A PROMISING APPROACH TO ENHANCE SOLUBILITY AND BIOAVAILABILITY BY SELF EMULSIFYING DRUG DELIVERY SYSTEM: A BRIEF REVIEW
AbstractObjective: The formulation of self-emulsifying drug delivery system of drugs is to enhance the solubility and bioavailability. More than 40% of available drugs exhibit poor water solubility, resulting in unsatisfactory oral drug delivery.Increasing the bioavailability of drugs is one of the challenges in oral formulations. SEDDS is one of the formulation design to improve the absorption process.SEDDS are the mixture of oil, surfactants and cosolvent/co-surfactants. After administration, the drug remains entrapped/solubilized in the oil phase of the emulsion that is formed in the gastrointestinal tract upon self-emulsification lead to increased solubilization and absorption resulting in increased bioavailability.Conclusion: The review focuses on SEDDS formulating design and characterization along with the technique by which the bioavailability can be improved.
Roger E, LagarceF, Benoit JP. Development and characterization of a novel lipid nanocapsule formulation of Sn38 for oral administration. Eur J Pharm Bio pharm 2011;79:181â€“188.
Sunil P, MaruO, ChanM. Novel lipid-based formulations enhancing the in vitro dissolution and permeability characteristics of a poorly water-soluble model drug piroxicam. Int J Pharm 2005;301: 209â€“216.
Amidon GL, LennernasH, ShahVP, CrisonJR. A theoretical basis for a biopharmaceutic drug classification: the correlation in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12: 413â€“420.
Porter CJ, Charman WN. In vitro assessment of oral lipid based formulations. Adv Drug DelivRev. 2001;50(1):127â€“147.
Charman WN, RoggeMC, BoddyAW, BergerBM. Effect of food and a monoglyceride emulsion formulation ondanazol bioavailability. J Clin Pharmacol 1993;33:381â€“386.
Pouton CW, Charman WN. The potential of oily formulations for drug delivery to the gastrointestinal tract: preface. Advanced Drug Delivery Reviews.1997;25(1):1â€“2.
Humberstone AJ, Charman WN.Lipid-based vehicles for the oral delivery of poorly water soluble drugs. Advanced Drug Delivery Reviews. 1997; 25(1):103â€“128.
DiMaio S, Carrier RL.Gastrointestinal contents in a fasted state and post-lipid ingestion: in vivo measurements and in vitro models for studying oral drug delivery. Journal of Controlled Release. 2011;151(2):110â€“122.
Chakraborty S, Shukla D, Mishra B, Singh S.Lipid an emerging platform for oral delivery of drugs with poor bioavailability. European Journal of Pharmaceutics and Biopharmaceutics. 2009; 73(1):1â€“15.
Porter CJ, Charman WN. In vitro assessment of oral lipid based formulations. Adv DrugDeliv Rev. 2001;50 (1):127â€“147.
Jannin V, Musakhanian J, Marchaud D. Approaches for the development of solid and semi-solid lipid-based formulations. Adv Drug Deliv Rev. 2008;60:734â€“746.
Pouton CW. Lipid formulations for oral administration of drugs: nonemulsifying, self-emulsifying and â€˜self-micro emulsifying' drug delivery systems. Eur J PharmSci. 2000;11(2) 93â€“98.
Hauss DJ, FogalSE, Ficorilli JV, PriceCA, Roy T, JayarajAA, et al. Lipid-based delivery systems for improving the bioavailability and lymphatic transport of a poorly water-soluble LTB4 inhibitor. J Pharm Sci. 1998;87:164â€“169.
Gursoy RN, Benita S.Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomedicine and Pharmacotherapy.2004;58(3):173â€“182.
Tang JL, Sun J, He ZG. Self-emulsifying drug delivery systems: a strategy for improving oral delivery of poorly soluble drugs. Current drug therapy. 2007; 2(1): 85â€“93.
.Kim J, Yoon KA, Hahn M, Park ES, Chi SC. Preparation and in vitro evaluation of self-micro emulsifying drug delivery systems containing idebenone. Drug Development and Industrial Pharmacy.2000;26(5):523â€“529.
Jadhav KR, Shaikh IM, Ambade KW, Kadam VJ. Applications of microemulsion based drug delivery system. Current Drug Delivery.2006;3(3): 267â€“273.
