Single non-ionic surfactant based self-nanoemulsifying drug delivery systems: formulation, characterization, cytotoxicity and permeability enhancement study

Abstract

Single non-ionic surfactant based self-nanoemulsifying drug delivery system (SNEDDS) was formulated and characterised for poor water soluble drug, Atorvastatin calcium. Capmul MCM oil showing highest solubility for Atorvastatin calcium was selected as oil phase. Self-nanoemulsifying capacity of Cremophor RH 40, Cremophor EL, Tween 20, Tween 60, Tween 80 and Labrasol were tested for the selected oil. In vitro dissolution studies were performed and were characterized by t85% and dissolution efficiency (DE). Cytotoxicity of the formulations and permeation enhancement of the drug across caco-2 cell monolayer was assessed. Capmul MCM was found to be better nanoemulsified in decreasing order of Cremophor RH 40 > Cremophor EL > Tween 20 > Tween 60 > Tween 80. Values of droplet size (range 11–83 nm), polydispersity index (range 0.07–0.65); zeta potential (range −3.97 to −19.0) and cloud point (60–85°C) before and after drug loading proves the uniformity and stability of the formulations. SNEDDS formulated with Tween 20 surfactant showed enhanced dissolution with t85% and DE values at 10 min and 78.70, respectively. None of the formulation showed cytotoxicity at the concentration tested. Tween 20 based SNEDDS enhanced permeation of the drug as compared with pure drug across cell lines. It can be concluded that SNEDDS can be formulated by using single non-ionic surfactant system for enhance dissolution and absorption of poorly soluble drug, Atorvastatin calcium.

Keywords::

• SNEDDS
• Cremophor RH 40
• Cremophor EL
• Tween 20
• Dissolution efficiency
• Cytotoxicity
• Caco-2 cell line

Acknowledgements

Authors are thankful to Torrent Pharmaceuticals, India; BASF Chemical, Germany; Gattefosse, France; Abitec corporation, USA for providing gift samples. Authors are also thankful to Associated Capsules, India, for gift sample of HPMC capsules. Mithun M. Bandivadekar is very thankful to IRSHA, Pune for availing facility for cell line studies.

Declaration of interest

We have no personal relationships with other people or organizations that could inappropriately influence the presented work or any affiliation with any organization with a financial interest, direct or indirect, in the subject matter or materials discussed in the manuscript.