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A Gelucire 44/14 and labrasol based solid self emulsifying drug delivery system: formulation and evaluation

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Abstract

A solid self emulsifying formulation (S-SEF) has been developed with an intention to improve the dissolution characteristics of poorly water soluble lercanidipine hydrochloride (LH). Suitable components for the formulation of liquid self emulsifying drug delivery systems (SEDDS) were selected after screening various vehicles via solubility studies. Formulations were designed with Gelucire® 44/14 as oil, labrasol as surfactant and transcutol-P as co surfactant. The prepared formulations were evaluated for self emulsifying efficiency and ternary phase diagram was used to designate optimum systems in the emulsifying domain. These systems were further investigated for robustness towards different pH conditions, globule size, thermodynamic stability, surface morphology, cloud point and in vitro drug release. The optimized LH loaded formulation possessed a mean globule size of 142.5 ± 5.37 nm and cloud point of 72 ± 2.66 °C. The liquid SEDDS was transformed into free flowing S-SEF by adsorbing on to an inert carrier, Neusilin US2®. The results revealed no difference in globule size and emulsification characteristics between liquid SEDDS and S-SEF. The solid state characterization studies indicated loss of crystallinity for the drug. Significant improvement in dissolution characteristics of LH for prepared S-SEF was observed compared with pure drug.

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Acknowledgments

The authors are much grateful to ABITEC Corporations, Cleveland, USA, Gatteffose, France and Fuji Chemicals, Japan for providing the gift samples of excipients. The authors also thank Sun Pharma, Ahmedabad for providing gift sample of lercanidipine HCl. The financial assistance to Kallakunta Venkata Raman and Basanth Babu Eedara by All India Council of Technical Education (New Delhi, India) in the form of Junior Research Fellowship is duly acknowledged. The authors also thank Mr. T. Jayapal Reddy, Chairman, St. Peter’s Institute of Pharmaceutical Sciences, Hanamkonda for providing the necessary facilities.

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The authors report no conflicts of interest.

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Authors and Affiliations

  1. Department of Pharmaceutics, St. Peter’s Institute of Pharmaceutical Sciences, Hanamkonda, Vidyanagar, Warangal, 506001, Andhra Pradesh, India

    Venkata Raman Kallakunta, Basanth Babu Eedara, Raju Jukanti, Ram Kishan Ajmeera & Suresh Bandari

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  1. Venkata Raman Kallakunta
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  2. Basanth Babu Eedara
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Correspondence to Suresh Bandari.

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Kallakunta, V.R., Eedara, B.B., Jukanti, R. et al. A Gelucire 44/14 and labrasol based solid self emulsifying drug delivery system: formulation and evaluation. Journal of Pharmaceutical Investigation 43, 185–196 (2013). https://doi.org/10.1007/s40005-013-0060-9

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  • DOI: https://doi.org/10.1007/s40005-013-0060-9

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