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Abstract Background Investigation of the association between leg axis alignment and biochemical MRI in young professional soccer players in order to identify a potential influence of the leg axis on cartilage regions at risk. Methods Sixteen professional soccer players (21 ± 3 years) underwent static and dynamic leg axis analysis via radiation free DIERS formetric 4 D as well as 3-T MRI examination of both knees. Quantitative T2* mapping of the knee cartilage was performed and T2* values were evaluated as 144 regions of interest. Subgroup analysis was performed in players with severe varus alignment (> 6°). Results Analysis of the leg axis geometry revealed a mean static alignment of 6.6° ± 2.5 varus and a mean dynamic alignment of 5.1° ± 2.6 varus. Quantitative T2* mapping showed significantly increased T2* values in the superficial cartilage layer compared to the deeper region (p

3D printed biomaterial implants are revolutionizing personalized medicine for tissue repair, especially in orthopedics. In this study, a radiopaque bismuth oxide (Bi 2 O 3 ) doped polycaprolactone (PCL) composite is developed and implemented to enable the use of diagnostic X-ray technologies, especially spectral photon counting X-ray computed tomography (SPCCT), for comprehensive tissue engineering scaffold (TES) monitoring. PCL filament with homogeneous Bi 2 O 3 nanoparticle (NP) dispersion (0.8 to 11.7 wt%) are first fabricated. TES are then 3D printed with the composite filament, optimizing printing parameters for small features and severely overhung geometries. These composite TES are characterized via micro-computed tomography (μCT), tensile testing, and a cytocompatibility study, with 2 wt% Bi 2 O 3 NPs providing improved tensile properties, equivalent cytocompatibility to neat PCL, and excellent radiographic distinguishability. Radiographic performance is validated in situ by imaging 4 and 7 wt% Bi 2 O 3 doped PCL TES in a mouse model with μCT, showing excellent agreement with in vitro measurements. Subsequently, CT image-derived swine menisci are 3D printed with composite filament and re-implanted in corresponding swine legs ex vivo. Re-imaging the swine legs via clinical CT allows facile identification of device location and alignment. Finally, the emergent technology of SPCCT unambiguously distinguishes the implanted meniscus in situ via means of color K-edge imaging., Competing Interests: Conflict of Interest The authors declare no conflicts of interest.

3D printed biomaterial implants are revolutionizing personalized medicine for tissue repair, especially in orthopedics. In this study, a radiopaque Bi 2 O 3 doped polycaprolactone ( PCL ) composite is developed and implemented to enable the use of diagnostic X-ray technologies, especially photon counting X-ray computed tomography ( PCCT ), for comprehensive in vivo device monitoring. PCL filament with homogeneous Bi 2 O 3 nanoparticle ( NP ) dispersion (0.8 to 11.7 wt%) are first fabricated. Tissue engineered scaffolds ( TES ) are then 3D printed with the composite filament, optimizing printing parameters for small feature size and severely overhung geometries. These composite TES are characterized via micro-computed tomography ( µ CT ), tensile testing, and a cytocompatibility study, with Bi 2 O 3 mass fractions as low as 2 wt% providing excellent radiographic distinguishability, improved tensile properties, and equivalent cytocompatibility of neat PCL. The excellent radiographic distinguishability is validated in situ by imaging 4 and 7 wt% TES in a mouse model with µCT, showing excellent agreement with in vitro measurements. Subsequently, CT image-derived swine menisci are 3D printed with composite filament and re-implanted in their corresponding swine legs ex vivo . Re-imaging the swine legs via clinical CT allows facile identification of device location and alignment. Finally, the emergent technology of PCCT unambiguously distinguishes implanted menisci in situ.

