FORMULATION AND EVALUATION OF IBRUTINIB NANOSPONGES INCOPORATED TABLET

Authors

  • MEDIPALLI VISWAJA TRR College of Pharmacy, Meerpet, Hyderabad, Telangana 500097, India
  • D. V. R. N. BHIKSHAPATHI TRR College of Pharmacy, Meerpet, Hyderabad, Telangana 500097, India
  • MAMATHA PALANATI TRR College of Pharmacy, Meerpet, Hyderabad, Telangana 500097, India https://orcid.org/0000-0001-8648-6432
  • A. KISHORE BABU School of Pharmacy, KPJ Healthcare, University, Kota Seriemas 71800, Negeri Sembilan, Malaysia
  • ARJUN GOJE TRR College of Pharmacy, Meerpet, Hyderabad, Telangana 500097, India

DOI:

https://doi.org/10.22159/ijap.2023v15i2.46813

Keywords:

Ibrutinib, Nanosponges, Anti-cancer agents, Polaxamer 188, Eudragit RL 30 D

Abstract

Objective: The present investigation was undertaken to prepare polymeric nanosponges of an anti-cancer drug, ibrutinib to achieve controlled and improved drug release.

Methods: Nanosponges using a polymer (ethyl cellulose, poloxamer 188 and eudragit RL 30 D) and polyvinyl alcohol as a cross-linker were prepared successfully by the emulsion solvent evaporation method. Prepared nanosponges were evaluated for particle size, zeta potential, entrapment efficiency and in vitro drug release. Nanosponges with good drug release were formulated into tablets and evaluated for miromeritic properties, post-compression parameters and in vitro release and the final optimised formulation was characterized for globule size, zeta-potential, FTIR, SEM and stability studies.

Results: The nanosponges' particle sizes were discovered to range between 86.31 nm and 162.4 nm, the Zeta Potential ranges from-22.1 to-29. It was discovered that the drug entrapment efficiency ranged from 92.21 to 99.23% and Formulation F18 exhibited the highest drug release rate of 99.73% in 12h and was discovered to demonstrate good, satisfying results. The tablet formulation's micromeritic and post-compression parameters were examined, and it was discovered that F18 had good flow qualities. F18 had a mean globule size of 133.6 nm, a zeta potential of-22.1 mV, and SEM images revealed a sphere-like structure. The complexation of ibrutinib and the amorphous condition of the medication and formulation were confirmed by the FT-IR, and stability investigations to be stable for three months.

Conclusion: Hence, Ibrutinib loading into nanosponges made using the emulsion solvent evaporation process thus successfully boosted and controlled the drug release.

Downloads

Download data is not yet available.

References

Gedam SS, Basarkar GD. Nanosponges: an attractive strategy for enhanced therapeutic profile. J Pharm Sci Res. 2019;11(6):2479-87.

Simranjot Kaur, Sandeep Kumar. The nanosponges: an innovative drug delivery system. Asian J Pharm Clin Res. 2019:60-7. doi: 10.22159/ajpcr.2019.v12i7.33879.

Penjuri SCB, Ravouru N, Damineni S, Bns S, Poreddy SR. Formulation and evaluation of lansoprazole-loaded nanosponges. Turk J Pharm Sci. 2016;13(3):304-10. doi: 10.4274/tjps.2016.04.

Bhowmik, Himangshu, Venkatesh D, Kuila, Anuttam, Kumar, Kammari. Nanosponges: a review. Int J Appl Pharm. 2018;10:1-10.

PJ, BT, KP, BC. An innovative advancement for targeted drug delivery: nanosponges. Indo Glob J Pharm Sci. 2016;06(2):59-64. doi: 10.35652/IGJPS.2016.02.

Aalipour A, Advani RH. Bruton’s tyrosine kinase inhibitors and their clinical potential in the treatment of B-cell malignancies: focus on ibrutinib. Ther Adv Hematol. 2014;5(4):121-33. doi: 10.1177/2040620714539906. PMID 25360238.

El-Assal MI. Nano-sponge novel drug delivery system as the carrier of an anti-hypertensive drug. Int J Pharm Pharm Sci. 2019:47-63. doi: 10.22159/ijpps.2019v11i10.34812.

