Abuse Deterrent Immediate Release Egg-Shaped Tablet (Egglets)
Using 3D Printing Technology: Quality by Design to Optimize Drug Release and
Extraction

Nukala, Pavan Kumar; Palekar, Siddhant; Patki, Manali; Patel, Ketan

doi:10.1208/s12249-019-1298-y

Cited by 78 publications

(27 citation statements)

References 36 publications

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“…This information can be used to design dosage forms without changing the filament composition to release the drug as per the patient’s requirements, thereby finding application in the field of personalized medicine. Technologies such as shell-core for the enteric coating of acid-labile drugs [ 19 ], hollow systems or multi-compartment systems [ 30 ], designs with abuse-deterrent properties [ 52 ] and platforms testing different polymers such as thermoplastic polyurethanes with high drug loads of theophylline and metformin [ 53 ], polyvinyl alcohol polymers (PVA) [ 29 ], polyvinyl pyrrolidone (PVP) [ 40 , 54 ], methacrylate polymers [ 25 ], polyethylene oxide polymers, and HPMC based polymers [ 12 , 22 ] have been extensively studied for their suitability to 3-D printing platforms. In the study by Goyanes, A. and colleagues (2015) , the main focus was to investigate the feasibility of using FDM processing in the development of modified-release formulations of two aminosalicylate isomers used in the treatment of inflammatory bowel disease (IBD) i.e., 5-aminosalicylic acid (5-ASA, mesalazine) and 4-aminosalicylic acid (4-ASA).…”

Section: Discussionmentioning

confidence: 99%

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

et al. 2020

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This research demonstrates the use of fill density as an effective tool for controlling the drug release without changing the formulation composition. The merger of hot-melt extrusion (HME) with fused deposition modeling (FDM)-based 3-dimensional (3-D) printing processes over the last decade has directed pharmaceutical research towards the possibility of printing personalized medication. One key aspect of printing patient-specific dosage forms is controlling the release dynamics based on the patient’s needs. The purpose of this research was to understand the impact of fill density and interrelate it with the release of a poorly water-soluble, weakly acidic, active pharmaceutical ingredient (API) from a hydroxypropyl methylcellulose acetate succinate (HPMC-AS) matrix, both mathematically and experimentally. Amorphous solid dispersions (ASDs) of ibuprofen with three grades of AquaSolveTM HPMC-AS (HG, MG, and LG) were developed using an HME process and evaluated using solid-state characterization techniques. Differential scanning calorimetry (DSC), powder X-ray diffraction (pXRD), and polarized light microscopy (PLM) confirmed the amorphous state of the drug in both polymeric filaments and 3D printed tablets. The suitability of the manufactured filaments for FDM processes was investigated using texture analysis (TA) which showed robust mechanical properties of the developed filament compositions. Using FDM, tablets with different fill densities (20–80%) and identical dimensions were printed for each polymer. In vitro pH shift dissolution studies revealed that the fill density has a significant impact (F(11, 24) = 15,271.147, p < 0.0001) and a strong negative correlation (r > −0.99; p < 0.0001) with the release performance, where 20% infill demonstrated the fastest and most complete release, whereas 80% infill depicted a more controlled release. The results obtained from this research can be used to develop a robust formulation strategy to control the drug release from 3D printed dosage forms as a function of fill density.

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Section: Discussionmentioning

confidence: 99%

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

et al. 2020

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“…In a few studies where drug-loaded PVA filaments were prepared by melt extrusion, Palekar et al 32 developed 3D printed tablets of baclofen to adjust doses for pediatric patients, Nukala et al 33 determined effects of printing patterns on disintegration and dissolution of PVA-based 3D printed tablets, and Tagami et al 34 investigated the feasibility of achieving zero-order drug release using mixtures of PVA and PLA (polylactic acid) as, respectively, water-soluble and water-insoluble polymers in 3D-printed tablets. Nukala et al 35 also used PVA to prepare abuse-deterrent tablets. Although higher drug loading in filaments could be obtained in these studies by melt extrusion, the drugs were, however, not molecularly dispersed in the PVA matrix and did not completely convert to amorphous form because the crushed filaments exhibited melting endotherms for drugs in differential scanning calorimetry (DSC) scans.…”

Section: Introductionmentioning

confidence: 99%

Development of 3D Printed Tablets by Fused Deposition Modeling Using Polyvinyl Alcohol as Polymeric Matrix for Rapid Drug Release

Wei

Solanki

Vasoya

et al. 2020

Journal of Pharmaceutical Sciences

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“…Thus, many researchers focused on conducting a formulation investigation and exploration, such as Illyes et al [ 53 ], who investigated the printability of various formulations loaded with Carvedilol. Additionally, other research groups used design optimization approaches for formulation selection, such as quality by design and design of experiments such as Palekar et al [ 54 ], Korte and Quodbach [ 11 ], and Nukala et al [ 55 ]. The driving system in most FFF 3D printers relies on the un-melted filament to push the melted portion and maintain the material flow.…”

Section: Resultsmentioning

confidence: 99%

Production of Drug Delivery Systems Using Fused Filament Fabrication: A Systematic Review

Shaqour

Samaro

Verleije³

et al. 2020

Pharmaceutics

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Fused filament fabrication (FFF) 3D printing technology is widely used in many fields. For almost a decade, medical researchers have been exploring the potential use of this technology for improving the healthcare sector. Advances in personalized medicine have been more achievable due to the applicability of producing drug delivery devices, which are explicitly designed based on patients’ needs. For the production of these devices, a filament—which is the feedstock for the FFF 3D printer—consists of a carrier polymer (or polymers) and a loaded active pharmaceutical ingredient (API). This systematic review of the literature investigates the most widely used approaches for producing drug-loaded filaments. It also focusses on several factors, such as the polymeric carrier and the drug, loading capacity and homogeneity, processing conditions, and the intended applications. This review concludes that the filament preparation method has a significant effect on both the drug homogeneity within the polymeric carrier and drug loading efficiency.

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Abuse Deterrent Immediate Release Egg-Shaped Tablet (Egglets) Using 3D Printing Technology: Quality by Design to Optimize Drug Release and Extraction

Cited by 78 publications

References 36 publications

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

Novel On-Demand 3-Dimensional (3-D) Printed Tablets Using Fill Density as an Effective Release-Controlling Tool

Development of 3D Printed Tablets by Fused Deposition Modeling Using Polyvinyl Alcohol as Polymeric Matrix for Rapid Drug Release

Production of Drug Delivery Systems Using Fused Filament Fabrication: A Systematic Review

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