Introduction: Osteoarthritis (OA) commonly occurs following anterior cruciate ligament reconstruction (ACLR), affecting over 50 % of patients within 10-15 years post-ACLR. The Hoffa-synovitis of the infrapatellar fat pad (IPFP) has been implicated as a major contributor to OA pathogenesis. While MRI is typically used to evaluate the IPFP, it is cost-prohibitive for routine screening. This study aimed to validate ultrasound as an alternative for detecting IPFP Hoffa-synovitis in participants post-ACLR., Methods: In this cross-sectional study, 15 participants (18-35 years, 1-5 years post-ACLR) underwent two imaging sessions separated by one week. First, a standardized bilateral anterior knee ultrasound assessment was used to examine IPFP echo-intensity. Second, MRI scans of both knees were graded by a board-certified musculoskeletal radiologist for Hoffa-synovitis according to the Anterior Cruciate Ligament Osteoarthritis Score grading system. IPFP echo-intensity were quantified on each ultrasound image, and a limb symmetry index (LSI) was calculated to assess between-limb differences. We used an independent t -test and Cohen's d effect sizes to compare IPFP echo-intensity LSI between people with and without MRI-confirmed Hoffa-synovitis., Results: Four of the 15 participants (27 %) exhibited MRI-confirmed Hoffa-synovitis. Significantly higher IPFP echo-intensity LSI values were found in participants with Hoffa-synovitis (32.1 ± 12.1 %) compared to those without (10.5 ± 10.4 %), confirming the ultrasound's ability to distinguish between the two groups ( t = -3.44; p = 0.004; d = 2.01)., Discussion: Ultrasound detects bilateral IPFP signal intensity alterations in participants post-ACLR with MRI-confirmed Hoffa-synovitis. This work should be seen as a proof-of-concept, and further validation in a larger, more diverse sample is essential for verifying these results.

Peposertib is an orally administered inhibitor of DNA-dependent protein kinase. We evaluated the effect of food on its pharmacokinetics, and examined the pharmacokinetics of an oral suspension (OS) of disintegrated tablets, in a phase I, open-label, crossover three-period study (NCT04702698). Twelve healthy volunteers were randomized to one of six treatment sequences. They received a single dose of peposertib 100 mg as film-coated tablets under fasted or fed conditions ("tablet fasted" or "tablet fed") or as an OS under fasted conditions ("OS fasted"), with washout between treatments. Using healthy volunteers was possible because, despite its mechanism of action being suppression of DNA repair, peposertib has shown no genotoxic effect in animals. A mild food effect was observed with peposertib tablets. Fed-to-fasted ratios were: area under the curve from time 0 to time t (AUC 0-t ), 123.81% (90% confidence interval [CI]: 108.04, 141.87%); AUC from zero to infinity (AUC 0-∞ ), 110.28% (90% CI 100.71, 120.77%); and maximum concentration (C max ) 104.47% (90% CI: 79.15, 137.90%). C max was delayed under fed conditions (median time to maximum concentration [T max ] was 3.5 h [tablet fed] vs. 1 h [tablet fasted]). OS-to-tablet (fasted) ratios were: AUC 0-t , 124.83% (90% CI: 111.50%, 139.76%); AUC 0-∞ , 119.05% (90% CI: 104.47, 135.67%); and C max 173.29% (90% CI: 135.78, 221.16%). Median T max was 0.5 h (OS fasted) versus 1 h (tablet). All treatments were well-tolerated in healthy volunteers. Peposertib tablets can be taken with or without food; if combined with chemotherapy or radiotherapy, the delay in C max must be considered to optimize the chemo- or radiosensitizing effect. The peposertib OS form represents an alternative route of administration in patients with specific cancers causing dysphagia. However, the OS form should be part of future dose optimization strategies in relevant settings., (© 2023 Merck KGaA and Nuvisan GmbH. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Macimorelin is an orally active growth hormone secretagogue indicated for the diagnosis of adult growth hormone deficiency. The primary objective of this study was to evaluate the effect of macimorelin on the baseline and placebo-corrected mean QT interval using Fridericia's formula (ΔΔQTcF). Secondary objectives were to determine QTcF for moxifloxacin; evaluate the effects of macimorelin on other cardiac intervals (PR, QRS, RR), heart rate, and electrocardiogram morphology parameters; characterize pharmacokinetics; and assess safety of macimorelin. The phase 1 thorough QT/QTc study, designed according to the International Council for Harmonisation E14 guideline, was a randomized, placebo-controlled, double-blind, 3-way complete crossover study comparing the effect of macimorelin 2.0 mg/kg with placebo and moxifloxacin 400 mg (positive control). Data were collected over a 3-month span from male (n=36) and female participants (n=24) aged 18 to 55 years with body mass index between 18.5 and 30.0 kg/m 2 . Fifty-six participants received all 3 treatments. The ΔΔQTcF for macimorelin showed a prolongation with a maximum mean value of 9.61 milliseconds (2-sided 90% confidence interval, 7.81 milliseconds and 11.41 milliseconds) at 4 hours after dosing. The 2-sided 90% confidence interval of this value also exceeded the 10 millisecond threshold at 3 hours after dosing. Assay sensitivity was confirmed with moxifloxacin. Other electrocardiogram parameters evaluated were not influenced by macimorelin. Macimorelin did not raise other safety concerns and was well tolerated. In summary, a single supratherapeutic dose of macimorelin prolonged cardiac repolarization according to the regulatory guideline., (© 2020 GlaxoSmithKline. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)

