The effect of particle size on dissolution rate of fast dissolving oral film containing diclofenac sodium

Fitrianti Darusman, Nyayu Ista Yulita, Gita Cahya Eka Darma

Abstract


Diclofenac sodium is a Non-Steroidal Anti Inflammatory Drugs that if being taken orally have the side effects of peptic ulcers and undergone the first pass metabolism, and also included in the Biopharmaceutics Classification System class 2 which resulted in the low rate of dissolution. This study aims to determine the influence of particle size reduction on the dissolution rate of diclofenac sodium in the form of an FDOF dosage. The formation of diclofenac sodium nanoparticles is carried out by ionic gelation method using chitosan and sodium tripolyphosphate as a crosslinker in various ratios characterized by Particle Size Analyzer and Scanning Electron Microscopy, then it is incorporated into the form of an FDOF that were prepared by solvent casting method at a dose of 12.5 mg using variations concentration of SSG as superdisintegrant and PEG 400 as plasticizer. From the research results, diclofenac sodium nanoparticles are formed in the ratio of chitosan-sodium tripolyphosphate 6:1, have a size of 804 nm and spherical-shaped. The best FDOF dosage formula is F8 containing HPMC E5 LV 35% as the film forming agent, SSG 8% as superdisintegrant and PEG 400 10% as plasticizer.  FDOF formula containing diclofenac sodium nanoparticles has a slightly bitter taste, disintegration time less than one minute, surface pH around 7 (neutral), drug content that meets the requirements of the range of determination which is 93.24 ± 0.96, the cumulative amount of drug dissolved in the 28th minute is higher by 88.45% compared to FDOF containing diclofenac sodium raw material, which is only 70.0%.


Keywords


diclofenac sodium; nanoparticle; ionic gelation; fast dissolving oral film; dissolution rate

Full Text:

PDF

References


Adeyeye, C. M., Li, P., & Chemistry, P. (1990). Diclofenac Sodium: Analytical Profiles of Drug Substances, Florey, K., 19, 123–144.

Anonymous. (2014). Farmakope Indonesia V. Indonesia: BPOM RI.

Anonymous. (2017). Combined Index to USP 41 and NF 36, 1–5, 1–72.

Bhumkar, D. R., & Pokharkar, V. B. (2006). Studies on Effect of pH on Cross-linking of Chitosan With Sodium Tripolyphosphate : A Technical Note, 7(2), 2–7.

Buzea, C., Blandino, I. I. P., & Robbie, K. (2007). Nanomaterials and nanoparticles : Sources and toxicity, 2(4), 1–103.

Davies, T. F., & Amino, N. (1993). A new classification for human autoimmune thyroid disease. Thyroid (Vol. 3). https://doi.org/10.1089/thy.1993.3.331

Ghorwade, V., Patil, A., Patil, S., Ikkurthi, K., Inuganti, K. S., & Porandla, V. (2011). Formulation and evaluation of Montelukast sodium fast dissolving films by using Gelatin as a film base. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 2(3), 880–888.

Irfan, M., Rabel, S., Bukhtar, Q., Imran, M., Jabeen, F., & Khan, A. (2016). Orally disintegrating films : A modern expansion in drug delivery system. Saudi Pharmaceutical Journal, 24(5), 537–546. https://doi.org/10.1016/j.jsps.2015.02.024

Kalyan, S., & Bansal, M. (2012). Recent Trends in the Development of Oral dissolving Film, 4(2), 725–733.

Karam, R. (2015). Biowaivers : criteria and requirements prepared by Dr . Mazen Kurdi, 1–11.

Katzung, B. G., Masters, S. B., & Trevor, A. (2012). Basic dan Clinical Pharmacology (Vol. 12). https://doi.org/10.1016/S0065-7743(08)61545-6

Mohanraj, V. J., & Chen, Y. (2007). Nanoparticles - A review. Tropical Journal of Pharmaceutical Research, 5(1), 561–573. https://doi.org/10.4314/tjpr.v5i1.14634

MS, A., & C, V. (2016). Formulation and evaluation of fast dissolving oral films of diazepam. Journal of Pharmacovigilance, 4(3), 1–5. https://doi.org/10.4172/2329-6887.1000210

Nagarajan, E., Shanmugasundaram, P., Ravichandiran, V., Vijayalakshmi, A., Senthilnathan, B., & Masilamani, K. (2015). Development and Evaluation of Chitosan Based Polymeric Nanoparticles of an Antiulcer Drug Lansoprazole, 5(4), 20–25. https://doi.org/10.7324/JAPS.2015.50404

Patravale, V. B., Date, A. A., & Kulkarni, R. M. (2004). Nanosuspensions : a promising drug delivery strategy, (1992), 827–840. https://doi.org/10.1211/0022357023691

Ruíz, A. A. B. (2015). Nanoparticle Technology for Drug Delivery, 3(2), 54–67.

Sweetman, S. C. (2009). Martindale The Complete Drug Reference (Vol. 53). https://doi.org/10.1017/CBO9781107415324.004

Wagh, M. P., & Patel, J. S. (2010). Biopharmaceutical classification system: Scientific basis for biowaiver extensions. International Journal of Pharmacy and Pharmaceutical Sciences, 2(1), 12–19.

Yeo, Y., & Kinam, P. (2007). Recent Advances in Microencapsulation Technology. Encyclopedia of Pharmaceutical Technology, 2315–2327. https://doi.org/10.1081/E-EPT-120028567




DOI: http://dx.doi.org/10.12928/pharmaciana.v10i2.15988

Refbacks

  • There are currently no refbacks.


Copyright (c) 2021 Fitrianti Darusman, Nyayu Ista Yulita, Gita Cahya Eka Darma

Creative Commons License
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

 
Pharmaciana
ISSN Print: 2088-4559 | ISSN Online: 2477-0256
Website: http://journal.uad.ac.id/index.php/PHARMACIANA
Office: Faculty of  Pharmacy, Universitas Ahmad Dahlan
Jl. Prof. Dr. Soepomo, S.H., Janturan, Warungboto, Umbulharjo, Yogyakarta, Indonesia
Kode pos 55164
Email: pharmaciana@pharm.uad.ac.id