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Curr Drug Deliv. 2019 Nov 11. doi: 10.2174/1567201816666191112111610. [Epub ahead of print]

In-Vitro and In-Vivo Evaluation of Supersaturable Self-Nanoemulsifying Drug Delivery System (SNEDDS) of Dutasteride.

Author information

1
School of Pharmacy, Taylor's University Lake view Campus, Subang Jaya, Selangor. Malaysia.
2
Department of Pharmaceutical Sciences, BabasahebBhimraoAmbedkar University (A Central University), Lucknow, Uttar Pradesh . India.

Abstract

OBJECTIVE:

A novel, Supersaturable Self-Nanoemulsifying Drug Delivery System (S-SNEDDS) has been prepared to improve the Dutasteride's poor aqueous solubility.

METHODS:

By adding Hydroxy Propyl Methyl Cellulose (HPMC) as a precipitation inhibitor to conventional SNEDDS, a supersaturable system was prepared. Firstly, prepared SNEDDS played an important role in increasing the aqueous solubility and hence oral absorption due to nano-range size. Secondly, prepared S-SNEDDS found advantageous over SNEDDS for having higher drug load and inhibition of dilution precipitation of Dutasteride. Formulated S-SNEDDS (F1-F9) ranged from 37.42 ± 1.02 to 68.92 ± 0.09 nm with PDI 0.219-0.34 and drug load of over 95 percent.

RESULTS:

Study of in-vitro dissolution revealed higher dissolution for S-SNEDDS compared to SNEDDS and Avodart soft gelatin capsule as commercial product. In addition, higher absorption was observed for S-SNEDDS showing approximately 1.28 and 1.27 fold AUC (0-24h) and Cmax compared to commercial product. Therefore, S-SNEDDS proven as a novel drug delivery system with higher drug load, higher self-emulsification efficiency, higher stability, higher dissolution and pronounced absorption.

CONCLUSION:

In conclusion, S-SNEDDS could be a new emerging approach to enhance aqueous solubility in many folds for drugs belonging to BCS Class II and IV and thus absorption and oral bioavailability.

KEYWORDS:

Dutasteride; Hydroxy Propyl Methyl Cellulose (HPMC); Nano-emulsion; Poor Aqueous Solubility; Supersaturated Self-Nanoemulsifying Drug Delivery (S-SNEDDS); higher self-emulsification efficiency

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