Author(s):
Vinod Kumar Yadav, Balamuralidhara V, Hemanth Kumar S
Email(s):
baligowda@jssuni.edu.in
DOI:
10.5958/0974-360X.2020.00469.2 
Address:
Vinod Kumar Yadav, Balamuralidhara V*, Hemanth Kumar S
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 6,
Year - 2020
ABSTRACT:
The aim of the present study is to improve the dissolution rate and developed Itraconazole solid powder. Cotton seed oil, tween 80 and transcutol were selected as key ingredients to formulated self-nanoemulsifying drug delivery system. Ternary phase diagrams were constructed, several formulations were designed. These formulations were characterized and evaluated for parameters such as thermodynamic stability, emulsifying rate, robustness to dilution and pH effects, globules size, zeta potential, in vitro study etc. The optimized formulation has globules size of 141.20±0.69 nm, pdi 0.29±0.04, zeta potential 11.2±0.69 mV and fast dissolution as within 30 min with more than 90 % drug released. Further cytotoxicity studies of optimized formulation revealed safe formulation. Using neusilin US2 as solid adsorbent method to transformed the optimized formulation into powder form. It was further characterized and evaluated and the obtained results are acceptable. In vitro drug released of solid self-nanoemulsifying formulation and liquid self-nanoemulsifying formulation has almost similar. Thus, can conclude that implementation of solid approach of this strategy could be considered as alternative approach.
Cite this article:
Vinod Kumar Yadav, Balamuralidhara V, Hemanth Kumar S. Design, Development and Evaluation of Solid Form of Liquid Self-Nanoemulsifying Formulation for improving the Oral Bioavailability of Itraconazole. Research J. Pharm. and Tech 2020; 13(6):2639-2646. doi: 10.5958/0974-360X.2020.00469.2
Cite(Electronic):
Vinod Kumar Yadav, Balamuralidhara V, Hemanth Kumar S. Design, Development and Evaluation of Solid Form of Liquid Self-Nanoemulsifying Formulation for improving the Oral Bioavailability of Itraconazole. Research J. Pharm. and Tech 2020; 13(6):2639-2646. doi: 10.5958/0974-360X.2020.00469.2 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-6-19
8. REFERENCES:
1. Ghosh S, Ghosh S, Sil PC. Role of nanostructures in improvising oral medicine. Toxicol Rep. 2019; 6:358-368.
2. Maghrebi S, Prestidge CA, Joyce P. An update on polymer-lipid hybrid systems for improving oral drug delivery. Expert Opin Drug Deliv. 2019; 16(5):507-524.
3. Swaminathan S, Sangwai M, Wawdhane S, Vavia P Soluble Itraconazole in Tablet Form Using Disordered Drug Delivery Approach: Critical Scale-up Considerations and Bio-equivalence Studies. AAPS Pharm Sci Tech. 2013; 14(1): 360–374.
4. Thiry J, Kok MG, Collard L, Frere A, Krier F, Fillet M, Evrard B. Bioavailability enhancement of itraconazole-based solid dispersions produced by hot melt extrusion in the framework of the Three Rs rule. Eur J Pharm Sci. 2017; 99:1-8.
5. Karashima M, Sano N, Yamamoto S, Arai Y, Yamamoto K, Amano N, Ikeda Y. Enhanced pulmonary absorption of poorly soluble itraconazole by micronized cocrystal dry powder formulations. Eur J Pharm Biopharm. 2017; 115:65-72.
6. Date AA, Desai N, Dixit R, Nagarsenker M. Self-nanoemulsifying drug delivery systems: formulation insights, applications and advances. Nanomedicine (Lond). 2010; 5:1595-1616.
7. Joshi RP et al. SNEDDS curcumin formulation leads to enhanced protection from pain and functional deficits associated with diabetic neuropathy: An insight into its mechanism for neuroprotection. Nanomedicine. 2013; 9:776-785.
8. Inugala S, Eedara BB, Sunkavalli S, Dhurke R, Kandadi P, Jukanti R, Bandari S. Solid self-nanoemulsifying drug delivery system (S-SNEDDS) of darunavir for improved dissolution and oral bioavailability: In vitro and in vivo evaluation. Eur J Pharm Sci. 2015; 74:1-10.
9. Hong JY, Kim JK, Song YK, Park JS, Kim CK. A new self-emulsifying formulation of itraconazole with improved dissolution and oral absorption. J Control Release. 2006; 110(2):332-338.
10. Salvam P, Kulkarni PK, Vegesna NSKV. Porous Polystyrene Spheres Loaded Self Nano-emulsifying systems of Rosuvastatin calcium. RSC Advances. 2015; 5:69642-69650.
11. Ahmad J, Kohli K, Mir SR, Amin S. Formulation of Self-Nanoemulsifying Drug Delivery System for Telmisartan with Improved Dissolution and Oral Bioavailability. J Dispersion SciTechnol 2011; 32:958–968.
12. Shakeel F, Haq N, Alanazi FK, Alsarra IA. Polymeric solid self-nanoemulsifying drug delivery system of glibenclamide using coffee husk as a low cost biosorbent.; Powder Technol. 2014; 256: 352–360.
13. AboulFotouh K, Allam AA, El-Badry M, El-Sayed AM. Development and in vitro/in vivo performance of self-nanoemulsifying drug delivery systems loaded with candesartan cilexetil. Eur J Pharm Sci. 2017; 109:503-513.
14. Alshahrani SM, Alshetaili AS, Alalaiwe A, Alsulays BB, Anwer MK, Al-Shdefat R, Imam F, Shakeel F. Anticancer Efficacy of Self-Nanoemulsifying Drug Delivery System of Sunitinib Malate. AAPS PharmSciTech. 2018; 19(1):123-133.
15. Rajesh SY et al. Impact of various solid carriers and spray drying on pre/post compression properties of solid SNEDDS loaded with glimepiride: in vitro-ex vivo evaluation and cytotoxicity assessment. Drug Dev Ind Pharm. 2018; 44 :1056-1069.
16. Tong Y et al., Systematic Development of Self-Nanoemulsifying Liquisolid Tablets to Improve the Dissolution and Oral Bioavailability of an Oily Drug, Vitamin K1.Pharmaceutis. 2018; 10(3):1-20.
17. El-Zahaby SA, Abou Ghaly MHH, Abdelbary GA, El-Gazayerly ON. Zero-order release and bioavailability enhancement of poorly water soluble Vinpocetine from self-nanoemulsifying osmotic pump tablet. Pharm Dev Technol. 2018; 23(9):900-910.
18. Patel G, Shelat P, Lalwani A. Statistical modeling, optimization and characterization of solid self-nanoemulsifying drug delivery system of lopinavir using design of experiment. Drug Deliv. 2016; 23(8):3027-3042.
19. Patel P, Pailla SR, Rangaraj N, Cheruvu HS, Dodoala S, Sampathi S.Quality by Design Approach for Developing Lipid-Based Nanoformulations of Gliclazide to Improve Oral Bioavailability and Anti-Diabetic Activity. AAPS PharmSciTech. 2019; 20(2):45:1-17.
20. Balakrishnan P et al. Enhanced oral bioavailability of dexibuprofen by a novel solid self-emulsifying drug delivery system (SEDDS). Eur J Pharm Biopharm. 2009; 72 :539-45.
21. Miao Y, Sun J, Chen G, Lili R, Ouyang P. Enhanced oral bioavailability of lurasidone by self-nanoemulsifying drug delivery system in fasted state. Drug Dev Ind Pharm. 2016; 42 :1234-1240.