Buyukozturk F, Benneyan JC, Carrier RL. Impact of emulsion-based drug delivery systems on intestinal permeability and drug release kinetics. Journal of Controlled Release. 2010.vol 142, no. 1, pp. 22â€“30,
Kimura M, Shizuki M, Miyoshi K, Sakai T, Hidaka H, Takamura H, et al. Relationship between the molecular structures and emulsification properties of edible oils. Bio Sci biotech Biochem.1994;58: 1258â€‘1261.
Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm. Res.2004; 21: 201â€“230.
Date AA, Nagarsenker MS. Parenteral micro emulsions: an overview.Int. J. Pharm.2008; 355: 19â€“30.
Meinzer A, Mueller E, Vonderscher J. Microemulsion a suitable galenical approach for the absorption enhancement of low soluble compounds. B T Gattefosse.1995;88:21â€‘26.
Craig DQ, Barkar SA, Banning D, Booth SW. An investigation into the mechanisms of self emulsification using particle size analysis and low frequency dielectric spectroscopy. Int J Pharm. 1995;144:103â€‘110.
Ren F, Jing Q, Cui J, Chen J, Shen Y. Self-Nano emulsifying drug delivery system (SNEDDS) of anethole trithione by the combined use of surfactants. J. Disp. Sci. Tech. 2009; 30: 664â€“670.
Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm. Res. 2004; 21: 201â€“230.
Gershanik T Benita S. Self-dispersing lipid formulations for improving oral absorption of lipophilic drugs. European Journal of Pharmaceutics and Biopharmaceutics.2000;50(1): 179â€“188.
Singh A, Singh V, Juyal D, Rawat G. Self emulsifying systems: A review. Asian J Pharm.2015;9:13-8.
Singh K, Chaurasiya A, Singh M, Upadhyay SC, Mukherjee R, Khar RK. Exemestane loaded self micro emulsifying drug delivery system (SMEDDS): development and optimization.AAPS PharmSciTech. 2008;9(2): 628â€“634.
Y.Wang, J. Sun, T. Zhang, H. Liu, F. He, He Z. Enhanced oral bioavailability of tacrolimus in rats by self micro emulsifying drug delivery systems. Drug Development and Industrial Pharmacy.2011;37(10):1225â€“1230.
Rang MJ, Miller CA. Spontaneous emulsification of oils containing N hydrocarbon, nonionic surfactant and oleyl alcohol.J Colloid Interface Sci.1999;209:179-192.
Narang AS, Delmarre D, Gao D.Stable drug encapsulation in micelles and microemulsions. International Journal of Pharmaceutics.2007; 345(2):9â€“25.
Zhang H, Cui Y, Zhu S, Feng F, Zheng X. Characterization and antimicrobial activity of a pharmaceutical microemulsion. International Journal of Pharmaceutics.2010;395(2):154â€“160.
Patil P, Joshi J, Paradkar P. Effect of formulation variables on preparation and evaluation of gelled self-emulsifying drug delivery system(SEDDS)of ketoprofen. AAPS Pharm Sci Tech. 2004; 5(3): 34-42.
Patil P, Vandana P, Paradkar P. Formulation of self emulsifying drug delivery system for oral delivery of simvastatin: In vitro and in vivo evaluation. Acta Pharma. 2007; 57: 111-122.
Wasan KM. Drug Dev Ind Pharm. 2001;27:267â€‘276.
Balakrishnan P, Lee BJ, Oh DH, et al.Enhanced oral bioavailability of Coenzyme Q10 by self-emulsifying drug delivery systems. International Journal of Pharmaceutics.2009:374(2): 66â€“72.
Atef E, Belmonte AA.Formulation and in vitro and in vivo characterization of a phenytoin self-emulsifying drug delivery system (SEDDS).European Journal of Pharmaceutical Sciences. 2008; 35( 4) 257â€“263.
Basalious EB, Shawky N, Badrldin SM.SNEDDS containing bio enhancers for improvement of dissolution and oral absorption of lacidipine Development and optimization. International Journal of Pharmaceutics.2010; 391(2): 203â€“211.
Kohli K, Chopra S, Dhar D, Arora S, Khar RK. Self emulsifying drug delivery systems: an approach to enhance oral bioavailability. Drug Discovery Today. 2010;15:(21-22): 958â€“965.
Parveen R, Baboota S, Ali J, Ahuja A, Vasudev SS, Ahmad. Oil based nanocarrier for improved oral delivery of silymarin: In vitro & In vivo studies. International Journal of Pharmaceutics.2011;413:(1-2): 245â€“253.
