3D printing of multilayered orodispersible films with in-process drying

Elbl, Jan; Gajdziok, Jan; Kolarczyk, Jan

doi:10.1016/j.ijpharm.2019.118883

Cited by 77 publications

(48 citation statements)

References 36 publications

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“…This study proposed a method for promoting automation in the manufacturing of personalized medicines [22]. In another study by Elbl et al [23], the multilayered ODF maltodextrin films of benzydamine hydrochloride were successfully fabricated using an in-house modified syringe extrusion 3D printer. In this study, the addition of different viscosity grades of hydroxyethylcellulose was used to adjust the viscosity of the ink in order to achieve successful printing with in-process drying.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film

Panraksa

Udomsom

et al. 2021

Polymers

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The application of hydrophilic polymers in designing and three-dimensional (3D) printing of pharmaceutical products in various dosage forms has recently been paid much attention. Use of hydrophilic polymers and syringe extrusion 3D printing technology in the fabrication of orodispersible films (ODFs) might hold great potential in rapid drug delivery, personalized medicine, and manufacturing time savings. In this study, the feasibility of 3D-printed ODFs fabrication through a syringe extrusion 3D printing technique and using five different hydrophilic polymers (e.g., hydroxypropyl methylcellulose E15, hydroxypropyl methylcellulose E50, high methoxyl pectin, sodium carboxymethylcellulose, and hydroxyethylcellulose) as film-forming polymers and printing materials has been investigated. Rheology properties and printability of printing gels and physicochemical and mechanical properties of 3D-printed ODFs were evaluated. Amongst the investigated hydrophilic polymers, sodium carboxymethylcellulose at a concentration of 5% w/v (SCMC-5) showed promising results with a good printing resolution and accurate dimensions of the 3D-printed ODFs. In addition, SCMC-5 3D-printed ODFs exhibited the fastest disintegration time within 3 s due to high wettability, roughness and porosity on the surface. However, the results of the mechanical properties study showed that SCMC-5 3D printed ODFs were rigid and brittle, thus requiring special packaging to prevent them from any damage before practical use.

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Section: Introductionmentioning

confidence: 99%

Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film

Panraksa

Udomsom

et al. 2021

Polymers

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“…AM, also known as 3-dimensional printing (3D printing), builds objects layer by layer from a computer-aided digital design [ 28 , 29 ]. Extrusion based AM processes, such as fused deposition modeling (FDM), are currently being explored to prepare thin film and membrane formulations [ 24 , 30 ]. However, the film’s design, printing parameters, and the physico-chemical characterization of the printed films have not been fully explored.…”

Section: Introductionmentioning

confidence: 99%

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Zhang

Thakkar

et al. 2021

Pharmaceutics

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Conventional oral dosage forms may not always be optimal especially for those patients suffering from dysphasia or difficulty swallowing. Development of suitable oral thin films (OTFs), therefore, can be an excellent alternative to conventional dosage forms for these patient groups. Hence, the main objective of the current investigation is to develop oral thin film (OTF) formulations using novel solvent-free approaches, including additive manufacturing (AM), hot-melt extrusion, and melt casting. AM, popularly recognized as 3D printing, has been widely utilized for on-demand and personalized formulation development in the pharmaceutical industry. Additionally, in general active pharmaceutical ingredients (APIs) are dissolved or dispersed in polymeric matrices to form amorphous solid dispersions (ASDs). In this study, acetaminophen (APAP) was selected as the model drug, and Klucel™ hydroxypropyl cellulose (HPC) E5 and Soluplus® were used as carrier matrices to form the OTFs. Amorphous OTFs were successfully manufactured by hot-melt extrusion and 3D printing technologies followed by comprehensive studies on the physico-chemical properties of the drug and developed OTFs. Advanced physico-chemical characterizations revealed the presence of amorphous drug in both HME and 3D printed films whereas some crystalline traces were visible in solvent and melt cast films. Moreover, advanced surface analysis conducted by Raman mapping confirmed a more homogenous distribution of amorphous drugs in 3D printed films compared to those prepared by other methods. A series of mathematical models were also used to describe drug release mechanisms from the developed OTFs. Moreover, the in vitro dissolution studies of the 3D printed films demonstrated an improved drug release performance compared to the melt cast or extruded films. This study suggested that HME combined with 3D printing can potentially improve the physical properties of formulations and produce OTFs with preferred qualities such as faster dissolution rate of drugs.

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“…The 3D printing methods can operate with a powder, which is bound with a liquid binder or sintered with a laser, a photosensitive resin, a thermoplastic material, or a semi-solid formulation extruded through the printer nozzle. Several techniques, such as stereolithography [10][11][12][13][14], selective laser sintering [8,15] digital light processing [16,17], binder jetting, [18,19], and extrusion-based methods including direct powder extrusion [20,21], semi-solid extrusion [22][23][24][25][26], and fused deposition modeling (FDM) [27,28], have been investigated for application in the pharmaceutical industry. The 3DP methods which can be introduced in the high-scale manufacturing process should be characterized by the high-speed production of uniform objects [29,30].…”

Section: Introductionmentioning

confidence: 99%

“…The combination of HME and FDM can induce phase transitions, including amorphization, which results in increased drug solubility. Further drug dissolution modification can be also achieved by changing the shape and surface of the printed dosage form [26].…”

Section: Introductionmentioning

confidence: 99%

Multivariate Design of 3D Printed Immediate-Release Tablets with Liquid Crystal-Forming Drug—Itraconazole

et al. 2020

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The simplicity of object shape and composition modification make additive manufacturing a great option for customized dosage form production. To achieve this goal, the correlation between structural and functional attributes of the printed objects needs to be analyzed. So far, it has not been deeply investigated in 3D printing-related papers. The aim of our study was to modify the functionalities of printed tablets containing liquid crystal-forming drug itraconazole by introducing polyvinylpyrrolidone-based polymers into the filament-forming matrices composed predominantly of poly(vinyl alcohol). The effect of the molecular reorganization of the drug and improved tablets’ disintegration was analyzed in terms of itraconazole dissolution. Micro-computed tomography was applied to analyze how the design of a printed object (in this case, a degree of an infill) affects its reproducibility during printing. It was also used to analyze the structure of the printed dosage forms. The results indicated that the improved disintegration obtained due to the use of Kollidon®CL-M was more beneficial for the dissolution of itraconazole than the molecular rearrangement and liquid crystal phase transitions. The lower infill density favored faster dissolution of the drug from printed tablets. However, it negatively affected the reproducibility of the 3D printed object.

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3D printing of multilayered orodispersible films with in-process drying

Cited by 77 publications

References 36 publications

Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film

Characterization of Hydrophilic Polymers as a Syringe Extrusion 3D Printing Material for Orodispersible Film

Development and Evaluation of Amorphous Oral Thin Films Using Solvent-Free Processes: Comparison between 3D Printing and Hot-Melt Extrusion Technologies

Multivariate Design of 3D Printed Immediate-Release Tablets with Liquid Crystal-Forming Drug—Itraconazole

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