Evidence map›Paper›PMID 23220079›Full record

ArticleInternational journal of pharmaceutics2013

Pharmaceutical development and optimization of azithromycin suppository for paediatric use.

Tina Kauss, Alexandra Gaubert, Chantal Boyer, Boubakar B Ba, Muriel Manse, Stephane Massip, Jean-Michel Léger, Fawaz Fawaz, Martine Lembege, Jean-Michel Boiron and 6 more

Open access · hybridAbstract readComparative Study
In one paragraph

Article in International journal of pharmaceutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
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

14 citing papers in PubMed, 35 citations in OpenAlex.

  1. Article
  2. Preparation and characterization of vaginal suppository of semisynthetic derivatives of ergot alkaloids cabergoline.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
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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

16 authors at 6 institutions in 4 countries.

Tina KaussUniv. Bordeaux, EA 4575 Analytical and Pharmaceutical Developments Applied to Neglected Diseases and Counterfeits, Bordeaux, France. tina.kauss@u-bordeaux2.fr
Alexandra Gaubert
Chantal Boyer
Boubakar B Ba
Muriel Manse
Stephane Massip
Jean-Michel Léger
Fawaz Fawaz
Martine Lembege
Jean-Michel Boiron
Xavier Lafarge
Niklas Lindegardh
Nicholas J White
Piero Olliaro
Pascal Millet
Karen Gaudin
Université de Bordeaux · FRÉtablissement Français du Sang · FRCentre National de la Recherche Scientifique · FRMahidol University · THNuffield Orthopaedic Centre · GBWorld Health Organization · CH

Funding

Wellcome Trust 085242/Z/08/ZWellcome Trust 089275Wellcome Trust 093956
6 · The paper itself

Abstract

Pharmaceutical development and manufacturing process optimization work was undertaken in order to propose a potential paediatric rectal formulation of azithromycin as an alternative to existing oral or injectable formulations. The target product profile was to be easy-to-use, cheap and stable in tropical conditions, with bioavailability comparable to oral forms, rapidly achieving and maintaining bactericidal concentrations. PEG solid solution suppositories were characterized in vitro using visual, HPLC, DSC, FTIR and XRD analyses. In vitro drug release and in vivo bioavailability were assessed; a study in rabbits compared the bioavailability of the optimized solid solution suppository to rectal solution and intra-venous product (as reference) and to the previous, non-optimized formulation (suspended azithromycin suppository). The bioavailability of azithromycin administered as solid solution suppositories relative to intra-venous was 43%, which compared well to the target of 38% (oral product in humans). The results of 3-month preliminary stability and feasibility studies were consistent with industrial production scale-up. This product has potential both as a classical antibiotic and as a product for use in severely ill children in rural areas. Industrial partners for further development are being sought.

Indexed as

Administration, RectalAnimalsAnti-Bacterial AgentsAzithromycinChildChild, PreschoolDrug CompoundingDrug StabilityExcipientsHumansPolyethylene GlycolsRabbitsSuppositoriesTropical ClimateAnti-Bacterial AgentsAzithromycinExcipientsPolyethylene GlycolsSuppositories

Identifiers

PMID23220079
PMCPMC3605574
OpenAlexW1970755576

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.