Evidence map›Paper›PMID 33919585›Full record

ArticlePharmaceutics2021

Spray-Dried Formulation of Epicertin, a Recombinant Cholera Toxin B Subunit Variant That Induces Mucosal Healing.

Micaela A Reeves, Joshua M Royal, David A Morris, Jessica M Jurkiewicz, Nobuyuki Matoba, Krystal T Hamorsky

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Micaela A ReevesDepartment of Pharmacology and Toxicology, University of Louisville School of Medicine, Louisville, KY 40202, USA.
Joshua M RoyalDepartment of Pharmacology and Toxicology, University of Louisville School of Medicine, Louisville, KY 40202, USA.
David A MorrisJames Graham Brown Cancer Center, University of Louisville School of Medicine, Louisville, KY 40202, USA.
Jessica M JurkiewiczJames Graham Brown Cancer Center, University of Louisville School of Medicine, Louisville, KY 40202, USA.
Nobuyuki MatobaDepartment of Pharmacology and Toxicology, University of Louisville School of Medicine, Louisville, KY 40202, USA.ORCID 0000-0001-7231-3004
Krystal T HamorskyJames Graham Brown Cancer Center, University of Louisville School of Medicine, Louisville, KY 40202, USA.
University of Louisville · US

Funding

The ExCITE Program: Expediting Commercialization, Innovation, Translation, & EntrepreneurshipU01HL127518 · NHLBI · UNIVERSITY OF LOUISVILLE · PI BATES, PAULA J., MILLER, DONALD M. · 2015 to 2017
$3.0M
Preclinical validation of oral therapeutic lead proteins targeting epithelial GM1 ganglioside for ulcerative colitis therapyR01DK123712 · NIDDK · UNIVERSITY OF LOUISVILLE · PI MATOBA, NOBUYUKI · 2020 to 2023
$1.8M
Leona M. and Harry B. Helmsley Charitable Trust N/ANIDDK NIH HHS R01 DK123712NIH HHS R01 DK123712NIH HHS U01 HL127518
6 · The paper itself

Abstract

Epicertin (EPT) is a recombinant variant of the cholera toxin B subunit, modified with a C-terminal KDEL endoplasmic reticulum retention motif. EPT has therapeutic potential for ulcerative colitis treatment. Previously, orally administered EPT demonstrated colon epithelial repair activity in dextran sodium sulfate (DSS)-induced acute and chronic colitis in mice. However, the oral dosing requires cumbersome pretreatment with sodium bicarbonate to conserve the acid-labile drug substance while transit through the stomach, hampering its facile application in chronic disease treatment. Here, we developed a solid oral formulation of EPT that circumvents degradation in gastric acid. EPT was spray-dried and packed into enteric-coated capsules to allow for pH-dependent release in the colon. A GM1-capture KDEL-detection ELISA and size-exclusion HPLC indicated that EPT powder maintains activity and structural stability for up to 9 months. Capsule disintegration tests showed that EPT remained encapsulated at pH 1 but was released over 180 min at pH 6.8, the approximate pH of the proximal colon. An acute DSS colitis study confirmed the therapeutic efficacy of encapsulated EPT in C57BL/6 mice upon oral administration without gastric acid neutralization pretreatment compared to vehicle-treated mice (

Indexed as

biopharmaceuticalscholera toxin B subunitepicertinpharmaceutical formulationspray-dryingulcerative colitis

Identifiers

PMID33919585
PMCPMC8073836
OpenAlexW3154596992

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.