PMID- 26638161
OWN - NLM
STAT- MEDLINE
DCOM- 20170116
LR  - 20181202
IS  - 1434-9949 (Electronic)
IS  - 0770-3198 (Linking)
VI  - 35
IP  - 4
DP  - 2016 Apr
TI  - Pharmacokinetic properties of low-dose SoluMatrix meloxicam in healthy adults.
PG  - 1099-104
LID - 10.1007/s10067-015-3121-9 [doi]
AB  - SoluMatrix(R) 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.
FAU - Hussaini, Azra
AU  - Hussaini A
AD  - PAREXEL International, Baltimore, MD, USA.
FAU - Solorio, Daniel
AU  - Solorio D
AD  - Iroko Pharmaceuticals LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 
      19112, USA.
FAU - Young, Clarence
AU  - Young C
AD  - Iroko Pharmaceuticals LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA, 
      19112, USA. cyoung@iroko.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151205
PL  - Germany
TA  - Clin Rheumatol
JT  - Clinical rheumatology
JID - 8211469
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Tablets)
RN  - 0 (Thiazines)
RN  - 0 (Thiazoles)
RN  - VG2QF83CGL (Meloxicam)
SB  - IM
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/*pharmacokinetics
MH  - Area Under Curve
MH  - Cross-Over Studies
MH  - Drug Compounding
MH  - Fasting
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Meloxicam
MH  - Middle Aged
MH  - Patient Safety
MH  - Solubility
MH  - Tablets
MH  - Thiazines/*pharmacokinetics
MH  - Thiazoles/*pharmacokinetics
MH  - Young Adult
OTO - NOTNLM
OT  - Healthy volunteers
OT  - Meloxicam
OT  - Pharmacokinetics
OT  - SoluMatrix
EDAT- 2015/12/08 06:00
MHDA- 2017/01/17 06:00
CRDT- 2015/12/07 06:00
PHST- 2015/10/12 00:00 [received]
PHST- 2015/11/13 00:00 [accepted]
PHST- 2015/11/12 00:00 [revised]
PHST- 2015/12/07 06:00 [entrez]
PHST- 2015/12/08 06:00 [pubmed]
PHST- 2017/01/17 06:00 [medline]
AID - 10.1007/s10067-015-3121-9 [pii]
AID - 10.1007/s10067-015-3121-9 [doi]
PST - ppublish
SO  - Clin Rheumatol. 2016 Apr;35(4):1099-104. doi: 10.1007/s10067-015-3121-9. Epub 
      2015 Dec 5.