Speed it up, slow it down…An issue of bicalutamide release from 3D printed tablets

Jamróz, Witold; Kurek, Mateusz; Szafraniec-Szczęsny, Joanna; Czech, Anna; Gawlak, Karolina; Knapik-Kowalczuk, Justyna; Leszczyński, Bartosz; Wróbel, Andrzej; Paluch, Marian; Jachowicz, Renata

doi:10.1016/j.ejps.2019.105169

Cited by 41 publications

(11 citation statements)

References 42 publications

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“…In our previous study, we investigated the 3D printing method by means of filament co-extrusion of drug-loaded filament and insoluble filament to obtain sustained-release dosage forms, from which the release profile of API can be changed “on demand” [ 34 ]. In the present study, we adapted this method to improve the dissolution rate of ketoprofen from tablets printed using the PVA-based filament containing 40% of the drug (F3) and water-soluble Kollicoat ® IR-based placebo filament.…”

Section: Resultsmentioning

confidence: 99%

“…The co-extrusion printing is based on simultaneous extrusion of two materials using only one nozzle, which leads to the preparation of a printlet with a complex structure at the level of a single layer. The co-extrusion of API-loaded filament and insoluble placebo filaments leads to further modification of drug release, as compared with extrusion of a single filament [ 34 , 35 ].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

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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“…Moreover, the bioactivity of the drugs can be altered due to the melting temperature of the polymers to be extruded and to avoid this, it is relevant to select an appropriate drug, whose melting point is above one of the polymers [12]. By appropriately selecting the process parameters and material composition of the filament, it is possible to manufacture high-quality filaments containing the API (active pharmaceutical ingredient) [10,22]. Other drawbacks include a reduced choice of thermoplastic materials with good melting-viscosity properties for the extrusion process and the difficulty of loading thermo-sensitive drugs during the extrusion process caused by the high processing temperatures [5,11].…”

Section: Introductionmentioning

confidence: 99%

3DP Printing of Oral Solid Formulations: A Systematic Review

et al. 2021

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Three-dimensional (3D) printing is a recent technology, which gives the possibility to manufacture personalised dosage forms and it has a broad range of applications. One of the most developed, it is the manufacture of oral solid dosage and the four 3DP techniques which have been more used for their manufacture are FDM, inkjet 3DP, SLA and SLS. This systematic review is carried out to statistically analyze the current 3DP techniques employed in manufacturing oral solid formulations and assess the recent trends of this new technology. The work has been organised into four steps, (1) screening of the articles, definition of the inclusion and exclusion criteria and classification of the articles in the two main groups (included/excluded); (2) quantification and characterisation of the included articles; (3) evaluation of the validity of data and data extraction process; (4) data analysis, discussion, and conclusion to define which technique offers the best properties to be applied in the manufacture of oral solid formulations. It has been observed that with SLS 3DP technique, all the characterisation tests required by the BP (drug content, drug dissolution profile, hardness, friability, disintegration time and uniformity of weight) have been performed in the majority of articles, except for the friability test. However, it is not possible to define which of the four 3DP techniques is the most suitable for the manufacture of oral solid formulations, because the selection is affected by different parameters, such as the type of formulation, the physical-mechanical properties to achieve. Moreover, each technique has its specific advantages and disadvantages, such as for FDM the biggest challenge is the degradation of the drug, due to high printing temperature process or for SLA is the toxicity of the carcinogenic risk of the photopolymerising material.

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“…Notably, Figure 1 exemplifies that an equivalent number of module variants in the conventional and proposed concept yields different degrees of product variety (one product variant vs. > three product variants in the example shown), with greater product variety accessible with the proposed modular product concept. This is due to the fact that conventional modular product archetypes are usually constructed by fixed assembly of modules into products [ 17 , 40 , 53 , 59 , 60 , 61 ]. Variety in the product offering is typically attainable through iterative modifications of a single initial product design until arriving at the variant of choice.…”

Section: Introductionmentioning

confidence: 99%

“…The drawback with this approach is that approaching lower volumes and higher variety of products is accompanied by a loss of economies of scale and an inevitable trade-off between affordability and variety [ 23 ]. This explains why most demonstrated oral dosage form modularization, even when some variety is present, still either exhibits interdependent dosage form size, dose, and drug release kinetics and/or a choice between fixed dose and fixed drug release kinetics at a given dosage form size [ 17 , 52 , 58 , 59 , 62 , 63 , 64 , 65 , 66 , 67 ]. From a product variety management perspective, conventional modular concepts are therefore limited in their ability to simultaneously deliver both the high variety and affordability necessary for individualization.…”

Section: Introductionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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Independent individualization of multiple product attributes, such as dose and drug release, is a crucial overarching requirement of pharmaceutical products for individualized therapy as is the unified integration of individualized product design with the processes and production that drive patient access to such therapy. Individualization intrinsically demands a marked increase in the number of product variants to suit smaller, more stratified patient populations. One established design strategy to provide enhanced product variety is product modularization. Despite existing customized and/or modular product design concepts, multifunctional individualization in an integrated manner is still strikingly absent in pharma. Consequently, this study aims to demonstrate multifunctional individualization through a modular product design capable of providing an increased variety of release profiles independent of dose and dosage form size. To further exhibit that increased product variety is attainable even with a low degree of product modularity, the modular design was based upon a fixed target dosage form size of approximately 200 mm3 comprising two modules, approximately 100 mm3 each. Each module contained a melt-extruded and molded formulation of 40% w/w metoprolol succinate in a PEG1500 and Kollidon® VA64 erodible hydrophilic matrix surrounded by polylactic acid and/or polyvinyl acetate as additional release rate-controlling polymers. Drug release testing confirmed the generation of predictable, combined drug release kinetics for dosage forms, independent of dose, based on a product’s constituent modules and enhanced product variety through a minimum of six dosage form release profiles from only three module variants. Based on these initial results, the potential of the reconfigurable modular product design concept is discussed for unified integration into a pharmaceutical mass customization/mass personalization context.

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Speed it up, slow it down…An issue of bicalutamide release from 3D printed tablets

Cited by 41 publications

References 42 publications

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

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

3DP Printing of Oral Solid Formulations: A Systematic Review

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

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