Evidence map›Paper›PMID 35214156›Full record

ArticlePharmaceutics2022

Interaction and Compatibility Studies in the Development of Olmesartan Medoxomil and Hydrochlorothiazide Formulations under a Real Manufacturing Process.

Mac Arturo Murillo-Fernández, Ernesto Montero-Zeledón, Ariadna Abdala-Saiz, José Roberto Vega-Baudrit, Andrea Mariela Araya-Sibaja

Abstract read
In one paragraph

Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Modafinil-excipient compatibility study using differential scanning calorimetry.Journal of advanced pharmaceutical technology & research
    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

5 authors.

Mac Arturo Murillo-FernándezEscuela de Física, Instituto Tecnológico de Costa Rica, Cartago 159-7050, Costa Rica.
Ernesto Montero-ZeledónEscuela de Física, Instituto Tecnológico de Costa Rica, Cartago 159-7050, Costa Rica.
Ariadna Abdala-SaizDepartamento de Investigación y Desarrollo, Calox de Costa Rica, San José 126224-01, Costa Rica.
José Roberto Vega-BaudritLaboratorio Nacional de Nanotecnología LANOTEC-CeNAT-CONARE, Pavas, San José 1174-1200, Costa Rica.ORCID 0000-0002-2002-1744
Andrea Mariela Araya-SibajaEscuela de Física, Instituto Tecnológico de Costa Rica, Cartago 159-7050, Costa Rica.

Funding

Vicerrectoría de Investigación, Instituto Tecnológico de Costa Rica 1450025
6 · The paper itself

Abstract

A drug-drug and drug-excipient interactions and compatibilities study was conducted for two fixed-dose combination (FDC) products containing olmesartan medoxomil (OLM)/hydrochlorothiazide (HCT) 20/12.5 mg and OLM/HCT 40/12.5 mg during their development including storage. The study consisted of the evaluation of samples retrieved during all stages of a real manufacturing process. Powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermogravimetry (TGA), Fourier transform infrared spectroscopy (FT-IR), and contact angle techniques were applied to the samples to determine interactions and incompatibilities. Dissolution tests and long-term stability studies were conducted to evaluate dosage form performance. Results showed weak solid-state interactions able to obtain a eutectic mixture of OLM and HCT while microcrystalline cellulose (MC) impacted the thermal stability of both drugs. Reliable dissolution and long-term stability tests confirmed that the interactions observed were not considered incompatibilities because they were not influenced by the performance of the final products.

Indexed as

antihypertensivecompatibility studyeutectic mixturesexcipientshydrochlorothiazideolmesartan medoxomilsolid–state characterization

Identifiers

PMID35214156
PMCPMC8875139

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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.