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Julia T. Schiele

Bio: Julia T. Schiele is an academic researcher from Heidelberg University. The author has contributed to research in topics: Swallowing & Dysphagia. The author has an hindex of 4, co-authored 4 publications receiving 232 citations.

Papers
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Journal ArticleDOI
TL;DR: One in 11 primary care patients had frequent difficulties in swallowing tablets and capsules while GPs grossly underestimated these problems, therefore, physicians should rule out swallowing difficulties regularly to avoid non-adherence and inappropriate drug modifications.
Abstract: We assessed the prevalence of difficulties in swallowing solid oral dosage forms in a general practice population. Reasons, nature, and characteristics of tablets and capsules causing such difficulties were investigated as well as general practitioners’ (GP) awareness of these difficulties. A questionnaire survey was conducted in 11 general practices and consecutive patients taking at least one solid oral dosage form for ≥4 weeks were invited to respond to a questionnaire at the practices and one at home. Physicians completed a short questionnaire for each included patient. Of all participants (N = 1,051), 37.4 % reported having had difficulties in swallowing tablets and capsules. The majority (70.4 %) of these patients was not identified by their GP. The occurrence of swallowing difficulties was related to gender (f>m), age (young>old), dysphagia [adjusted odds ratio (adOR): 7.9; p < 0.0001] and mental illness (adOR: 1.8; p < 0.05). By asking “Do you choke while eating or drinking?”, affected patients could be identified with a sensitivity of 62.6 % and a specificity of 78.1 %. Because of these difficulties, 58.8 % of the affected patients had already modified their drugs in a way that may alter safety and efficacy and 9.4 % indicated to be non-adherent. One in 11 primary care patients had frequent difficulties in swallowing tablets and capsules while GPs grossly underestimated these problems. Therefore, physicians should rule out swallowing difficulties regularly to avoid non-adherence and inappropriate drug modifications. Special attention should be paid to specific patient groups (e.g. women and patients with dysphagia, dysphagia indicators, or mental illness).

189 citations

Journal ArticleDOI
TL;DR: Safety and effectiveness of swallowing tablets and capsules should be evaluated routinely in video-endoscopic examinations, tablets/capsules should rather be provided with TMW than with milk, and the appropriateness of “non per os except medication” orders for dysphagic stroke patients should be questioned.
Abstract: We evaluated the prevalence of difficulties swallowing solid dosage forms in patients with stroke-induced dysphagia and whether swallowing tablets/capsules increases their risk of penetration and aspiration. Concurrently, we explored whether routinely performed assessment tests help identify patients at risk. Using video endoscopy, we evaluated how 52 patients swallowed four different placebos (round, oval, and oblong tablets and a capsule) with texture-modified water (TMW, pudding consistency) and milk and rated their swallowing performance according to the Penetration Aspiration Scale (PAS). Additionally, Daniels Test, Bogenhausener Dysphagiescore, Scandinavian Stroke Scale, Barthel Index, and Tinetti’s Mobility Test were conducted. A substantial proportion of the patients experienced severe difficulties swallowing solid oral dosage forms (TMW: 40.4 %, milk: 43.5 %). Compared to the administration of TMW/milk alone, the placebos increased the PAS values in the majority of the patients (TMW: median PAS from 1.5 to 2.0; milk: median PAS from 1.5 to 2.5, each p value <0.0001) and residue values were significantly higher (p < 0.05). Whereas video-endoscopic examination reliably identified patients with difficulties swallowing medication, neither patients’ self-evaluation nor one of the routinely performed bedside tests did. Therefore, before video-endoscopic evaluation, many drugs were modified unnecessarily and 20.8 % of these were crushed inadequately, although switching to another dosage form or drug would have been possible. Hence, safety and effectiveness of swallowing tablets and capsules should be evaluated routinely in video-endoscopic examinations, tablets/capsules should rather be provided with TMW than with milk, and the appropriateness of “non per os except medication” orders for dysphagic stroke patients should be questioned.

41 citations

Journal ArticleDOI
TL;DR: Both techniques were remarkably effective in participants with and without reported difficulties swallowing pills and should be recommended regularly.
Abstract: To evaluate whether 2 techniques (the pop-bottle method for tablets and the lean-forward technique for capsules) ease swallowing of tablets and capsules, we conducted a cross-sectional study including 151 adults of the general German population. Participants swallowed 16 differently shaped placebos, rated their ease of swallowing on an 8-point Likert scale, and swallowed the 2 dosage forms that they had rated most difficult again using the appropriate technique. The pop-bottle method substantially improved swallowing of tablets in 59.7% (169/283) and the lean-forward technique for capsules in 88.6% (31/35). Both techniques were remarkably effective in participants with and without reported difficulties swallowing pills and should be recommended regularly.

35 citations

Journal ArticleDOI
TL;DR: The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety.
Abstract: Aims The aim of this work is to understand the process of drug administration and identify points in the workflow that resulted in interventions by clinical information systems in order to improve patient safety. Methods To identify a generic way to structure the drug administration process we performed peer-group discussions and supplemented these discussions with a literature search for studies reporting errors in drug administration and strategies for their prevention. Results We concluded that the drug administration process might consist of up to 11 sub-steps, which can be grouped into the four sub-processes of preparation, personalization, application and follow-up. Errors in drug handling and administration are diverse and frequent and in many cases not caused by the patient him/herself, but by family members or nurses. Accordingly, different prevention strategies have been set in place with relatively few approaches involving e-health technology. Conclusions A generic structuring of the administration process and particular error-prone sub-steps may facilitate the allocation of prevention strategies and help to identify research gaps.

