BUDESONIDE SELF-NANOEMULSION FORMULATION AS AN ORAL DRUG DELIVERY SYSTEM: PREPARATION, CHARACTERIZATION AND CYTOTOXICITY STUDIES

Year 2017, Volume: 5 Issue: 1, 41 - 46, 30.06.2017

Burcu Mesut , Seyma Hande Tekarslan Sahin Yildiz Ozsoy

https://doi.org/10.17261/Pressacademia.2017.569

Abstract

Lipophilic
drugs which are poorly water soluble need specific applications like lipid
based delivery systems to increase their oral absorption across
gastrointestinal tract. Selfnanoemulsifying drug delivery systems are Lipid
Based Drug Delivery systems (SNEEDs) and are consists of an isotropic mixture
of oil, surfactant(s) and co-surfactant. This drug delivery systems are
prepared at room temperature with gentle stirring process without using any
other component or heating process and become nanoemulsion form upon gentle
agitation in aqueous phase.  SNEDDs have
many advantages such as they can be produced easily and they are affected less
from other outside factors, its scaleup process is easy, unaffected by lipid
digestion, carry and protect peptides which can be enzymatically hydrolyzed.
The aim of this study was to increase solubility of Budesonide by using new
Snedds formulation approach.

 

Keywords

Budesonide, self-nanoemulsion drug delivery, oral drug delivery, cytotoxicity

References

• Ali, H. S., York, P., Blagden, N., Soltanpour, S., Acree Jr., W. E., Jouyban, A. 2010. “Solubility of budesonide, hydrocortisone, and prednisolone in ethanol + water mixtures at 298.2 K,” , Journal of Chemical and Engineering Data, vol. 55(1), pp. 578–582.
• Amidon, G.L., Lennernäs, H., Shah, V.P., Crison, J.R. 1995. “A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability”, Pharmaceutical Research, vol. 12, pp. 413–420.
• Balakumar, K., Raghavan, C.V., Selvan, N.T., Prasad, R.H., Abdu, S. 2013. “Self nanoemulsifying drug delivery system (SNEDDS) of Rosuvastatin calcium: Design, formulation, bioavailability and pharmacokinetic evaluation”. Colloids and Surfaces B: Biointerfaces, vol. 112, pp. 337–343.
• Bernkop-Schnürch, A. 2013, “Nanocarrier systems for oral drug delivery: Dowereally need them?”. European Journal of Pharmaceutical Sciences, vol. 49, pp. 272–277.
• Bua, P., Narayanana, S., Dalrymplec, D., Chenga, X., Serajuddin A.T.M. 2016, “Cytotoxicity assessment of lipid-based self-emulsifying drug delivery system with Caco-2 cell model: Cremophor EL as the surfactant”, European Journal of Pharmaceutical Sciences, vol. 91, pp. 162– 171.
• Ek, A., Larsson, K., Siljerud, S., Palmberg, L. 1999. “Fluticasone and budesonide inhibit cytokine release in human lung epithelial cells and alveolar macrophages”, Allergy, vol. 54, pp. 691–699.
• Fotakis, G., Timbrell, J.A. 2006. “In vitro cytotoxicity assays: comparison of LDH, neutral red, MTT and protein assay in hepatoma cell lines following exposure to cadmium chloride”, Toxicol Lett., vol. 160(2), pp. 171-177.
• http://www.marketsandmarkets.com/Market-Reports/north-american-drug-delivery-technologies-market-1209.html, Accessed on 17.03.2017
• http://www.marketsandmarkets.com/Market-Reports/north-american-drug-delivery-technologies-market-1209.html, Accessed on 17.03.2017
• Hvizdos, K.M., Jarvis, B, 2000. “Budesonide inhalation suspension: a review of its inflammatory respiratory disorders”, Drugs, vol. 60 (5), pp.1141–1178.
• Janković, J., Djekic, L., Dobričićc, V., Primoracb. 2016. “Evaluation of critical formulation parameters in design and differentiation of selfmicroemulsifying drug delivery systems (SMEDDSs) for oral delivery of acyclovir”, International Journal of Pharmacy, vol. 497(1–2), pp. 301–311.
• Meloche, C.A., Sharma, V., Swedmark, S., Andersson, P., Falany, C.N. 2002. “Sulfation of budesonide by human cytosolic sulfotransferase, dehydroepiandrosteronesulfotransferase (DHEA-ST)”, Drug Metabolism & Disposition, vol. 30, pp. 582–585.
• Mosmann T. 1983. “Rapid colorimetric assay for cellular growth and survival: application to proliferation and cytotoxicity assays”. Journal of Immunologyc Methods, vol. 65(1-2), pp. 55-63.
• Mueller, H., Kassack, M.U., Wiese, M. 2004. “Comparison of the usefulness of the MTT, ATP, and calcein assays to predict the potency of cytotoxic agents in various human cancer cell lines”. Journal of Biomolecular Screening, vol. 9(6), pp. 506-515.
• Parmar, N., Singla, N., Amin, S., Kohli, K. 2011. “Study of cosurfactant effect on nanoemulsifying area and development of lercanidipine loaded (SNEDDS) self nanoemulsifying drug delivery system”. Colloids Surface. B: Biointerfaces, vol. 86, pp. 327–338.
• Piao, H.-M., Cho, H.-J., Oh, E.-C., Chung, S.-J., Shim, .C.-K., Kim, D.-D. 2009. “Budesonide Microemulsions for Enhancing Solubility and Dissolution Rate”, Journal of Korea Pharmaceutical Sciences, vol. 39 (6), pp. 417-422.
• Pouton C.W. 2000, “Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and ‘self-microemulsifying’ drug delivery systems”, European Journal of Pharmaceutical Science, vol. 11, pp. 93–98.
• Xi, J., Chang, Q., Chan, C.K., Meng, Z.Y., Wang, G.N., Sun, J.B., Wang, Y.T., Tong, H.H., Zheng, Y. 2009 “Formulation development and bioavailability evaluation of a self-nanoemulsified drug delivery system of oleanolic acid”. AAPS PharmSciTech, vol. 10, pp. 172–182.
• USP 31, http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/m10458budesonide.pdf, Accesed on 20.03.2017
• Qi, X., Wang, L., Zhu, J., Hu, Z., Zhang, J. 2011 “Self-double-emulsifying drug delivery system (SDEDDS): a new way for oral delivery of drugs with high solubility and low permeability” International Journal of Pharmacy, vol. 409, pp. 245–251.