Risk-Guided Optimization of an Ethylcellulose-Hypromellose Coated Empagliflozin Tablet for Programmed Pulsatile Release
Abstract: Objective: To develop a 10-mg empagliflozin tablet with an approximately 6-h in-vitro lag period followed by rapid drug release. Methods: A 150-mg direct-compression core was screened, then seal-coated and covered with a Surelease® ethylcellulose/ HPMC E5 functional film. HPMC E5 content and coating weight gain were screened using a risk-guided approach. Results: Core F9 showed hardness of 5.3 ± 0.2 kg/cm2, friability of 0.49%, disintegration in 2.6 ± 0.2 min, and drug content of 98.73 ± 0.52%. The selected C5 coat showed a reported lag time of 6.18 ± 0.11 h and 5.8 ± 0.5% release at 6 h. The final evaluation reached 98.1 ± 0.8% release at 12 h; the marketed immediate-release comparator released 87.6 ± 1.6% by 2 h. Conclusion: The coating produced a delayed, then accelerated, in-vitro release profile. These findings support formulation feasibility only and do not establish in-vivo timing or clinical benefit.
Keywords: Empagliflozin, pulsatile drug delivery, ethylcellulose, hypromellose, Quality by Design, lag time
How to Cite?: Jacinth Medah J, K. Malarvizhi, J. Karthi, Prakash Murugan, "Risk-Guided Optimization of an Ethylcellulose-Hypromellose Coated Empagliflozin Tablet for Programmed Pulsatile Release", Volume 15 Issue 10, October 2026, International Journal of Science and Research (IJSR), Pages: 845-850, https://www.ijsr.net/getabstract.php?paperid=SR261013121350, DOI: https://dx.doi.org/10.21275/SR261013121350