Self-emulsifying drug delivery system for enhanced solubility of asenapine maleate: design, characterization, in vitro, ex vivo and in vivo appraisal

Reference

• Hauss DJ. Oral lipid-based formulations. Adv Drug Deliv Rev. 2007;59:667–676.
   PubMed Web of Science ®Google Scholar
• Morishita M, Peppas NA. Advances in oral drug delivery: improved bioavailability of poorly absorbed drugs by tissue and cellular optimization. Adv Drug Deliv Rev. 2012;64:479.
   PubMed Web of Science ®Google Scholar
• O'driscoll CM, Griffin BT. Biopharmaceutical challenges associated with drugs with low aqueous solubility-the potential impact of lipid-based formulations. Adv Drug Deliv Rev. 2008;60:617–624.
   PubMed Web of Science ®Google Scholar
• Fleisher D, Bong R, Stewart BH. Improved oral drug delivery: solubility limitations overcome by the use of prodrugs. Adv Drug Deliv Rev. 1996;19:115–130.
   Web of Science ®Google Scholar
• Kawakami K. Modification of physicochemical characteristics of active pharmaceutical ingredients and application of supersaturatable dosage forms for improving bioavailability of poorly absorbed drugs. Adv Drug Deliv Rev. 2012;64:480–495.
   PubMed Web of Science ®Google Scholar
• Porter CJ, Pouton CW, Cuine JF, et al. Enhancing intestinal drug solubilisation using lipid-based delivery systems. Adv Drug Deliv Rev. 2008;60:673–691.
   PubMed Web of Science ®Google Scholar
• Pouton CW. Formulation of self-emulsifying drug delivery systems. Adv Drug Deliv Rev. 1997;25:47–58.
   Web of Science ®Google Scholar
• Basalious EB, Shawky N, Badr-Eldin SM. SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: development and optimization. Int J Pharm. 2010;391:203–211.
   PubMed Web of Science ®Google Scholar
• Patel K, Sarma V, Vavia P. Design and evaluation of Lumefantrine–Oleic acid self nanoemulsifying ionic complex for enhanced dissolution. Daru. 2013;21:27.
   PubMed Web of Science ®Google Scholar
• Mukherjee T, Plakogiannis FM. Development and oral bioavailability assessment of a supersaturated self-microemulsifying drug delivery system (SMEDDS) of albendazole . J Pharm Pharmacol. 2010;62:1112–1120.
   PubMed Web of Science ®Google Scholar
• Zhuang X, Tian X, Zheng Y, et al. Formulation and physicochemical characterisation of a novel self-microemulsifying delivery system as hydrotropic and solubilising agent for penfluridol. Procedia Engineer. 2011;18:59–65.
   Google Scholar
• Negi LM, Tariq M, Talegaonkar S. Nano scale self-emulsifying oil based carrier system for improved oral bioavailability of camptothecin derivative by P-Glycoprotein modulation. Coll Surf B: Biointerf. 2013;111:346–353.
   PubMed Web of Science ®Google Scholar
• Li F, Hu R, Wang B, et al. Self-microemulsifying drug delivery system for improving the bioavailability of huperzine A by lymphatic uptake. Acta Pharmaceutica Sinica B. 2017;7:353–360.
   PubMed Web of Science ®Google Scholar
• National Center for Biotechnology Information. PubChem Compound Database; CID=6917875 [cited 2003 Jan 23], Available From: https://pubchem.ncbi.nlm.nih.gov/compound/6917875
   Google Scholar
• Aneesh TP, Rajasekaran A. Stress degradation studies and development and validation of RP-HPLC method for the estimation of asenapine maleate. Int J Pharm Pharma Sci. 2012;4:448–451.
   Google Scholar
• Do Thi T, Van Speybroeck M, Barillaro V, et al. Formulate-ability of ten compounds with different physicochemical profiles in SMEDDS. Eur J Pharma Sci. 2009;38:479–488.
   PubMed Web of Science ®Google Scholar
• Azeem A, Rizwan M, Ahmad FJ, et al. Nanoemulsion components screening and selection: a technical note. AAPS PharmSciTech. 2009;10:69–76.
   PubMed Web of Science ®Google Scholar
• Balakrishnan P, Lee BJ, Oh DH, et al. Enhanced oral bioavailability of dexibuprofen by a novel solid self-emulsifying drug delivery system (SEDDS). Eur J Pharma Biopharma. 2009;72:539–545.
   PubMed Web of Science ®Google Scholar
• Mantri SK, Pashikanti S, Murthy KV. Development and characterization of self-nanoemulsifying drug delivery systems (SNEDDS) of atorvastatin calcium. Cdd. 2012;9:182–196.
   PubMed Web of Science ®Google Scholar
• Jain S, Jain AK, Pohekar M, et al. Novel self-emulsifying formulation of quercetin for improved in vivo antioxidant potential: implications for drug-induced cardiotoxicity and nephrotoxicity. Free Rad Biol Med. 2013;65:117–130.
   PubMed Web of Science ®Google Scholar
• Khoo SM, Humberstone AJ, Porter CJ, et al. Formulation design and bioavailability assessment of lipidic self-emulsifying formulations of halofantrine. Int J Pharma. 1998;167:155–164.
   Web of Science ®Google Scholar
• Avasarala H, Jayanthi VR. The development and validation of a spectrophotometric method for a novel anti psychotic drug asenapine maleate. Int J ChemTech Res. 2015;8:549–553.
