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Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled soft gelatin capsule with a diclofenac potassium tablet.
Expert Opin Pharmacother. 2010 Apr; 11(5):701-8.EO

Abstract

OBJECTIVE

To compare the pharmacokinetic profiles of diclofenac potassium liquid-filled soft gelatin capsules (DPSGC) using patented ProSorb dispersion technology with an immediate-release, diclofenac potassium 50-mg comparator tablet in two open-label, single-dose, randomized, crossover relative bioavailability studies in healthy volunteers.

METHODS

In Study 1, volunteers (n = 21) received DPSGC 50 mg or a diclofenac potassium 50-mg comparator tablet in two inpatient study periods. In Study 2 (n = 54), volunteers received DPSGC 25 mg, DPSGC 50 mg, or a diclofenac potassium 50-mg comparator immediate-release tablet in three inpatient study periods.

RESULTS

In both studies, DPSGC 50 mg displayed a significantly shorter T(max) and higher C(max) than the 50-mg diclofenac potassium comparator tablet. DPSGC 25 mg (Study 2) produced a shorter T(max) (0.45 h) and an equivalent C(max) (1125 ng/ml) to the 50-mg comparator drug. Plasma diclofenac concentration-time courses for the diclofenac potassium 50-mg comparator tablet showed many low, delayed, or multiple peaks compared with DPSGC treatments.

CONCLUSIONS

DPSGC 25 mg and 50 mg were more rapidly and consistently absorbed than diclofenac potassium 50-mg comparator tablets. The C(max) of DPSGC 25 mg was equivalent to the 50-mg diclofenac potassium comparator tablet. These characteristics may be beneficial when fast, consistent drug absorption is needed.

Authors+Show Affiliations

AAIPharma, Inc, Wegenerstrasse 13, D-89231 Neu-Ulm, Germany. michael.lissy@aaipharma.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20187842

Citation

Lissy, Michael, et al. "Pharmacokinetic Comparison of an Oral Diclofenac Potassium Liquid-filled Soft Gelatin Capsule With a Diclofenac Potassium Tablet." Expert Opinion On Pharmacotherapy, vol. 11, no. 5, 2010, pp. 701-8.
Lissy M, Scallion R, Stiff DD, et al. Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled soft gelatin capsule with a diclofenac potassium tablet. Expert Opin Pharmacother. 2010;11(5):701-8.
Lissy, M., Scallion, R., Stiff, D. D., & Moore, K. (2010). Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled soft gelatin capsule with a diclofenac potassium tablet. Expert Opinion On Pharmacotherapy, 11(5), 701-8. https://doi.org/10.1517/14656561003614773
Lissy M, et al. Pharmacokinetic Comparison of an Oral Diclofenac Potassium Liquid-filled Soft Gelatin Capsule With a Diclofenac Potassium Tablet. Expert Opin Pharmacother. 2010;11(5):701-8. PubMed PMID: 20187842.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacokinetic comparison of an oral diclofenac potassium liquid-filled soft gelatin capsule with a diclofenac potassium tablet. AU - Lissy,Michael, AU - Scallion,Ralph, AU - Stiff,Dwight D, AU - Moore,Keith, PY - 2010/3/2/entrez PY - 2010/3/2/pubmed PY - 2010/6/18/medline SP - 701 EP - 8 JF - Expert opinion on pharmacotherapy JO - Expert Opin Pharmacother VL - 11 IS - 5 N2 - OBJECTIVE: To compare the pharmacokinetic profiles of diclofenac potassium liquid-filled soft gelatin capsules (DPSGC) using patented ProSorb dispersion technology with an immediate-release, diclofenac potassium 50-mg comparator tablet in two open-label, single-dose, randomized, crossover relative bioavailability studies in healthy volunteers. METHODS: In Study 1, volunteers (n = 21) received DPSGC 50 mg or a diclofenac potassium 50-mg comparator tablet in two inpatient study periods. In Study 2 (n = 54), volunteers received DPSGC 25 mg, DPSGC 50 mg, or a diclofenac potassium 50-mg comparator immediate-release tablet in three inpatient study periods. RESULTS: In both studies, DPSGC 50 mg displayed a significantly shorter T(max) and higher C(max) than the 50-mg diclofenac potassium comparator tablet. DPSGC 25 mg (Study 2) produced a shorter T(max) (0.45 h) and an equivalent C(max) (1125 ng/ml) to the 50-mg comparator drug. Plasma diclofenac concentration-time courses for the diclofenac potassium 50-mg comparator tablet showed many low, delayed, or multiple peaks compared with DPSGC treatments. CONCLUSIONS: DPSGC 25 mg and 50 mg were more rapidly and consistently absorbed than diclofenac potassium 50-mg comparator tablets. The C(max) of DPSGC 25 mg was equivalent to the 50-mg diclofenac potassium comparator tablet. These characteristics may be beneficial when fast, consistent drug absorption is needed. SN - 1744-7666 UR - https://www.unboundmedicine.com/medline/citation/20187842/Pharmacokinetic_comparison_of_an_oral_diclofenac_potassium_liquid_filled_soft_gelatin_capsule_with_a_diclofenac_potassium_tablet_ L2 - https://www.tandfonline.com/doi/full/10.1517/14656561003614773 DB - PRIME DP - Unbound Medicine ER -