School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0001-8072-5172
SACHIN KUMAR SINGH School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0003-3823-6572
DILEEP SINGH BAGHEL School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0002-5370-3741
KALVATALA SUDHAKAR School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0002-1123-9864
SAURABH SINGH School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India https://orcid.org/0000-0002-8474-6007

DOI:

https://doi.org/10.22159/ijap.2024v16i1.49254

Keywords:

Box-behnken design, Water in oil emulsion cross-linking method, Berberine HCl, Microspheres

Abstract

Objective: The current work sought to optimize Berberine hydrochloride (BBH)-loaded microspheres by examining the link between design parameters and experimental results.

Methods: BBH-loaded microspheres were prepared by using the water-in-oil emulsion cross-linking process and optimized with a three-factor, three-level Box-Behnken design (BBD). Grafted gum polyvinyl alcohol (PVA) ratio (w/w) (A), Revolutions per minute (RPM) (B), and Span 20 (%) (C) were independent variables. The dependent variables were Percent Entrapment Efficiency (% EE) (R1), Percent Drug Loading (% DL) (R2), and Particle Size (µm) (R3). The generated polynomial equations and response surface plots were used to relate the dependent and independent variables. Microscopic examination, %EE, and % DL were determined to evaluate the optimized formulation. Fourier transforms infrared (FT-IR) spectroscopy studies and stability studies of optimized formulation were also carried out.

Results: The optimized formulation (FMS6) had a polymer content of 2% w/v [Grafted gum (36.96): PVA (63.04)], a span 20 (0.78 %), and a prepared at the speed of 1225.92 rpm. The observed responses were close to the improved formulation's predicted values. The particle size, % EE, and % DL were found to be 1.10 µm, 82.79% and 16.48%, respectively. FT-IR spectroscopy study indicated that the drug was entrapped in microspheres.

Conclusion: BBD provides a systematic approach to optimize the BBH microsphere preparation process. Additionally, the stability study results confirmed that FMS6 is not only the ideal formulation but also stable, ensuring its suitability for practical applications.

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