OPTIMIZATION OF COCONUT OIL BASED SELF MICRO EMULSIFYING DRUG DELIVERY SYSTEMS OF OLMESARTAN MEDOXOMIL BY SIMPLEX CENTROID DESIGN
Objective: To develop and optimize self-micro emulsifying drug delivery systems of Olmesartan Medoxomil using formulation by design approach for improvement of solubility and dissolution rate.
Methods: A simplex centroid design was employed as statistical tools to optimize the formulation variables, X1 (Coconut oil), X2 (Kolliphor RH) and X3 (PEG 400). The high and low levels of these factors were selected according the micro-emulsion region obtained from the pseudo-ternary phase diagram. The response variables studied were mean globule size (Y1) and average absorbance (Y2).
Results: The optimized formulation consisted of 21.54% of coconut oil, 36.04% of Kolliphor RH and 42.42% of PEG 400 which could provide a globule size of 125.94 nm and an average absorbance of 0.85. Dissolution studies revealed a marked increase in dissolution of the optimized formulation when compared with the pure drug.
Conclusion: Thus, it was concluded that self-micro emulsifying drug delivery systems (SMEDDS) provided a promising formulation approach for the solubility and dissolution enhancement of the poorly soluble drug, Olmesartan Medoxomil.
2. Chabukswar AR, Kuchekara BS, Jagdalea SC, Mehetrea DM, Morea AS, Lokhande PD. Development and validation of a RP-HPLC method for simultaneous estimation of olmesartan medoxomil and amlodipine besylate in tablet dosage form. Arch Appl Sci Res 2010;2:307â€“12.
3. Raval C, Joshi N, Patel J, Upadhyay UM. Enhanced oral bioavailability of olmesartan by using novel solid self-emulsifying drug delivery system. Int J Adv Pharm 2012;2:82â€“92.
4. Kang MJ, Kim HS, Jeon HS, Park JH, Lee BS, Ahn BK, et al. In situ intestinal permeability and in vivo absorption characteristics of olmesartan medoxomil in self-micro emulsifying drug delivery system. Drug Dev Ind Pharm 2012;38:587â€“96.
5. Sriamornsak P, Limmatvapirat S, Piriyaprasarth S, Mansukmanee P, Huang Z. A new self-emulsifying formulation of mefenamic acid with enhanced drug dissolution. Asian J Pharm Sci 2015;10:121-7.
6. Parmar K, Patel J, Sheth N. Self nano-emulsifying drug delivery system for embelin: design, characterization and in vitro studies. Asian J Pharm Sci 2015;10:396-404.
7. Shukla JB, Koli AR, Ranch KM, Parikh RK. Self micro emulsifying drug delivery system. Int J Pharm Sci 2010;1:13â€“33.
8. Gursoy RN, Benita S. Self-emulsifying drug delivery systems (SEDDS) for improved oral delivery of lipophilic drugs. Biomed Pharmacother 2004;58:173â€“82.
9. Khamkar GS. Self-micro emulsifying drug delivery system (SMEED) o/w microemulsion for BCS class II drugs: an approach to enhance an oral bioavailability. Int J Pharm Pharm Sci 2011;3:28â€“30.
10. Sheth NS. Mistry RB. A review: self-emulsifying drug delivery system. Int J Pharm Pharm Sci 2011;3:23â€“8.
11. Kumanan R, Jitendra MR, Manasa R. Stability indicating RP-HPLC method development and validation of olmesartan medoxomil. Asian J Pharm Biol Res 2011;1:79-86.
12. Li WW, Yi SL, Wang ZH, Chen S, Xin S, Xie JW, et al. Self-nano emulsifying drug delivery system of persimmon leaf extract: optimization and bioavailability studies. Int J Pharm 2011;420:161â€“71.
13. Khan BA, Bakhsh S, Khan H, Mahmood T, Rasul A. Basics of self-micro emulsifying drug delivery system. J Alternative Complementary Med 2012;1:13â€“20.
14. Rai S, Yasir M. Cinnarizine loaded lipid-based system: Preparation, optimization and in vitro evaluation. IOSR J Pharm 2012;2:47â€“56.
15. Baek MK, Lee JH, Cho YO, Kim HH, Lee GW. Self-micro emulsifying drug delivery system for improved oral bioavailability of pranlukast hemihydrate: preparation and evaluation. Int J Nanomed 2013;8:167â€“76.
16. Bahloul B, Lassoued MA, Souad S. A novel approach for the development and optimization of self-emulsifying drug delivery system using HLB and response surface methodology: application to fenofibrate encapsulation. Int J Pharm 2014;466:341â€“8.
17. Pawar YB, Purohit H, Valicherla GR, Munjal B, Lale SV, Patel SB, et al. Novel lipid based oral formulation of curcumin: development and optimization by the design of experiments approach. Int J Pharm 2012;436:617â€“23.
18. Suresh PK, Sharma S. Formulation and in vitro characterization of self nano emulsifying drug delivery system of Cinnarizine. Pharm Globale 2011;9:1â€“6.
19. Barth HG, Sun ST. Particle size analysis. Anal Chem 1989;61:143â€“52.
20. Agrawal AG, Kumar A, Gide PS. Self-emulsifying drug delivery system for enhanced solubility and dissolution of glipizide. Colloids Surf B 2015;126:553-60.
21. Dash RN, Habibuddin M, Humaira, Ramesh D. Design, optimization and evaluation of glipizide solid self-emulsifying drug delivery for enhanced solubility and dissolution. Saudi Pharm J 2015;23:528-40.
22. Villar AMS, Naveros BC, Campmany ACC, Trenchs MA, Rocabert CB, Bellowa LH. Design and optimization of self-nano emulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil. Int J Pharm 2012;431:161â€“75.
23. Patel J, Patel A, Raval M, Sheth N. Formulation and development of a self-nano emulsifying drug delivery system of irbesartan. J Adv Pharm Technol Res 2011;2:9â€“16.
24. Singh SK, Verma PR, Razdan B. Glibenclamide-loaded self-nano emulsifying drug delivery system: development and characterization. Drug Dev Ind Pharm 2010;36:933-45.
25. Wu XG, Li G, Gao YL. Optimization of the preparation of nalmefene-loaded sustained-release microspheres using central composite design. Chem Pharm Bull 2006;54:977-81.