Tags

Type your tag names separated by a space and hit enter

A pharmacokinetic analysis of diclofenac potassium soft-gelatin capsule in patients after bunionectomy.
Am J Ther. 2010 Sep-Oct; 17(5):460-8.AJ

Abstract

The clinical utility of diclofenac potassium, a nonsteroidal anti-inflammatory drug, may be lessened by inconsistent gastrointestinal absorption. Diclofenac potassium liquid filled soft-gelatin capsule (DPSGC) is an investigational formulation that uses ProSorb dispersion technology to facilitate rapid and consistent gastrointestinal absorption. In this study, the pharmacokinetic (PK) properties of DPSGC are investigated and compared with a commercially available oral diclofenac potassium tablet in patients after primary unilateral first metatarsal bunionectomy. In an open-label, randomized study, 53 patients received ProSorb-D 12.5 mg (the liquid equivalent of DPSGC), DPSGC 25 mg, DPSGC 50 mg, or immediate-release diclofenac potassium 50-mg tablet administered every 8 hours for a 24-hour inpatient period followed by 7 days of outpatient dosing. Diclofenac steady-state PK was evaluated over an 8-hour sampling period 4 days after surgery. Delayed and/or multiple peaks in the diclofenac plasma concentration-time course profiles occurred more frequently with the commercially available oral diclofenac potassium 50-mg tablet than with the other DPSGC formulations. PK data for ProSorb-D 12.5-mg liquid, DPSGC 25 mg, DPSGC 50 mg, and diclofenac potassium 50-mg tablet revealed mean peak plasma concentrations (Cmax) of 302, 749, 1006, and 902 ng/mL, respectively, whereas area under the plasma concentration curve values were 316, 595, 1029, and 1166 ng-hour/mL, respectively. Mean times to Cmax (tmax) were 0.49, 0.63, 0.95, and 1.26 h, respectively. When compared with absorption characteristics of diclofenac potassium 50-mg tablet, DPSGC was more rapidly and consistently absorbed after bunionectomy. These characteristics should be advantageous when rapid pain relief is desired.

Authors+Show Affiliations

AAIPharma, Inc., Wilmington, NC, USA. mkowalski@viventia.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19531931

Citation

Kowalski, Mark, et al. "A Pharmacokinetic Analysis of Diclofenac Potassium Soft-gelatin Capsule in Patients After Bunionectomy." American Journal of Therapeutics, vol. 17, no. 5, 2010, pp. 460-8.
Kowalski M, Stoker DG, Bon C, et al. A pharmacokinetic analysis of diclofenac potassium soft-gelatin capsule in patients after bunionectomy. Am J Ther. 2010;17(5):460-8.
Kowalski, M., Stoker, D. G., Bon, C., Moore, K. A., & Boesing, S. E. (2010). A pharmacokinetic analysis of diclofenac potassium soft-gelatin capsule in patients after bunionectomy. American Journal of Therapeutics, 17(5), 460-8. https://doi.org/10.1097/MJT.0b013e3181aa3eda
Kowalski M, et al. A Pharmacokinetic Analysis of Diclofenac Potassium Soft-gelatin Capsule in Patients After Bunionectomy. Am J Ther. 2010 Sep-Oct;17(5):460-8. PubMed PMID: 19531931.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A pharmacokinetic analysis of diclofenac potassium soft-gelatin capsule in patients after bunionectomy. AU - Kowalski,Mark, AU - Stoker,Douglas G, AU - Bon,Charles, AU - Moore,Keith A, AU - Boesing,Stephen E, PY - 2009/6/18/entrez PY - 2009/6/18/pubmed PY - 2011/3/5/medline SP - 460 EP - 8 JF - American journal of therapeutics JO - Am J Ther VL - 17 IS - 5 N2 - The clinical utility of diclofenac potassium, a nonsteroidal anti-inflammatory drug, may be lessened by inconsistent gastrointestinal absorption. Diclofenac potassium liquid filled soft-gelatin capsule (DPSGC) is an investigational formulation that uses ProSorb dispersion technology to facilitate rapid and consistent gastrointestinal absorption. In this study, the pharmacokinetic (PK) properties of DPSGC are investigated and compared with a commercially available oral diclofenac potassium tablet in patients after primary unilateral first metatarsal bunionectomy. In an open-label, randomized study, 53 patients received ProSorb-D 12.5 mg (the liquid equivalent of DPSGC), DPSGC 25 mg, DPSGC 50 mg, or immediate-release diclofenac potassium 50-mg tablet administered every 8 hours for a 24-hour inpatient period followed by 7 days of outpatient dosing. Diclofenac steady-state PK was evaluated over an 8-hour sampling period 4 days after surgery. Delayed and/or multiple peaks in the diclofenac plasma concentration-time course profiles occurred more frequently with the commercially available oral diclofenac potassium 50-mg tablet than with the other DPSGC formulations. PK data for ProSorb-D 12.5-mg liquid, DPSGC 25 mg, DPSGC 50 mg, and diclofenac potassium 50-mg tablet revealed mean peak plasma concentrations (Cmax) of 302, 749, 1006, and 902 ng/mL, respectively, whereas area under the plasma concentration curve values were 316, 595, 1029, and 1166 ng-hour/mL, respectively. Mean times to Cmax (tmax) were 0.49, 0.63, 0.95, and 1.26 h, respectively. When compared with absorption characteristics of diclofenac potassium 50-mg tablet, DPSGC was more rapidly and consistently absorbed after bunionectomy. These characteristics should be advantageous when rapid pain relief is desired. SN - 1536-3686 UR - https://www.unboundmedicine.com/medline/citation/19531931/A_pharmacokinetic_analysis_of_diclofenac_potassium_soft_gelatin_capsule_in_patients_after_bunionectomy_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=19531931.ui DB - PRIME DP - Unbound Medicine ER -