High-performance liquid chromatographic assay for piroxicam in human plasma

Boudinot, F. Douglas; Ibrahim, Safaa

doi:10.1016/s0378-4347(00)83181-3

Cited by 26 publications

(12 citation statements)

References 6 publications

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“…As noted in the introduction, the double peak phenomena is reported for piroxicam [4][5][6][7][8][9], ranitidine [10][11][12][13][14][15][16], talinolol [18,19], alprazolam [20], phenazopyridine [21] and many other drugs in humans. Ranitidine double peaks are reportedly caused by multiple site absorption [10,17].…”

Section: Resultsmentioning

confidence: 99%

“…Double peak absorption has been described with several orally administered drugs such as cimetidine [1,2], furosemide [3], piroxicam [4][5][6][7][8][9], ranitidine [10][11][12][13][14][15][16][17], talinolol [18,19], alprazolam [20] and phenazopyridine [21]. Several possible explanations are stated for double peak phenomena; some of the double or multiple peak phenomena can be explained sufficiently by a parallel first order absorption model or a multisegment absorption model.…”

Section: Introductionmentioning

confidence: 99%

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A simple pharmacokinetics subroutine for modeling double peak phenomenon

Mirfazaelian¹,

Mahmoudian²

2006

Biopharm. Drug Dispos.

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Double peak absorption has been described with several orally administered drugs. Numerous reasons have been implicated in causing the double peak. DRUG-KNT--a pharmacokinetic software developed previously for fitting one and two compartment kinetics using the iterative curve stripping method--was modified and a revised subroutine was incorporated to solve double-peak models. This subroutine considers the double peak as two hypothetical doses administered with a time gap. The fitting capability of the presented model was verified using four sets of data showing double peak profiles extracted from the literature (piroxicam, ranitidine, phenazopyridine and talinolol). Visual inspection and statistical diagnostics showed that the present algorithm provided adequate curve fit disregarding the mechanism involved in the emergence of the secondary peaks. Statistical diagnostic parameters (RSS, AIC and R2) generally showed good fitness in the plasma profile prediction by this model. It was concluded that the algorithm presented herein provides adequate predicted curves in cases of the double peak phenomenon.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A simple pharmacokinetics subroutine for modeling double peak phenomenon

Mirfazaelian¹,

Mahmoudian²

2006

Biopharm. Drug Dispos.

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“…Plasma piroxicam concentrations were determined by a modified HPLC method [24]. Calibration samples were prepared by making the appropriate dilution of stock solution of piroxicam (1 mg/mL in 0.04 M phosphate buffer pH 8.0) in drug free rat plasma.…”

Section: Methodsmentioning

confidence: 99%

Enhanced Dissolution and Oral Bioavailability of Piroxicam Formulations: Modulating Effect of Phospholipids

et al. 2010

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Several biologically relevant phospholipids were assessed as potential carriers/additives for rapidly dissolving solid formulations of piroxicam (Biopharmaceutics Classification System Class II drug). On the basis of in vitro dissolution studies, dimyristoylphosphatidylglycerol (DMPG) was ranked as the first potent dissolution rate enhancer for the model drug. Subsequently, the solid dispersions of varying piroxicam/DMPG ratios were prepared and further investigated. Within the concentration range studied (6.4-16.7 wt %), the dissolution rate of piroxicam from the solid dispersions appeared to increase as a function of the carrier weight fraction, whereas the cumulative drug concentration was not significantly affected by piroxicam/DMPG ratio, presumably due to a unique phase behavior of the aqueous dispersions of this carrier phospholipid. Solid state analysis of DMPG-based formulations reveled that they are two-component systems, with a less thermodynamically stable form of piroxicam (Form II) being dispersed within the carrier. Finally, oral bioavailability of piroxicam from the DMPG-based formulations in rats was found to be superior to that of the control, as indicated by the bioavailability parameters, cmax and especially Tmax (53 μg/mL within 2 h vs. 39 μg/mL within 5.5 h, respectively). Hence, DMPG was regarded as the most promising carrier phospholipid for enhancing oral bioavailability of piroxicam and potentially other Class II drugs.

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“…Within-and between-day precision and accuracy of the 3 QCs and LLOQ of piroxicam in human plasma were listed in Table 1. [5][6][7][8][9] Pharmacokinetics and Bioequivalence Evaluation Precision was expressed as the percentage of the CV.…”

Section: Assay Validationmentioning

confidence: 99%

“…1,2 Due to the long half life ($50 hours) of piroxicam, steady-state blood levels are reached within 7-12 days. [5][6][7][8][9] However, a new simple technique, compared with the existing methods, was developed and successfully validated according to the guidelines of Food and Drug Administration (FDA). 4 The metabolism of piroxicam is predominantly mediated via cytochrome P450 2C9.…”

mentioning

confidence: 99%

Piroxicam immediate release formulations: A fasting randomized open‐label crossover bioequivalence study in healthy volunteers

Helmy

El-Bedaiwy

2014

Clinical Pharm in Drug Dev

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Piroxicam is a NSAID with analgesic and antipyretic properties, used for the treatment of rheumatoid diseases. The aim of this study was to evaluate the bioequivalence of two brands of piroxicam capsules (20 mg) in 24 Egyptian volunteers. The in vivo study was established according to a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study with a washout period of 3 weeks. Under fasting conditions, 24 healthy male volunteers were randomly selected to receive a single oral dose of one capsule (20 mg) of either test or reference product. Plasma samples were obtained over a 144-hour interval and analyzed for piroxicam by HPLC with UV detection. The pharmacokinetic parameters Cmax , tmax , AUC0-t , AUC0-∞ , Vd /F, Cl/F, and t1/2 were determined from plasma concentration-time profiles. The 90% confidence intervals for the ratio of log transformed values of Cmax , AUC0-t , and AUC0-∞ of the two treatments were within the acceptable range (0.8-1.25) for bioequivalence. From PK perspectives, the two piroxicam formulations were considered bioequivalent, based on the rate and extent of absorption. No adverse events occurred or were reported after a single 20-mg piroxicam and both formulations were well-tolerated.

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High-performance liquid chromatographic assay for piroxicam in human plasma

Cited by 26 publications

References 6 publications

A simple pharmacokinetics subroutine for modeling double peak phenomenon

A simple pharmacokinetics subroutine for modeling double peak phenomenon

Enhanced Dissolution and Oral Bioavailability of Piroxicam Formulations: Modulating Effect of Phospholipids

Piroxicam immediate release formulations: A fasting randomized open‐label crossover bioequivalence study in healthy volunteers

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