Preparation and characterisation of self-emulsifying drug delivery system (SEDDS) for enhancing oral bioavailability of metformin hydrochloride using hydrophobic ion pairing complexation

References

• Alizadeh, M.N., Shayanfar, A., and Jouyban, A., 2018. Solubilization of drugs using sodium lauryl sulfate: experimental data and modeling. Journal of molecular liquids, 268, 410–414.
   Web of Science ®Google Scholar
• American Diabetes Association, 2014. Diagnosis and classification of diabetes mellitus. Diabetes care, 37 (Supplement_1), S81–S90.
   PubMed Web of Science ®Google Scholar
• Amidon, G.L., et al., 1995. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical research, 12 (3), 413–420.
   PubMed Web of Science ®Google Scholar
• Asfour, M.H., et al., 2020. Hydrophobic ion pair loaded self-emulsifying drug delivery system (SEDDS): a novel oral drug delivery approach of cromolyn sodium for management of bronchial asthma. International journal of pharmaceutics, 585, 119494.
   PubMed Web of Science ®Google Scholar
• Bahiraei, M., Derakhshandeh, K., and Mahjub, R., 2022. Hydrophobic ion pairing with cationic derivatives of α-, ß-, and γ-cyclodextrin as a novel approach for development of a self-nano-emulsifying drug delivery system (SNEDDS) for oral delivery of heparin. Drug development and industrial pharmacy, 47 (11), 1–15.
   PubMed Web of Science ®Google Scholar
• Bailey, C.J., 2017. Metformin: historical overview. Diabetologia, 60 (9), 1566–1576.
   PubMed Web of Science ®Google Scholar
• Banerjee, A., et al., 2016. Role of nanoparticle size, shape and surface chemistry in oral drug delivery. Journal of controlled release: official journal of the controlled release society, 238, 176–185.
   PubMed Web of Science ®Google Scholar
• Bonnet, F. and Scheen, A., 2017. Understanding and overcoming metformin gastrointestinal intolerance. Diabetes, obesity & metabolism, 19 (4), 473–481.
   PubMed Web of Science ®Google Scholar
• Chatterjee, B., et al., 2016. Controversies with self-emulsifying drug delivery system from pharmacokinetic point of view. Drug delivery, 23 (9), 3639–3652.
   PubMed Web of Science ®Google Scholar
• Cheng, C.-L., et al., 2004. Biowaiver extension potential to BCS class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tablet. European journal of pharmaceutical sciences: official journal of the European Federation for Pharmaceutical Sciences, 22 (4), 297–304.
   PubMed Web of Science ®Google Scholar
• Cherniakov, I., Domb, A.J., and Hoffman, A., 2015. Self-nano-emulsifying drug delivery systems: an update of the biopharmaceutical aspects. Expert opinion on drug delivery, 12 (7), 1121–1133.
   PubMed Web of Science ®Google Scholar
• Choi, S.H. and Park, T.G., 2000. Hydrophobic ion pair formation between leuprolide and sodium oleate for sustained release from biodegradable polymeric microspheres. International journal of pharmaceutics, 203 (1-2), 193–202.
   PubMed Web of Science ®Google Scholar
• Dai, W.-G. and Dong, L.C., 2007. Characterization of physiochemical and biological properties of an insulin/lauryl sulfate complex formed by hydrophobic ion pairing. International journal of pharmaceutics, 336 (1), 58–66.
   PubMed Web of Science ®Google Scholar
• Derakhshandeh, K. and Fathi, S., 2012. Role of chitosan nanoparticles in the oral absorption of Gemcitabine. International journal of pharmaceutics, 437 (1-2), 172–177.
   PubMed Web of Science ®Google Scholar
• Derakhshandeh, K., Hosseinalizadeh, A., and Nikmohammadi, M., 2011. The effects of PLGA microparticles on intestinal absorption of p-glycoprotein substrate using the everted rat intestinal sac model. Archives of pharmacal research, 34 (11), 1989–1997.
   PubMed Web of Science ®Google Scholar
• Dixit, P., Jain, D.K., and Dumbwani, J., 2012. Standardization of an ex vivo method for determination of intestinal permeability of drugs using everted rat intestine apparatus. Journal of pharmacological and toxicological methods, 65 (1), 13–17.
   PubMed Web of Science ®Google Scholar
• Friedl, H., et al., 2013. Development and evaluation of a novel mucus diffusion test system approved by self-nanoemulsifying drug delivery systems. Journal of pharmaceutical sciences, 102 (12), 4406–4413.
   PubMed Web of Science ®Google Scholar
• Giannarelli, R., et al., 2003. Reducing insulin resistance with metformin: the evidence today. Diabetes & metabolism, 29 (4 Pt 2), 6S28–6S35.
