Evidence map›Paper›PMID 32599822›Full record

ArticlePharmaceutics2020

Novel Cleaning-in-Place Strategies for Pharmaceutical Hot Melt Extrusion.

Martin Spoerk, Ioannis Koutsamanis, Josip Matić, Simone Eder, Carolina Patricia Alva Zúñiga, Johannes Poms, Jesús Alberto Afonso Urich, Raymar Andreína Lara García, Klaus Nickisch, Karin Eggenreich and 5 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Martin SpoerkResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.ORCID 0000-0001-5606-3607
Ioannis KoutsamanisResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Josip MatićResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.ORCID 0000-0001-5645-048X
Simone EderResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Carolina Patricia Alva ZúñigaResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Johannes PomsResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Jesús Alberto Afonso UrichResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Raymar Andreína Lara GarcíaResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Klaus NickischEvestra Inc., 6410 Tri County Parkway, Schertz, TX 78154, USA.
Karin EggenreichEvestra Inc., 6410 Tri County Parkway, Schertz, TX 78154, USA.
Andreas BerghausColVisTec AG, Max-Planck-Straße 3, 12489 Berlin, Germany.
Kathrin ReuschLeistritz Extrusionstechnik GmbH, Markgrafenstraße 38, 90459 Nuremberg, Germany.
Yorick RelleLeistritz Extrusionstechnik GmbH, Markgrafenstraße 38, 90459 Nuremberg, Germany.
Johannes KhinastResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Amrit PaudelResearch Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.

Funding

Österreichische Forschungsförderungsgesellschaft COMET
6 · The paper itself

Abstract

To avoid any type of cross-contamination, residue-free production equipment is of utmost importance in the pharmaceutical industry. The equipment cleaning for continuous processes such as hot melt extrusion (HME), which has recently gained popularity in pharmaceutical applications, necessitates extensive manual labour and costs. The present work tackles the HME cleaning issue by investigating two cleaning strategies following the extrusion of polymeric formulations of a hormonal drug and for a sustained release formulation of a poorly soluble drug. First, an in-line quantification by means of UV-Vis spectroscopy was successfully implemented to assess very low active pharmaceutical ingredient (API) concentrations in the extrudates during a cleaning procedure for the first time. Secondly, a novel

Indexed as

API contaminationcleaning-in-placecleaning verificationestradiolestriolhot melt extrusionibuprofenprocess analytical technologyswab and rinse testsUV–Vis spectroscopy

Identifiers

PMID32599822
PMCPMC7356020

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.