   Google Scholar
• Shahba AA, Mohsin K, Alanazi FK. The studies of phase equilibria and efficiency assessment for self-emulsifying lipid-based formulations. AAPS PharmSciTech. 2012;13:522–533.
   PubMed Web of Science ®Google Scholar
• Parmar N, Singla N, Amin S, et al. Study of cosurfactant effect on nanoemulsifying area and development of lercanidipine loaded (SNEDDS) self nanoemulsifying drug delivery system. Coll Surf B Biointerfaces. 2011;86:327–338.
   PubMed Web of Science ®Google Scholar
• Kallakunta VR, Bandari S, Jukanti R, et al. Oral self emulsifying powder of lercanidipine hydrochloride: formulation and evaluation. Powder Technol. 2012;221:375–382.
   Web of Science ®Google Scholar
• Costa P, Lobo JM. Modeling and comparison of dissolution profiles. Eur J Pharma Sci. 2001;13:123–133.
   PubMed Web of Science ®Google Scholar
• Nipun TS, Islam SA. SEDDS of gliclazide: preparation and characterization by in-vitro, ex-vivo and in-vivo techniques. Saudi Pharma J. 2014;22:343–348.
   PubMed Web of Science ®Google Scholar
• ICH Q1A(R2) Guidelines: Stability testing of new drug substances and products; 2015 [cited 2019 Aug 19]. Available From: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf
   Google Scholar
• Yan S, You ZL, Zhao QY, et al. Antidepressant-like effects of Sanyuansan in the mouse forced swim test, tail suspension test, and chronic mild stress model. Kaohsiung J Med Sci. 2015;31:605–612.
   PubMed Web of Science ®Google Scholar
• Peng WH, Lo KL, Lee YH, et al. Berberine produces antidepressant-like effects in the forced swim test and in the tail suspension test in mice. Life Sci. 2007;81:933–938.
   PubMed Web of Science ®Google Scholar
• Becker A, Peters B, Schroeder H, et al. Ketamine-induced changes in rat behaviour: a possible animal model of schizophrenia. Prog Neuro-Psychopharmacol Biol Psychiatr. 2003;27:687–700.
   PubMed Web of Science ®Google Scholar
• Gobira PH, Ropke J, Aguiar DC, et al. Animal models for predicting the efficacy and side effects of antipsychotic drugs. Rev Bras Psiquiatr. 2013;35:S132–S139.
   PubMed Web of Science ®Google Scholar
• Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharma. 2016;7:27.
   PubMedGoogle Scholar
• Sistik P, Turjap M, Iordache AM, et al. Quantification of selected antidepressants and antipsychotics in clinical samples using chromatographic methods combined with mass spectrometry: a review (2006–2015). Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016;160:39–53.
   PubMed Web of Science ®Google Scholar
• Singh SK, Kosuru R, Dewangan HK, et al. An overview on asenapine maleate: PK-PD, preclinical and clinical update. Pharmasociety. 2015;11:110–115.
   Google Scholar
• Agrawal AG, Kumar A, Gide PS. Self emulsifying drug delivery system for enhanced solubility and dissolution of glipizide. Coll Surf B Biointerf. 2015;126:553–560.
   PubMed Web of Science ®Google Scholar
• Dash RN, Mohammed H, Humaira T, et al. Design, optimization and evaluation of glipizide solid self-nanoemulsifying drug delivery for enhanced solubility and dissolution. Saudi Pharma J. 2015;23:528–540.
   PubMed Web of Science ®Google Scholar
• Gupta S, Chavhan S, Sawant KK. Self-nanoemulsifying drug delivery system for adefovir dipivoxil: design, characterization, in vitro and ex vivo evaluation. Coll Surf A: Physicochem Engineer Aspects. 2011;392:145–155.
   Web of Science ®Google Scholar
• Wang L, Dong J, Chen J, et al. Design and optimization of a new self-nanoemulsifying drug delivery system. J Colloid Interface Sci. 2009;330:443–448.
   PubMed Web of Science ®Google Scholar
• Sriamornsak P, Limmatvapirat S, Piriyaprasarth S, et al. A new self-emulsifying formulation of mefenamic acid with enhanced drug dissolution. Asian J Pharma Sci. 2015;10:121–127.
   Web of Science ®Google Scholar
• Mahmoud EA, Bendas ER, Mohamed MI. Preparation and evaluation of self-nanoemulsifying tablets of carvedilol. AAPS Pharmscitech. 2009;10:183–192.
   PubMed Web of Science ®Google Scholar
• Beaulieu PL, De Marte J, Garneau M, et al. A prodrug strategy for the oral delivery of a poorly soluble HCV NS5B thumb pocket 1 polymerase inhibitor using self-emulsifying drug delivery systems (SEDDS). Bioorganic Med Chem Lett. 2015;25:210–215.
   PubMed Web of Science ®Google Scholar
• Wu Z, Guo D, Deng L, et al. Preparation and evaluation of a self-emulsifying drug delivery system of etoposide-phospholipid complex. Drug Dev Ind Pharm. 2011;37:103–112.
   PubMed Web of Science ®Google Scholar
• Elnaggar YS, Shehata EM, Galal S, et al. Self-emulsifying preconcentrates of daidzein–phospholipid complex: design, in vitro and in vivo appraisal. Nanomed. 2017;12:893–910.
   PubMed Web of Science ®Google Scholar