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Sheridan M Hoy
An intravenous bolus formulation of the non-steroidal anti-inflammatory drug diclofenac sodium has been developed using hydroxypropyl-β-cyclodextrin (HPβCD) as a solubility enhancer. HPβCD diclofenac (Dyloject(TM)) is available for use in adults in the USA for the management of mild to moderate pain, and as monotherapy or in combination with opioid analgesics for the management of moderate to severe pain. In two multicentre, phase III studies in adults with acute moderate to severe postoperative pain, HPβCD diclofenac significantly reduced pain intensity and the need for rescue medication compared with placebo...
August 2016: Drugs
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December 21, 2015: Medical Letter on Drugs and Therapeutics
Fred Mermelstein, Douglas A Hamilton, Curtis Wright, Peter G Lacouture, Atulkumar Ramaiya, Daniel B Carr
STUDY OBJECTIVE: To evaluate single- and repeated-dose pharmacokinetics (PK) and dose proportionality of hydroxypropyl-β-cyclodextrin (HPβCD)-diclofenac compared with Voltarol after intravenous (IV) and intramuscular (IM) administration. DESIGN: Study 1: Single-dose randomized four-way crossover study. Study 2: Multiple-dose randomized three-way crossover study. SETTING: Clinical research center. SUBJECTS: Healthy adult volunteers...
October 2013: Pharmacotherapy
Stephen Daniels, Timothy Melson, Douglas A Hamilton, Eric Lang, Daniel B Carr
OBJECTIVES: A novel injectable formulation of diclofenac, Dyloject, utilizes hydroxypropyl-β-cyclodextrin (HPβCD) as a solubilizing agent, allowing dosing as a small-volume intravenous bolus for postoperative pain. In this test of the efficacy and safety of HPβCD diclofenac, we hypothesized that HPβCD diclofenac would relieve moderate and severe pain after orthopedic surgery. PATIENTS AND METHODS: Adults 18 to 85 years old with moderate and severe pain within 6 hours after surgery were randomized to HPβCD diclofenac, ketorolac tromethamine, or placebo, and stratified by risk cohort...
August 2013: Clinical Journal of Pain
Tong J Gan, Stephen E Daniels, Neil Singla, Douglas A Hamilton, Daniel B Carr
BACKGROUND: Injectable formulations of diclofenac have long been available in Europe and other countries. These formulations use a default dose of 75 mg of diclofenac delivered IV over 30 to 120 minutes or as an IM injection. A novel formulation of injectable diclofenac sodium, Dyloject®, is solubilized with hydroxypropyl β-cyclodextrin (HPβCD) so that it can be given IV or IM in a small volume bolus. In this multicenter, multiple-dose, multiple-day, randomized, double-blind, parallel-group phase 3 study, we investigated whether lower doses of HPβCD diclofenac delivered as a small volume bolus would be effective for the management of acute pain after abdominal or pelvic surgery...
November 2012: Anesthesia and Analgesia
Kyle Christensen, Stephen Daniels, Donald Bandy, Cynthia C Ernst, Douglas A Hamilton, Fred H Mermelstein, Jianyuan Wang, Daniel B Carr
Dyloject is a novel formulation of diclofenac intended for intravenous (IV) administration. This formulation employs the solubilizing agent hydroxypropyl-β-cyclodextrin to permit bolus IV administration. The efficacy and safety of 5 dose levels of IV diclofenac were compared with IV ketorolac and placebo following third molar extraction. This was a single-dose, randomized, double-blind, placebo- and comparator-controlled, parallel-group study. A total of 353 subjects with moderate to severe pain received placebo; ketorolac 30 mg; or IV diclofenac 3...
2011: Anesthesia Progress
Kenneth A Bauer, William Gerson, Curtis Wright, Jianyuan Wang, Ewan McNicol, Ryan K Lanier, William Kramer, Daniel B Carr
STUDY OBJECTIVE: To assess platelet function and safety following single-dose administration of a novel formulation of intravenous (IV) diclofenac sodium (Dyloject) 37.5 mg versus oral diclofenac 50 mg, IV ketorolac 30 mg, and oral acetylsalicylic acid (ASA) 325 mg. DESIGN: Open-label, randomized, single-dose, 4-treatment crossover study. SETTING: Clinical research unit. PATIENTS: 30 healthy, ASA physical status I adult men...
November 2010: Journal of Clinical Anesthesia
Paul L McCormack, Lesley J Scott
*A new formulation of the nonselective NSAID diclofenac sodium suitable for intravenous bolus injection has been developed using hydroxypropyl beta-cyclodextrin as a solubility enhancer (HPbetaCD diclofenac). * HPbetaCD diclofenac intravenous bolus injection was shown to be bioequivalent to the existing parenteral formulation of diclofenac containing propylene glycol and benzyl alcohol as solubilizers (PG-BA diclofenac), which is relatively insoluble and requires slow intravenous infusion over 30 minutes. * Single-dose HPbetaCD diclofenac 3...
2008: Drugs
Rachel M Leeson, Sheelah Harrison, Cynthia C Ernst, Douglas A Hamilton, Fred H Mermelstein, Daniel G Gawarecki, Michael Moshman, Daniel B Carr
BACKGROUND AND OBJECTIVES: Voltarol for injection (a diclofenac sodium formulation employing polyethylene glycol and benzyl alcohol [PG-BA] as excipients) is marketed in Europe but not in North America. A suspension, PG-BA diclofenac sodium, requires preparation for each patient and slow IV infusion to minimize venous irritation. Dyloject, a novel diclofenac formulation, employs hydroxypropyl beta-cyclodextrin (HPbetaCD) to solubilize diclofenac in a small volume. We compared the efficacy and safety of an IV HPbetaCD diclofenac sodium bolus, a 30-minute PG-BA diclofenac sodium infusion, and placebo in post-molar extraction pain...
July 2007: Regional Anesthesia and Pain Medicine
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