Evidence map›Paper›PMID 34683893›Full record

ArticlePharmaceutics2021

Solid-State Stability Profiling of Ramipril to Optimize Its Quality Efficiency and Safety.

Katarzyna Regulska, Joanna Musiał, Beata J Stanisz

Abstract 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Angiotensin-converting enzyme inhibitors for ovarian cancer? - a new adjuvant option or a silent trap.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2023
    Review
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

3 authors.

Katarzyna RegulskaGreater Poland Cancer Center, 15th Garbary Street, 61-866 Poznan, Poland.ORCID 0000-0002-9584-3128
Joanna MusiałDepartment of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka Street, 60-780 Poznan, Poland.ORCID 0000-0002-5487-3523
Beata J StaniszDepartment of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka Street, 60-780 Poznan, Poland.ORCID 0000-0003-4611-7039

Funding

Greater Poland Cancer Center 4/2020(235)Poznan University of Medical Sciences 2753
6 · The paper itself

Abstract

High global expenditure on out-of-label-date drugs, along with safety concerns associated with the accumulation of degradation impurities, justify the need for stability profiling. In this article, a comprehensive study on the solid-state stability of ramipril (RAM) was performed via isothermal methods under stress conditions. A validated stability-indicating HPLC protocol was used. The effects of various factors on the rate of RAM degradation were investigated, including: temperature, relative air humidity (RH), excipients (talc, starch, methylcellulose and hydroxypropyl methylcellulose), mode of tablet storage, and immediate packaging. The degradation impurities were also identified by HPLC-MS. It was found that RAM was unstable, and temperature accelerated its degradation. RAM was also vulnerable to RH changes, suggesting that it must be protected from moisture. The reaction followed first-order kinetics. The studied excipients stabilized RAM as a pure substance. The tableting process deteriorated its stability, explaining the need for appropriate immediate packaging. RAM in the form of tablets must be stored in blisters, and it cannot be crushed into two halves. The degradation impurities were ramiprilat and the diketopiperazine derivative.

Indexed as

degradation impuritiesexcipientsramiprilstability in solid statetablets

Identifiers

PMID34683893
PMCPMC8538641

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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.