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Pharmacokinetics of ibuprofen following a single administration of a suspension containing enteric-coated microcapsules.
Arzneimittelforschung. 1995 Aug; 45(8):886-90.A

Abstract

The relative bioavailability of ibuprofen (CAS 15687-27-1) was investigated following a single administration of a suspension containing enteric-coated microcapsules (A) in comparison to a rapid-release film-coated tablet (B) and a sustained-release tablet (C). The study was carried out in a three-way crossover design in 9 healthy male volunteers. Each formulation contained 800 mg ibuprofen. Plasma concentrations of ibuprofen were determined with a specific HPLC method. A mean relative bioavailability of 0.96 (B) and 1.01 (C) was determined for the test formulation. Since the corresponding 90% confidence intervals were within the recommended limits, bioequivalence for the extent of bioavailability of the test formulation can be concluded. Differences in pharmacokinetics were observed for the rate-dependent parameters. For the test formulation, the highest mean maximum plasma concentration (54.3 micrograms/ml) was measured with a corresponding tmax of 1.9 h. For the reference formulations, mean peak plasma concentrations of 45.2 micrograms/ml after 2.6 h (B) and 25.7 micrograms/ml after 5.6 h (C) were observed. Despite the enteric coating of the microcapsules, a very short lagtime of 0.03 h was determined for the suspension. For the other rapid release formulation (B), the lagtime was in a similar magnitude (0.11 h), while the absorption from the sustained-release tablet was clearly decelerated (tlag = 0.97 h). In comparison to the other rapid-release formulation (B), significant higher amounts of the drug were absorbed from the test formulation (A) within the first hour.

Authors+Show Affiliations

Klinge Pharma GmbH, Munich, Germany.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

7575754

Citation

Walter, K, et al. "Pharmacokinetics of Ibuprofen Following a Single Administration of a Suspension Containing Enteric-coated Microcapsules." Arzneimittel-Forschung, vol. 45, no. 8, 1995, pp. 886-90.
Walter K, Weiss G, Laicher A, et al. Pharmacokinetics of ibuprofen following a single administration of a suspension containing enteric-coated microcapsules. Arzneimittelforschung. 1995;45(8):886-90.
Walter, K., Weiss, G., Laicher, A., & Stanislaus, F. (1995). Pharmacokinetics of ibuprofen following a single administration of a suspension containing enteric-coated microcapsules. Arzneimittel-Forschung, 45(8), 886-90.
Walter K, et al. Pharmacokinetics of Ibuprofen Following a Single Administration of a Suspension Containing Enteric-coated Microcapsules. Arzneimittelforschung. 1995;45(8):886-90. PubMed PMID: 7575754.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetics of ibuprofen following a single administration of a suspension containing enteric-coated microcapsules. AU - Walter,K, AU - Weiss,G, AU - Laicher,A, AU - Stanislaus,F, PY - 1995/8/1/pubmed PY - 1995/8/1/medline PY - 1995/8/1/entrez SP - 886 EP - 90 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 45 IS - 8 N2 - The relative bioavailability of ibuprofen (CAS 15687-27-1) was investigated following a single administration of a suspension containing enteric-coated microcapsules (A) in comparison to a rapid-release film-coated tablet (B) and a sustained-release tablet (C). The study was carried out in a three-way crossover design in 9 healthy male volunteers. Each formulation contained 800 mg ibuprofen. Plasma concentrations of ibuprofen were determined with a specific HPLC method. A mean relative bioavailability of 0.96 (B) and 1.01 (C) was determined for the test formulation. Since the corresponding 90% confidence intervals were within the recommended limits, bioequivalence for the extent of bioavailability of the test formulation can be concluded. Differences in pharmacokinetics were observed for the rate-dependent parameters. For the test formulation, the highest mean maximum plasma concentration (54.3 micrograms/ml) was measured with a corresponding tmax of 1.9 h. For the reference formulations, mean peak plasma concentrations of 45.2 micrograms/ml after 2.6 h (B) and 25.7 micrograms/ml after 5.6 h (C) were observed. Despite the enteric coating of the microcapsules, a very short lagtime of 0.03 h was determined for the suspension. For the other rapid release formulation (B), the lagtime was in a similar magnitude (0.11 h), while the absorption from the sustained-release tablet was clearly decelerated (tlag = 0.97 h). In comparison to the other rapid-release formulation (B), significant higher amounts of the drug were absorbed from the test formulation (A) within the first hour. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/7575754/Pharmacokinetics_of_ibuprofen_following_a_single_administration_of_a_suspension_containing_enteric_coated_microcapsules_ L2 - https://antibodies.cancer.gov/detail/CPTC-GSTMu1-6 DB - PRIME DP - Unbound Medicine ER -