Purpose: To compare a femoral physeal sparing anterior cruciate ligament (ACL) reconstruction technique utilizing a posteromedial portal to traditional transphyseal techniques with regards to anatomic tunnel positioning and proximity to important neurovascular structures., Methods: Eight cadaveric knees were obtained for the study. Femoral tunnel guide pins were placed utilizing four different techniques: accessory anterior medial portal, posteromedial portal, trans-tibial, and figure-4 methods. The knees were then dissected and the following measurements taken: distance of each pin to the saphenous and peroneal nerve, popliteus tendon, neurovascular bundle, femoral ACL footprint and articular cartilage, and the angle of the guide pin entering the lateral femoral condyle. Fluoroscopic imaging was taken to determine the disruption of the physeal scar., Results: Posteromedial portal guide pin was significantly closer to the neurovascular bundle, popliteal tendon and saphenous nerve when compared to the other 3 techniques, but was further from the peroneal nerve. It also had the smallest distance from the anatomic footprint of the ACL, and the largest angle to the lateral femoral condyle. The posteromedial portal guide pin had similar distance from the articular cartilage as the accessory anterior medial portal and figure-4 guide pin, with the trans-tibial guide pin being the farthest. The posteromedial portal guide pin failed to disrupt the physeal scar in all specimens, while the other three techniques consistently violated the physeal scar., Conclusion: The posteromedial portal technique offers an appropriate method for anatomic ACL reconstruction while protecting the distal femoral physis from injury. Care needs to be taken with this technique as it comes in closer proximity to some of the important neurovascular structures. This study indicates that posteromedial portal technique is a less technically challenging approach for physeal-sparing ACL repair with special attention required for the protection of neurovascular bundle from potential injury.