Patel AR, Vavia PR. Preparation and in vivo evaluation of SMEDDS (self-micro emulsifying drug delivery system) containing fenofibrate. The AAPS Journal.2007;9(3):344â€“ 352.
Hiral M, Makadia A.Self-nano Emulsifying Drug Delivery System (SNEDDS): Future Aspects. Asian J. Pharm.2013;3:(1): 21-27.
Shafiq S. Development and bioavailability assessment of ramipril nanoemulsion formulation. Eur. J. Pharm. Biopharm. 2007; 66: 227â€“243.
.Karamustafa F, Celebi N. Development of an oral microemulsion formulation of alendronate: Effects of oil and cosurfactant type on phase behavior. Journal of Microencapsulation.2008; 25(5):315â€“323.
Bali V, Ali M, Ali J. Nanocarrier for the enhanced bioavailability of a cardiovascular agent: in vitro, pharmacodynamic, pharmacokinetic and stability assessment. International Journal of Pharmaceutics.2011;403(1-2): 45â€“56.
De Campos LMP, Araujo JA. Thomazine, Lopez RFV. Development of microemulsions to topically deliver 5-aminolevulinic acid in photodynamic therapy. European Journal of Pharmaceutics and Biopharmaceutics.2010; 75(1): 48â€“55.
Huang Y, Zhou Y, Liu Y. Development of silymarin self micro emulsifying drug delivery system with enhanced oral bioavailability. AAPS PharmSciTech.2010;11(2):,672â€“678.
Kim HJ, Yoon KA, Hahn M, Park ES, Chi SC. Preparation and in vitro evaluation of self-micro emulsifying drug delivery systems containing idebenone. Drug Development and Industrial Pharmacy.2000; 26(5):523â€“529.
Borhade V, Nair H, Hegde D. Design and evaluation Of self-microemulsifying drug delivery system (SMEDDS) of tacrolimus. AAPS PharmSciTech.2008;9(1):13â€“21.
Kale AA, Patravale VB. Design and evaluation of self emulsifying drug delivery systems (SEDDS) of nimodipine. AAPS PharmSciTech.2008( 9):191â€“196.
Edwards GA, PorterCJH, CaliphSM, KhooSM, Charman WN. Animal models for the study of intestinal lymphatic drug transport. Adv DrugDelRev 2001;50:45â€“60.
Perry CM, NobleS. Saquinavir soft-gel capsule formulation. A review of its use in patients with HIV infection. Drugs 1998;55:461â€“86.
Priya T, Vrushali M, Pankaj B, Jaydeep D, Sanjay K.A review on self-emulsified drug delivery system.Pharmaceutical and biological evaluations.2016;3 (2): 140-153.
Joshua, S, Garret, E, Amin, E, Daniel, B. Methods of forming a self-supporting film for delivery of therapeutic agents. US8632839B2 (2014).
Florian, B., Emad, H., Lionel, S. Self-micro emulsifying mitotane composition. US8486445 (2013).
Ma, H, Guo T. Rhizoma corydalis total alkaloids self-emulsifying drug delivery system and preparation method and application thereof. CN101912447B (2013).
Hao WH., Wang, JJ, Hsu, C.S. Self-emulsifying pharmaceutical composition with enhanced bioavailability. EP2062571B1 (2012).
Laurent, S, Martin L, Martin M, Heribert JW, Simone A, Raymond B, Birgit H, Fabien R. Oil-in-water emulsion and its use for the delivery of functionality. AU2006316507B2 (2012).
Klaveness JEJ, Berge G, Hustvedt SO, Olesen PH, Muellertz A. Coated capsules and tablets of a fatty acid oil mixture. CA2781525A1 (2011).
Schwarz FX. Process for dosing self-emulsifying drug delivery systems. EP2136785B1 (2011).
.Hong CIL, Ki MH, Kwon DS, Lee SG, Shin HJ. Formulation of self emulsifying matrix type mucosal and transdermal absorbent. KR20010093728 A (2010).
Holmberg C, Siekmann B. New self emulsifying drug delivery system. US20100266683 (2010).
Zanchetta B, Chaud MV, Santana MHA. Self-Emulsifying Drug Delivery Systems (SEDDS) in Pharmaceutical Development. J Adv Chem Eng.2015; 5 (3):1-7.