   PubMed Web of Science ®Google Scholar
• Goo, Y.T., et al., 2022. Enhanced dissolution and bioavailability of revaprazan using self-nanoemulsifying drug delivery system. Pharmaceutical development and technology, 27 (4), 1–11.
   Web of Science ®Google Scholar
• Graham, G.G., et al., 2011. Clinical pharmacokinetics of metformin. Clinical pharmacokinetics, 50 (2), 81–98.
   PubMed Web of Science ®Google Scholar
• Griesser, J., et al., 2017. Hydrophobic ion pairing: key to highly payloaded self-emulsifying peptide drug delivery systems. International journal of pharmaceutics, 520 (1-2), 267–274.
   PubMed Web of Science ®Google Scholar
• Gursoy, R.N. and Benita, S., 2004. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomedicine & pharmacotherapy = biomedecine & pharmacotherapie, 58 (3), 173–182.
   PubMed Web of Science ®Google Scholar
• Hafeez, A.-E., et al., 2022. Design and optimization of metformin hydrophobic ion pairs for efficient encapsulation in polymeric drug carriers. Scientific reports, 12 (1), 1–14.
   PubMed Web of Science ®Google Scholar
• Hasan, A.A., Madkor, H., and Wageh, S., 2013. Formulation and evaluation of metformin hydrochloride-loaded niosomes as controlled release drug delivery system. Drug delivery, 20 (3-4), 120–126.
   PubMed Web of Science ®Google Scholar
• He, C.-X., He, Z.-G., and Gao, J.-Q., 2010. Microemulsions as drug delivery systems to improve the solubility and the bioavailability of poorly water-soluble drugs. Expert opinion on drug delivery, 7 (4), 445–460.
   PubMed Web of Science ®Google Scholar
• Hemati Azandaryani, A., Kashanian, S., and Derakhshandeh, K., 2017. Folate conjugated hybrid nanocarrier for targeted letrozole delivery in breast cancer treatment. Pharmaceutical research, 34 (12), 2798–2808.
   PubMed Web of Science ®Google Scholar
• Honary, S. and Zahir, F., 2013. Effect of zeta potential on the properties of nano-drug delivery systems-a review (Part 2). Tropical journal of pharmaceutical research, 12 (2), 265–273.
   Google Scholar
• Hu, L.-D., et al., 2006. Preparation and in vitro/in vivo evaluation of sustained-release metformin hydrochloride pellets. European journal of pharmaceutics and biopharmaceutics: official journal of arbeitsgemeinschaft fur pharmazeutische verfahrenstechnik e.V, 64 (2), 185–192.
   PubMed Web of Science ®Google Scholar
• Hussain, A., et al., 2019. Solidified SNEDDS for the oral delivery of rifampicin: evaluation, proof of concept, in vivo kinetics, and in silico GastroPlusTM simulation. International journal of pharmaceutics, 566, 203–217.
   PubMed Web of Science ®Google Scholar
• Izgelov, D., et al., 2020. The effect of medium chain and long chain triglycerides incorporated in self-nano emulsifying drug delivery systems on oral absorption of cannabinoids in rats. International journal of pharmaceutics, 580, 119201.
   PubMed Web of Science ®Google Scholar
• Kanwal, T., et al., 2021. Design of absorption enhancer containing self-nanoemulsifying drug delivery system (SNEDDS) for curcumin improved anti-cancer activity and oral bioavailability. Journal of molecular liquids, 324, 114774.
   Web of Science ®Google Scholar
• Karamanidou, T., et al., 2015. Effective incorporation of insulin in mucus permeating self-nanoemulsifying drug delivery systems. European journal of pharmaceutics and biopharmaceutics : official journal of arbeitsgemeinschaft fur pharmazeutische verfahrenstechnik e.V, 97 (Pt A), 223–229.
   PubMed Web of Science ®Google Scholar
• Kehlenbrink, S., et al., 2019. The burden of diabetes and use of diabetes care in humanitarian crises in low-income and middle-income countries. The lancet. Diabetes & endocrinology, 7 (8), 638–647.
   PubMed Web of Science ®Google Scholar
• Kumar, R., et al., 2019. Self-nanoemulsifying drug delivery system of fisetin: formulation, optimization, characterization and cytotoxicity assessment. Journal of drug delivery science and technology, 54, 101252.
   Web of Science ®Google Scholar
• LaMoia, T.E. and Shulman, G.I., 2021. Cellular and molecular mechanisms of metformin action. Endocrine reviews, 42 (1), 77–96.
   PubMed Web of Science ®Google Scholar
• Li, F., et al., 2017. Self-microemulsifying drug delivery system for improving the bioavailability of huperzine A by lymphatic uptake. Acta pharmaceutica sinica B, 7 (3), 353–360.
