Statistical design of experiment-based formulation development and optimization of 3D printed oral controlled release drug delivery with multi target product profile

Than, Yee Mon; Titapiwatanakun, Varin

doi:10.1007/s40005-021-00542-y

Cited by 10 publications

(6 citation statements)

References 96 publications

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“…Filaments were kept in sealed plastic bags and stored in a desiccator at room temperature until further characterizations. The 3D-printed tablets were successfully produced by using a commercial-material-extrusion 3D printer, MakerBot Replicator 2× (MakerBot Inc., Brooklyn, NY 11201, USA), with a dual nozzle of 0.4 mm diameter [ 25 , 26 ]. The printing temperature was set at 200 °C for all formulations.…”

Section: Methodsmentioning

confidence: 99%

“…Thermal analysis was used to understand the polymer composites, but the mechanical factor was neglected. A texture analyzer was applied, and the breaking stress and breaking distance of the successful printed filaments were studied to determine the optimal extrusion range [ 24 , 25 , 26 ]; however, the mechanical measurement still does not mimic the thermal factor in the extrusion process [ 18 ].…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, polymer composites containing hydroxypropyl cellulose have a high potential to fabricate 3D-printed medicines, as there have been a number of published articles [ 24 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 ]. Therefore, the present study aimed to investigate the rheological properties in terms of viscosity, shear-thinning behavior and viscoelastic properties of 17 hydroxypropyl cellulose-based mixtures, which were successfully printed in the form of immediate and controlled release delivery systems [ 25 , 26 ]. Additional polymers (Soluplus ® , Kollidon ® VA 64 or Eudragit ® EPO, RS or RL) and/or disintegrants (sodium starch glycolate, microcrystalline cellulose, croscarmellose sodium, crospovidone or low substituted hydroxypropyl cellulose) were combined into the feedstock filament at various ratios, as presented in Table 1 .…”

Section: Introductionmentioning

confidence: 99%

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Rheological Investigation of Hydroxypropyl Cellulose–Based Filaments for Material Extrusion 3D Printing

2022

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The rheological properties of drug–polymer mixtures have a significant influence on their processability when using transformative techniques, such as hot-melt-extrusion and material-extrusion 3D printing; however, there has been limited data on printable systems. This study investigated the rheological properties of 17 formulations of successful printed tablets for both immediate and controlled release. Hydroxypropyl cellulose was used in various ratios to obtain printable filaments in combination with various drugs (indomethacin or theophylline), polymers and disintegrants. The complex viscosity, shear thinning behavior and viscoelastic properties were affected by the drug load, polymer composite, disintegrant type, temperature and shear rate applied. Larger windows of processing viscosity were revealed. The viscosity of the printable blends could be as low as the range 10–1000 Pa·s at 100 rad/s angular frequency. All formulations showed shear thinning behavior with a broad slope of complex viscosity from −0.28 to −0.74. The addition of 30–60% drug or disintegrant tended to have greater viscosity values. While microcrystalline cellulose was found to be an alternative additive to lower the storage and loss modulus among disintegrants. This rheological data could be useful for the preformulation and further development of material-extrusion 3D-printing medicines.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Rheological Investigation of Hydroxypropyl Cellulose–Based Filaments for Material Extrusion 3D Printing

2022

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“…However, even quality by design (QbD)-based approach studies at the laboratory scale are not enough, as is the case with the pilot or commercial scale. The lack of the fundamental understanding of the theory of particle formation in SFEE following the lack of scientific analysis of experimental data for controlling fine particle formation from lab scale to scale-up can be compensated by studies using QbD-based approaches [93][94][95][96][97][98]. Thus, to achieve successful GMP scale-up and commercial mass production technology, it is essential to establish validated and robust technology through a scientific and statistical strategy based on the QbD approach [99,100].…”

Section: Expert Opinions and Perspectivesmentioning

confidence: 99%

Pharmaceutical Applications of Supercritical Fluid Extraction of Emulsions for Micro-/Nanoparticle Formation

Park

Kim

et al. 2021

Pharmaceutics

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Micro-/nanoparticle formulations containing drugs with or without various biocompatible excipients are widely used in the pharmaceutical field to improve the physicochemical and clinical properties of the final drug product. Among the various micro-/nanoparticle production technologies, emulsion-based particle formation is the most widely used because of its unique advantages such as uniform generation of spherical small particles and higher encapsulation efficiency (EE). For this emulsion-based micro-/nanoparticle technology, one of the most important factors is the extraction efficiency associated with the fast removal of the organic solvent. In consideration of this, a technology called supercritical fluid extraction of emulsions (SFEE) that uses the unique mass transfer mechanism and solvent power of a supercritical fluid (SCF) has been proposed to overcome the shortcomings of several conventional technologies such as solvent evaporation, extraction, and spray drying. This review article presents the main aspects of SFEE technology for the preparation of micro-/nanoparticles by focusing on its pharmaceutical applications, which have been organized and classified according to several types of drug delivery systems and active pharmaceutical ingredients. It was definitely confirmed that SFEE can be applied in a variety of drugs from water-soluble to poorly water-soluble. In addition, it has advantages such as low organic solvent residual, high EE, desirable release control, better particle size control, and agglomeration prevention through efficient and fast solvent removal compared to conventional micro-/nanoparticle technologies. Therefore, this review will be a good resource for determining the applicability of SFEE to obtain better pharmaceutical quality when researchers in related fields want to select a suitable manufacturing process for preparing desired micro-/nanoparticle drug delivery systems containing their active material.

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“…The fastest release was observed for formulations containing crospovidone [22]. The impact of disintegrants has also been analyzed by several other research groups [23][24][25]. Hussain et al analyzed HPC SL-based formulations containing captopril and disintegrants.…”

Section: Introductionmentioning

confidence: 99%

Fused Deposition Modeling as a Possible Approach for the Preparation of Orodispersible Tablets

et al. 2022

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Additive manufacturing technologies are considered as a potential way to support individualized pharmacotherapy due to the possibility of the production of small batches of customized tablets characterized by complex structures. We designed five different shapes and analyzed the effect of the surface/mass ratio, the influence of excipients, and storage conditions on the disintegration time of tablets printed using the fused deposition modeling method. As model pharmaceutical active ingredients (APIs), we used paracetamol and domperidone, characterized by different thermal properties, classified into the various Biopharmaceutical Classification System groups. We found that the high surface/mass ratio of the designed tablet shapes together with the addition of mannitol and controlled humidity storage conditions turned out to be crucial for fast tablet’s disintegration. As a result, mean disintegration time was reduced from 5 min 46 s to 2 min 22 s, and from 11 min 43 s to 2 min 25 s for paracetamol- and domperidone-loaded tablets, respectively, fulfilling the European Pharmacopeia requirement for orodispersible tablets (ODTs). The tablet’s immediate release characteristics were confirmed during the dissolution study: over 80% of APIs were released from printlets within 15 min. Thus, this study proved the possibility of using fused deposition modeling for the preparation of ODTs.

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Statistical design of experiment-based formulation development and optimization of 3D printed oral controlled release drug delivery with multi target product profile

Cited by 10 publications

References 96 publications

Rheological Investigation of Hydroxypropyl Cellulose–Based Filaments for Material Extrusion 3D Printing

Rheological Investigation of Hydroxypropyl Cellulose–Based Filaments for Material Extrusion 3D Printing

Pharmaceutical Applications of Supercritical Fluid Extraction of Emulsions for Micro-/Nanoparticle Formation

Fused Deposition Modeling as a Possible Approach for the Preparation of Orodispersible Tablets

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