Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Study on Formulation Development and Shelf Life Indicating Stability of Artesunate Loaded Self-Nanoemulsifying Drug Delivery System


Affiliations
1 Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India
     

   Subscribe/Renew Journal


Solubility plays an important role in the formulation. When a drug is poorly soluble, their bioavailability will be affected. However, the solubility of the drug can be enhanced by using various methods like pharmaceutical approach, pharmacokinetic approach and biological approach. It can also be improved by formulating a lipid based drug delivery system. In the present study, nanoemulsion has been developed by using oil, surfactant and a co-surfactant in order to increase the solubility of poorly soluble BCS Class II and Class IV drugs. Nanoemulsions can be prepared by different techniques. In the current study, nanoemulsion has been formulated by using simple spontaneous emulsification approach. Artesunate was used as a choice of drug and capryol 90 was used as oil in the present study. Pseudo-ternary phase diagrams were used in order to determine the oil and Smix ratio. After the formulation, the product was subjected to various evaluation studies like droplet size, zeta potential, PDI and viscosity etc. Further, the in-vitro dissolution test was carried out for the formulated product, marketed formulation and the pure drug. And it was observed that the formulated product showed an improved drug release. In addition to these evaluation tests, accelerated stability studies according to the ICH guidelines were also carried in order to determine the shelf life as well as the effect of added ingredients on the stability of the product. The shelf life of the product was observed to be 2.38 years at room temperature.

Keywords

Artesunate, Solubility, Nanoemulsion, Stability Studies, Shelf Life.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Vieth M, Siegel MG, Higgs RE, Watson IA, Robertson DH. Characteristic physicalproperties and structural fragments of marketed oral drugs. Journal of Medicinal Chemistry. 2004; 47 (1): 224- 232.

  • Muller R.H, Peters K, Becker R, Kruss B. Nanosuspension for IV administration of poorly soluble drugs-stability during sterilization and long term storage. 22ndInternational symposium, Control Release Bioact. Mater, Seattle.29, 1995: 574-575.

  • Abdalla A, Klein S, Mader K. A new self-emulsifying drug delivery system (SEDDS) for poorly soluble drugs: characterization, dissolution, in vitro digestion and incorporation into solid pellets. European Journal of Pharmaceutical Sciences. 2008; 35(5): 457-464.

  • Shafiq S., Shakeel F., Talegaonkar S., Ali J., Baboota S., Ahuja A., Khar R.K., MushirA. Formulation development and optimization using nanoemulsion technique: A technical note. An Official Journal of the American Association of Pharmaceutical Scientists. 2007; 8(2): E1-E6.

  • Faiyaz Shakeel, Sanjula Baboota, Alka Ahuja, Javed Ali and Sheikh Shafiq. Stability evaluation of celecoxib nanoemulsions containing Tween 80. Thai Journal of Pharmaceutical Sciences. 2008; 32: 4-9.

  • Yosra S.R.Elnaggar, Magda A.El-Massik and Ossama Y.Abdallah. Self-nanoemulsifying drug delivery systems of tamoxifen citrate: Design and optimization. International Journal of Pharmaceutics. 2009; 380 (1-2): 133-141.

  • Abhijit A. Date, M. S. Nagarsenker. Design and evaluation of self-nanoemulsifying drug delivery systems (SNEDDS) for cefpodoxime proxetil. International Journal of Pharmceutics. 2007; 329 (1-2): 166-172.

  • Megha pokharana, rajat vaishnav, anju goyal, aseem shrivastava. Stability testing guidelines of pharmaceutical products. Journal of Drug Delivery and Therapeutics. 2018; 8 (2): 169-175.

  • Bo Tang, Gang Cheng, Jian-Chun Gu, Cai-Hong Xu. Development of solid self-emulsifying drug delivery systems: Preparation techniques and dosage forms. Drug Discovery Today. 2008; 13 (13-14): 606-612.

  • Rasool A.A, Anwar A. H, Lewis W.D. Solubility enhancement of some water insoluble drugs in the presence of nicotinamide and related compounds, Journal of Pharmaceutical Sciences. 2002; 80 (4): 387-393.

  • Yohei Kawabata, Koichi Wada, Manabu Nakatani, Shizuo Yamada, Satomi Onoue. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: Basic approaches and practical applications. International Journal of Pharmceutics. 2011; 420 (1): 1– 10.

  • L. Wang, X. Li, G. Zhang, J. Dong and J. Eastoe. Oil-in-Water Nanoemulsions for Pesticide Formulations. Journal of Colloid and Interface Science. 2007; 314(1): 230-235.

