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Preparation and Characterization of 3D-Printed Dose-Flexible Printlets of Tenofovir Disoproxil Fumarate

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  • Novel Advances in 3-D Printing Technology in Drug Delivery
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Abstract

The aim of this work was to design pediatric-friendly, dose-flexible orally disintegrating drug delivery systems (printlets) of the antiviral drug tenofovir disoproxil fumarate (TDF) by selective laser sintering (SLS) for potential use in hospitals along with other antiviral drugs. In order to obtain a consistent quality of printlets with desired properties, it is important to understand certain critical quality attributes for their main and interactions effect. The printlets were optimized by Box-Behnken’s design of the experiment by varying process variables while keeping the composition constant. The composition contained 16.3% TDF, 72.7% polyvinyl pyrrolidone K16-18, 8% magnesium aluminum silicate, 3% Candurin® NXT Ruby Red, and 0.3% colloidal silicon dioxide. The process variables studied were surface (X1), chamber temperatures (X2), and laser scanning speed (X3). The range of variable levels was 75–85°C for X1, 50–70°C for X2, and 200–240 mm/s for X3, respectively. The responses studied were hardness, disintegration time, dissolution, physiochemical, and pharmacokinetic characterization. X-ray powder diffraction indicated partial or complete conversion of the crystalline drug into amorphous form in the printlets. Comparative pharmacokinetics between Viread® (generic) and printlets in rats were superimposable. Pharmacokinetic parameters showed statistically insignificant differences between the two formulations in terms of Tmax, Cmax, and AUC of (p > 0.05). Printlets were bioequivalent to Viread® as per FDA bioequivalence criteria. Thus, the SLS printing method showed the fabrication of dose-flexible printlets with quality, and in vivo performance equivalent to commercial tablets.

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Data Availability

The data that support the findings of this study are available on request from the corresponding author.

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Acknowledgements

The use of the TAMU materials characterization facility is acknowledged for allowing us to use SEM.

Funding

This work was supported by National Institute of Health R56 grant #1R56HD106612, and partly by R01 grant #1R01HD112077.

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Authors and Affiliations

  1. Reynolds Medical Sciences Building, Irma Lerma Rangel School of Pharmacy, Texas A&M Health Science Center, Texas A&M University, Suite 159, College Station, Texas, 77843-1114, USA

    Canberk Kayalar, Ziyaur Rahman, Eman M. Mohamed, Sathish Dharani, Tahir Khuroo, Nada Helal & Mansoor A. Khan

  2. Department of Engineering Technology & Industrial Distribution, College of Engineering, Texas A&M University, College Station, Texas, 77843, USA

    Mathew A. Kuttolamadom

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Contributions

Canberk Kayalar: conceptualization, validation, investigation, visualization, writing—review and editing

Nada Helal: validation, investigation, visualization

Sathish Dharani: validation, investigation, visualization

Eman M. Mohamed: validation, investigation, visualization

Tahir Khuroo: validation, investigation, visualization

Mathew A. Kuttolamadom: conceptualization, formal analysis, writing—review and editing

Ziyaur Rahman: conceptualization, formal analysis, writing—review and editing, supervision, project administration

Mansoor A. Khan: conceptualization, formal analysis, writing—review and editing, supervision, project administration

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Correspondence to Mansoor A. Khan.

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Kayalar, C., Rahman, Z., Mohamed, E.M. et al. Preparation and Characterization of 3D-Printed Dose-Flexible Printlets of Tenofovir Disoproxil Fumarate. AAPS PharmSciTech 24, 171 (2023). https://doi.org/10.1208/s12249-023-02623-7

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