Determination of fluticasone propionate in nasal sprays by a validated stability-indicating MEKC method.
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A micellar electrokinetic chromatography method (MEKC) is developed and validated for the analysis of fluticasone propionate (FP) in nasal sprays. The MEKC method is performed on a fused-silica capillary (50 mum i.d.; effective length, 40 cm). The background electrolyte consists of 25 mM borate and 25 mM anionic detergent SDS solution at pH 9. The capillary temperature is maintained at 35 degrees C, and the applied voltage is 20 kV. The injection is performed using the hydrodynamic mode at 50 mbar for 6 s with detection at 238 nm. The method is linear in the range of 2-80 mug/mL (r(2) = 0.9956). The specificity and stability-indicating capability are proven through forced degradation studies inclusive by mass spectrometry, which also shows that there is no interference of the excipients. The limit of detection and limit of quantitation are 0.56 and 2 mug/mL, respectively. Moreover, method validation demonstrates acceptable results for accuracy, precision, and robustness. The proposed method was successfully applied for the quantitative analysis of FP nasal sprays, and the results were compared to a validated reversed-phase liquid chromatographic method, showing non-significant difference (P > 0.05). (+info)
Inhalation delivery of a novel diindolylmethane derivative for the treatment of lung cancer.
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Enhanced absorption of Nasulin, an ultrarapid-acting intranasal insulin formulation, using single nostril administration in normal subjects.
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BACKGROUND: This pharmacokinetic (PK) study was designed to investigate the maximum intranasal insulin dose that could be achieved by repeated doses in a single nostril of a nasal spray of recombinant regular human insulin 1% in combination with cyclopentadecalactone (CPE-215) 2%, a compound that enhances absorption of molecules across mucous membranes (Nasulin, CPEX Pharmaceuticals, Inc.). METHOD: A nine-period crossover study of 8 healthy, nonsmoking subjects (ages 18-50, body mass index <33 kg/m(2), weight >70 kg) were studied. In a fasted state, subjects were randomly given 25, 50, and 75 U in a single nostril on the first day and randomly given 50, 75, and 100 U doses utilizing both nostrils on two subsequent days. After a 45-minute PK assessment, subjects were given a meal. To determine the mechanism of enhanced absorption in a single nostril, a second study utilizing 24 subjects under similar conditions received 25 U, placebo (P) that included CPE-215 plus 25 U, and 50 U in a single nostril. RESULTS: Single nostril administration revealed enhanced absorption with maximum concentrations (C(max)) of 13, 65, and 96 microU/ml for the 25, 50, and 75 U doses, respectively. Dual nostril administration in two cohorts resulted in C(max) of 31/42, 65/52, and 88/79 microU/ml for the 50, 75, and 100 U, respectively. In the second cohort, C(max) was 23, 19, 56 microU/ml for the 25, P + 25, and 50 U doses, respectively. CONCLUSIONS: Repeated dosing in a single nostril resulted in enhanced absorption; this was not due to the increased CPE-215 but to the increased insulin administered. (+info)
The nasal dendritic cell-targeting Flt3 ligand as a safe adjuvant elicits effective protection against fatal pneumococcal pneumonia.
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