Hypericum perforatum L. (St. John's wort) is used to treat mild-to-moderate depression. Its potential safety risks are pharmacokinetic drug interactions via cytochrome P450 (CYP) enzymes and P-glycoprotein, presumably caused by hyperforin. In a phase I, open-label, nonrandomized, single-sequence study, the low-hyperforin Hypericum extract Ze 117 was investigated using a drug cocktail in 20 healthy volunteers. No pharmacokinetic interactions of Ze 117 were observed for CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein. Area under the curve (AUC) and peak plasma concentration (C max ) of the used probe drugs showed 90% confidence intervals (CIs) of the geometric mean ratios of the drugs taken together with Ze 117 vs. probe drug alone, well within the predefined bioequivalence range of 80-125%. Though Ze 117 did not induce dextromethorphan metabolism by CYP2D6, it weakly increased dextromethorphan AUC ratio (mean 147.99, 95% CI 126.32-173.39) but not the corresponding metabolic ratio. Ze 117 does not show clinically relevant pharmacokinetic interactions with important CYPs and P-glycoprotein., (© 2019 Max Zeller & Söhne AG. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Background: A rare cause of patellar tendon (PT) ruptures is complications after bone-PT-bone (BPTB) graft harvest for anterior cruciate ligament (ACL) reconstruction. The atypical tear pattern in these patients can be technically challenging to address., Description of Technique: A Krackow suture fixation of the medial, tibial based PT was fixed with a knotless suture anchor to the patella. A Krackow suture fixation of the lateral, patella based PT was fixed with a knotless suture anchor to the tibia. Fiber Tape was used for an Internal Brace., Patient and Methods: We retrospectively reviewed a single patient with a proximal-medial and distal-lateral PT rupture following BPTB graft harvest for an ACL reconstruction. The described repair technique was used to repair the PT rupture. Follow-up was 6-months. Range of motion (ROM), functional outcome scores, and patient-reported outcomes were assessed and recorded., Results: Six-months postoperatively, the patient has regained full knee extension and flexion to 130 degrees. The patient has good quadriceps strength, and manual muscle testing shows no deficits in the operative leg. The patient is able to perform all of her activities of daily living and is discharged from physical therapy., Conclusion: We describe a novel technique that effectively repairs the atypical PT rupture pattern seen after ACL reconstruction using BPTB autograft. This technique allows for aggressive post-operative rehabilitation in ROM and strengthening., Level of Evidence: Level V., Competing Interests: Conflict of Interest: ML Arthrex Speakers Bureau, (Copyright: © Indian Orthopaedic Research Group.)

Background: Biceps tenotomy and biceps tenodesis are the primary methods of treating biceps pathology. This study describes a new technique of tenotomy with the goal of autotenodesis to give the biceps a higher load to failure and decreased chance of a Popeye deformity., Purpose: The purpose of this study was to evaluate the strength of the "biceps knot", which is an outlet tenodesis of the biceps tendon and compare the biomechanical properties of this technique to tenotomy., Methods: Ten matched cadaver shoulder pairs were used. In the tenotomy group, an arthroscopic tenotomy was performed at the labral biceps junction using a narrow angled biter. For the biceps knot group, a self-retrieving suture passing device was used to pass a suture as far lateral as possible. The suture was passed from just distal to the biceps insertion on the superior labrum and tied with a standard non-sliding arthroscopic knot. The humerus and biceps tendon were rigidly fixed to a materials testing machine and cyclically loaded at 10-20 N for 100 cycles at 1 Hz. After cyclic testing, a 2 N preload was placed on the tendon and the tendon was pulled in line with the bicipital groove until failure., Results: The peak load to failure for the biceps knot was 58.9 N (SEM 8.2 N) and 37.3 N (SEM 4.6 N) for the tenotomy group (p = 0.046). The average stiffness for the biceps knot group was 4.2 N/mm (SEM 0.4 N/mm) and 3.2 N/mm (SEM 0.2 N/mm) for the tenotomy group (p = 0.031)., Conclusion: Performing the biceps knot is a quick, easy and cost effective alternative to the current tenodesis options available.

Background: Adequate folate supplementation in the periconceptional phase is recommended to reduce the risk of neural tube defects. Oral contraceptives may provide a reasonable delivery vehicle for folate supplementation before conception in women of childbearing potential. This study aimed to demonstrate that a fixed-dose combination of an oral contraceptive and levomefolate calcium leads to sustainable improvements in folate status compared with an oral contraceptive + folic acid., Methods: This was a double-blind, randomized, parallel-group study in which 172 healthy women aged 18-40 years received ethinylestradiol (EE)-drospirenone-levomefolate calcium or EE-drospirenone + folic acid for 24 weeks (invasion phase), and EE-drospirenone for an additional 20 weeks (folate elimination phase). The main objective of the invasion phase was to examine the area under the folate concentration time-curve for plasma and red blood cell (RBC) folate, while the main objective of the elimination phase was to determine the duration of time for which RBC folate concentration remained ≥ 906 nmol/L after cessation of EE-drospirenone-levomefolate calcium., Results: Mean concentration-time curves for plasma folate, RBC folate, and homocysteine were comparable between treatment groups during both study phases. During the invasion phase, plasma and RBC folate concentrations increased and approached steady-state after about 8 weeks (plasma) or 24 weeks (RBC). After cessation of treatment with levomefolate calcium, folate concentrations decreased slowly. The median time to RBC folate concentrations falling below 906 nmol/L was 10 weeks (95% confidence interval 8-12 weeks) after cessation of EE-drospirenone-levomefolate calcium treatment. Plasma and RBC folate levels remained above baseline values in 41.3% and 89.3% of women, respectively, at the end of the 20-week elimination phase., Conclusion: Improvements in folate status were comparable between EE-drospirenone-levomefolate calcium and EE-drospirenone + folic acid. Plasma and RBC folate levels remained elevated for several months following cessation of treatment with EE-drospirenone-levomefolate calcium.

