Evidence map›Paper›PMID 28416417›Full record

ArticleJournal of pharmaceutical sciences2017

In Vitro Evaluation of Nasogastric Tube Delivery Performance of Esomeprazole Magnesium Delayed-Release Capsules.

Alicia Hoover, Dajun Sun, Hong Wen, Wenlei Jiang, Minglei Cui, Xiaojian Jiang, David Keire, Changning Guo

Abstract read
In one paragraph

Article in Journal of pharmaceutical sciences, 2017. 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
2.0field-weighted citation impact, top 13% 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

2 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
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

8 authors at 1 institution in 1 country.

Alicia HooverDivision of Pharmaceutical Analysis, Food and Drug Administration, 645 S Newstead Avenue, Saint Louis, Missouri 63110.
Dajun SunOffice of Generic Drugs, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Hong WenOffice of Generic Drugs, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Wenlei JiangOffice of Generic Drugs, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Minglei CuiOffice of Generic Drugs, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Xiaojian JiangOffice of Generic Drugs, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
David KeireDivision of Pharmaceutical Analysis, Food and Drug Administration, 645 S Newstead Avenue, Saint Louis, Missouri 63110.
Changning GuoDivision of Pharmaceutical Analysis, Food and Drug Administration, 645 S Newstead Avenue, Saint Louis, Missouri 63110. Electronic address: Changning.Guo@fda.hhs.gov.
United States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Enteral feeding tubes are used to deliver food or drugs to patients who cannot swallow. To deliver delayed-release drugs that are formulated as enteric coated granules to these patients via feeding tubes requires that they be suspended in water before administration. Importantly, the suspension of enteric granules in water of varying pH can cause damage to the enteric coating and affect the bioavailability of the drug. Here, analytical methods for testing acid resistance stability and particle size distribution (PSD) of esomeprazole granules were used to monitor the integrity of the granule enteric coating after water pretreatment and delivery through an oral syringe and nasogastric (NG) tube. Granules from esomeprazole magnesium delayed-release capsules were transferred to an oral syringe, suspended in water, and delivered on the bench through an NG tube. Subsequently, acid resistance stability (i.e., the amount of drug released after 2-h acid dissolution) was determined via high-performance liquid chromatography, and the PSD were measured with a laser diffraction system. All the granules demonstrated acid resistance stability when the granules were delivered immediately (0 min incubation) through the oral syringe and NG tube. In contrast, some granules demonstrated significant drug release during acid exposure after a 15-min incubation period which mimics a possible delay in delivery of the drug from the syringe by the caregiver. A bimodal PSD was observed with these granules, which was attributed to debris from damaged enteric coating and particle agglomeration. The methods developed in this study could be used to distinguish batches with suboptimal product quality for delivery using NG tubes and to confirm the substitutability of generic drug products for this alternative route of administration.

Indexed as

AcidsAnti-Ulcer AgentsCapsulesDelayed-Action PreparationsDrug Delivery SystemsDrug LiberationEsomeprazoleHumansIntubation, GastrointestinalSolubilityAcidsAnti-Ulcer AgentsCapsulesDelayed-Action PreparationsEsomeprazoledissolutiongastrointestinalHPLC (high-performance/pressure liquid chromatography)particle sizetargeted drug delivery

Identifiers

PMID28416417
PMCPMC5564165
OpenAlexW2605962975

What OpenQuestion holds

Textmetadata
LicenceTDM
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.