Optimization of the Büchi B-90 spray drying process using central composite design for preparation of solid dispersions

Gu, Bing; Linehan, Brian; Tseng, Yin‐Chao

doi:10.1016/j.ijpharm.2015.06.006

Cited by 75 publications

(29 citation statements)

References 20 publications

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“…Quality by design (QbD) and design of experiment (DoE) approaches have been widely used in the development of various pharmaceutical formulations (Gu et al ., 2015; Kumar et al ., 2014; Xu et al ., 2012a). Mathematical models generated from DoE studies can also be used for response prediction and formulation optimization purposes (Xu et al ., 2011, 2012b).…”

Section: Introductionmentioning

confidence: 99%

Prediction of dexamethasone release from PLGA microspheres prepared with polymer blends using a design of experiment approach

Burgess

2015

International Journal of Pharmaceutics

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Hydrophobic drug release from poly (lactic-co-glycolic acid) (PLGA) microspheres typically exhibits a tri-phasic profile with a burst release phase followed by a lag phase and a secondary release phase. High burst release can be associated with adverse effects and the efficacy of the formulation cannot be ensured during a long lag phase. Accordingly, the development of a long-acting microsphere product requires optimization of all drug release phases. The purpose of the current study was to investigate whether a blend of low and high molecular weight polymers can be used to reduce the burst release and eliminate/minimize the lag phase. A single emulsion solvent evaporation method was used to prepare microspheres using blends of two PLGA polymers (PLGA5050 (25KDa) and PLGA9010 (113KDa)). A central composite design approach was applied to investigate the effect of formulation composition on dexamethasone release from these microspheres. Mathematical models obtained from this design of experiments study were utilized to generate a design space with maximized microsphere drug loading and reduced burst release. Specifically, a drug loading close to 15% can be achieved and a burst release less than 10% when a composition of 80% PLGA9010 and 90 mg of dexamethasone is used. In order to better describe the lag phase, a heat map was generated based on dexamethasone release from the PLGA microsphere/PVA hydrogel composite coatings. Using the heat map an optimized formulation with minimum lag phase was selected. The microspheres were also characterized for particle size/size distribution, thermal properties and morphology. The particle size was demonstrated to be related to the polymer concentration and the ratio of the two polymers but not to the dexamethasone concentration.

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Section: Introductionmentioning

confidence: 99%

Prediction of dexamethasone release from PLGA microspheres prepared with polymer blends using a design of experiment approach

Burgess

2015

International Journal of Pharmaceutics

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“…The raisin-like morphology of the nCmP can be attributed to the early formation of nanoparticle shells in the solution droplets during spray drying, which determines the geometric size of nCmP. As the drying process proceeds, the remaining solvent evaporates from the droplet center, resulting in hollow particles that tend to shrink (Atalar and Dervisoglu, 2015; Gu et al, 2015). …”

Section: Resultsmentioning

confidence: 99%

Development and physicochemical characterization of acetalated dextran aerosol particle systems for deep lung delivery

Wang

Gupta

Meenach

2017

International Journal of Pharmaceutics

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Biocompatible, biodegradable polymers are commonly used as excipients to improve the drug delivery properties of aerosol formulations, in which acetalated dextran (Ac-Dex) exhibits promising potential as a polymer in various therapeutic applications. Despite this promise, there is no comprehensive study on the use of Ac-Dex as an excipient for dry powder aerosol formulations. In this study, we developed and characterized pulmonary drug delivery aerosol microparticle systems based on spray-dried Ac-Dex with capabilities of (1) delivering therapeutics to the deep lung, (2) targeting the particles to a desired location within the lungs, and (3) releasing the therapeutics in a controlled fashion. Two types of Ac-Dex, with either rapid or slow degradation rates, were synthesized. Nanocomposite microparticle (nCmP) and microparticle (MP) systems were successfully formulated using both kinds of Ac-Dex as excipients and curcumin as a model drug. The resulting MP were collapsed spheres approximately 1 µm in diameter, while the nCmP were similar in size with wrinkled surfaces, and these systems dissociated into 200 nm nanoparticles upon reconstitution in water. The drug release rates of the Ac-Dex particles were tuned by modifying the particle size and ratio of fast to slow degrading Ac-Dex. The pH of the environment was also a significant factor that influenced the drug release rate. All nCmP and MP systems exhibited desirable aerodynamic diameters that are suitable for deep lung delivery (e.g. below 5 µm). Overall, the engineered Ac-Dex aerosol particle systems have the potential to provide targeted and effective delivery of therapeutics into the deep lung.

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“…According to this technique, drug solution is dispersed into very small droplets and the solvent is rapidly evaporated in a hot dry air to achieve dry powder. This procedure produces powder with a high degree of purity and narrow particle size distribution [16][17][18]. Various solvents, alone or in combination, have been used to prepare feed solutions.…”

Section: Discussionmentioning

confidence: 99%

Application of Spray Drying Technique for Flowability enhancement of Divalproex Sodium

et al. 2017

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Optimization of the Büchi B-90 spray drying process using central composite design for preparation of solid dispersions

Cited by 75 publications

References 20 publications

Prediction of dexamethasone release from PLGA microspheres prepared with polymer blends using a design of experiment approach

Prediction of dexamethasone release from PLGA microspheres prepared with polymer blends using a design of experiment approach

Development and physicochemical characterization of acetalated dextran aerosol particle systems for deep lung delivery

Application of Spray Drying Technique for Flowability enhancement of Divalproex Sodium

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