The objectives of this study were to establish the basic intravenous (IV) single-dose PK of safinamide and its major human metabolites, the absolute bioavailability (BA) and food effect on safinamide tablets. Fourteen healthy adult male and female subjects received 50 mg safinamide single-dose treatments according to a randomized, 3-period, 2-sequence crossover design: immediate release (IR) tablets, administered after an overnight fast and after a standardized high-fat, high-calorie breakfast, and IV solution, administered over 30 minutes. Treatments were separated by wash-out intervals of at least 17 days. Serial blood samples were collected for 240 hours postdosing to evaluate safinamide parent drug and metabolite concentrations for the determination of PK parameters. The absolute BA of safinamide 50 mg IR tablets was high, with geoMean AUC0-∞ ratios of about 95% (90% CI: 90-99%) indicating that safinamide is virtually completely absorbed after oral administration. Safinamide IR tablets did not display a food effect on exposure parameters; both 90% CIs for the ratios fed/fasted of AUC0-∞ and Cmax were entirely within the bioequivalence acceptance margins of 80-125%. Only tmax was delayed by about 30% in the fed state. Oral and IV safinamide 50 mg single-dose administrations were generally well tolerated., (© The Author(s) 2013.)

Background: Posterior cruciate ligament injuries can occur as isolated ligament ruptures or in association with the multiligament-injured knee. Delayed reconstruction, at 2-3 weeks post-injury, is predominantly recommended for posterior cruciate ligament tears in the multiligament-injured knee. While acute bone and soft tissue avulsion patterns of injury can be amenable to repair, the described techniques have been associated with some difficulties attaching the avulsed ligament., Description of Technique: As part of a reconstruction/repair of a multiligament-injured knee, we performed arthroscopic primary repair of the posterior cruciate ligament by passing Bunnell-type stitches into the substance of the ligament using a reloadable suture passer. We then passed the sutures through drill holes into the femoral footprint of the ligament and tied them over a bony bridge., Patients and Methods: We retrospectively reviewed three patients with posterior cruciate ligament tears associated with a multiligament-injured knee. All patients had posterior cruciate ligament soft tissue avulsions or "peel off" injuries diagnosed by MRI. The described repair technique was used to repair the posterior cruciate ligament avulsion. Minimum followup was 64 months (mean, 68 months; range, 64-75 months). ROM, stability testing, and functional outcome scores (Lysholm and modified Cincinnati) were recorded., Results: Mean ROM was 0° to 127°. Posterior drawer testing was negative in all three patients. The mean Lysholm score was 92 and the mean modified Cincinnati score was 94. Followup MRI confirmed ligament healing in all patients., Conclusions: We believe arthroscopic posterior cruciate ligament repair for soft tissue peel off injuries is a technique that, when applied to carefully selected patients, may be helpful to the surgeon treating patients with a multiligament-injured knee., Level of Evidence: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Background: HX575, licensed under the brand names Binocrit®, Epoetin Alfa Hexal®, and Abseamed®, was approved in 2007 as the first biosimilar recombinant human erythropoietin alfa (epoetin alfa) in the EU using Erypo®/Eprex® as reference product., Objectives: The aim of this study was to investigate the bioequivalence and potency of registered epoetin alfa products that have not been compared before in a randomized controlled clinical study., Methods: The study was conducted in two parts: part A compared the European-marketed HX575 and the US-marketed Epogen®; part B compared the European-marketed Erypo®/Eprex® and HX575 manufactured at two different drug substance production sites (HX575-TT denoting the already-approved technology-transfer product from an additional manufacturing site). In analyses across both study parts, Epogen® was exploratorily compared with Erypo®/Eprex®. A dense-sampling 48-hour pharmacokinetic profile was recorded at steady state after 11 doses of 100 IU epoetin alfa per kg of bodyweight. The hemoglobin response over 4 weeks of study medication administration was analyzed as the primary efficacy surrogate parameter using an ANCOVA model with the baseline value as co-variate. The per-protocol population comprised a total of 268 subjects, 76 in part A (equally randomized to HX575 or Epogen®) and 192 in part B (equally randomized to HX575, HX575-TT, or Erypo®/Eprex®). Pairs of study arms were compared in terms of the ratio of the mean epoetin alfa area under the curve (AUC) and the ratio of the mean hemoglobin area under the effect curve (AUEC)., Results: Bioequivalence was shown in all pair-wise comparisons with the 90% confidence intervals of the AUC ratios falling within the standard bioequivalence limits of 80-125%. Moreover, an equivalent pharmacodynamic response was achieved with all compared epoetin alfa products, as confirmed by the hemoglobin AUEC ratio's 90% CI falling within the predefined acceptance margins of 96.8-103.2%. Thus, bioequivalence and equivalent potency was demonstrated for HX575 and Epogen® in part A of the study, as well as for HX575, HX575-TT and Erypo®/Eprex® in part B of the study. Pair-wise comparison across study parts indicated similar pharmacokinetic and pharmacodynamic profiles of Epogen® and Erypo®/Eprex®. All compared epoetin alfa products were well tolerated and had a similar safety profile. No subject developed anti-erythropoietin antibodies upon administration of study medication., Conclusion: The results show, for the first time in a prospective randomized clinical study, equivalent bioavailability at steady state and similar potency of the US-marketed Epogen® and the European-marketed Binocrit®. Differences in the formulation between the epoetin alfa products had no apparent clinical impact. The high degree of similarity between Epogen® and Erypo®/Eprex® provides justification for linking and comparing results from clinical studies that were conducted using either US- or European-marketed epoetin alfa products.

