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      3D Printing of Drug-Loaded Thermoplastic Polyurethane Meshes: A Potential Material for Soft Tissue Reinforcement in Vaginal Surgery

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          Abstract

          Current strategies to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI), include the surgical implantation of vaginal meshes. Recently, there have been multiple reports of issues generated by these meshes conventionally made of poly(propylene). This material is not the ideal candidate, due to its mechanical properties leading to complications such as chronic pain and infection. In the present manuscript, we propose the use of an alternative material, thermoplastic polyurethane (TPU), loaded with an antibiotic in combination with fused deposition modelling (FDM) to prepare safer vaginal meshes. For this purpose, TPU filaments containing levofloxacin (LFX) in various concentrations (e.g., 0.25%, 0.5%, and 1%) were produced by extrusion. These filaments were used to 3D print vaginal meshes. The printed meshes were fully characterized through different tests/analyses such as fracture force studies, attenuated total reflection-Fourier transform infrared, thermal analysis, scanning electron microscopy, X-ray microcomputed tomography (μCT), release studies and microbiology testing. The results showed that LFX was uniformly distributed within the TPU matrix, regardless the concentration loaded. The mechanical properties showed that poly(propylene) (PP) is a tougher material with a lower elasticity than TPU, which seemed to be a more suitable material due to its elasticity. In addition, the printed meshes showed a significant bacteriostatic activity on both Staphylococcus aureus and Escherichia coli cultures, minimising the risk of infection after implanting them. Therefore, the incorporation of LFX to the TPU matrix can be used to prepare anti-infective vaginal meshes with enhanced mechanical properties compared with current PP vaginal meshes.

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          Most cited references45

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          A review of melt extrusion additive manufacturing processes: I. Process design and modeling

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            Fused-filament 3D printing (3DP) for fabrication of tablets

            The use of fused-filament 3D printing (FF 3DP) to fabricate individual tablets is demonstrated. The technology permits the manufacture of tablets containing drug doses tailored to individual patients, or to fabrication of tablets with specific drug-release profiles. Commercially produced polyvinyl alcohol (PVA) filament was loaded with a model drug (fluorescein) by swelling of the polymer in ethanolic drug solution. A final drug-loading of 0.29% w/w was achieved. Tablets of PVA/fluorescein (10 mm diameter) were printed using a 3D printer. It was found that changing the degree of infill percentage in the printer software varied the weight and volume of the printed tablets. The tablets were mechanically strong and no significant thermal degradation of the active occurred during printing. Dissolution tests were conducted in modified Hank's buffer. The results showed release profiles were dependent on the infill percentage used to print the tablet. The study indicates that FF 3DP has the potential to offer a new solution for fabricating personalized-dose medicines or unit dosage forms with controlled-release profiles. In addition, the low cost of FDM printers means the paradigm of extemporaneous or point-of-use manufacture of personalized-dose tablets is both feasible and attainable.
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              Risk factors for pelvic organ prolapse and its recurrence: a systematic review

              Introduction and hypothesis Pelvic organ prolapse (POP) is a common condition with multifactorial etiology. The purpose of this systematic review was to provide an overview of literature on risk factors for POP and POP recurrence. Methods PubMed and Embase were searched with “pelvic organ prolapse” combined with “recurrence” and combined with “risk factors,” with Medical Subject Headings and Thesaurus terms and text words variations until 4 August 2014, without language or publication date restrictions. Only cohort or cross-sectional studies carried out in western developed countries containing multivariate analyses and with a definition of POP based on anatomical references were included. POP recurrence had to be defined as anatomical recurrence after native tissue repair without mesh. Follow-up after surgery should have been at least 1 year. Articles were excluded if POP was not a separate entity or if it was unclear whether the outcome was primary POP or recurrence. Results PubMed and Embase revealed 2,988 and 4,449 articles respectively. After preselection, 534 articles were independently evaluated by two researchers, of which 15 met the selection criteria. In 10 articles on primary POP, 30 risk factors were investigated. Parity, vaginal delivery, age, and body mass index (BMI) were significantly associated in at least two articles. In 5 articles on POP recurrence, 29 risk factors were investigated. Only preoperative stage was significantly associated in at least two articles. Conclusion Parity, vaginal delivery, age, and BMI are risk factors for POP and preoperative stage is a risk factor for POP recurrence.
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                Author and article information

                Journal
                Pharmaceutics
                Pharmaceutics
                pharmaceutics
                Pharmaceutics
                MDPI
                1999-4923
                13 January 2020
                January 2020
                : 12
                : 1
                : 63
                Affiliations
                [1 ]School of Pharmacy, Queen’s University Belfast, Lisburn Road 97, Belfast BT9 7BL, UK; j.dominguezrobles@ 123456qub.ac.uk (J.D.-R.); c.mancinelli3@ 123456campus.uniurb.it (C.M.); b.gilmore@ 123456qub.ac.uk (B.F.G.)
                [2 ]Department of Biomolecular Sciences, University of Urbino Carlo Bo, Piazza del Rinascimento 6, 61029 Urbino, Italy; luca.casettari@ 123456uniurb.it
                [3 ]Nanotechnology and Integrated Bio-Engineering Centre (NIBEC), Ulster University, Jordanstown Campus, Jordanstown BT37 0QB, UK; e.mancuso@ 123456ulster.ac.uk
                [4 ]Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast BT9 7BL, UK; I.Garcia-Romero@ 123456qub.ac.uk
                Author notes
                [* ]Correspondence: e.larraneta@ 123456qub.ac.uk (E.L.); d.lamprou@ 123456qub.ac.uk (D.A.L.)
                [†]

                These authors contributed equally to this work.

                Author information
                https://orcid.org/0000-0003-1742-1656
                https://orcid.org/0000-0001-6907-8904
                https://orcid.org/0000-0003-3710-0438
                https://orcid.org/0000-0002-8740-1661
                Article
                pharmaceutics-12-00063
                10.3390/pharmaceutics12010063
                7023419
                31941047
                4118f5fb-c0f7-4bdb-a3af-55375a4655c4
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 20 December 2019
                : 09 January 2020
                Categories
                Article

                3d printing,fused deposition modelling,extrusion,vaginal meshes,mechanical properties,drug release,anti-infective devices,pelvic organ prolapse,stress urinary incontinence

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