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Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults

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Abstract

SoluMatrix® meloxicam has been developed using SoluMatrix Fine Particle Technology™ to produce a meloxicam drug product with enhanced absorption properties to enable treatment at lower doses than available oral meloxicam drug products. This follows recognition of serious dose-dependent adverse events (AEs) associated with nonsteroidal anti-inflammatory drugs, including meloxicam. This study investigated the pharmacokinetic (PK) properties of SoluMatrix meloxicam 5-mg (fasting conditions) and 10-mg capsules (fasting and fed conditions) and compared SoluMatrix meloxicam 10-mg capsules with meloxicam 15-mg tablets under fasting conditions. This four-period crossover study randomized 28 healthy adult participants to receive single doses of SoluMatrix meloxicam 5-mg capsules (fasting) and 10-mg capsules (fasting or fed) and meloxicam tablets 15 mg (fasting). Meloxicam plasma concentrations were assessed through 96 h postdose. Safety was assessed. Twenty-five participants (89.3 %) completed the study. Under fasting conditions, SoluMatrix meloxicam 10 mg [1252.8 (254.22) ng/mL] produced similar meloxicam mean (standard deviation (SD)) maximum plasma concentrations vs meloxicam 15-mg tablets [1288.8 (424.40) ng/mL]. The overall mean (SD) systemic meloxicam exposure was 33 % lower for SoluMatrix meloxicam 10 mg [29,173.01 (11,042.09) ng*h/mL] vs meloxicam 15-mg tablets [40,875.6 (11,733.47) ng*h/mL]. The median time to maximum plasma meloxicam levels occurred earlier following SoluMatrix meloxicam 5 mg (2.0 h) and 10 mg (2.0 h) administration vs meloxicam 15-mg tablets (4.0 h). Few study-medication-related AEs were reported. SoluMatrix meloxicam 10 mg was more rapidly absorbed and associated with a lower overall exposure compared with meloxicam 15-mg tablets in this study in healthy adults under fasting conditions.

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Notes

  1. SoluMatrix® is a registered trademark of iCeutica Pty Ltd and is licensed to Iroko.

  2. SoluMatrix Fine Particle Technology ™ is a trademark of iCeutica Inc., and the technology is licensed to Iroko for exclusive use in NSAIDs.

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Acknowledgments

This study was sponsored by Iroko Pharmaceuticals, LLC. Editorial assistance from Jill See, PhD; and Cole Brown, MD; of AlphaBioCom, LLC, was funded by Iroko. The authors thank Alexis Gomez, Olaolu Imasogie, Claire Sheridan, Melanie Lauterio, Jason Ferrante, and the participants and investigators who participated in this study.

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Authors and Affiliations

  1. PAREXEL International, Baltimore, MD, USA

    Azra Hussaini

  2. Iroko Pharmaceuticals LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 19112, USA

    Daniel Solorio & Clarence Young

Authors
  1. Azra Hussaini
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  2. Daniel Solorio
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  3. Clarence Young
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Corresponding author

Correspondence to Clarence Young.

Ethics declarations

PAREXEL International Corporation (Baltimore, MD, USA) conducted the study and analyses. The study was approved by the Aspire Institutional Review Board (Santee, CA, USA) and conducted in accordance with the Declaration of Helsinki, including the International Conference on Harmonisation principles of Good Clinical Practice [9, 10]. Participants provided written informed consent prior to study conduct.

Conflict of interest

Azra Hussaini is an employee of PAREXEL International Corporation, Baltimore, MD, USA. Daniel Solorio and Clarence Young are employees of Iroko Pharmaceuticals, LLC, Philadelphia, PA, USA.

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Hussaini, A., Solorio, D. & Young, C. Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults. Clin Rheumatol 35, 1099–1104 (2016). https://doi.org/10.1007/s10067-015-3121-9

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  • DOI: https://doi.org/10.1007/s10067-015-3121-9

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