Evidence map›Paper›PMID 29689061›Full record

ArticlePloS one2018

The role of SeDeM for characterizing the active substance and polyvinyilpyrrolidone eliminating metastable forms in an oral lyophilizate-A preformulation study.

Paloma Flórez Borges, Encarna García-Montoya, Pilar Pérez-Lozano, Enric Jo, Montserrat Miñarro, Albert Manich, Josep Maria Suñé-Negre

Abstract read
In one paragraph

Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Main Aspects of Pharmaceutical Development ofCurrent pharmaceutical biotechnology · 2024
    Review
  2. Review
  3. Pharmacotechnical and analytical preformulation studies for cannabidiol orodispersible tablets.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2021
    Article
  4. 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

7 authors.

Paloma Flórez BorgesPharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.ORCID 0000-0002-5122-3410
Encarna García-MontoyaPharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
Pilar Pérez-LozanoPharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
Enric JoReig Jofre Group. Sant Joan Despí, Spain.
Montserrat MiñarroPharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.
Albert ManichIQAC-CSIC. Institute of Advanced Chemistry of Catalonia. Barcelona, Spain.
Josep Maria Suñé-NegrePharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, University of Barcelona. Barcelona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A preformulation study of an oral lyophilisate with cetirizine dihydrochloride (CTZ) as active ingredient, mannitol and PVP K30 as bulking agents is presented. CTZ shown a humidity content of 0.150% and a spontaneous hygroscopicity of 0.200% (both determined by SeDeM diagram), demonstrating an adequate stability behavior in solid form. A design of experiments (DoE) performed with both mannitol and PVP K30, followed by a simple factorial design (32) has determined the optimum combination of excipients and CTZ, and showed that a higher proportion of PVP K30 was able to prevent metastable forms generated by mannitol.

Indexed as

Administration, OralCalorimetry, Differential ScanningCetirizineDrug CompoundingFreeze DryingMannitolPowdersPyrrolidinonesTabletsWettabilityCetirizineMannitolPowdersPyrrolidinonesTablets

Identifiers

PMID29689061
PMCPMC5916852

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.