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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

Walter K
Klinge Pharma GmbH, Munich, Germany.
Weiss G
No affiliation info available
Laicher A
No affiliation info available
Stanislaus F
No affiliation info available

MeSH

AdultBiological AvailabilityCapsulesChromatography, High Pressure LiquidCross-Over StudiesDelayed-Action PreparationsHalf-LifeHumansIbuprofenMaleSuspensionsTablets, Enteric-Coated

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 -