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Guerra P.AuthorFrias J.AuthorRuiz B.AuthorSoto A.AuthorCarcas A.Author
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Article

Bioequivalence of allopurinol and its metabolite oxipurinol in two tablet formulations

Publicated to:JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS. 26 (2): 113-119 - 2001-05-03 26(2), DOI: 10.1046/j.1365-2710.2001.00329.x

Authors: Guerra P; Frias J; Ruiz B; Soto A; Carcas A; Govantes C; Montuenga C; Fernández A

Affiliations

Laboratorios Normon - Author
Universidad Autónoma de Madrid - Author
Universidad Autónoma de Madrid; Universidad Autónoma de Madrid - Author

Abstract

Objective: To test for the bioequivalence of two allopurinol 300 mg tablet formulations (generic allopurinol (Normon) and Zyloric tablets). Method: A single dose study was carried out in 24 healthy volunteers with a two-sequence, cross-over block-randomized design. Blood samples were taken prior to each administration and at 19 points within 72 h after the dose. Plasma concentrations of allopurinol and oxypurinol were determined by HPLC. The pharmacokinetic parameters Cmax and Tmax were obtained directly from plasma allopurinol and oxypurinol concentrations. ke was estimated by log-linear regression and AUC was calculated by the linear trapezoidal rule for both allopurinol and oxypurinol. The pharmacokinetic parameters AUC and Cmax were tested for equivalence after log-transformation of data. Differences of Tmax were evaluated by a non-parametric test. The 90% standard confidence intervals of the mean values for the test/reference ratios were for AUC and for Cmax, within the acceptable bioequivalence limits of 0·80-1·25 for both allopurinol and oxypurinol. Conclusion: The two formulations are bioequivalent and therefore interchangeable.

Keywords
Active metabolites bioequivalenceAllopurinolDrug bioequivalenceOxypurinol

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2001, it was in position , thus managing to position itself as a Q2 (Segundo Cuartil), in the category Pharmacology (Medical). Notably, the journal is positioned en el Cuartil Q3 for the agency WoS (JCR) in the category Pharmacology & Pharmacy.

From a relative perspective, and based on the normalized impact indicator calculated from the Field Citation Ratio (FCR) of the Dimensions source, it yields a value of: 1.1, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: Dimensions May 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-05-09, the following number of citations:

  • WoS: 12
  • Scopus: 15
  • Europe PMC: 3
  • OpenCitations: 12
Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-05-09:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 19.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 19 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 6.

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
Leadership analysis of institutional authors

There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: First Author (GUERRA LOPEZ, PEDRO ENRIQUE) .