Structure-function correlation and personalized 3D printed tablets using a quality by design (QbD) approach

Zhang, Jiaxiang; Thakkar, Rishi; Maniruzzaman, Mohammed

doi:10.1016/j.ijpharm.2020.119945

Cited by 41 publications

(33 citation statements)

References 36 publications

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“…Box-Behnken is a frequently used Response Surface Methodology based second-order design alongside 3 k factorial and central composite designs [28][29][30] . Box-Behnken has the advantage of not including all the combinations in which all variables are on the highest or the lowest levels [31][32][33] . This reduces the number of runs while maintaining the integrity of the design.…”

Section: Degradationmentioning

confidence: 99%

Selective Laser Sintering of a Photosensitive Drug: Impact of Processing and Formulation Parameters on Degradation, Solid-State, and Quality of 3D Printed Dosage Forms

Thakkar¹,

Davis²,

Williams³

et al. 2021

Preprint

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This research study utilized a light-sensitive drug, nifedipine (NFD), to understand the impact of processing parameters, and formulation composition on drug degradation, crystallinity, and quality attributes (dimensions, hardness, disintegration time) of selective laser sintering (SLS) based 3D printed dosage forms. Selective laser sintering (SLS), in most cases, uses an ultraviolet laser source, and drugs tend to absorb radiation at varying intensities around this wavelength (455 nm). This phenomenon may lead to chemical degradation, and solid-state transformation, which was assessed for nifedipine in formulations with varying amounts of vinyl pyrrolidone-vinyl acetate copolymer (Kollidon® VA 64) and potassium aluminum silicate-based pearlescent pigment (Candurin®), processed under different SLS conditions in the presented work. After preliminary screening Candurin®, surface temperature (ST), and laser speed (LS) were identified as the significant independent variables. Further, using the identified independent variables a 17-run, randomized, Box-Behnken design was developed to understand the correlation trends and quantify the impact on degradation (%), crystallinity, quality attributes (dimensions, hardness, disintegration time) employing qualitative and quantitative analytical tools. The design of experiments (DoE) and statistical analysis observed that LS and Candurin® (%wt) had a strong negative correlation on drug degradation, hardness, and weight, whereas ST had a strong positive correlation with, drug degradation, amorphous conversion, and hardness of the 3D printed dosage form. From this study, it can be concluded that formulation and processing parameters have a critical impact on stability and performance; hence these parameters should be evaluated and optimized before exposing light-sensitive drugs to the SLS processes.

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Section: Degradationmentioning

confidence: 99%

Selective Laser Sintering of a Photosensitive Drug: Impact of Processing and Formulation Parameters on Degradation, Solid-State, and Quality of 3D Printed Dosage Forms

Thakkar¹,

Davis²,

Williams³

et al. 2021

Preprint

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“…27 Although FDM has been successful in developing patient-specific, controlled release formulations for ASDs, and finds utility due to its capability of printing complex structures, it is dependent on techniques such as HME to create these ASDs before printing them. 28 The capability for SLS-3DP to provide patient-tailored medications and fixed-dose combinations has been established but, applying the SLS-3DP process to improve the solubility of poorly water-soluble drugs by forming an amorphous solid dispersion has not been investigated. We hypothesize that optimizing printing parameters, not previously investigated (e.g., hatch spacing), in addition to understanding the energy requirement needed to render a composition amorphous when mixing is absent, can make SLS-3DP a viable 1step process to create final pharmaceutical dosage forms in the amorphous state.…”

Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Davis

Thakkar

et al. 2021

Journal of Pharmaceutical Sciences

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This study reports the development of ritonavir-copovidone amorphous solid dispersions (ASDs) and dosage forms thereof using selective laser sintering (SLS) 3-dimensional (3-D) printing in a single step, circumventing the post-processing steps required in common techniques employed to make ASDs. For this study, different drug loads of ritonavir with copovidone were processed at varying processing conditions to understand the impact, range, and correlation of these parameters for successful ASD formation. Further, ASDs characterized using conventional and advanced solid-state techniques including wide-angle X-ray scattering (WAXS), solid-state nuclear magnetic resonance (ssNMR), revealed the full conversion of the crystalline drug to its amorphous form as a function of laser-assisted selective fusion in a layer-by-layer manner. It was observed that an optimum combination of the powder flow properties, surface temperature, chamber temperature, laser speed, and hatch spacing was crucial for successful ASD formation, any deviations resulted in print failures or only partial amorphous conversion. Moreover, a 21fold increase in solubility was demonstrated by the SLS 3-D printed tablets. The results confirmed that SLS 3-D printing can be used as a single-step platform for creating ASD-based pharmaceutical dosage forms with a solubility advantage.

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“…Researchers can then use the model to predict what variable settings will result in an optimal outcome. To date, DoE in 3DP of pharmaceuticals has been applied to evaluate structure-function relationships of various parameters for FDM, SLS and SSE [127][128][129][130][131].…”

Section: Design Of Experimentsmentioning

confidence: 99%

Harnessing artificial intelligence for the next generation of 3D printed medicines

Elbadawi

McCoubrey

Gavins

et al. 2021

Advanced Drug Delivery Reviews

102

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Structure-function correlation and personalized 3D printed tablets using a quality by design (QbD) approach

Cited by 41 publications

References 36 publications

Selective Laser Sintering of a Photosensitive Drug: Impact of Processing and Formulation Parameters on Degradation, Solid-State, and Quality of 3D Printed Dosage Forms

Selective Laser Sintering of a Photosensitive Drug: Impact of Processing and Formulation Parameters on Degradation, Solid-State, and Quality of 3D Printed Dosage Forms

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Harnessing artificial intelligence for the next generation of 3D printed medicines

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