   PubMed Web of Science ®Google Scholar
• Li, L., Zhou, C. H., and Xu, Z. P., 2019. Self-nanoemulsifying drug-delivery system and solidified self-nanoemulsifying drug-delivery system. In: Shyam Mohapatra, Shivendu Ranjan, Nandita Dasgupta, Raghvendra Mishra, and Sabu Thomas, eds. Nanocarriers for drug delivery. Elsevier, 421–449.
   Google Scholar
• Li, M., et al., 2020. Development and evaluation of controlled release of metformin hydrochloride for improving the oral bioavailability based on a novel enteric osmotic pump capsule. Journal of drug delivery science and technology, 60, 102054.
   Web of Science ®Google Scholar
• Li, Y., et al., 2014. Improving oral bioavailability of metformin hydrochloride using water-in-oil microemulsions and analysis of phase behavior after dilution. International journal of pharmaceutics, 473 (1-2), 316–325.
   PubMed Web of Science ®Google Scholar
• Mahjub, R., et al., 2015. Oral self-nanoemulsifying peptide drug delivery systems: impact of lipase on drug release. Journal of microencapsulation, 32 (4), 401–407.
   PubMed Web of Science ®Google Scholar
• Mahmoudian, M., et al., 2020. Enhancement of the intestinal absorption of bortezomib by self-nanoemulsifying drug delivery system. Pharmaceutical development and technology, 25 (3), 351–358.
   PubMed Web of Science ®Google Scholar
• Md, S., et al., 2021. Resveratrol loaded self-nanoemulsifying drug delivery system (SNEDDS) for pancreatic cancer: formulation design, optimization and in vitro evaluation. Journal of drug delivery science and technology, 64, 102555.
   Web of Science ®Google Scholar
• Menzel, C., et al., 2018. In vivo evaluation of an oral self-emulsifying drug delivery system (SEDDS) for exenatide. Journal of controlled release: official journal of the controlled release society, 277, 165–172.
   PubMed Web of Science ®Google Scholar
• Rani, S., et al., 2019. Self-emulsifying oral lipid drug delivery systems: advances and challenges. AAPS pharmscitech, 20 (3), 1–12.
   Web of Science ®Google Scholar
• Rege, B.D., Kao, J.P., and Polli, J.E., 2002. Effects of nonionic surfactants on membrane transporters in Caco-2 cell monolayers. European journal of pharmaceutical sciences: official journal of the European Federation for Pharmaceutical Sciences, 16 (4-5), 237–246.
   PubMed Web of Science ®Google Scholar
• Soltani, Y., Goodarzi, N., and Mahjub, R., 2017. Preparation and characterization of self nano-emulsifying drug delivery system (SNEDDS) for oral delivery of heparin using hydrophobic complexation by cationic polymer of β-cyclodextrin. Drug development and industrial pharmacy, 43 (11), 1899–1907.
   PubMed Web of Science ®Google Scholar
• Soodvilai, S., et al., 2017. Interaction of pharmaceutical excipients with organic cation transporters. International journal of pharmaceutics, 520 (1-2), 14–20.
   PubMed Web of Science ®Google Scholar
• Tucker, G., et al., 1981. Metformin kinetics in healthy subjects and in patients with diabetes mellitus. British journal of clinical pharmacology, 12 (2), 235–246.
   PubMed Web of Science ®Google Scholar
• Verma, R., et al., 2021. Improved pharmacodynamic potential of rosuvastatin by self-nanoemulsifying drug delivery system: an in vitro and in vivo evaluation. International journal of nanomedicine, 16, 905–924.
   PubMed Web of Science ®Google Scholar
• Wang, L., et al., 2009. Design and optimization of a new self-nanoemulsifying drug delivery system. Journal of colloid and interface science, 330 (2), 443–448.
   PubMed Web of Science ®Google Scholar
• Yang, W., et al., 2014. Acarbose compared with metformin as initial therapy in patients with newly diagnosed type 2 diabetes: an open-label, non-inferiority randomised trial. The lancet. Diabetes & endocrinology, 2 (1), 46–55.
   PubMed Web of Science ®Google Scholar
• Zimmet, P., et al., 2016. Diabetes mellitus statistics on prevalence and mortality: facts and fallacies. Nature reviews. Endocrinology, 12 (10), 616–622.
   PubMed Web of Science ®Google Scholar
• Zupančič, O., et al., 2016. Development, in vitro and in vivo evaluation of a self-emulsifying drug delivery system (SEDDS) for oral enoxaparin administration. European journal of pharmaceutics and biopharmaceutics: official journal of arbeitsgemeinschaft fur pharmazeutische verfahrenstechnik e.V, 109, 113–121.
   PubMed Web of Science ®Google Scholar