Evidence map›Paper›PMID 31118565›Full record

ArticleDrug design, development and therapy2019

In vitro comparative quality assessment of different brands of norfloxacin tablets available in Jimma, Southwest Ethiopia.

Solomon Hambisa, Sileshi Belew, Sultan Suleman

Abstract readComparative Study
In one paragraph

Article in Drug design, development and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

3 authors.

Solomon HambisaDepartment of Pharmacy, College of Health Sciences, Mizan-Tepi University, Mizan-Teferi, Ethiopia, s.hambisa@gmail.com.
Sileshi BelewJimma University Laboratory of Drug Quality (JuLaDQ), Jimma University, Jimma, Ethiopia.
Sultan SulemanJimma University Laboratory of Drug Quality (JuLaDQ), Jimma University, Jimma, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmaceuticals play a pivotal role in maintaining human health and promoting well-being. However, safety, efficacy, and quality of the drugs should be ascertained to provide a desired pharmacological effect.

aimThe aim of the present study was to determine the quality as well as the physicochemical equivalence of nine brands of norfloxacin tablets marketed in Jimma, Ethiopia.

methodsNine norfloxacin brands were subjected to in vitro tests associated with quality of tablet dosage form, and the tests were conducted according to procedures described in the United States Pharmacopeia (USP).

resultsThis study indicated that all brands of norfloxacin complied with the USP for uniformity of weight, friability, hardness, and assay of active ingredient. However, two of the nine brands evaluated failed to release 80% of their drug contents within 30 minutes as outlined in the USP. Correspondingly, all of the brands studied were within the specification for hardness test. Furthermore, different dissolution profile comparison methods have proven the similarity in dissolution profile of Negaflox and Norcin with the comparator product (Trizolin). Mathematical models-dependent approaches have shown that the drug release data fit well to the Weibull release model.

conclusionThe physicochemical evaluation showed that all the norfloxacin brands met the quality specification with respect to uniformity of weight, hardness, friability, and assay. With regard to dissolution test, two brands of norfloxacin were found to be out of the specified pharmacopeial requirement. The study also revealed the similarity in the dissolution profile of two brands of norfloxacin with the comparator product.

Indexed as

Quality ControlAnti-Bacterial AgentsDrug LiberationEthiopiaKineticsNorfloxacinTabletsAnti-Bacterial AgentsNorfloxacinTabletsassaydissolution profilefriabilityhardnessJimmanorfloxacinuniformity of weight

Identifiers

PMID31118565
PMCPMC6475098

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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.