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

Zidan, Ahmed S.; Sammour, Omaima A.; Hammad, Mohammed; Megrab, Nagia A.; Habib, Muhammad J.; Khan, Mansoor A.

doi:10.1016/j.ijpharm.2006.09.060

Cited by 125 publications

(57 citation statements)

References 18 publications

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“…The zeta potential is an important physicochemical characteristic of the nanoparticles. Zeta potential values in therange of −15 mV to −30 mV are common for wellstabilized nanoparticles (Pandya et al 2010;Zidan et al 2007). Famotidine micronized suspension had -3 mv zeta potential value.…”

Section: Characterization Of Optimized Famotidine Nanosuspensionmentioning

confidence: 99%

Design and evaluation of famotidine mucoadhesive nanoparticles for aspirin induced ulcer treatment

Patel

Patel²

2013

Braz. arch. biol. technol.

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Section: Characterization Of Optimized Famotidine Nanosuspensionmentioning

confidence: 99%

Design and evaluation of famotidine mucoadhesive nanoparticles for aspirin induced ulcer treatment

Patel

Patel²

2013

Braz. arch. biol. technol.

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“…This is because these design methods provide suitable mathematical models; for example, the quadratic model in order to predict the responses being studied. Box-Behnken designs are suitable for exploring quadratic response surfaces and constructs according to a second-order polynomial model, thus assisting in the optimization of a formulation with a small number of experimental runs (Zidan et al, 2007). Due to these advantages, Box-Behnken designs have been recently applied toward the optimization of different types of formulations.…”

Section: Analysis Of the Statistical Designmentioning

confidence: 99%

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Shamma

Elkasabgy

2014

Drug Delivery

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Spironolactone (SL) is a poorly water-soluble drug. Being poorly soluble affects its dissolution rate which in turn affects its oral bioavailability. This work aimed to prepare freeze-dried SL-Soluplus Õ /polyvinyl alcohol (PVA) oral thin film in an attempt to enhance the drug solubility on one hand and at the same time prepare a solid dosage form convenient for the pediatric use. SL-Soluplus Õ /PVA films were prepared using polyethylene glycol 400 (PEG 400) as a plasticizer applying the solvent-casting technique. The prepared films were evaluated for their thickness, tensile strength, and in vitro dissolution studies. Box-Behnken design (17 runs) was applied to optimize the effects of the formulation variables on the film properties. The optimized film formulation was freeze-dried after casting so as to enhance the drug dissolution. Moreover, the optimized freeze-dried film was re-characterized in vitro and evaluated in vivo in human volunteers to investigate its palatability and satisfaction. The results showed that the optimized formulation composed of 10% polymer concentration containing Soluplus Õ :PVA (0.33:0.66) and plasticized with 30% PEG 400 possessed the highest desirability value (0.836). Freeze-drying of the optimized formulation succeeded to improve SL in vitro dissolution due to the preparation of a more porous film compared to the non-freeze-dried one. In vivo evaluation of the optimized freeze-dried film showed high satisfaction among the participating volunteers concerning the ease of administration and sensation thereafter, where all the film specimens dissolved without the need for water and no film residues remained in the mouth following film dissolution. In conclusion, freeze-dried Soluplus Õ /PVA-based oral thin film proved to be a successful carrier for the oral delivery of insoluble drugs like SL for pediatrics.

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“…The aim of pharmaceutical formulation optimization is generally to find the levels of the variable that affect the chosen responses and determine the levels of the variable from which a robust product with high quality characteristics may be produced (17). All the measured responses that may affect the quality of the product should be taken into consideration during the optimization procedure.…”

Section: Formulation Optimization Using the Desirability Functionmentioning

confidence: 99%

Formulation and Optimization of Nanosuspensions for Enhancing Simvastatin Dissolution Using Central Composite Design

Pandya¹,

Patel²,

Patel³

2011

Dissolution Technol.

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Simvastatin is a poorly water-soluble drug, and bioavailability from its crystalline form is very low. The purpose of this investigation was to increase the solubility and dissolution rate of simvastatin by the preparation of nanosuspensions with Pluronic F127 and zirconium oxide (ZrO 2 ) beads using a wet-milling technique at the laboratory scale. Prepared nanosuspensions were evaluated for particle size and in vitro dissolution. A 3 2 central composite design was employed to study the effect of the independent variables (i.e., amount of Pluronic F127, X 1 , and amount of ZrO 2 , X 2 ) on the dependent variables (i.e., particle size [nm] and percentage of drug released after 10 min, Q 10 ). The relationship between the dependent and independent variables was further elucidated using multiple liner regression analysis (MLRA) and contour plots. The results show that nanosuspensions prepared with the higher concentrations of Pluronic F127 and the higher quantities of ZrO 2 (up to 8 g) reduced the particle size and enhanced the dissolution rate of the formulation. The dissolution rate of the optimized nanosuspension was enhanced (64% in 10 min) relative to that of a micronized suspension of simvastatin (3.5% in 10 min), mainly because of the formation of nanosized particles. These results show that the preparation of simvastatin-loaded nanosuspensions significantly improved the in vitro dissolution rate, thus possibly enhancing the fast onset of therapeutic drug effect.

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

Cited by 125 publications

References 18 publications

Design and evaluation of famotidine mucoadhesive nanoparticles for aspirin induced ulcer treatment

Design and evaluation of famotidine mucoadhesive nanoparticles for aspirin induced ulcer treatment

Design of freeze-dried Soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use

Formulation and Optimization of Nanosuspensions for Enhancing Simvastatin Dissolution Using Central Composite Design

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