  • S. M. Jafari, Y. He and B. Bhandari. Optimization of Nanoemulsion Production by Microfluidization. European Food Research Technology. 2007; 225(5-6): 733-741.

  • I. Sole, A. Maestro, C. M. Pey, C. Gonzalez, C. Solans and J. M. Gutierrez. Nanoemulsions Preparation by Low Energy Methods in an Ionic Surfactant System. Colloids and Surfaces A: Physiochemical Engineering Aspects. 2006; 288 (1-3): 138-143.

  • I. Sole, C. M. Pey, A. Maestro, C. Gonzalez, M. Porras, C. Solans and J. M. Gutierrez. Nanoemulsions Prepared by Phase Inversion Composition Method: Preparation Variables and Scale up. Journal of Colloid and Interface Science. 2010; 44(2): 417-423.

  • N. Anton and T. Vandamme. The Universality of Low- Energy Nano-Emulsification. International Journal of Pharmceutics. 2009; 377(1-2): 142-147.

  • O. Sonneville-Aubrun, J. T. Simonnet and F. L’Alloret. Nanoemulsions: A New Vehicle for Skincare Products. Advances in Colloids and Interface Science. 2004; 108-109: 145-149.

  • P. Shah, D. Bhalodia and P. Shelat. Nanoemulsion: A Pharmaceutical Review. Systematic Reviews in Pharmacy. 2010; 1(1): 24-32.

  • T. P. U. Ravi and T. Padma. Nanoemulsions for Drug Delivery through Different Routes. Research in Bio-technology. 2011; 2(3): 1-13.

  • T. G. Mason, S. M. Graves, J. N. Wilking and M. Y. Lin. Extreme Emulsification: Formation and Structure of Nanoemulsions. Journal of Physics and Condensed Matter. 2006; 9(1): 193-199.

  • T. Tadros, P. Izquierdo, J. Esquena and C. Solans. Formation and Stability of Nanoemulsions. Advances in Colloid and Interface Science. 2004; 108-109: 303-318.

  • M. Nagajyothi, K. Pramod, E.N. Bijin, Jomon N. Baby, J. Valsalakumari. Accelerated Stability Studies of Atorvastatin Loaded Nanoemulsion Asian Journal of Pharmacy and Technology. 2015; 5(3): 188-191.

  • Faiyaz Shakeel, Sanjula Baboota, Alka Ahuja, Javed Ali and Sheikh Shafiq. Accelerated stability testing of celecoxib nanoemulsion containing Cremophor-EL. African Journal of Pharmacy and Pharmacology. 2008; 2(8): 179-183.


Abstract Views: 327

PDF Views: 0




  • Study on Formulation Development and Shelf Life Indicating Stability of Artesunate Loaded Self-Nanoemulsifying Drug Delivery System

Abstract Views: 327  |  PDF Views: 0

Authors

S. K. Janani
Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India
R. Suresh Kumar
Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India
Chenmala Karthika
Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India
C. Vasanthi
Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India
Shaik Rafi Kapoor
Department of Pharmaceutics, JSS College of Pharmacy, (Affiliated to JSS University of Higher Education and Research, Mysuru), Ootacamund, India

Abstract


Solubility plays an important role in the formulation. When a drug is poorly soluble, their bioavailability will be affected. However, the solubility of the drug can be enhanced by using various methods like pharmaceutical approach, pharmacokinetic approach and biological approach. It can also be improved by formulating a lipid based drug delivery system. In the present study, nanoemulsion has been developed by using oil, surfactant and a co-surfactant in order to increase the solubility of poorly soluble BCS Class II and Class IV drugs. Nanoemulsions can be prepared by different techniques. In the current study, nanoemulsion has been formulated by using simple spontaneous emulsification approach. Artesunate was used as a choice of drug and capryol 90 was used as oil in the present study. Pseudo-ternary phase diagrams were used in order to determine the oil and Smix ratio. After the formulation, the product was subjected to various evaluation studies like droplet size, zeta potential, PDI and viscosity etc. Further, the in-vitro dissolution test was carried out for the formulated product, marketed formulation and the pure drug. And it was observed that the formulated product showed an improved drug release. In addition to these evaluation tests, accelerated stability studies according to the ICH guidelines were also carried in order to determine the shelf life as well as the effect of added ingredients on the stability of the product. The shelf life of the product was observed to be 2.38 years at room temperature.

Keywords


Artesunate, Solubility, Nanoemulsion, Stability Studies, Shelf Life.

References