20 citations

Journal ArticleDOI
TL;DR: In this paper , the authors evaluated the bioavailability of 10, 50, and 100 mg tablets of venetoclax compared to a 100 mg tablet and developed oral suspension powder formulations to facilitate dosing in pediatrics.
Abstract: Venetoclax is an approved BCL-2 inhibitor, currently under evaluation in different hematological malignancies in adult and pediatric populations. Venetoclax is available as 10, 50, and 100 mg tablets. To provide an alternative to patients who find taking the commonly prescribed 100 mg tablet a challenge, the interchangeability of lower-strength tablets with the 100 mg tablet was investigated. Additionally, newly developed oral suspension powder formulations to facilitate dosing in pediatrics were evaluated.Pharmacokinetic data from 80 healthy female participants from three phase I studies were utilized to evaluate the bioavailability of (1) 10 and 50 mg tablets relative to a 100 mg tablet; (2) 0.72 and 7.2% (drug to total weight) oral powder formulations relative to the 100 mg tablet; and (3) oral powder formulations administered using different vehicles (apple juice, apple sauce, and yogurt) relative to water under fed conditions.Bioavailability assessments at a 100 mg dose of venetoclax demonstrated bioequivalence across the 10, 50, and 100 mg tablet strengths. Oral powder formulations met the bioequivalence criteria (0.80-1.25) with respect to area under the concentration-time curve to time of the last measurable concentration (AUCt) and to infinite time (AUC∞) but exhibited a slightly lower maximum plasma concentration (Cmax). Exposure-response analyses were utilized to demonstrate that the lower Cmax observed with the powder formulations is not clinically meaningful. The delivery vehicles tested did not affect the bioavailability of venetoclax oral powder formulations.The smaller-sized tablets (10 and 50 mg) and the newly developed oral powder formulations of venetoclax can be used interchangeably with the 100 mg tablets to improve the patients' experience, while maintaining adequate exposure. CLINICAL TRIALS IDENTIFIERS: NCT01682616, 11 September 2012; NCT02005471, 9 December 2013; NCT02242942, 17 September 2014; NCT02203773, 30 July 2014; NCT02287233, 10 November 2014; NCT02993523, 15 December 2016; NCT03069352, 3 March 2017.

1 citations


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Journal ArticleDOI
TL;DR: This paper aims to review the processes that can be used in pharmaceutics, including the parameters to be controlled, to give an overview on the pragmatic tools, which can beused for designing customized drug delivery systems using 3D printing.

479 citations

Journal ArticleDOI
TL;DR: Various3D printing technologies such as stereolithographic, powder based, selective laser sintering, fused deposition modelling and semi-solid extrusion 3D printing are presented and their advantages particularly with adaptability in the pharmaceutical field have been highlighted.
Abstract: The recent introduction of the first FDA approved 3D-printed drug has fuelled interest in 3D printing technology, which is set to revolutionize healthcare. Since its initial use, this rapid prototyping (RP) technology has evolved to such an extent that it is currently being used in a wide range of applications including in tissue engineering, dentistry, construction, automotive and aerospace. However, in the pharmaceutical industry this technology is still in its infancy and its potential yet to be fully explored. This paper presents various 3D printing technologies such as stereolithographic, powder based, selective laser sintering, fused deposition modelling and semi-solid extrusion 3D printing. It also provides a comprehensive review of previous attempts at using 3D printing technologies on the manufacturing dosage forms with a particular focus on oral tablets. Their advantages particularly with adaptability in the pharmaceutical field have been highlighted, which enables the preparation of dosage forms with complex designs and geometries, multiple actives and tailored release profiles. An insight into the technical challenges facing the different 3D printing technologies such as the formulation and processing parameters is provided. Light is also shed on the different regulatory challenges that need to be overcome for 3D printing to fulfil its real potential in the pharmaceutical industry.

397 citations

Journal ArticleDOI
TL;DR: This unique approach provides a low cost production method for on demand manufacturing of individualised dosage forms and explores the impact of the nature of filler, compatibility with the gears of the 3D printer and polymer: filler ratio on the3D printing process.

239 citations

Journal ArticleDOI
TL;DR: This work demonstrates that the selection and use of new excipients can overcome one of the major disadvantages in FDM printing, drug degradation due to thermal heating, making this technology suitable for drugs with lower melting temperatures.

222 citations

Journal ArticleDOI
TL;DR: This review has summarized a holistic materials–process perspective for polymers on extrusion-based 3D printing, and elaborates the discussion on the comparison of3D printing with the traditional direct compression process, the necessity of rheology, and the characterization techniques required for the printed structure, drug, and excipients.
Abstract: Three dimensional (3D) printing as an advanced manufacturing technology is progressing to be established in the pharmaceutical industry to overcome the traditional manufacturing regime of 'one size fits for all'. Using 3D printing, it is possible to design and develop complex dosage forms that can be suitable for tuning drug release. Polymers are the key materials that are necessary for 3D printing. Among all 3D printing processes, extrusion-based (both fused deposition modeling (FDM) and pressure-assisted microsyringe (PAM)) 3D printing is well researched for pharmaceutical manufacturing. It is important to understand which polymers are suitable for extrusion-based 3D printing of pharmaceuticals and how their properties, as well as the behavior of polymer-active pharmaceutical ingredient (API) combinations, impact the printing process. Especially, understanding the rheology of the polymer and API-polymer mixtures is necessary for successful 3D printing of dosage forms or printed structures. This review has summarized a holistic materials-process perspective for polymers on extrusion-based 3D printing. The main focus herein will be both FDM and PAM 3D printing processes. It elaborates the discussion on the comparison of 3D printing with the traditional direct compression process, the necessity of rheology, and the characterization techniques required for the printed structure, drug, and excipients. The current technological challenges, regulatory aspects, and the direction toward which the technology is moving, especially for personalized pharmaceuticals and multi-drug printing, are also briefly discussed.

181 citations