Can filaments be stored as a shelf-item for on-demand manufacturing of oral 3D printed tablets? An initial stability assessment

3D printing of oral solid dosage forms is a recently introduced approach for dose personalisation. Fused deposition modelling (FDM) is one of the promising and heavily researched 3D printing techniques in the pharmaceutical field. However, the successful application of this technique relies greatly on the mass manufacturing of physically and chemically stable filaments, that can be readily available as a shelf item to be 3D printed on-demand. In this work, the stability of methacrylate polymers (Eudragit EPO, RL, L100-55 and S100), hydroxypropyl cellulose (HPC SSL) and polyvinyl pyrrolidone (PVP)-based filaments over 6 months were investigated. Filaments manufactured by hot melt extrusion (HME) were stored at either 5 °C or 30 °C + 65 %RH with/without vacuuming. The effects of storage on their dimensions, visual appearance, thermal properties, and ‘printability’ were analysed. Theophylline content, as well as in vitro release from the 3D printed tablets were also investigated. The filaments were analysed before storage, then after 1, 3 and 6 months from the manufacturing date. Storing the filaments at these conditions had a significant effect on their physical properties, such as shape, dimensions, flexibility and hence compatibility with FDM 3D printing. In general, the methacrylate-based filaments were more physically stable and compatible with FDM 3D printing following storage. Owing to their hygroscopic nature, cellulose- and PVP-based filaments demonstrated a reduction in their glass transition temperature upon storage, leading to increased flexibility and incompatibility with FDM 3D printer. Theophylline contents was not significantly changed during the storage. This work provides preliminary data for the impact of polymer species on the long-term stability of filaments. In general, storage and packaging conditions have a major impact on the potential of on-demand manufacturing of 3D printed tablets using hot melt extruded filaments

Panel 4 : Report of the Microbiology Panel

Objective. To perform a comprehensive review of the literature from July 2011 until June 2015 on the virology and bacteriology of otitis media in children. Data Sources. PubMed database of the National Library of Medicine. Review Methods. Two subpanels comprising experts in the virology and bacteriology of otitis media were created. Each panel reviewed the relevant literature in the fields of virology and bacteriology and generated draft reviews. These initial reviews were distributed to all panel members prior to meeting together at the Post-symposium Research Conference of the 18th International Symposium on Recent Advances in Otitis Media, National Harbor, Maryland, in June 2015. A final draft was created, circulated, and approved by all panel members. Conclusions. Excellent progress has been made in the past 4 years in advancing our understanding of the microbiology of otitis media. Numerous advances were made in basic laboratory studies, in animal models of otitis media, in better understanding the epidemiology of disease, and in clinical practice. Implications for Practice. (1) Many viruses cause acute otitis media without bacterial coinfection, and such cases do not require antibiotic treatment. (2) When respiratory syncytial virus, metapneumovirus, and influenza virus peak in the community, practitioners can expect to see an increase in clinical otitis media cases. (3) Biomarkers that predict which children with upper respiratory tract infections will develop otitis media may be available in the future. (4) Compounds that target newly identified bacterial virulence determinants may be available as future treatment options for children with otitis media.Peer reviewe

Outcomes of Intracorporeal Urinary Diversion after Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium

INTRODUCTION AND OBJECTIVE: This study aims to provide an update and compare perioperative outcomes and complications of Intracorporeal urinary diversion (ICUD) and extracorporeal urinary diversion (ECUD) following RARC from a multi-institutional, prospectively maintained database, the International Robotic Cystectomy Consortium (IRCC). METHODS: A retrospective review of 2125 patients from 26 institutions was performed. ICUD was compared with ECUD Multivariate (stepwise variable selection) logistic regression models were fit to evaluate preoperative, operative, and postoperative predictors of receiving ICUD, operative time, high grade complications and 90-days readmissions after RARC. RESULTS: 51% (n=1094) patients underwent ICUD in our cohort. ICUD patients demonstrated shorter operative times (357 vs 400 minutes, p<0.001), less blood loss (300 vs 350 ml, p<0.001), and fewer blood transfusions (4% vs 19%, p<0.001). ICUD patients experienced more high grade complications (13 vs 10%, p=0.02). Utilization of ICUD increased from 9% of all urinary diversions in 2005 to 97% in 2015. Complications after ICUD decreased significantly over time (p<0.001). On multivariable analysis, higher annual cystectomy volume (OR 1.02, 95% CI (1.01-1.03), p<0.002) and year of RARC 2013-2016 (OR 68, 95% CI 44-105, p<0.001) and ASA score <3 (OR 1.75, 95% CI 1.38-2.22, p<0.001) were associated with receiving ICUD. ICUD was associated with shorter operative time (27 minutes, p=0.001). CONCLUSION: Utilization of ICUD has increased over the past decade. Higher annual institutional volume of RARCs was associated with performing ICUD. ICUD was associated with shorter operative times. Although ICUD was associated with higher grade complications compared to ECUD, they decreased over time

Role of collagenase clostridium histolyticum in Peyronie&#39;s disease

Taylor C Peak,1 Gregory C Mitchell,2 Faysal A Yafi,2 Wayne J Hellstrom2 1Department of Urology, Tulane University School of Medicine, 2Section of Andrology, Department of Urology, Tulane University School of Medicine, New Orleans, LA, USA Abstract: Peyronie&#39;s disease is a localized connective tissue disease characterized by an active, inflammatory phase and a stable, quiescent phase, with the eventual development of collagenous plaques within the tunica albuginea of the penis. Risk factors primarily associated with Peyronie&#39;s disease include Dupuytren&#39;s contracture, penile trauma, and family history. A variety of treatment strategies have been utilized, including oral and topical agents, electromotive drug administration, intralesional injections, extracorporeal shockwave therapy, penile traction, and surgery. However, most of these strategies are ineffective, with surgery being the only definitive treatment. Collagenase clostridium histolyticum is a newly US Food and Drug Administration-approved agent for intralesional injection. It is thought to downregulate many of the disease-related genes, cytokines, and growth factors and degrade collagen fibers. It also suppresses cell attachment, spreading, and proliferation. Collagenase clostridium histolyticum has been clinically proven to be a safe and effective therapeutic option, demonstrating decreases in penile curvature and plaque consistency, as well as increases in patient satisfaction. During clinical evaluation, the Peyronie&#39;s Disease Questionnaire was validated as an effective tool for assessing treatment outcomes. Keywords: connective tissue disease, CCH, Xiaflex, Peyronie&#39;s Disease Questionnair

Adipose Tissue-Derived Stem Cells for the Treatment of Erectile Dysfunction

PMID = 2675790