Quality by design: understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function.

  title={Quality by design: understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function.},
  author={Ahmed Samir Zidan and Omaima Ahmed Sammour and Mohammed A. Hammad and Nagia A. Megrab and Muhammad J. Habib and Mansoor Ali Khan},
  journal={International journal of pharmaceutics},
  volume={332 1-2},
Quality by design (QBD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QBD is the understanding of factors and their interaction effects by a desired set of experiments. The present project deals with a case study to understand the effect of formulation variables of nanoemulsified particles of a model drug, cyclosporine A (CyA). A three-factor, three-level design of experiment (DOE) with response surface… Expand
Development and optimization of self-nanoemulsifying drug delivery system with enhanced bioavailability by Box-Behnken design and desirability function.
The BBD demonstrated its effectiveness in optimizing theSNEDDS formulation and in understanding the effects of formulation variables on the performance of SNEDDS. Expand
Application of Box-Behnken design in understanding the quality of genistein self-nanoemulsified drug delivery systems and optimizing its formulation
The Box-Behnken experimental design allowed us to understand the effect of formulation variables on the rapid dissolution of GN from SNEDDS, and optimize the formulation to obtain a rapid drug dissolution at 5 min. Expand
In vitro characterization of statistically optimized quetiapine-loaded self-nanoemulsified systems with quality by design
Objective: To optimize and characterize quetiapine (QP)-loaded self-nanoemulsified drug delivery systems (SNEDDS) by 3-factorial 3-level Box–Behnken design (BBD) to improve the dissolution. Methods:Expand
Objective-The present study deals with a case study to understand the effect of formulation variables of microspheres of a model drug, levodopa (LD). Methods-A three-factor, three-level design ofExpand
Quality by Design Based Development of Self Nano Emulsifying Drug Delivery System of Ritonavir
Objectives: Ritonavir is an antiretroviral agent which belongs to Biopharmaceutical Classification System (BCS) II having poor water solubility. The purpose of this study was to design Self-NanoExpand
Design and Development of Darunavir loaded Self Micro Emulsifying Drug Delivery System using Extreme Vertices Mixture Design in a Quality by Design Framework
The development of hard to achieve formulation techniques like SMEDDS involving BCS class 2 and 4 drugs can be sustainably achieved with minimal time and resources, matching regulatory requirements can be attained by the application of EVMD, under QbD framework. Expand
Formulation by design of felodipine loaded liquid and solid self nanoemulsifying drug delivery systems using Box–Behnken design
This study indicates that owing to nanosize, SNEDDS and S-SNEDDS of FLD have potential to enhance its absorption and may serve an efficient oral delivery. Expand
Formulation of Rosuvastatin-Loaded Self-Nanoemulsifying Drug Delivery System Using Box-Behnken Design
The objectives of present study were to understand the effect of formulation variables of self-nanoemulsifying drug delivery system (SNEDDS) of rosuvastatin (RSV). Box-Behnken design in conjunctionExpand
A novel approach for the development and optimization of self emulsifying drug delivery system using HLB and response surface methodology: application to fenofibrate encapsulation.
Optimize SEDDS showed significant increase in dissolution rate compared to conventional prepared gelatin capsules and was demonstrated the reliability, rapidity, and robustness of the approach. Expand
Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: A review.
Quality-by-design (QbD) approach has been applied to optimize lipid-based nanosystems formulations, including solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC) and nanoemulsions,Expand


Self-emulsifying drug delivery systems (SEDDS) of coenzyme Q10: formulation development and bioavailability assessment.
SEDDS have improved the bioavailability of CoQ10 significantly and the potential use of SEDDS to provide an efficient way of improving oral absorption of lipophilic drugs is suggested. Expand
Preparation and in vitro characterization of a eutectic based semisolid self-nanoemulsified drug delivery system (SNEDDS) of ubiquinone: mechanism and progress of emulsion formation.
A eutectic based semisolid self-emulsified delivery system that can overcome the drawbacks of the traditional emulsified systems such as low solubility and irreversible precipitation of the active drug in the vehicle with time is revealed. Expand
Factors Affecting the Efficiency of a Self- Emulsifying Oral Delivery System
AbstractDosage forms containing a self-emulsifying system have shown significant promise in improving the in vitro dissolution rate and oral absorption of lipophilic drugs. In such a system, aExpand
Self-emulsifying drug delivery systems (SEDDS) with polyglycolyzed glycerides for improving in vitro dissolution and oral absorption of lipophilic drugs
Abstract The ability of polyglycolyzed glycerides (PGG) with varying fatty acid and polyethylene glycol (PEG) chain lengths to produce the self-emulsification of oil in water has been investigated.Expand
pH-sensitive nanoparticles for improving the oral bioavailability of cyclosporine A.
The potential of pH-sensitive nanoparticles for the oral delivery of CyA was confirmed and in vitro release experiments revealed that the nanoparticles exhibited perfect pH-dependant release profiles. Expand
Optimisation and characterisation of bioadhesive controlled release tetracycline microspheres.
A Box-Behnken experimental design was employed to statistically optimise the formulation parameters of a tetracycline microsphere preparation for maximum bioadhesion and controlled drug release and revealed that drug release followed Fickian diffusion while textural analysis showed minimal hydration over the test period. Expand
Formulation and physical characterization of water-in-oil microemulsions containing long- versus medium-chain glycerides
Abstract Stable self-emulsifying water-in-oil (w/o) microemulsions of extremely small particle size (5–30 nm) and consisting of an oil, a blend of a low and high HLB surfactants and an aqueous phase,Expand
Lipid formulations for oral administration of drugs: non-emulsifying, self-emulsifying and 'self-microemulsifying' drug delivery systems.
  • C. W. Pouton
  • Chemistry, Medicine
  • European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
  • 2000
A simple classification system for lipid formulations, based on the polarity of the blend and reviewed here, will help comparison of data between laboratories and priorities for future work are discussed. Expand
Cyclosporin. A review of the pharmacokinetic properties, clinical efficacy and tolerability of a microemulsion-based formulation (Neoral).
Although confirmation of existing efficacy and tolerability data is required, the characteristic pharmacokinetic properties of the microemulsion formulation make it an attractive option for the oral delivery of cyclosporin in transplant recipients, offering more predictable and more extensive drug absorption than the standard formulation. Expand
Cyclosporine-loaded polycaprolactone nanoparticles: immunosuppression and nephrotoxicity in rats.
NP improve the oral bioavailability of CyA and its uptake by lymphocytes in vitro above 25 microM and in vivo, specific immunosuppression and adverse effects were not simultaneously increased. Expand