The use of the Box–Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation

Ragonese, R; Macka, Mirek; Hughes, Jeff G.; Petocz, Peter

doi:10.1016/s0731-7085(01)00659-8

Cited by 136 publications

(64 citation statements)

References 8 publications

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“…The combinations of variables are at the midpoints of the edges of the process space and at the center. 18) This method is advantageous over other response surface methodologies as it avoids combination of extreme factors. Also, it does not contain combinations for which all factors are simultaneously at their highest or lowest levels.…”

Section: Introductionmentioning

confidence: 99%

Formulation Optimization and Characterization of Spray Dried Microparticles for Inhalation Delivery of Doxycycline Hyclate

Mishra

2011

YAKUGAKU ZASSHI

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The local delivery of antibiotics in the treatment of infectious respiratory diseases is an attractive alternative to deliver high concentration of antimicrobials directly to the lungs and minimize systemic side eŠects. In this study, inhalable microparticles containing doxycycline hyclate, sodium carboxymethylcellulose, leucine and lactose were prepared by spray drying of aqueous ethanol formulations. Box-Behnken design was used to study the in‰uence of various independent variables such as polymer concentration, leucine concentration, ethanol concentration and inlet temperature of the spray dryer on microparticle characteristics. The microparticles were characterized in terms of particle morphology, drug excipient interaction, yield, entrapment e‹ciency, Carr's index, moisture content, thermal properties, X-ray powder diŠraction, aerosolization performance and in vitro drug release. The eŠect of independent variables on spray dryer outlet temperature was also studied. The overall shape of the particles was found to be spherical like doughnuts in the size range of 1.16 5.2 mm. The optimized formulation (sodium carboxymethylcellulose concentration 14％ w/v, leucine concentration 33％ w/v, ethanol concentration 36％ v/v, inlet temperature of 140°C) exhibited the following properties: yield 56.69％, moisture content 3.86％, encapsulation e‹ciency 61.74％, theoretical aerodynamic diameter 3.11 mm and Carr's index 23.5％ at an outlet temperature 77°C. The powders generated were of a suitable mass median aerodynamic diameter (4.89 mm) with 49.3％ˆne particle fraction and exhibited a sustained drug release proˆle in vitro.

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Section: Introductionmentioning

confidence: 99%

Formulation Optimization and Characterization of Spray Dried Microparticles for Inhalation Delivery of Doxycycline Hyclate

Mishra

2011

YAKUGAKU ZASSHI

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“…14 A modified central composite experimental design, Box-Behnken design, is an independent, rotatable or nearly rotatable quadratic design (contains no embedded factorial or fractional factorial design), in which the treatment combinations are at the midpoints of the edges of the process space and at the center. 15 Among all the RSM designs, Box-Behnken design requires fewer runs (15 runs) in a 3-factor experimental design. A 3-factor, 3-level design would require a total of 27 unique runs without any repetitions and a total of 30 runs with 3 repetitions.…”

Section: Introductionmentioning

confidence: 99%

Response surface methodology for optimization and characterization of limonene-based coenzyme Q10 self-nanoemulsified capsule dosage form

2004

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The aim of this study was to systematically obtain a model of factors that would yield an optimized self-nanoemulsified capsule dosage form (SNCDF) of a highly lipophilic model compound, Coenzyme Q10 (CoQ). Independent variables such as amount of R-(+)-limonene (X 1 ), surfactant (X 2 ), and cosurfactant (X 3 ), were optimized using a 3-factor, 3-level Box-Behnken statistical design. The dependent variables selected were cumulative percentage of drug released after 5 minutes (Y 1 ) with constraints on drug release in 15 minutes (Y 2 ), turbidity (Y 3 ), particle size (Y 4 ), and zeta potential (Y 5 ). A mathematical relationship obtained, Y 1 = 78.503 + 6.058X 1 + 13.738X 2 + 5.986X 3 -25.831X 1 2 + 9.12X 1 X 2 -26.03 X 1 X 3 -38.67 X 2 2 +11.02X 2 X 3 -15.55 X 3 3 (r 2 = 0.97), explained the main and quadratic effects, and the interaction of factors that affected the drug release. Response surface methodology (RSM) predicted the levels of factors X 1 , X 2 , and X 3 (0.0344, 0.216, and 0.240, respectively), for a maximized response of Y 1 with constraints of >90% release on Y 2 . The observed and predicted values of Y 1 were in close agreement. In conclusion, the Box-Behnken experimental design allowed us to obtain SNCDF with rapid (>90%) drug release within 5 minutes with desirable properties of low turbidity and particle size.

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“…In comparison with the central composite design, the Box-Behnken design requires relatively few experiments and offers higher efficiency. The Box-Behnken design requires not all influencing factors to be at a high level at the same time and ensures that all the experimental conditions are within a safe operating area (Ragonese et al 2002;Kehoe and Stokes 2011).…”

Section: Introductionmentioning

confidence: 99%

Optimization of Microwave-Hydrogen Peroxide Pretreatment of Cellulose

Su¹,

Zhu²,

Wang³

et al. 2016

BioResources

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A hydrogen peroxide (H2O2) solution was adapted for microwave pretreatment of microcrystalline cellulose, which can be further used for heavy metal adsorption. The H2O2 concentration, temperature, and retention time were the key factors affecting the microwave/hydrogen peroxide pretreatment process. A Box-Benhken design (BBD) with response surface methodology (RSM) was employed to design and optimize the microwave-hydrogen peroxide pretreatment process (H2O2 pretreatment) of cellulose. After the H2O2 pretreatment, the crystallinity of cellulose decreased by 20% and the degree of polymerization (DP) decreased by up to 30%. The optimal conditions obtained by BBD were a H2O2 concentration of 8.37%, a temperature of 90 °C, and a retention time 5.33 min. Under these conditions, a minimum DP of 91.74 was achieved. The results indicated that all three of the factors notably affected the reduction of cellulose polymerization degree and pronounced interactions existed among the response variables. The predictive model developed was able to optimize the pretreatment process for the reduction of cellulose polymerization degree, which could improve the cellulose modification reactivity.

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The use of the Box–Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation

Cited by 136 publications

References 8 publications

Formulation Optimization and Characterization of Spray Dried Microparticles for Inhalation Delivery of Doxycycline Hyclate

Formulation Optimization and Characterization of Spray Dried Microparticles for Inhalation Delivery of Doxycycline Hyclate

Response surface methodology for optimization and characterization of limonene-based coenzyme Q10 self-nanoemulsified capsule dosage form

Optimization of Microwave-Hydrogen Peroxide Pretreatment of Cellulose

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