Alcoholinduced dose dumping is a major concern in modified release formulations. We developed green tea polyphenols encapsulated albumin nanoparticles (GTPALBNPs) to check the key factors governing alcoholinduced dose dumping. GTPALBNPs were prepared from 10 % albumin solution and 5 mg/ml GTP. Nanoparticles were characterized by dynamic light scattering (DLS), atomic force microscopy (AFM) and highresolution scanning electron microscopy (HRSEM). Drug solubility, swelling behavior, media uptake, and wettability/contact angle measurement were studied. In vitro drug release was studied in release medium with different quantities of alcohol and release kinetics was determined. The similarity factor (f2) test was used to assess the dissolving characteristics of drug in both alcoholic and nonalcoholic medium and the corresponding change in the medium was calculated. GTPALBNPs of < 100 nm size were synthesized. GTP became more soluble when the amount of alcohol in the release media was increased. Similar results were witnessed for swelling behavior and the media uptake studies. Contact angle measurements showed all dissolution profiles to be < 90 º. Cumulative release of GTP was increased with increase of alcohol in the release medium. Maximum GTP release (~95 %) was observed in PBS with 40 % alcohol in 48 h, showing no dose dumping. The release data followed anomalous mode of drug dissolution and were modelled into zero order kinetics. The six months stability testing conducted at 25 ± 2 ºC revealed no significant difference. GTPALBNPs showed a positive effect in alcoholic media compared to nonalcoholic medium. Increased alcohol proportion increased along with the drug release percentage. GTPALBNPs could be safe with respect to alcoholinduced dose dumping and used as a potent carrier of GTP.
Keywords: Albumin nanoparticles, anomalous transport, dose dumping, green tea polyphenols, similarity factor, zero order kinetics
Full text and supplemented materials
References
Abbasi, S., Paul, A., Shao, W., and Prakash, S., Cationic albumin nanoparticles for enhanced dug delivery to treat breast cancer: preparation and in vitro assessment, J. Drug Delivery, 2011, vol. 2012, pp. 1–8. https://doi.org/10.1155/2012/686108
Costa, P. and Lobo, J.M.S., Modelling and comparison of dissolution profiles, Eur. J. Pharm. Sci., 2001, vol. 13, no. 2, pp. 123–133. https://doi.org/10.1016/S0928-0987(01)00095-1
Fadda, H.M., Mohamed, A.M., and Basit, A.W., Impairment of the in vitro drug release behavior of oral modified release preparations in the presence of alcohol, Int. J. Pharm., 2018, vol. 360, nos. 1–2, pp. 171–176. https://doi.org/10.1016/j.ijpharm.2008.04.035
Fagerberg, J.H., Al-Tikriti, Y., Ragnarsson, G., and Bergstrom, C.A.S., Ethanol effects on apparent solubility of poorly soluble drugs in simulated intestinal fluid, Mol. Pharm., 2012, vol. 9, no. 7, pp. 1942–1952. https://doi.org/10.1021/mp2006467
Fagerberg, J.H., Sjogren, E., and Bergstrom, C.A.S., Concomitant intake of alcohol may increase the absorption of poorly soluble drugs, Eur. J. Pharm. Sci., 2015, vol. 67, pp. 12–20. https://doi.org/10.1016/j.ejps.2014.10.017
Hao, H., Ma, Q., Huang, C., He, F., and Yao, P., Preparation, characterization and in vivo evaluation of doxorubicin loaded BSA nanoparticles with folic acid modified dextran surface, Int. J. Pharm., 2013, vol. 444, nos. 1–2, pp. 77–84. https://doi.org/10.1016/j.ijpharm.2013.01.041
Hassanin, I. and Elzoghby, A., Albumin-based nanoparticles: a promising stratergy to overcome cancer drug resistance, Cancer Drug Resist., 2020, vol. 3, no. 4, pp. 930–946. https://doi.org/10.20517/cdr.2020.68
Huang, Y., Yu, H., and Xiao, C., pH sensitive cationic guar gum/poly (acrylic acid) polyelectrolyte hydrogels: swelling and in vitro drug release, Carbohydr. Polym., 2007, vol. 69, no. 4, pp. 774–783. https://doi.org/10.1016/j.carbpol.2007.02.016
Jedinger, N., Schrank, S., Mohr, S., Feichtinger, A., Khinast, J., and Roblegg, E., Alcohol dose dumping: the influence of ethanol on hot melt extruded pellets comprising solid lipids, Eur. J. Pharm. Biopharm., 2015, vol. 92, pp. 83–95. https://doi.org/10.1016/j.ejpb.2015.02.022
Khan, N. and Mukhtar, H., Tea polyphenols in promotion of human health, Nutrients, 2019, vol. 11, no. 1, p. 39. https://doi.org/10.3390/nu11010039
Kreye, F., Siepmann, F., and Siepmann, J., Drug release mechanism of compressed lipid implants, Int. J. Pharm., 2011, vol. 404, nos. 1–2, pp. 27–35. https://doi.org/10.1016/j.ijpharm.2010.10.048
Lennernas, H., Ethanol-drug absorption interaction: potential for a significant effect on the plasma pharmacokinetics of ethanol vulnerable formulations, Mol. Pharm., 2009, vol. 6, no. 5, pp. 1429–1440. https://doi.org/10.1021/mp9000876
Li, C., Zhang, D., Guo, H., Hao, L., Zheng, D., Liu, G., Shen, J., Tian, X., and Zhang, Q., Preparation and characterization of galactosylated bovine serum albumin nanoparticles for liver targeted delivery of oridonin, Int. J. Pharm., 2013, vol. 448, no. 1, pp. 79–86. https://doi.org/10.1016/j.ijpharm.2013.03.019
Maderuelo, C., Zarzuelo, A., and Lanao, J.M., Critical factors in the release of drugs from sustained release hydrophilic matrices, J. Controlled Release, 2011, vol. 154, no. 1, pp. 2–19. https://doi.org/10.1016/j.jconrel.2011.04.002
Missaghi, S., Fegely, K.A., and Rajabi-Siahboomi, A.R., Investigation of the effects of hydroalcoholic solutions on textural and rheological properties of various controlled release grades of Hypromellose, AAPS Pharm. Sci. Tech., 2009, vol. 10, no. 1, pp. 77–80. https://doi.org/10.1208/s12249-008-9181-2
Moore, J.W. and Flanner, H.H., Mathematical comparison of dissolution profiles, Pharma Tech., 1996, vol. 20, pp. 64–74.