Davids MS, Brown JR. Ibrutinib: a first-in-class covalent inhibitor of Bruton’s tyrosine kinase. Future Oncol. 2014 May;10(6):957-67. doi: 10.2217/fon.14.51, PMID 24941982.

Honigberg LA, Smith AM, Sirisawad M, Verner E, Loury D, Chang B. The bruton tyrosine kinase inhibitor PCI-32765 blocks B-cell activation and is efficacious in models of autoimmune disease and B-cell malignancy. Proc Natl Acad Sci USA. 2010;107(29):13075-80. doi: 10.1073/pnas.1004594107, PMID 20615965.

Kassem MA, Abdallah FI, Elsherif YA. Design, evaluation and bioavailability of oxybutynin chloride nanosponges on healthy human volunteers. J Drug Deliv Sci Technol. 2020;60:101943. doi: 10.1016/j.jddst.2020.101943.

Madhuri, Shete, Rajkumar. Formulation and evaluation of gliclazide nanosponges. Solunke, Rahul and Borge, Uday and Murthy, Krishna and Deshmukh. Int J Appl Pharm. 2019;11:181-9.

Swaminathan S, Vavia PR, Trotta F, Torne S. Formulation of Βcyclodextrin based nanosponges of itraconazole. J Incl Phenom Macrocycl Chem. 2007;57:89-94.

Arvapally S, Harini M, Harshitha G, Arun Kumar A. Formulation and in vitro evaluation of glipizide nanosponges. Am J PharmTech Res. 2017;7:341-61.

Rangaraj N, Pailla SR, Chowta P, Sampathi S. Fabrication of ibrutinib nanosuspension by quality by design approach: intended for enhanced oral bioavailability and diminished fast fed variability. AAPS PharmSciTech. 2019;20(8):326. doi: 10.1208/s12249-019-1524-7, PMID 31659558.

Remya PN, Saraswathi TS, Sangeetha S, Damodharan NK. Formulation and evaluation of immediate-release tablets of acyclovir. J Pharm Sci Res. 2016;8(11):1258-61.

Alburyhi M, Alwan M, Aboghanem A. Effect of different excipients on the formulation of immediate-release artemether/lumefantrine tablets. J Chem Pharm Res. 2013;5(11):617-25.

Chime SA, Brown S, Ugwu. Effect of binder type and concentration on the in vitro properties of Alstonia boonei. Int J Pharm Sci Rev Res. 2012;2(2):5-9.

Dubey P, Sharma HK, Shah S, Tyagi CK, Chandekar AR, Jadon RS. Formulations and evaluation of Cyclodextrin complexed Ceadroxil loaded nanosponges. Int J Drug Deliv. 2017;9(3):84-100. doi: 10.5138/09750215.2180.

ICH. Stability testing guidelines: stability of new drug substances and product: methodology in processing of ICH Geneva. Vol. Q1A(R2); 2003.

Chen Z, Zhai J, Liu X, Mao S, Zhang L, Rohani S. Solubility measurement and correlation of form A of ibrutinib in organic solvents from 278.15 to 323.15 K. J Chem Thermodyn. 2016;103:342-8. doi: 10.1016/j.jct.2016.08.034.

Vamshi Priya V, Rao GC, Reddy DS, Reddy VP. The effect of different superdisintegrants and their concentrations on the dissolution of topiramate. Immed Release Tablets. 2009;2(2):531-6.

Palanati M, Kumar JA, Bhikshapathi DVRN. Design and optimization of ibrutinib solid lipid nanoparticles using design of experiment. IJBPAS. 2021 Sep;10(9):723-37.

Atram SC. Formulation and evaluation of immediate-release tablet using response surface methodology. Asian J Pharm. 2011;5(1):46-51. doi: 10.4103/0973-8398.80069.

Published

07-03-2023

How to Cite

VISWAJA, M., BHIKSHAPATHI, D. V. R. N., PALANATI, M., BABU, A. K., & GOJE, A. (2023). FORMULATION AND EVALUATION OF IBRUTINIB NANOSPONGES INCOPORATED TABLET. International Journal of Applied Pharmaceutics, 15(2), 92–97. https://doi.org/10.22159/ijap.2023v15i2.46813

Issue

Section

Original Article(s)