Personalised dosing: Printing a dose of one’s own medicine

Alomari, Mustafa; Mohamed, F; Basit, Abdul W.; Gaisford, Simon

doi:10.1016/j.ijpharm.2014.12.006

Cited by 214 publications

(139 citation statements)

References 62 publications

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“…In the pharmaceutical field, the future of medicine design and manufacture may move away from industrial production of tablets/capsules of limited dose range towards in situ fabrication of unit dosage forms with doses and/or drug combinations tailored to the patient 6 . To face these challenges, pharmaceutical research has to evaluate, develop and adapt these novel productive technologies to the high quality requirements demanded and regulated by the pharmaceutical industry.…”

Section: Introductionmentioning

confidence: 99%

3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics

et al. 2015

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Citation: Goyanes A, Wang J, Buanz A, Martinez-Pacheco R, Telford R, Gaisford S and Basit AW (2015) 3D printing of medicines: Engineering novel oral devices with unique design and drug release characteristics. Molecular Pharmaceutics. 12(11): 3783-4174. Key wordsThree dimensional printing; controlled-release; fused deposition modelling; PVA; paracetamol; acetaminophen; caffeine; hot melt extrusion; Raman mapping 2 AbstractThree dimensional printing (3DP) was used to engineer novel oral drug delivery devices, with specialised design configurations loaded with multiple actives, with applications in personalised medicine. A filament extruder was used to obtain drug-loaded -paracetamol (acetaminophen) or caffeine -filaments of polyvinyl alcohol with characteristics suitable for use in fused-deposition modelling 3D printing. A multi-nozzle 3D printer enabled fabrication of capsule-shaped solid devices, containing paracetamol and caffeine, with different internal structures. The design configurations included a multilayer device, with each layer containing drug, whose identity was different from the drug in the adjacent layers; and a two-compartment device comprising a caplet embedded within a larger caplet (DuoCaplet), with each compartment containing a different drug. Raman spectroscopy was used to collect 2-dimensional hyper spectral arrays across the entire surface of the devices. Processing of the arrays using direct classical least squares component matching to produce false colour representations of distribution of the drugs showed clearly the areas that contain paracetamol and caffeine, and that there is a definitive separation between the drug layers.Drug release tests in biorelevant media showed unique drug release profiles dependent on the macrostructure of the devices. In the case of the multilayer devices, release of both drugs was simultaneous and independent of drug solubility. With the DuoCaplet design it was possible to engineer either rapid drug release or delayed release by selecting the site of incorporation of the drug in the device, and the lag-time for release from the internal compartment was dependent on the characteristics of the external layer. The study confirms the potential of 3D printing to fabricate multiple-drug containing devices with specialized design configurations and unique drug release characteristics, which would not otherwise be possible using conventional manufacturing methods.3

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Section: Introductionmentioning

confidence: 99%

3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics

et al. 2015

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“…With the Federal Drug Administration's (FDA) approval (FDA, 2015) of Spritam (the first commercially produced 3D printed medication, Aprecia Pharmaceuticals) there has been a further increase in interest in additive manufacturing (AM) based platforms to produce both personalized medicines and novel function (Alomari et al, 2015). Inkjet printing has been highlighted as a promising additive method due to its precision, accuracy, low cost, ability to deposit multiple materials contemporaneously, and simple scale up/out, with material throughput being dependant on the size of the printer and number of jets (Alomari et al, 2015; de Gans et al, 2004;Daly et al 2015).…”

Section: Introductionmentioning

confidence: 99%

“…Inkjet printing has been highlighted as a promising additive method due to its precision, accuracy, low cost, ability to deposit multiple materials contemporaneously, and simple scale up/out, with material throughput being dependant on the size of the printer and number of jets (Alomari et al, 2015; de Gans et al, 2004;Daly et al 2015). It is a well-established tool for commercial and consumer image production, and has been incorporated into 3D printing methods for prototyping (O'Neil, 2012) and manufacture (FDA, 2015).…”

Section: Introductionmentioning

confidence: 99%

“…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%

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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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“…Moreover, the dosage amount can be adjusted according to the patient's needs, by simply changing the drop size or number of drops deposited per dosage. Although different material systems with a wide range of properties can be deposited using DoD technology (12), until recently a limited range of materials have been used in the pharmaceutical inkjet printing applications, namely, solvent-or nano-suspension-based formulations (13,14). Using the developed dropwise additive manufacturing process for pharmaceuticals (DAMPP), different drug formulations including solventbased systems, i.e., solvent-polymer-API solutions, as well as melt-based systems, i.e., polymer-API melts, can be printed.…”

Section: Introductionmentioning

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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Personalised dosing: Printing a dose of one’s own medicine

Cited by 214 publications

References 62 publications

3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics

3D Printing of Medicines: Engineering Novel Oral Devices with Unique Design and Drug Release Characteristics

3D printing of tablets using inkjet with UV photoinitiation

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

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