Processability of poly(vinyl alcohol) Based Filaments With Paracetamol Prepared by Hot-Melt Extrusion for Additive Manufacturing

Macedo, Joana; Samaro, Aseel; Vanhoorne, Valérie; Vervaet, Chris; Pinto, João F.

doi:10.1016/j.xphs.2020.09.016

Cited by 31 publications

(19 citation statements)

References 32 publications

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“…In a recent study, Govender et al examined this issue, showing good stability with high percentages of drug incorporation, albeit with a polymer insoluble in water [43]. It has also been demonstrated that amorphization via hot-melt extrusion and subsequent FDM can produce formulations in which the drug quickly recrystallizes [44]. These limitations of FDM are starting to be addressed via the use of a combinatorial approach involving novel hybrid systems, comprising one part produced via FDM and another part produced by a different technique to overcome the shortcomings of their respective techniques [45].…”

Section: Introductionmentioning

confidence: 99%

3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs

et al. 2021

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Fused deposition modelling (FDM) is the most extensively employed 3D-printing technique used in pharmaceutical applications, and offers fast and facile formulation development of personalized dosage forms. In the present study, mesoporous materials were incorporated into a thermoplastic filament produced via hot-melt extrusion and used to produce oral dosage forms via FDM. Mesoporous materials are known to be highly effective for the amorphization and stabilization of poorly soluble drugs, and were therefore studied in order to determine their ability to enhance the drug-release properties in 3D-printed tablets. Celecoxib was selected as the model poorly soluble drug, and was loaded into mesoporous silica (MCM-41) or mesoporous magnesium carbonate. In vitro drug release tests showed that the printed tablets produced up to 3.6 and 1.5 times higher drug concentrations, and up to 4.4 and 1.9 times higher release percentages, compared to the crystalline drug or the corresponding plain drug-loaded mesoporous materials, respectively. This novel approach utilizing drug-loaded mesoporous materials in a printed tablet via FDM shows great promise in achieving personalized oral dosage forms for poorly soluble drugs.

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Section: Introductionmentioning

confidence: 99%

3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs

et al. 2021

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“…Throughout the HME operation, the materials are blended and heated in the extruder, the melted mass being subsequently pressed through a die in furtherance of filament shaping, through rapid solidification by cooling. The primary advantage of the methodology is achievement of high drug loading, as preparation of 3D printable filaments with a 50% w/w drug content was reported [ 10 ]. In addition, HME provides the opportunity to surpass the solubility issues of poorly soluble APIs through solid dispersion preparation, a system wherein the drug is molecularly disseminated into the carrier matrix [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Polyvinyl Alcohol-Based 3D Printed Tablets: Novel Insight into the Influence of Polymer Particle Size on Filament Preparation and Drug Release Performance

et al. 2021

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Three-dimensional printing (3DP) by fused deposition modeling (FDM) has gained momentum as a promising pharmaceutical manufacturing method due to encouraging forward-looking perspectives in personalized medicine preparation. The current challenges the technology has for applicability in the fabrication of solid dosage forms include the limited range of suitable pharmaceutical grade thermoplastic materials. Hence, it is important to investigate the implications of variable properties of the polymeric carrier on the preparation steps and the final output, as versatile products could be obtained by using the same material. In this study, we highlighted the influence of polyvinyl alcohol (PVA) particle size on the residence time of the mixtures in the extruder during the drug-loaded filament preparation step and the consequent impact on drug release from the 3D printed dosage form. We enhanced filament printability by exploiting the plasticizing potential of the active pharmaceutical ingredient (API) and we explored a channeled tablet model as a design strategy for dissolution facilitating purposes. Our findings disclosed a new perspective regarding material considerations for the preparation of PVA-based solid dosage forms by coupling hot melt extrusion (HME) and FDM-3DP.

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“…On the other hand, filaments consisting of K12PF:PEO (70:30) and KVA64:PEO (70:30) displayed high hygroscopicity (14.32% and 8.70% moisture content, respectively). It was shown previously that water uptake negatively impacts the mechanical stability of filaments due to the plasticizing effect of water [ 18 , 56 ]. Elasticity modulus and stress at break decreased and strain at break increased for the filaments with a higher moisture content, changing their feeding behaviour.…”

Section: Resultsmentioning

confidence: 99%

“…Elasticity modulus and stress at break decreased and strain at break increased for the filaments with a higher moisture content, changing their feeding behaviour. Unfortunately, the printability behaviour also changed, e.g., print temperature had to be changed in function of the storage time at 25

/60% RH for a poly(vinyl alcohol)-based filament containing paracetamol (10–50% w / w ) due to a change in the glass transition temperature [ 56 ]. Therefore, a low hygroscopicity of the feedstock filament is favorable in terms of stability of the feedability and printability behaviour.…”

Section: Resultsmentioning

confidence: 99%

Development of a 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal Therapy

Henry¹,

Vadder²,

Decorte³

et al. 2021

Pharmaceutics

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The long-term use of benzodiazepine receptor agonists (BZRAs) is associated with multiple side effects, such as increased sedation, hangover or an elevated risk of dependency and abuse. Unfortunately, the long-term use of BZRAs is reaching worrying intake rates, and therefore, the need for action is high. It was demonstrated already that the overall willingness of patients for deprescription increased when a slow dose reduction scheme with the possibility for dose increase, if needed, is employed. The current study aims to develop a flexible dosing platform of zolpidem hemitartrate (ZHT) to facilitate such withdrawal therapy. As this is the first report on the extrusion and 3D printing of ZHT, its thermal behaviour and sensitivity towards photolytic degradation was characterised. It was shown that ZHT possesses multiple polymorphs and was especially prone to oxidative photolysis. Next, a variety of immediate release polymers (Eudragit EPO, Kollidon VA64, Kollidon 12PF and Soluplus) were blended and extruded with Polyox WSR N10 to investigate their feedability and printability by mechanical and rheological analysis. The addition of PEO was shown to enable printing of these brittle pharmaceutical polymers, although the processing temperature was deemed critical to avoid surface defects on the resulting filaments. An EPO(70)PEO(30) system was selected based on its suitable mechanical properties and low hygroscopicity favoring ZHT stability. The matrix was blended with 1% or 10% API. The effect of certain printing parameters (caplet size, nozzle diameter, % overlap) on dissolution behaviour and caplet weight/dimensions/quality was assessed. A flexible dosing platform capable of delivering <1 mg and up to 10 mg of ZHT was created. Either caplet modification (incorporation of channels) or disintegrant addition (Primojel, Explotab, Ac-Di-Sol, Primellose and Polyplasdone-XL) failed to achieve an immediate release profile. This study provides the first report of a 3D-printed flexible dosing platform containing ZHT to aid in withdrawal therapy.

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Processability of poly(vinyl alcohol) Based Filaments With Paracetamol Prepared by Hot-Melt Extrusion for Additive Manufacturing

Cited by 31 publications

References 32 publications

3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs

3D-Printed Mesoporous Carrier System for Delivery of Poorly Soluble Drugs

Polyvinyl Alcohol-Based 3D Printed Tablets: Novel Insight into the Influence of Polymer Particle Size on Filament Preparation and Drug Release Performance

Development of a 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal Therapy

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