International journal of pharmaceutics
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Randomized Controlled Trial Clinical Trial
Pulmonary and nasal deposition of ketorolac tromethamine solution (SPRIX) following intranasal administration.
Ketorolac tromethamine is a racemic, non-steroidal, anti-inflammatory drug (NSAID). An intra-nasal (IN) formulation, SPRIX(®), is approved for the treatment of short term (up to 5 days) acute moderate to moderately severe pain. The primary objective of this study was to determine whether (99m)Tc-diethylenetriaminepenta acetic acid (DTPA) radiolabelled ketorolac tromethamine formulation (31.5 mg) was deposited in the lungs of healthy subjects (4 men and 9 women) following nasal inhalation of different intensities (gentle or vigorous sniff) and under different postural conditions (upright or semi-supine). ⋯ The visual spread patterns within the nasal cavity were most uniform following administration in the upright position regardless of inhalation manoeuvre. Clearance from the nasal cavity was initially very rapid, with only 16-30% of the dose remaining after 10 min and 6-14% after 6 h. Retention was greatest following gentle inhalation.
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Randomized Controlled Trial Clinical Trial
Menthol facilitates the skin analgesic effect of tetracaine gel.
The aim of this study is to observe the effect of menthol on the percutaneous penetration and skin analgesic action of tetracaine gel (T-gel). Anesthetic gels containing 4% tetracaine in carbomer vehicle with and without menthol were prepared. The menthol penetration-enhanced gel conferred significantly higher diffusion of tetracaine across full-thickness mouse skin than non-penetration-enhanced gel, in a dose-dependent manner. ⋯ To determine the efficacy of menthol penetration-enhanced tetracaine gel in the management of pain, a double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. The mean verbal pain scores (VPS) were significantly lower in volunteers treated with penetration-enhanced tetracaine gel than those in volunteers receiving non-penetration-enhanced tetracaine gel or placebo. Menthol improved the analgesic efficacy of the tetracaine 4% gel in part through enhanced percutaneous permeation.
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Randomized Controlled Trial Comparative Study Clinical Trial
In Check Dial: accuracy for Diskus and Turbuhaler.
The In Check Dial was developed to evaluate whether a patient is able to generate an adequate peak inspiratory flow (PIF) through a certain inhalation device. The inhalation profile recorder (IPR) is a calibrated instrument that measures flows through Diskus and Turbuhaler in our research setting. The aim of this study was to compare the PIFs of patients when inhaling through a Diskus or Turbuhaler connected with the IPR (PIF_diskus and PIF_TH) to the flows through the corresponding orifices of the In Check Dial (Diskus_In Check and TH_In Check). ⋯ Measuring PIF through Diskus and Turbuhaler using the IPR and the In Check Dial, respectively shows a disagreement of 3.9l/min. A disagreement of 3.5l/min was found for the Turbuhaler. The In Check Dial did not identify two of four patients as 'non-optimal' users.