Systematic implementation of quality-by-design (QbD) to develop NSAID-loaded nanostructured lipid carriers for ocular application: preformulation screening studies and statistical hybrid-design for optimization of variables

Rathod, Vishal; Shah, Dhaval A.; Dave, Rutesh H.

doi:10.1080/03639045.2020.1724135

Cited by 36 publications

(20 citation statements)

References 40 publications

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“…90 Rathod et al prepared nonsteroidal anti-inammatory drug-loaded NLCs using dynasan 114 as the solid lipid and miglyol 840 as the liquid lipid for the treatment of postoperative ocular inammation. In in vitro drug release studies, the NLCs exhibited sustained drug release up to 12 h. 91 The NLC surface can be modied with a suitable polymer to make it bioadhesive and enhance its retention at the disease site. Selvaraj et al developed chitosan-coated itraconazoleloaded NLCs using a high-pressure homogenization method.…”

Section: Solid Lipid Nanoparticles and Nanostructured Lipid Carriersmentioning

confidence: 97%

Nanocarriers for ocular drug delivery: current status and translational opportunity

et al. 2020

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Section: Solid Lipid Nanoparticles and Nanostructured Lipid Carriersmentioning

confidence: 97%

Nanocarriers for ocular drug delivery: current status and translational opportunity

et al. 2020

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“…In this study, seven initially considered variables were quickly screened with only 12 experimental runs and only three of them were detected to be actively contributing to modifying the responses under investigation. The optimisation of NLC was then obtained following a Box-Behnken design [116], as described later in Section 3.5.3.…”

Section: Plackett-burman Designsmentioning

confidence: 99%

“…A good number of examples are available in the literature for the optimisation of lipid-based nanocarriers, as depicted in Table 4 [116,[134][135][136][137][138][139].…”

Section: Box-behnken Designs (Bbds)mentioning

confidence: 99%

“…The first study here presented shows a sequential approach in which Rathod and colleagues [116] started with an initial Plackett-Burman experimental design (see Section 3.4) to develop ibuprofen-loaded NLC. Seven initial factors (amongst others, surfactant Another advantage is the reduced number of experimental runs required in comparison to other response surface methodologies.…”

Section: Box-behnken Designs (Bbds)mentioning

confidence: 99%

“…The first study here presented shows a sequential approach in which Rathod and colleagues [116] started with an initial Plackett-Burman experimental design (see Section 3.4) to develop ibuprofen-loaded NLC. Seven initial factors (amongst others, surfactant type and concentration, lipid concentration, homogenisation speed and time) were quickly screened in only 12 experimental runs by assessing their influence on three responses: particle average size, PDI and zeta potential.…”

Section: Box-behnken Designs (Bbds)mentioning

confidence: 99%

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Lipid-Based Nanocarriers for Ophthalmic Administration: Towards Experimental Design Implementation

González-Fernández

Bianchera

Gasco³

et al. 2021

Pharmaceutics

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Nanotherapeutics based on biocompatible lipid matrices allow for enhanced solubility of poorly soluble compounds in the treatment of ophthalmic diseases, overcoming the anatomical and physiological barriers present in the eye, which, despite the ease of access, remains strongly protected. Micro-/nanoemulsions, solid lipid nanoparticles (SLN) or nanostructured lipid carriers (NLC) combine liquid and/or solid lipids with surfactants, improving drug stability and ocular bioavailability. Current research and development approaches based on try-and-error methodologies are unable to easily fine-tune nanoparticle populations in order to overcome the numerous constraints of ocular administration routes, which is believed to hamper easy approval from regulatory agencies for these systems. The predictable quality and specifications of the product can be achieved through quality-by-design (QbD) implementation in both research and industrial environments, in contrast to the current quality-by-testing (QbT) framework. Mathematical modelling of the expected final nanoparticle characteristics by variation of operator-controllable variables of the process can be achieved through adequate statistical design-of-experiments (DoE) application. This multivariate approach allows for optimisation of drug delivery platforms, reducing research costs and time, while maximising the understanding of the production process. This review aims to highlight the latest efforts in implementing the design of experiments to produce optimised lipid-based nanocarriers intended for ophthalmic administration. A useful background and an overview of the different possible approaches are presented, serving as a starting point to introduce the design of experiments in current nanoparticle research.

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Compatibility studies with pharmaceutical excipients for aripiprazole–heptakis (2,6-di-O-methyl)-β-cyclodextrin supramolecular adduct

Tănase

Sbârcea

Ledeţi

et al. 2020

J Therm Anal Calorim

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Systematic implementation of quality-by-design (QbD) to develop NSAID-loaded nanostructured lipid carriers for ocular application: preformulation screening studies and statistical hybrid-design for optimization of variables

Cited by 36 publications

References 40 publications

Nanocarriers for ocular drug delivery: current status and translational opportunity

Nanocarriers for ocular drug delivery: current status and translational opportunity

Lipid-Based Nanocarriers for Ophthalmic Administration: Towards Experimental Design Implementation

Compatibility studies with pharmaceutical excipients for aripiprazole–heptakis (2,6-di-O-methyl)-β-cyclodextrin supramolecular adduct

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