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[The bioavailability of enteric coated diclofenac formulations. 2. Bioavailability following single administration of a multiple-unit formulation in comparison to a single-unit formulation under fasting and non-fasting conditions].
Arzneimittelforschung. 1994 Apr; 44(4):544-50.A

Abstract

Relative bioavailability of enteric-coated diclofenac (CAS 15307-86-5) was investigated after a single-dose administration of a multiple-unit formulation (Diclo-Puren 50, test) in comparison to a single-unit formulation (reference). The study was carried out in a four-way change-over design including a group of 12 healthy male volunteers. Each formulation was administered after 10 h of fasting or just after (5 min) finishing a meal (standard breakfast). Diclofenac plasma concentrations were measured using a selective and sensitive GLC-MS method after liquid-liquid extraction and derivatisation. Area under the curve (AUC), maximum plasma concentrations (Cmax), time of maximum plasma concentration (tmax), time of delay of first measurable concentrations (tlag) and plateau time of concentrations above minimum effective concentrations (MEC) of 50 ng/ml (tMEC(50)) and 100 ng/ml (tMEC(100)), respectively, were evaluated as pharmacokinetic characteristics. Additionally, for AUC and Cmax, 90%-confidence intervals (parametric: ANOVA, ANOVAlog, non-parametric: Mann-Whitney) were calculated to evaluate the influence of food on bioavailability of each formulation. Mean (median) relative bioavailabilities of diclofenac of the test formulation (comparison: postprandial vs. fasting conditions) were determined for the test formulation as 96% (103%) and for the reference product as 70% (83%). Mean +/- SD (median) maximum plasma concentrations of the test formulation were determined as 695 +/- 313 (677) ng/ml (fasting) and as 452 +/- 163 (456) ng/ml (postprandial). Maximum plasma concentration occurred 1.2 +/- 0.5 (1.0) h and 4.8 +/- 1.0 (5.0) h after administration, respectively.(

ABSTRACT

TRUNCATED AT 250 WORDS)

Authors+Show Affiliations

Zentrallaboratorium Deutscher Apotheker, Eschborn.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Controlled Clinical Trial
English Abstract
Journal Article

Language

ger

PubMed ID

8011009

Citation

Scheidel, B, et al. "[The Bioavailability of Enteric Coated Diclofenac Formulations. 2. Bioavailability Following Single Administration of a Multiple-unit Formulation in Comparison to a Single-unit Formulation Under Fasting and Non-fasting Conditions]." Arzneimittel-Forschung, vol. 44, no. 4, 1994, pp. 544-50.
Scheidel B, Blume H, Walter K, et al. [The bioavailability of enteric coated diclofenac formulations. 2. Bioavailability following single administration of a multiple-unit formulation in comparison to a single-unit formulation under fasting and non-fasting conditions]. Arzneimittelforschung. 1994;44(4):544-50.
Scheidel, B., Blume, H., Walter, K., Stanislaus, F., & Babej-Dölle, R. M. (1994). [The bioavailability of enteric coated diclofenac formulations. 2. Bioavailability following single administration of a multiple-unit formulation in comparison to a single-unit formulation under fasting and non-fasting conditions]. Arzneimittel-Forschung, 44(4), 544-50.
Scheidel B, et al. [The Bioavailability of Enteric Coated Diclofenac Formulations. 2. Bioavailability Following Single Administration of a Multiple-unit Formulation in Comparison to a Single-unit Formulation Under Fasting and Non-fasting Conditions]. Arzneimittelforschung. 1994;44(4):544-50. PubMed PMID: 8011009.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [The bioavailability of enteric coated diclofenac formulations. 2. Bioavailability following single administration of a multiple-unit formulation in comparison to a single-unit formulation under fasting and non-fasting conditions]. AU - Scheidel,B, AU - Blume,H, AU - Walter,K, AU - Stanislaus,F, AU - Babej-Dölle,R M, PY - 1994/4/1/pubmed PY - 1994/4/1/medline PY - 1994/4/1/entrez SP - 544 EP - 50 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 44 IS - 4 N2 - Relative bioavailability of enteric-coated diclofenac (CAS 15307-86-5) was investigated after a single-dose administration of a multiple-unit formulation (Diclo-Puren 50, test) in comparison to a single-unit formulation (reference). The study was carried out in a four-way change-over design including a group of 12 healthy male volunteers. Each formulation was administered after 10 h of fasting or just after (5 min) finishing a meal (standard breakfast). Diclofenac plasma concentrations were measured using a selective and sensitive GLC-MS method after liquid-liquid extraction and derivatisation. Area under the curve (AUC), maximum plasma concentrations (Cmax), time of maximum plasma concentration (tmax), time of delay of first measurable concentrations (tlag) and plateau time of concentrations above minimum effective concentrations (MEC) of 50 ng/ml (tMEC(50)) and 100 ng/ml (tMEC(100)), respectively, were evaluated as pharmacokinetic characteristics. Additionally, for AUC and Cmax, 90%-confidence intervals (parametric: ANOVA, ANOVAlog, non-parametric: Mann-Whitney) were calculated to evaluate the influence of food on bioavailability of each formulation. Mean (median) relative bioavailabilities of diclofenac of the test formulation (comparison: postprandial vs. fasting conditions) were determined for the test formulation as 96% (103%) and for the reference product as 70% (83%). Mean +/- SD (median) maximum plasma concentrations of the test formulation were determined as 695 +/- 313 (677) ng/ml (fasting) and as 452 +/- 163 (456) ng/ml (postprandial). Maximum plasma concentration occurred 1.2 +/- 0.5 (1.0) h and 4.8 +/- 1.0 (5.0) h after administration, respectively.(ABSTRACT TRUNCATED AT 250 WORDS) SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/8011009/[The_bioavailability_of_enteric_coated_diclofenac_formulations__2__Bioavailability_following_single_administration_of_a_multiple_unit_formulation_in_comparison_to_a_single_unit_formulation_under_fasting_and_non_fasting_conditions]_ DB - PRIME DP - Unbound Medicine ER -