Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing

Fernández-García, Raquel; Prada, María; Bolás‐Fernández, F.; Ballesteros, M.; Serrano, Dolores R.

doi:10.1007/s11095-020-02847-3

Cited by 43 publications

(20 citation statements)

References 81 publications

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“…To provide quality and safety of obtained tablets, 3D printing processes for pharmaceutical use need to be complementary with Good Manufacturing Practice (GMP) pharmaceutical standards. In accordance with the described procedure of preparation of the photoreactive suspensions and printing of tablets with DLP 3D technology, this process, as well as other 3D printing technologies, could take a role in preparations of personalized dosage forms in community and hospital pharmacies [ 49 ]. The benefits of using the DLP printer here demonstrated are the possibility of customization of the printing parameters depending on the formulation factors, fast printing of pharmaceutical dosage forms, as well as printing at room temperature.…”

Section: Resultsmentioning

confidence: 99%

Digital Light Processing (DLP) 3D Printing of Atomoxetine Hydrochloride Tablets Using Photoreactive Suspensions

et al. 2020

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Three-dimensional (3D) printing technologies are based on successive material printing layer-by-layer and are considered suitable for the production of dosage forms customized for a patient’s needs. In this study, tablets of atomoxetine hydrochloride (ATH) have been successfully fabricated by a digital light processing (DLP) 3D printing technology. Initial materials were photoreactive suspensions, composed of poly(ethylene glycol) diacrylate 700 (PEGDA 700), poly(ethylene glycol) 400 (PEG 400), photoinitiator and suspended ATH. The amount of ATH was varied from 10.00 to 25.00% (w/w), and a range of doses from 12.21 to 40.07 mg has been achieved, indicating the possibility of personalized therapy. The rheological characteristics of all photoreactive suspensions were appropriate for the printing process, while the amount of the suspended particles in the photoreactive suspensions had an impact on the 3D printing process, as well as on mechanical and biopharmaceutical characteristics of tablets. Only the formulation with the highest content of ATH had significantly different tensile strength compared to other formulations. All tablets showed sustained drug release during at least the 8h. ATH crystals were observed with polarized light microscopy of photoreactive suspensions and the cross-sections of the tablets, while no interactions between ATH and polymers were detected by FT-IR spectroscopy.

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Section: Resultsmentioning

confidence: 99%

Digital Light Processing (DLP) 3D Printing of Atomoxetine Hydrochloride Tablets Using Photoreactive Suspensions

et al. 2020

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“…Additive manufacturing is forecast to become a significant element of the fourth industrial revolution leading to mass customization of medicine. Three-dimensional printing technologies allow the production of personalized fix-dose combinations with the desired release profile, which simplifies therapy and minimizes the risk of side effects related to under- or overdosing [ 1 ]. Additionally, in the case of printed dosage forms, their shape, color, or even flavor can be easily modified, which increases the attractiveness of therapy and affect patients’ compliance—the two aspects particularly important in the case of pediatric or geriatric groups [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

How to Obtain the Maximum Properties Flexibility of 3D Printed Ketoprofen Tablets Using Only One Drug-Loaded Filament?

et al. 2021

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The flexibility of dose and dosage forms makes 3D printing a very interesting tool for personalized medicine, with fused deposition modeling being the most promising and intensively developed method. In our research, we analyzed how various types of disintegrants and drug loading in poly(vinyl alcohol)-based filaments affect their mechanical properties and printability. We also assessed the effect of drug dosage and tablet spatial structure on the dissolution profiles. Given that the development of a method that allows the production of dosage forms with different properties from a single drug-loaded filament is desirable, we developed a method of printing ketoprofen tablets with different dose and dissolution profiles from a single feedstock filament. We optimized the filament preparation by hot-melt extrusion and characterized them. Then, we printed single, bi-, and tri-layer tablets varying with dose, infill density, internal structure, and composition. We analyzed the reproducibility of a spatial structure, phase, and degree of molecular order of ketoprofen in the tablets, and the dissolution profiles. We have printed tablets with immediate- and sustained-release characteristics using one drug-loaded filament, which demonstrates that a single filament can serve as a versatile source for the manufacturing of tablets exhibiting various release characteristics.

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“…Additive printing process which enables the design of a customized oral dosage forms is triggering a paradigm shift in the way medicines are manufactured and administered [42]. Furthermore, this process could make possible the printing of medicines in pandemic outbreak areas to mitigate drug shortages and supply chain disruptions, and potential for making available printing of medicines in war zones, in clinical trials in hospital settings [43,44] and preparation of individualized fixed-dose combination products [44][45][46]. Perhaps, the current regulatory landscape on additive printing is flexible enough to accommodate this technology for mass production in addition to its benefits in extemporaneous compounding of medicines.…”

Section: Application Of Additive Manufacturing In Personalized Orodispersible Dosage Formsmentioning

confidence: 99%

Applications of Alginates in the Design and Preparation of Orodispersible Dosage Forms

Khalid¹,

Selmin²

2022

Properties and Applications of Alginates

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Orodispersible dosage forms are attractive and innovative drug delivery systems that can fulfill individual patient needs, especially in children, elderly and among dysphagic patients. Indeed, they rapidly disperse in the mouth upon contact with the saliva without the need for water or munching. Examples of such dosage forms include orodispersible tablets (ODT), and orodispersible films (ODF). The ability to obtain ODF with different dimensions (sizes and thicknesses) makes them a suitable for personalized dosing of single or a fixed-dose combination of drugs in special patient populations. Several biopolymers are currently being exploited in the development of orodispersible dosage forms including alginates due to their versatility, availability, naturally occurring, and biosafety profile. This chapter provides an appraisal on the various applications of alginates in the preparations and their role on the properties of orodispersible dosage forms and highlights future perspectives of this very versatile biopolymer for these innovative drug delivery systems.

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Oral Fixed-Dose Combination Pharmaceutical Products: Industrial Manufacturing Versus Personalized 3D Printing

Cited by 43 publications

References 81 publications

Digital Light Processing (DLP) 3D Printing of Atomoxetine Hydrochloride Tablets Using Photoreactive Suspensions

Digital Light Processing (DLP) 3D Printing of Atomoxetine Hydrochloride Tablets Using Photoreactive Suspensions

How to Obtain the Maximum Properties Flexibility of 3D Printed Ketoprofen Tablets Using Only One Drug-Loaded Filament?

Applications of Alginates in the Design and Preparation of Orodispersible Dosage Forms

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