Self-nanoemulsifying Drug Delivery Systems: Formulation Insights, Applications and Advances

Abhijit A Date; Neha Desai; Rahul Dixit; Mangal Nagarsenker

Disclosures

Nanomedicine. 2010;5(10) 

In This Article

Limitations of Liquid SNEDDS

Self-nanoemulsifying drug delivery systems, being liquid in nature, need to be delivered through either soft/hard gelatin or hydroxypropylmethylcellulose capsules. There are few issues associated with these systems when presented in capsules, such as incompatibility of components with the capsule shell in the long term, precipitation of drugs during fabrication and storage at low temperature and critical method of production, among others.[103] In addition, SNEDDS may not be useful for hydrophobic drugs that can undergo pH catalyzed or solution-state degradation. We observed that modified oily phases used for SNEDDS fabrication have acidic pH owing to the presence of traces of free fatty acids. These acids can catalyze the degradation of pH-sensitive drugs, such as cefpodoxime proxetil on long-term storage. We observed that cefpodoxime proxetil undergoes hydrolysis to a completely insoluble product (cefpodoxime acid) on 3 months of storage as per the ICH guidelines [Date AA, Unpublished Data]. We also observed that simvastatin SNEDDS formulation was susceptible to hydrolytic degradation at accelerated conditions of storage owing to reactive ester and lactone moiety [Dixit RP, Unpublished Data] and on long-term storage of SNEDDS. In view of our experience, we believe that chemical stability of drugs in SNEDDS needs to be studied at accelerated conditions.

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