Abstract
Three-dimensional (3D) printing offers the greatest potential to revolutionize the future of pharmaceutical manufacturing by overcoming challenges of conventional pharmaceutical operations and focusing design and production of dosage forms on the patient’s needs. Of the many technologies available, fusion deposition modelling (FDM) is considered of the lowest cost and higher reproducibility and accessibility, offering clear advantages in drug delivery. FDM requires in-house production of filaments of drug-containing thermoplastic polymers by hot-melt extrusion (HME), and the prospect of connecting the two technologies has been under investigation. The ability to integrate HME and FDM and predict and tailor the filaments’ properties will extend the range of printable polymers/formulations. Hence, this work revises the properties of the most common pharmaceutical-grade polymers used and their effect on extrudability, printability, and printing outcome, providing suitable processing windows for different raw materials. As a result, formulation selection will be more straightforward (considering the characteristics of drug and desired dosage form or release profile) and the processes setup will be more expedite (avoiding or mitigating typical processing issues), thus guaranteeing the success of both HME and FDM. Relevant techniques used to characterize filaments and 3D-printed dosage forms as an essential component for the evaluation of the quality output are also presented.
Highlights
Three-dimensional (3D) printing, known as additive manufacturing, has recently been attracting the attention of the scientific community in many different areas, including pharmaceutics. This technology, which encompasses a range of 3D-printing techniques, presents many advantages such as (a) the possibility to produce dosage forms on demand, with a specific and precise dose [1]; (b) the incorporation of several drugs into a single dosage form [2]; (c) the modulation of drug release profile by tailoring shape and density [3] of dosage forms; (d) the production of complex multi-doses and release profiles by printing several drugs and using barrier coatings [4] or loading withparticles [5]; and (e) high reproducibility [6]
The possibility of combining multiple drugs in one dosage unit, each presenting a tailored release profile, can improve patient compliance, treatment effectivity, and cost-effectiveness [8]. Such approach has been exploited in recent years, and dosage forms containing more than one active pharmaceutical ingredient (API), designated as multi- or polypills, have been developed [8,9,10]
3D printing is regarded as an asset to help drugs meet clinical needs, either by (a) repeated dose adjustment depending on body mass or age or in case of narrow therapeutic margin drugs; (b) ameliorating organoleptic properties by taste masking and production of dosage forms suited to a particular age group, such as children; or (c) managing of polymedication or complex therapeutic regimens, drug incompatibility, need for different release profiles of the same drug, by using multiple drugs in the same unit
Summary
5. Characterization of Filaments and 3D Dosage Forms Produced by HME-Coupled with FDM. Thermal Properties and Other Characterization at Molecular Level Techniques 5.4. In Vitro and In Vivo Characterization 5.5.
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