The Experts below are selected from a list of 1038 Experts worldwide ranked by ideXlab platform
Salomon A Stavchansky - One of the best experts on this subject based on the ideXlab platform.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allow- ing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1206-1219, 2009
V Binjesoh - One of the best experts on this subject based on the ideXlab platform.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allow- ing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1206-1219, 2009
Keith A. Moore - One of the best experts on this subject based on the ideXlab platform.
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pharmacokinetic comparison of an oral Diclofenac Potassium liquid filled soft gelatin capsule with a Diclofenac Potassium tablet
Expert Opinion on Pharmacotherapy, 2010Co-Authors: Michael Lissy, Ralph Scallion, Dwight D Stiff, Keith A. MooreAbstract: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 Tmax and higher Cmax than the 50-mg Diclofenac Potassium comparator tablet. DPSGC 25 mg (Study 2) produced a shorter Tmax (0.45 h) and an equivalent Cmax (1125 ng/ml) to the 50-mg comparator drug. Plasma Diclofenac concentration–time courses for the Diclofenac Potassium 50-mg comparator ...
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A pharmacokinetic analysis of Diclofenac Potassium soft-gelatin capsule in patients after bunionectomy.
American journal of therapeutics, 2010Co-Authors: Mark M. Kowalski, Douglas G Stoker, Charles Bon, Keith A. Moore, Stephen E BoesingAbstract: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 (C max ) 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 C max (t max ) 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.
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single dose pharmacokinetic study of rapidly dispersing Diclofenac Potassium formulations in healthy volunteers
Current Medical Research and Opinion, 2009Co-Authors: Michael Lissy, Mark M. Kowalski, Dwight D Stiff, Keith A. MooreAbstract:The clinical utility of Diclofenac Potassium, a commonly prescribed analgesic that provides mild to moderate pain relief, may be hindered by its delayed, depressed, and/or inconsistent absorption c...
Stephen E Boesing - One of the best experts on this subject based on the ideXlab platform.
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an assessment of the efficacy and safety of Diclofenac Potassium liquid filled capsules in patients with various levels of baseline pain intensity
Current Medical Research and Opinion, 2012Co-Authors: Stephen E Daniels, Dennis Riff, Eric Diamond, Francis Clark, Stephen E BoesingAbstract:AbstractContext:Diclofenac Potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor) is a novel formulation of Diclofenac Potassium used to treat mild to moderate acute pain.Objective:To investigate whether DPSGC 25 mg provided significant reduction in pain intensity compared with placebo, regardless of baseline pain intensity, a post hoc analysis was performed of pooled data from two replicate randomized controlled trials (NCT00366444 and NCT00375934) that evaluated the safety and efficacy of DPSGC in postbunionectomy treatment.Methods:Patients from the two randomized trials were assigned to one of two subgroups: patients with baseline numerical pain rating scale (NPRS) scores of 4 or greater to less than 7 and those with baseline NPRS scores of 7 or greater. Within each subgroup, efficacy and safety of DPSGC was compared with placebo.Results:Across the two studies, 73 DPSGC- and 59 placebo-treated patients had baseline pain intensity scores ranging from 4 or greater to less than 7, while 128 DPSGC- a...
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controlled phase iii clinical trial of Diclofenac Potassium liquid filled soft gelatin capsule for treatment of postoperative dental pain
Journal of Oral and Maxillofacial Surgery, 2010Co-Authors: John R Zuniga, Hans Malmstrom, Robert J Noveck, John H Campbell, Steven Christensen, Robert Glickman, B J Tomasetti, Stephen E BoesingAbstract:Purpose The purpose of the present study was to assess the safety and efficacy of oral Diclofenac Potassium liquid-filled soft gelatin capsule (DPSGC) that uses ProSorb dispersion technology (Xanodyne Pharmaceuticals, Inc, licensed from AAIPharma, Wilmington, NC), to treat adult patients with acute pain after third molar extraction. Patients and Methods In the present multicenter, randomized, double-blind, placebo-controlled trial, patients experiencing a baseline level of pain (≥50 mm on a 100-mm visual analog scale within 4 hours after surgery) were randomized to receive a single dose of DPSGC at 25, 50, or 100 mg or placebo. Pain intensity and relief were assessed for 6 hours after dosing. The efficacy endpoints included the summed pain intensity difference, total pain relief, and the median time to the onset of perceptible and meaningful pain relief (using the 2-stopwatch method). Results A total of 249 randomized patients had a significant increase in the summed pain intensity difference and total pain relief values at 3 and 6 hours across all DPSGC-treated groups compared with the placebo group (P Conclusions The results from the present single-dose study of postoperative dental pain suggest that DPSGC offers significant pain relief compared with placebo and that the study medication provided was well tolerated by patients who required pain relief after third molar extraction.
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A pharmacokinetic analysis of Diclofenac Potassium soft-gelatin capsule in patients after bunionectomy.
American journal of therapeutics, 2010Co-Authors: Mark M. Kowalski, Douglas G Stoker, Charles Bon, Keith A. Moore, Stephen E BoesingAbstract: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 (C max ) 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 C max (t max ) 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.
B Chuasuwan - One of the best experts on this subject based on the ideXlab platform.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allowing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8.
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biowaiver monographs for immediate release solid oral dosage forms Diclofenac sodium and Diclofenac Potassium
Journal of Pharmaceutical Sciences, 2009Co-Authors: B Chuasuwan, V Binjesoh, James E Polli, H Zhang, Gordon L Amidon, H E Junginger, K K Midha, V P Shah, Salomon A StavchanskyAbstract:Literature data are reviewed regarding the scientific advisability of allow- ing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either Diclofenac Potassium and Diclofenac sodium. Within the biopharmaceutics classification system (BCS), Diclofenac Potassium and Diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic use, therapeutic index, pharmacokinetic properties, potential for excipient interactions, and performance in reported BE/bioavailability (BA) studies, provided: (a) test and comparator contain the same Diclofenac salt; (b) the dosage form of the test and comparator is identical; (c) the test product contains only excipients present in Diclofenac drug products approved in ICH or associated countries in the same dosage form, for instance as presented in this paper; (d) test drug product and comparator dissolve 85% in 30 min or less in 900 mL buffer pH 6.8, using the paddle apparatus at 75 rpm or the basket apparatus at 100 rpm; and (e) test product and comparator show dissolution profile similarity in pH 1.2, 4.5, and 6.8. 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:1206-1219, 2009