The Self-emulsifying drug delivery systems (SEDDS) containing lipids, surfactants, and co-surfactants are a promising oral platform for drugs with problematic solubility and/or permeability. However, those systems presenting a liquid phase may have certain shortcomings, such as in vivo drug precipitation, limited lymphatic transport, and storage problems. Including some polymers in their composition would increase the system’s stability during storage and dispersion in the gastrointestinal tract. For example, alendronate sodium (NaALD), a Biopharmaceutical Classification System (BCS) class III drug, is characterized by low permeability and good solubility. Its biopharmaceutical characteristics could be improved by inclusion in w/o/w SEDDS formulation.
The present study aimed to investigate the effect of the natural polymer gelatine and co-emulsifier soybean phosphatidylcholine on the physical stability of Alendronate Sodium-loaded coconut oil based w/o/w self-double-emulsifying systems (w/o/w SDEDDS-NaALD).
Pseudo-phase diagrams were used for the determination of the excipient ratios of self-emulsification. We prepared the model self-emulsifying systems by a two-stage emulsification technique and a high-speed homogenizer at 65°C. Four models were developed and were physically and thermodynamically characterized by sedimentation analysis and spectrophotometric analysis, self-emulsification time determination, and Dynamic Light Scattering (DLS).