Abstract
The purpose of the current research work was to prepare a nanosuspension of the model drug lansoprazole (LSP) and investigate the effect of various stabilizers on the stability of the nanosuspension prepared using the high shear homogenization technique. In this study, polymeric stabilizers like polyvinylpyrrolidone K-30, polyvinylpyrrolidone K-90, polyvinyl alcohol, sodium alginate, and hydroxypropyl methylcellulose E15 and surfactants like sodium lauryl sulfate and Tween 80 were explored. The prepared nanosuspensions were evaluated for particle size distribution (PSD), polydispersity index (PI), zeta potential, and drug loading. Saturation solubility and in-vitro dissolution studies of optimized nanosuspension and coarse LSP powder were also carried out to determine the extent of solubility enhancement. PSD and zeta potential revealed that all the stabilizers when used alone could not significantly reduce the particle size and stabilize the colloidal dispersion. However, a combination of polymeric stabilizer and surfactant showed significant particle size reduction with an average particle size of 428.5 nm, PI 0.363, and a stable zeta potential value of −25.8 mV. Therefore, it can be concluded that LSP nanosuspension prepared by the high shear homogenization technique can be effectively stabilized by a combination of stabilizers.
Highlights
A nanosuspension consists of pure drug particles in the nanometer range that are usually suspended in an aqueous dispersion medium containing a surface modifier to maintain the particle size in the nanometer domain (Khadka et al, 2014)
Various stabilizers explored in this study showed a huge variance with respect to key characterization parameters of nanosuspension
Preliminary investigative studies and evaluation of critical parameters like zeta potential, particle size distribution (PSD), and polydispersity index (PI) indicate that the combination of HPMC E15 and sodium lauryl sulfate (SLS) exhibits a narrow range of size distribution of nanocrystals with a mean particle size of 428.5 nm and a stable zeta potential value −25.8 mV
Summary
A nanosuspension consists of pure drug particles in the nanometer range that are usually suspended in an aqueous dispersion medium containing a surface modifier (stabilizer) to maintain the particle size in the nanometer domain (Khadka et al, 2014). High shear homogenization has been used for preparing nanocrystals in combination with bottom-up techniques (Junyaprasert and Morakul, 2015) and has not been explored much as a single technique for producing drug nanocrystals. Shende et al (2016) reported about the formulation and characterization of engineered nanosuspension of LSP prepared by conjugating it with β-cyclodextrin and preparing its nanosponges containing β-cyclodextrin to enhance its solubility and stability. The oral solubility enhancement of LSP from stabilized nanosuspension is the prime objective with the high shear homogenizer playing pivotal role in formulation development. The current study throws light on comparative studies of plausible effects of various stabilizers on critical parameters required for nanosuspension stabilization
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