ENCAPSULATION EFFICIENCY, POLYMER COMPATIBILITY, AND CONTROLLED RELEASE KINETICS OF THERAPEUTIC MOLECULES LOADED INTO PLANT-POLYMER HARD CAPSULES
DOI:
https://doi.org/10.53555/nbkec833Keywords:
Encapsulation efficiency, Drug release, Plant-polymer capsules, Release kinetics, Higuchi model, FTIR compatibility, Stability studies, HPMC–alginate capsulesAbstract
This work investigates the encapsulation performance, drug-polymer compatibility, and release kinetics of a therapeutic organic molecule loaded into optimized plant-polymer capsules developed in Paper-1. Drug loading was performed using direct-fill methods, after which encapsulation efficiency, FTIR/DSC compatibility, dissolution behavior, stability testing, and kinetic modeling were evaluated. The capsules exhibited high encapsulation efficiency (82–91%), satisfactory drug content uniformity (95–102%), and controlled release of 38–52% at 30 minutes and 68–79% at 60 minutes. Release modeling showed excellent correlation with the Higuchi diffusion model (R² = 0.96), indicating release governed primarily by polymer-matrix diffusion. FTIR and DSC revealed no major chemical incompatibilities, and stability testing for 90 days confirmed retention of hardness and absence of cracking under ICH conditions. Overall, the system demonstrates strong potential for delivering small-molecule therapeutics through environmentally friendly plant-based capsules.
References
1. Patel, R., & Mehta, D. (2019). Plant-based capsule technologies: A review of materials and applications. International Journal of Pharmaceutics, 565, 123–139.
2. Kumar, S., & Bansal, A. (2017). Factors influencing encapsulation efficiency in polymeric dosage forms. Journal of Drug Delivery Science and Technology, 40, 86–95.
3. Zhang, Y., Li, J., & Wang, X. (2018). Optimizing capsule shell thickness and drying parameters to improve drug retention. Journal of Pharmaceutical Sciences, 107(6), 1597–1607.
4. Silva, P., & Rodrigues, M. (2016). Surface modification strategies to enhance API retention in biodegradable capsules. European Journal of Pharmaceutics and Biopharmaceutics, 105, 47–56.
5. Gomez, L., & Torres, H. (2020). Role of plasticizers and polymer ratios in natural polymer capsules. Carbohydrate Polymers, 246, 116578.
6. Singh, R., & Pandey, P. (2015). FTIR and DSC as tools for drug–polymer compatibility studies. Analytical Methods in Pharmaceutical Research, 2(1), 22–36.
7. Oliveira, F., et al. (2017). Spectroscopic evidence of physical interactions in drug-loaded hydrophilic matrices. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 179, 326–334.
8. Chen, H., & Zhao, Q. (2019). Hygroscopic drugs in hydrophilic polymer matrices: stability issues and mitigation. International Journal of Pharmaceutics, 569, 118567.
9. Costa, P., & Sousa Lobo, J. M. (2001). Modeling and comparison of dissolution profiles. European Journal of Pharmaceutical Sciences, 13(2), 123–133.
10. Higuchi, T. (1963). Mechanism of sustained action medication: Theoretical analysis of release from solid matrices. Journal of Pharmaceutical Sciences, 52(12), 1145–1149.
11. Le, T., & Nguyen, H. (2018). Influence of HPMC on drug release from polysaccharide matrices. International Journal of Pharmaceutics, 547(1–2), 410–418.
12. Park, J., & Kim, S. (2016). Alginate and agar blends for controlled drug release: A comparative study. Carbohydrate Polymers, 148, 92–100.
13. Reddy, A., et al. (2019). Multi-polymer matrices for tunable release of small molecules. Journal of Controlled Release, 301, 23–34.
14. Nair, A. B., et al. (2017). Manipulating disintegration and release via polymer ratios and plasticization. Current Drug Delivery, 14(8), 1031–1043.
15. Patel, K., & Shah, A. (2015). Strategies to improve dissolution of poorly water-soluble drugs encapsulated in polymeric systems. Drug Development and Industrial Pharmacy, 41(6), 998–1006.
16. ICH Q1A(R2). (2003). Stability testing of new drug substances and products. International Council for Harmonisation.
17. Martins, G., & Almeida, S. (2018). Stability of biopolymer capsules under accelerated conditions. Journal of Pharmaceutical Innovation, 13(2), 139–150.
18. United States Pharmacopeia (USP 43). (2020). Uniformity of dosage units and dissolution testing. United States Pharmacopeial Convention.
19. Souza, R., & Lopes, M. (2016). Correlating SEM morphology with release behavior in polymer capsules. Microscopy Research and Technique, 79(5), 355–364.
20. Banerjee, S., & Ghosh, A. (2017). Statistical modeling and ANOVA in formulation optimization. Journal of Pharmaceutical Analysis, 7(3), 201–210.
21. Dash, S., Murthy, P. N., Nath, L., & Chowdhury, P. (2010). Kinetic modeling of drug release from polymeric systems. Acta Poloniae Pharmaceutica, 67(3), 217–223.
22. Kumar, R., & Ahuja, M. (2012). Encapsulation efficiency and release behavior of natural polymer capsules. Carbohydrate Polymers, 88(2), 1061–1068.
23. United States Pharmacopeia (USP 43). (2020). Uniformity of dosage units: Capsules. Rockville, MD: United States Pharmacopeial Convention.
24. Higuchi, T. (1963). Mechanism of sustained drug release from polymer matrices. Journal of Pharmaceutical Sciences, 52(12), 1145–1149.
25. Carstensen, J. T. (2001). Drug stability: Principles and practices (3rd ed.). Marcel Dekker.
26. ICH Q1A(R2). (2003). Guideline for stability testing of new drug substances and products. International Council for Harmonisation.
Licensed under CC BY 4.0 International.