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Abstract
Self-Nanoemulsifying Drug Delivery System (SNEDDS) has potential to be developed for oral protein delivery because it is free from water, hence preserving the stability of protein, protecting protein from enzymatic degradation, and enhancing the protein permeability in the gastrointestinal tract (GIT). However, protein-based SNEDDS formulation is challenging due to low solubility property of protein in oil, which is towards zero. This present study aimed to obtain the most compatible SNEDDS system for protein using HLB approach. Bovine serum albumin (BSA) was used as a protein model in this study. A number of 78 formulae with HLB ranging between 11 and 15 were screened to acquire stable SNEDDS composition without the presence of phase separation. Of 13 stable formulae, two were selected (F30, F45) with HLB 15, and then loaded with BSA. Physical characteristics of both formulae were then evaluated and the results suggested that SNEDDS with single hydrophilic surfactant (F45) and HLB 15 was the best formula for protein template as the stability testing showed that phase separation and precipitation did not appear. It was robust to pH and dilution with percentage of transmittance of 96.40±1.05% and the droplet size of 180.9nm. F45 also had uniform distribution of droplets size since the polydispersity index was less than 0.1. The zeta potential of F45 was -0.12mv with loading efficiency 83.57±1.77%. The emulsifying time of F45 was > 2min due to the formation of crystalline gel that was difficult to disperse.
Highlights
Oral delivery system is the most convenient route because it can improve patient adherence, especially among patients with chronic diseases (Noha et al, 2006)
Surfactant is a vital component of self-nanoemulsifying drug delivery system (SNEDDS) (Shahba et al, 2012)
The present study showed the results of SNEDDS design for Bovine Serum Albumin (BSA) based on HLB value approach
Summary
Oral delivery system is the most convenient route because it can improve patient adherence, especially among patients with chronic diseases (Noha et al, 2006). Some techniques have been tested to improve protein bioavailability, including the use of absorption enhancer (Takatsuka et al, 2006), protease inhibitor (Bernkop-Schnürch and Scerbe-Saiko, 1998), encapsulation on several delivery systems using nanoparticles (Sonaje et al, 2009), microemulsion (Sharma et al, 2010), self-nanoemulsifying drug delivery system (SNEDDS) (Li et al, 2014; Ma et al, 2006; Sakloetsakun et al, 2013), and liposom (Wu et al, 2011) This present research employs Bovine Serum Albumin (BSA) as a protein model as it is sufficiently stable and widely used to evaluate a drug delivery system (Ravi Kumar et al, 2009). Afterward the formulation was subsequently subjected to the physicochemical characterization for oral delivery of protein
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