QbD-based formulation development of resveratrol nanocrystal incorporated into soluble mesoporous material: Pharmacokinetic proof of concept study.

Resveratrol (RSV) has powerful antioxidant activities. However, the bioavailability is still limited due to low solubility and transport issues. Nanocrystal technology has been introduced to address these issues; however, the bulky formulation of the nanocrystal process through nanosuspension faces a big challenge in terms of stability and scale-up ability.

Rational Design and Development of a Soluble Mesoporous Carrier for the Solidification of a Preconcentrated Self-Nanoemulsion Formulation.

The solidification of self-preconcentrated nanoemulsion without changes in nanodroplet formation gains particular consideration due to the interaction between solidified carriers. This work aimed to develop mannitol mesoporous as a soluble carrier for supersaturated self-nanoemulsion (SSNE) using a design of experiment (DoE) approach. The mesoporous carrier was prepared by a spray-drying technique.

Resveratrol Nanocrystal Incorporated into Mesoporous Material: Rational Design and Screening through Quality-by-Design Approach.

Bioflavonoids from grape seeds feature powerful antioxidant and immunostimulant activities, but they present problems related to solubility and bioavailability. Nanocrystal (NC) incorporated into a mesoporous carrier is a promising strategy to address these issues. However, the preparation of this formulation involves the selection of factors affecting its critical quality attributes.

Assessment of the effect of polymers combination and effervescent component on the drug release of swellable gastro-floating tablet formulation through compartmental modeling-based approach.

The aim of this research was to assess the effect of polymer blend and effervescent components on the floating and swelling behaviors of swellable gastro-floating formulation as well as the drug release through a compartmental modeling analysis. Swellable gastro-floating formulation of freely water-soluble drug, metformin HCl as a drug model, was formulated and developed using D-optimal design. Polymer combination between interpolymer complex (IPC) (poly-vinyl acetate-copolymer methacrylate) and hydroxy propyl methyl cellulose (HPMC), and effervescent components were studied and optimized in this work.

Assessment of Fractional Factorial Design for the Selection and Screening of Appropriate Components of a Self-nanoemulsifying Drug Delivery System Formulation.

Recently, a self-nanoemulsifying drug delivery system (SNEDDS) has shown great improvement in the enhancement of drug bioavailability. The selection of appropriate compositions in the SNEDDS formulation is the fundamental step towards developing a successful formulation. This study sought to evaluate the effectiveness of fractional factorial design (FFD) in the selection and screening of a SNEDDS composition.

Understanding the effect of lipid formulation loading and ethanol as a diluent on solidification of pitavastatin super-saturable SNEDDS using factorial design approach.

Solidification of a preconcentrate lipid formulation namely self-nano emulsifying drug delivery system (SNEDDS) is required to achieve feasibility, flexibility, and a new concept of "dry nano-emulsion". The purpose of this study was to assess the effect of SNEDDS loading and ethanol as a diluent on the solidification of pitavastatin supersaturable SNEDDS (S-SNEDDS). A 2 full factorial design approach with a center point addition as a curvature was implemented to determine the effect of S-SNEDDS loading and ethanol on the physical characteristics, namely flowability, compactibility, and drug release behavior.

Assessment of the Effect of PLGA Co-polymers and PEG on the Formation and Characteristics of PLGA-PEG-PLGA Co-block Polymer Using Statistical Approach.

To assess the effect of the lactic acid (LA)-to-glycolic acid (GA) molar ratio and polyethylene glycol (PEG) concentration on the formation of poly-lactide co-glycolide acid (PLGA)-PEG-PLGA co-block polymers simultaneously using statistical approach. A 2 full factorial design with the addition of a point in the center of the design, namely curvature, was applied. Fourier transform infrared (FTIR), differential scanning calorimetry (DSC), and nuclear magnetic resonance (NMR) were performed to confirm the formation of the co-block polymer.

Reducing Burst Release Effect of Freely Water-Soluble Drug Incorporated into Gastro-Floating Formulation Below HPMC Threshold Concentration Through Interpolymer Complex.

Undesired-burst release effect is observed in a freely water-soluble drug formulated into a gastro-floating formulation with effervescent (GFFE) delivery system. In order to address this limitation, interpolymer complex (IPC) of two swellable and non-soluble polymers, poly-ammonium methacrylate and poly-vinyl acetate, was incorporated into hydroxypropyl methyl cellulose (HPMC)-based matrix GFFE. This research studied the effect and interaction of the IPC-HPMC blending on the drug release of GFFE using a freely water-soluble drug, metformin HCl, under different threshold concentration levels and curing effect.

Development and optimization of a meloxicam/β-cyclodextrin complex for orally disintegrating tablet using statistical analysis.

The purpose of this research was to develop an inclusion complex of meloxicam (MEL)/β-cyclodextrin (β-CD) incorporated into an orally disintegrating tablet (ODT), using statistical analysis to optimize the ODT formulation based on a quality by design (QbD) approach. MEL/β-CD complexation was performed by kneading, co-precipitation and spray drying methods under different molar ratios. Fourier transform infrared spectroscopy, X-ray diffraction and thermal analysis were utilized to evaluate the complexes.

Improvement of Meloxicam Solubility Using a β-Cyclodextrin Complex Prepared via the Kneading Method and Incorporated into an Orally Disintegrating Tablet.

The aim of this research was to formulate and develop an orally disintegrating tablet (ODT) that incorporated a MEL/β-CD complex, using a quality by design (QbD) approach to enhance solubility and drug release. Multiple regression linear analysis was conducted to develop the kneading process and ODT formulation. Mixing time and amount of solvent were used as independent variables in kneading process optimisation, while the superdisintegrants were used to obtain the desired formulation.