Evidence map›Paper›PMID 25105064›Full record

ArticleClinical & experimental pharmacology2014

Potency and Stability of Intradermal Capsaicin: Implications for Use as a Human Model of Pain in Multicenter Clinical Trials.

Pavan Balabathula, Himanshu Bhattacharjee, Laura A Thoma, Robert J Nolly, Frank P Horton, Gwendolyn D Stornes, Jim Y Wan, Ian M Brooks, Gloria A Bachmann, David C Foster and 1 more

Open access · bronzeAbstract read
In one paragraph

Article in Clinical & experimental pharmacology, 2014. 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
0.4field-weighted citation impact, top 34% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Stability, permeation, and cytotoxicity reduction of capsicum extract nanoparticles loaded hydrogel containing wax gourd extract.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2020
    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

11 authors at 1 institution in 1 country.

Pavan BalabathulaPlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Himanshu BhattacharjeePlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Laura A ThomaPlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Robert J NollyPlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Frank P HortonPlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Gwendolyn D StornesPlough Center for Sterile Drug Delivery Systems, College of Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
Jim Y WanDepartment of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
Ian M BrooksBiomedical Informatics, University of Tennessee Health Science Center, Memphis TN, USA.
Gloria A BachmannUniversity Medical Dental School of New Jersey-Robert Wood Johnson, New Brunswick NJ, USA.
David C FosterDepartment of Obstetrics and Gynecology, University of Rochester School of Medicine and Dentistry, Rochester NY, USA.
Candace S BrownDepartment of Clinical Pharmacy, University of Tennessee Health Science Center, Memphis TN, USA.
University of Tennessee Health Science Center · US

Funding

A Controlled Trial of Gabapentin in Vulvodynia: Biological Correlates of ResponseR01HD065740 · NICHD · UNIVERSITY OF TENNESSEE HEALTH SCI CTR · PI BACHMANN, GLORIA A, BROWN, CANDACE S · 2011 to 2014
$2.5M
NICHD NIH HHS R01 HD065740
6 · The paper itself

Abstract

Intradermally injected capsaicin has been used extensively both as a human pain model and to assess analgesic efficacy. Factors such as dose, formulation, route, and site are known to affect its sensitivity. We determined whether potency and stability of capsaicin solutions were further sources of variability when following strict manufacturing guidelines. Capsaicin solution (1.0 mg/mL) was prepared according to Current Good Manufacturing Practice (cGMP) guidelines and aseptically filled into sterile amber borosilicate vials and stored at 5°C, 25°C, and 30°C. All samples were analyzed at one, three, six, and twelve months. Chemical stability was determined using HPLC and physical stability was evaluated by visual inspection of color changes, clarity, particulate matter, and product/ container closure abnormalities during each sampling time. Capsaicin intradermal injection was found to be sterile and retained 95% of the initial concentration for at least one year, regardless of studied storage temperatures (P<0.0001). Visual inspection indicated no changes in color, clarity, particulate matter, and product/ container closure abnormalities in all samples. These data show that capsaicin solutions (1.0 mg/mL) maintain their potency and stability over one year when manufactured according to cGMP guidelines. These results suggest that in clinical trials manufacturing of capsaicin solutions is recommended over extemporaneous compounding.

Indexed as

CapsaicinHuman pain modelIntradermalManufactureVariability

Identifiers

PMID25105064
PMCPMC4122245
OpenAlexW2228580134

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.