Evidence map›Paper›PMID 28480758›Full record

Trial reportDrug delivery2017

Loratadine bioavailability via buccal transferosomal gel: formulation, statistical optimization, in vitro/in vivo characterization, and pharmacokinetics in human volunteers.

Mohammed H Elkomy, Shahira F El Menshawe, Heba A Abou-Taleb, Marwa H Elkarmalawy

Abstract readClinical Trial
In one paragraph

Trial report in Drug delivery, 2017. 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
–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

14 citing papers in PubMed.

  1. Article
  2. Review
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  8. Review
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  11. Review
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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

4 authors.

Mohammed H Elkomya Department of Pharmaceutics and Industrial Pharmacy , Beni-Suef University , Beni-Suef , Egypt and.
Shahira F El Menshawea Department of Pharmaceutics and Industrial Pharmacy , Beni-Suef University , Beni-Suef , Egypt and.
Heba A Abou-Talebb Department of Pharmaceutics and Clinical Pharmacy , Nahda University , Beni-Suef , Egypt.
Marwa H Elkarmalawyb Department of Pharmaceutics and Clinical Pharmacy , Nahda University , Beni-Suef , Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Loratadine (LTD) is an antihistaminic drug that suffers limited solubility, poor oral bioavailability (owing to extensive first-pass metabolism), and highly variable oral absorption. This study was undertaken to develop and statistically optimize transfersomal gel for transbuccal delivery of LTD. Transfersomes bearing LTD were prepared by conventional thin film hydration method and optimized using sequential Quality-by-Design approach that involved Placket-Burman design for screening followed by constrained simplex-centroid design for optimization of a Tween-80/Span-60/Span-80 mixture. The transferosomes were characterized for entrapment efficiency, particle size, and shape. Optimized transferosomes were incorporated in a mucoadhesive gel. The gel was characterized for rheology, ex vivo permeation across chicken pouch buccal mucosa, in vitro release, and mucoadhesion. Pharmacokinetic behavior of LTD formulations was investigated in healthy volunteers following administration of a single 10-mg dose. Optimal transferosomes characterized by submicron size (380 nm), spherical shape and adequate loading capacity (60%) were obtained by using quasi-equal ratio surfactant mixture. In terms of amount permeated, percentage released, and mucoadhesion time, the transferosomal gel proved superior to control, transferosome-free gel. Bioavailability of the transferosomal gel was comparable to Claritin® oral tablets. However, inter-individual variability in C

Indexed as

Administration, BuccalBiological AvailabilityChemistry, PharmaceuticalHealthy VolunteersHumansLoratadineLoratadinebioavailabilitybuccalLoratadinemucoadhesive geltransferosomes

Identifiers

PMID28480758
PMCPMC8241167

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Registered trials

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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.