Crystallization and Dissolution Behavior of Naproxen/Polyethylene Glycol Solid Dispersions

Zhu, Qi; Toth, Scott J.; Simpson, Garth J.; Hsu, Hui‐Chin; Taylor, Lynne S.; Harris, Michael T.

doi:10.1021/jp3106716

Cited by 43 publications

(31 citation statements)

References 29 publications

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“…Recent research in inkjet printed pharmaceuticals has focused on solutions (Alomari et al, 2015;Genina et al, 2013;Scoutaris et al, 2011;Sandler et al, 2011;Raijada et al, 2013;Lee et al, 2012;Acosta-Vélez et al 2017), nanosuspensions (Pardeike et al, 2011), and melts Zhu et al, 2013), each of which is primarily 2D. Reel to reel type flexographic (Raijada et al, 2013;Palo et al, 2015) printing, as well as inkjet printing in combination with electrospinning have also been utilized.…”

Section: Introductionmentioning

confidence: 99%

“…Varan et al has investigated the prolonged release behaviour of inkjet printed paxitaxel in a cyclodextrin inclusion complex and cidofovir encapsulated in polycaprolactone nanoparticles dispensed onto bioadhesive films . Low melting temperature PEG/naproxen mixtures Zhu et al, 2013;Hsu et al, 2015) have been reported for melt based inkjet applications in which crystalline domains of the drug could be affected by PEG coatings (Hsu et al, 2015), or controlled melt cooling . Lee et al successfully produced paxlitaxel loaded poly(lactic-co-glycolic acid) microparticles with various geometries (honeycombs, grids, rings and circles) and observed that the drug release rate was dependant on the surface area of the microparticles (Lee et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

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3D printing of tablets using inkjet with UV photoinitiation

Clark

Alexander

Irvine

et al. 2017

International Journal of Pharmaceutics

173

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2 Additive manufacturing (AM) offers significant potential benefits in the field of drug delivery and pharmaceutical/medical device manufacture. Of AM processes, 3D inkjet printing enables precise deposition of a formulation, whilst offering the potential for significant scale up or scale out as a manufacturing platform. This work hypothesizes that suitable solvent based ink formulations can be developed that allow the production of solid dosage forms that meet the standards required for pharmaceutical tablets, whilst offering a platform for flexible and personalised manufacture. We demonstrate this using piezo-activated inkjetting to 3D print ropinirole hydrochloride. The tablets produced consist of a cross-linked poly(ethylene glycol diacrylate) (PEGDA) hydrogel matrix containing the drug, photoinitiated in a low oxygen environment using an aqueous solution of Irgacure 2959. At a Ropinirole HCl loading of 0.41mg, drug release from the tablet is shown to be Fickian. Raman and IR spectroscopy indicate a high degree of cross-linking and formation of an amorphous solid dispersion. This is the first publication of a UV inkjet 3D printed tablet. Consequently, this work opens the possibility for the translation of scalable, high precision and bespoke ink-jet based additive manufacturing to the pharmaceutical sector.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

3D printing of tablets using inkjet with UV photoinitiation

Clark

Alexander

Irvine

et al. 2017

International Journal of Pharmaceutics

173

View full text Add to dashboard Cite

show abstract

“…Previous studies of model systems have suggested detection limits on the order of ppm for crystallinity within amorphous solid dispersions. 28–32 …”

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confidence: 99%

Parts per Million Powder X-ray Diffraction

et al. 2015

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Here we demonstrate the use of second harmonic generation (SHG) microscopy-guided synchrotron powder X-ray diffraction (PXRD) for the detection of trace crystalline active pharmaceutical ingredients in a common polymer blend. The combined instrument is capable of detecting 100 ppm crystalline ritonavir in an amorphous hydroxypropyl methylcellulose matrix with a high signal-to-noise ratio (>5000). The high spatial resolution afforded by SHG microscopy allows for the use of a minibeam collimator to reduce the total volume of material probed by synchrotron PXRD. The reduction in probed volume results in reduced background from amorphous material. The ability to detect low crystalline loading has the potential to improve measurements in the formulation pipeline for pharmaceutical solid dispersions, for which even trace quantities of crystalline active ingredients can negatively impact the stability and bioavailability of the final drug product.

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“…The melt formulation consisted of 15% naproxen and 85% polyethylene glycol 3350 (PEG 3350) by weight. This formulation was selected based on the studies done by Zhu et al (2013) which showed that naproxen and PEG 3350 form a eutectic mixture at a composition of 15% naproxen (27). The formulation was co-melted at 65°C, at which temperature the polymer melts and the drug dissolved in the molten polymer.…”

Section: Resultsmentioning

confidence: 99%

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality

et al. 2015

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ABSTRACT. The features of a drop-on-demand-based system developed for the manufacture of meltbased pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.

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Crystallization and Dissolution Behavior of Naproxen/Polyethylene Glycol Solid Dispersions

Cited by 43 publications

References 29 publications

3D printing of tablets using inkjet with UV photoinitiation

3D printing of tablets using inkjet with UV photoinitiation

Parts per Million Powder X-ray Diffraction

Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality

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