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.

Objective: 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 characteristics. A diclofenac potassium formulation using proprietary dispersion technology (ProSorb) was developed to overcome these limitations. The authors evaluated and compared the pharmacokinetics (PK) of 2 investigational diclofenac potassium liquid filled soft gelatin capsule (DPSGC) preparations and one investigational diclofenac liquid formulation, each incorporating the proprietary dispersion technology, to establish bioequivalence and identify a formulation for further clinical study., Research Design and Methods: In an open-label, single-dose, three-way crossover, relative bioavailability study, 24 healthy volunteers were randomized to receive each of the 25-mg DPSGC formulations (development processes A and B) and the 1-mL (25-mg) liquid diclofenac formulation (similar to the fill liquid used in the DPSGC products) during three inpatient visits. Each dose was separated by 3 days. Plasma samples were collected at preselected time points through 6 hours post dose. Diclofenac concentrations were determined using a validated HPLC method. Bioequivalence was established within the 80% to 125% acceptance range. Safety and tolerability were monitored throughout., Results: Area under the plasma concentration-time curves (AUC(0-)(t)) for the three formulations were between 577 and 585 ng-hr/mL and peak plasma concentrations (C(max)) were between 958 and 1087 ng/mL, with the DPSGC process B group having the highest C(max). The times to C(max) (t(max)) were all below 30 minutes, with the liquid formulation producing the shortest t(max) (15 minutes). Plasma concentration-time course profiles were similar for all three rapidly dispersing diclofenac potassium formulations. One mild adverse event was observed (lingual paresthesia) and one participant discontinued due to an unrelated event (acute tonsillitis)., Conclusions: These data show that diclofenac potassium formulations using proprietary dispersion technology are rapidly and consistently absorbed. These characteristics may be beneficial in settings where rapid and consistent drug absorption is desirable. These results may differ in other patient populations such as those experiencing pain or illness.