Prakash, R.T. and Mandal, A.K.A., Effect of alcohol on release of green tea polyphenols from casein nanoparticles and its mathematical modeling, Res. J. Biotechnol., 2015, vol. 10, no. 8, pp. 99–104
Rajan, J., Rajan, V., and Kaur, B., Alcohol induced dose dumping in modified release formulations in vivo and in vitro studies: Comprehensive review, Int. J. Health Sci., 2022, vol. 6, no. S3, pp. 9633–9650. https://doi.org/10.53730/ijhs.v6nS3.8011
Ramesh, N. and Mandal, A.K.A., Encapsulation of epigallocatechin-3-gallate into albumin nanoparticles improves pharmacokinetic and bioavailability in rat model, 3 Biotech, 2019, vol. 9, no. 6, p. 238. https://doi.org/10.1007/s13205-019-1772-y
Ren, K., Dusad, A., Dong, R., and Quan, L., Albumin as a delivery carrier for rheumatoid arthritis, Nanomed. Nanotechnol., 2013, vol. 4, pp. 176–178. https://doi.org/10.4172/2157-7439.1000176
Roberts, M., Cespi, M., Ford, J.L., Dyas, A.M., Downing, J., Martini, L.G., and Crowley, P.J., Influence of ethanol on aspirin release from hypromellose matrices, Int. J. Pharm., 2007, vol. 332, pp. 31–37. https://doi.org/10.1016/j.ijpharm.2006.09.055
Shah, V.P., Tsong, Y., Sathe, P., and Liu, J., In vitro dissolution profile comparison- statistics and analysis of the similarity factor, f2, Pharm. Res., 1998, vol. 15, pp. 889–896. https://doi.org/10.1023/a:1011976615750
Smith, A.P., Moore, T.W., Westenberger, B.J., and Doub, W.H., In vitro dissolution of oral modified-release tablets and capsules in ethanolic media, Int. J. Pharm., 2010, vol. 398, nos. 1–2, pp. 93–96. https://doi.org/10.1016/j.antiviral.2005.06.010
Song, J., Lee, K., and Seong, B., Antiviral effect of catechins in green tea on influenza virus, Antiviral Res., 2005, vol. 68, no. 2, pp. 66–74. https://doi.org/10.1016/j.ijpharm.2010.07.031
Spada, A., Emami, J., Tuszynski, J.A., and Lavasanifar, A., The uniqueness of albumin as a carrier in nanodrug delivery, Mol. Pharm., 2021, vol. 15, no. 5, pp. 1862–1894. https://doi.org/10.1021/acs.molpharmaceut.1c00046
Swain, T. and Hillis, W.E., The phenolic constituents of Prunus domestica. I.—The quantitative analysis of phenolic constituents, J. Sci. Food Agric., 1959, vol. 10, no. 1, pp. 63–68. https://doi.org/10.1002/jsfa.2740100110
Tallei, T.E., Fatimawali, Niode N.J., Idroes, R., Zidan, B.M.R.M., Mitra, S., Celik, I., Nainu, F., Agagunduz, D., Emran, T.B., and Capasso, R., A comprehensive review of the potential use of green tea polyphenols in the management of COVID-19, J. Evidence-Based Complementary Altern. Med., 2021. https://doi.org/10.1155/2021/7170736
Upputuri, R.T.P. and Mandal, A.K.A., Sustained release of green tea polyphenols from liposomal nanoparticles; release kinetics and mathematical modelling, Iran. J. Biotechnol., 2017, vol. 15, no. 4, pp. 277–283. https://doi.org/10.15171%2Fijb.1322
Verma, D., Gulati, N., Kaul, S., Mukherjee, S., and Nagaich, U., Protein based nanostructures for drug delivery, J. Pharm., 2018, p. 9285854. https://doi.org/10.1155/2018/9285854
Weber, C., Coester, C., Kreuter, J., and Langer, K., Desolvation process and surface characterization of protein nanoparticles, Int. J. Pharm., 2000, vol. 194, no. 1, pp. 91–102. https://doi.org/10.1016/s0378-5173(99)00370-1
Zhang, J., He, B., Qu, W., Cui, Z., Wang, Y., Zhang, H., Wang, J., and Zhang, Q., Preparation of the albumin nanoparticle system loaded with both paclitaxel and sorafenib and its evaluation in vitro and in vivo, J. Microencapsulation, 2011, vol. 28, no. 6, pp. 528–536. https://doi.org/10.3109/02652048.2011.590614