Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century

Tiwari, Roshan V.; Patil, Hemlata; Repka, Michael A.

doi:10.1517/17425247.2016.1126246

Cited by 134 publications

(61 citation statements)

References 53 publications

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“…15,17) Hot-melt extrusion is an established method that uses an extruder. 23,24) In contrast, the soaking method involves the simple soaking of a polymer filament in organic solvent saturated with the drug (in this case, a drug ethanoic solution) and the drug diffuses into the polymer filament. The soaking method is limited to drugs soluble in organic solvent, and the resulting loaded amount of drug is lower than obtained using the hot-melt extrusion method.…”

Section: Resultsmentioning

confidence: 99%

3D Printing Factors Important for the Fabrication of Polyvinylalcohol Filament-Based Tablets

Tagami

Fukushige

Ogawa

et al. 2017

Biological & Pharmaceutical Bulletin

118

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Three-dimensional (3D) printers have been applied in many fields, including engineering and the medical sciences. In the pharmaceutical field, approval of the first 3D-printed tablet by the U.S. Food and Drug Administration in 2015 has attracted interest in the manufacture of tablets and drugs by 3D printing techniques as a means of delivering tailor-made drugs in the future. In current study, polyvinylalcohol (PVA)-based tablets were prepared using a fused-deposition-modeling-type 3D printer and the effect of 3D printing conditions on tablet production was investigated. Curcumin, a model drug/fluorescent marker, was loaded into PVA-filament. We found that several printing parameters, such as the rate of extruding PVA (flow rate), can affect the formability of the resulting PVA-tablets. The 3D-printing temperature is controlled by heating the print nozzle and was shown to affect the color of the tablets and their curcumin content. PVA-based infilled tablets with different densities were prepared by changing the fill density as a printing parameter. Tablets with lower fill density floated in an aqueous solution and their curcumin content tended to dissolve faster. These findings will be useful in developing drug-loaded PVA-based 3D objects and other polymerbased articles prepared using fused-deposition-modeling-type 3D printers. Key words three-dimensional (3D) printing; fused deposition modeling; polyvinylalcohol (PVA); tablet; curcuminThe production of various objects by three-dimensional (3D) printers has developed extensively as the printers have evolved.1,2) 3D printers are used by the creator to rapidly design prototype parts and can thus considerably cut production times and costs. 3D printers have been used to manufacture parts for cars, home electronic devices, aircraft engines, buildings, and for other practical uses. It is speculated that 3D printers have potential for many applications and that the 3D printer market will expand.The medical applications of 3D printers have been expanding and bringing innovation to the field.3) For example, the 3D printing of organs and body parts is used to provide blueprints 4) for surgeons and patients to understand disease sites.5-7) In addition, bioprinting, which involves the placement of cells, proteins and genes on a substrate, is also being conducted in the anticipation of future applications in tissue engineering.8,9) Future artificial organs and implantable devices are also being designed. 10,11) In the pharmaceutical industry, a new tablet (SPRITAM ® , a rapid disintegrating tablet containing levetiracetam) prepared by 3D printing was approved by the U.S. Food and Drug Administration (FDA) in 2015.12) The application of 3D printing in medicine, including tablets, holds promise for made-to-order drugs and removes mass product manufacturing from the production line, although the technology in pharmaceutical industry is still in infancy.13) Moreover, it is predicted that the internet of things (IoT) will increase the future use of 3D printers by reinforcing man...

