DESIGN AND CHARACTERIZATION OF MICROEMULSION GEL FOR TRANSDERMAL DRUG DELIVERY SYSTEM OF DULOXETINE HYDROCHLORIDE
Objective: The objective was to improve the bioavailability, stability of formulation, and skin permeability of Duloxetine HCl.
Method: Microemulsion was prepared with oleic acid as oil, water, and Smix ratio of tween 20 to propylene glycol (1:3). Pseudo-ternary phase diagrams were constructed to determine the region of existence of microemulsions prepared using oil titration method. Optimization of formulations was done based on the in vitro diffusion studies. The microemulsion was gelled using carbopol 934p and HPMCK 100 as the gelling agent.
Result: After the analysis of different evaluation parameter and drug release, the F3 batch was selected as a promising formulation for delivery of duloxetine HCl as a microemulsion gel for transdermal drug delivery with 79.607% drug release in 10 h.
Conclusion: It was observed that transdermal microemulsion gel can be formulated successfully for duloxetine HCl with improved bioavailability. Among the other batches, the F3 batch was selected as an optimized batch because all the evaluation parameters results are satisfactory. From stability data, the formulation was found to be stable as no phase separation or turbidity was observed in the formulation after 3 months.
2. Shingade GM, Aamer Q, Sabale PM, Grampurohit ND, Gadhave MV, Jadhav SL, et al. Review on: Recent trend on transdermal drug delivery system. J Drug Deliv Ther 2012;2:66-75.
3. Loyd V, Allen JR, Popovich NG, Ansel HC. Pharmaceutical Dosage Forms and Drug Delivery Systems. 8th ed. Philadelphia, PA: Lippincott-Williams and Wilkins; 2005. p. 298-9.
4. Kumar R, Philip A. Modified transdermal technologies: Breaking the barriers of drug permeation via the skin. Trop J Pharm Res 2007;6:633 44.
5. Rizwan M, Aqil M, Talegoankar S, Azeem A, Sultana Y, Ali A. Enhanced transdermal drug delivery techniques: An extensive review on patents. Recent Pat Drug Deliv Formul 2009;3:105-24.
6. Mishra A, Keshari AK, Singh AK, Maity S, Nandy B, Saha S. Oxidative stress-based hepatotoxicity of duloxetine in wistar rats. Int J Pharm Pharm Sci 2016;8:28-32.
7. Kaur J, Nautiyal U, Kumar S, Singh D, Anwar F. Microemulsions: A potential novel drug delivery system. Int J Pharm Med Res 2014;2:15 20.
8. Beg S, Jena SS, Patra ChN, Rizwan M, Swain S, Sruti J, et al. Development of solid self-nanoemulsifying granules (SSNEGs) of ondansetron hydrochloride with enhanced bioavailability potential. Colloids Surf B Biointerfaces 2013;101:414-23.
9. Dixit P, Nagarsenker M. Self-nanoemulsifying granules of Ezetimibe: Design, optimization and evaluation. Eur J Pharm Sci 2008;35:183-92.
10. Patel J, Patel A, Raval M, Sheth N. Formulation and development of a self-nanoemulsifying drug delivery system of irbesartan. J Adv Pharm Technol Res 2011;2:9-16.
11. Kalhapure R, Krishnacharya G, Kamanchi A. Oleic acid based heterolipidsynthesis, characterization and application in self-microemulsifying drug deliver system. Int J Pharm 2012;425:9-18.
12. Patel RM, Patel BR, Parikh RJ, Bhatt KK, Solanki BA. Investigating the effect of vehicle on in vitro skin permeation of ketoconazole applied in O/W Microemulsions. Acta Pharm Sci 2010;52:65-77.
13. Madikattu K, Naidu KV, Srisailam K. Microemulsion based transdermal gels of isradipine to enhance bioavailability: In vitro and in vivo evaluation. Asian J Pharm 2016;9:23-30.
14. Wani RR, Patil MP, Dhurjad P, Chaudhari CA, Kshirsagar SJ. Microemulsion based gel: A novel approach in delivery of hydrophobic drugs. Int J Pharm Res Sch 2015;4:398-410.
15. Tirunagari M, Jangala VR, Khagga M, Gannu R. Transdermal therapeutic system of isradipine: Effect of hydrophilic and hydrophobic matrix on in vitro and ex vivo characteristics. Arch Pharm Res 2010;33:1025-33.
16. Shaikh HK, Kshirsagar RV, Patil SG. Mathematical models for drug release characterization: A review. World J Pharm Pharm Sci 2016;4:324-38.
17. Cartensen J., ICH Guidelines. Drug Stability Principles and Practices. 2nd ed. New York: Marcel Dekker Inc.; 1995: 541-6.
18. U.S. Department of Health and Human Services FDA, Guidance for Industry Q1A (R2) Stability Testing Of New Drug Substances and Products, ICH Revision; 2003. p. 5.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.