Objective: In the present work attempt has been made to stabilize optimized nanosuspensions of glimepiride by solidification using a novel Oral Thin Film (OTF) formulation.Methods: Nanosuspensions were characterized for particle size, zeta potential as well as in vitro dissolution profile. As nanosuspensions are prone to destabilization by Ostwald's ripening or agglomeration/aggregation, OTF formulation as a novel approach for stabilization through solidification of optimized nanosuspension was attempted. OTF formulation method is a simple, easy and scalable method for the preparation of solid oral dosage form. Prepared formulations were evaluated for physicochemical parameters like folding endurance, disintegration time, tensile strength, in vitro drug release, in vivo bioavailability and stability. Results:The mean particle size of the nanoparticles in OTF was found to be 57.2 nm. It was observed from the results of in vivo bioavailability studies that high plasma drug concentrations(Cmax) were achieved for nanosuspension loaded OTF (NSOTF) i.e. 4900 ng/ml as compared to marketed oral formulation (Cmax-2900 ng/ml). Results of the stability studies indicated that nanosize of the particles was retained even after 3 mo of the study. Conclusion:Therefore it can be concluded that OTF formulation has a potential for stabilization of nanosuspensions.

Objective: Nanosuspension is known to enhance the saturation solubility and dissolution velocity of poorly soluble drugs owing to the increased surface area of nanosized particles. Stability of these solubility enhancing systems can be improved by converting them into solidified forms. To simultaneously achieve enhanced dissolution and improved stability, an attempt has been made to increase the dissolution rate of poorly soluble drug tadalafil by formulating immediate release pellets of its nanosuspension. Methods: Tadalafil nanosuspensions were prepared using high shear homogenization technique and hydroxypropyl methylcellulose (HPMC) E 15, sodium dodecyl sulphate (SDS) as stabilizers. Prepared nanosuspensions were subjected to the characterization of particle size distribution, zeta potential, drug loading and saturation solubility. Optimized nanosuspension was solidified by preparing immediate release pellets: for improved stability, where tadalafil nanosuspension was used as a binder. Pellets were prepared by extrusion-spheronization technique using κ-carrageenan as a pelletizing aid. Results: Prepared immediate release pellets disintegrated within 03 min. In vitro dissolution studies showed 85% drug release within 45 min in pH 1.2 buffer from immediate release pellets containing tadalafil nanosuspension. Conclusion: It can be concluded that formulation of nanosuspension of poorly soluble drug and its use as a binder for the preparation of immediate release pellets markedly improved the dissolution rate.

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.