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Section: Resultsmentioning

confidence: 99%

3D Printing Factors Important for the Fabrication of Polyvinylalcohol Filament-Based Tablets

Tagami

Fukushige

Ogawa

et al. 2017

Biological & Pharmaceutical Bulletin

118

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“…Hence, HME has been recognized as a suitable alternative over the conventional methods of manufacturing tablets, films, implants, etc. which can be delivered through the oral, transdermal and the transmucosal routes (18, 19). The novel aim of this study was to formulate a BCS class III drug (OND) into a buccal tablet comprising of two concentrations of oleic acid via the hot-melt extrusion technology and to investigate the effect of the concentration of the fatty acid on the physicochemical characteristics of the tablet.…”

Section: Introductionmentioning

confidence: 99%

Bioadhesive Drug Delivery System for Enhancing the Permeability of a BCS Class III Drug via Hot-Melt Extrusion Technology

et al. 2017

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As the buccal route of administration has the ability to avoid the GI tract and first pass effect by directing the absorption towards the cheek area, the bioavailability of BCS class III drugs can be increased through this route. Only a handful of studies have been conducted using oleic acid as a permeation enhancer in any transbuccal drug delivery system. Therefore the objective of this novel study was to develop a buccal tablet using two concentrations of oleic acid for a model BCS class III drug via hot-melt extrusion technology and to investigate the effects of oleic acid on the physicochemical properties of the tablet. The model drug selected was ondansetron hydrochloride. Formulations consisting of the polymers (hydroxypropyl methylcellulose and polyethylene oxide) and two concentrations of oleic acid were prepared by hot-melt extrusion techniques. A melting point depression of the drug was obtained in the extruded granules as seen by the DSC thermograms. The ex-vivo permeation studies showed a greater permeation of the drug in the formulation containing 10% oleic acid (F2) as compared to the formulation containing 20% oleic acid (F1), although not statistically significant. The in-vitro bioadhesion studies, swelling studies and surface pH measurements of the tablets were also conducted. In conclusion, permeation studies exhibited the potential of oleic acid as a buccal permeation enhancer as a significant permeation of the drug was obtained in the formulations. Hot-melt extrusion technology was successfully employed to formulate buccal tablets of ondansetron hydrochloride.

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“…HME is a processing technique that is gaining traction within the pharmaceutical industry [6–8]. It is used in the production of a variety of dosage forms, including tablets, pellets, and novel drug delivery systems [9–11].…”

Section: Introductionmentioning

confidence: 99%

Process analytical quality control of tailored drug release formulation prepared via hot-melt extrusion technology

Park

Lee

Kang

et al. 2017

Journal of Drug Delivery Science and Technology

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The objective of the present study was to compare the influence of Eudragit® RS PO and RL PO blends on the release of water-soluble and insoluble drugs from hot-melt extruded formulations. In addition, we aimed to evaluate drug content uniformity and distribution by Fourier transform-infrared (FT-IR) chemical imaging. Theophylline (TP) and carbamazepine (CBZ) were selected as the water-soluble and insoluble model drugs, respectively. Eudragit® RS PO and RL PO were selected as the polymeric matrices. FT-IR chemical imaging clearly demonstrated the content uniformity and distribution for both drugs in the extrudates, which was confirmed by HPLC. Increasing the ratio of Eudragit® RL PO led to an increase in the in vitro drug release, whereas an increase in the ratio of Eudragit® RS PO sustained the drug release for up to 12 h. The hot-melt extrusion of TP and CBZ with varying ratios of Eudragit® RS PO and RL PO can be employed to tailor the drug release profiles. In this study, we demonstrated, for the first time, the use of FT-IR chemical imaging as a process analytical technique to determine the drug content uniformity and distribution. Our data correlated well with the results of HPLC analysis in the study of tailored drug release from the prepared hot-melt extruded formulation.

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Contribution of hot-melt extrusion technology to advance drug delivery in the 21st century

Cited by 134 publications

References 53 publications

3D Printing Factors Important for the Fabrication of Polyvinylalcohol Filament-Based Tablets

3D Printing Factors Important for the Fabrication of Polyvinylalcohol Filament-Based Tablets

Bioadhesive Drug Delivery System for Enhancing the Permeability of a BCS Class III Drug via Hot-Melt Extrusion Technology

Process analytical quality control of tailored drug release formulation prepared via hot-melt extrusion technology

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