Capsaicin 8% dermal patch in clinical practice: an expert opinion.

INTRODUCTION: Neuropathic pain (NP) is caused by a lesion or disease of the somatosensory system, which can severely impact patients' quality of life. The current-approved treatments for NP comprise of both centrally acting agents and topical drugs, including capsaicin 8% dermal patches, which is approved for the treatment of peripheral NP. AREAS COVERED: The authors summarize literature data regarding capsaicin use in patients who suffer from NP and discuss the clinical applications of this topical approach. EXPERT OPINION: Overall, the capsaicin 8% dermal patch is as effective in reducing pain intensity as other centrally active agents (i.e. pregabalin). Some studies have also reported fewer systemic side effects, a faster onset of action and superior treatment satisfaction compared with systemic agents. In our opinion, capsaicin 8% dermal patches also present additional advantages, such as a good systemic tolerability, the scarcity of adverse events, the possibility to combine it with other agents, and a good cost-effective profile. It is important to note that, as the mechanism of action of capsaicin 8% is the 'defunctionalization' of small afferent fibers through interaction with TRPV1 receptors, the peripheral expression of this receptor on nociceptor fibers, is crucial to predict patient's response to treatment.

Narrative medicine to highlight values of Italian pain therapists in a changing healthcare system.

Until 2010 pain management in Italy was only partially covered and no structural and qualitative mapping had ever been realized. The VEDUTA project was designed to provide a tool to unite pain therapists in national cooperation. Quantitative questionnaires and narrative plots were sent to 350 Italian specialists; 184 therapists completed the first section and 87 also wrote their stories. Narratives were analyzed through transactional analysis and emotional intelligence. Overall, results show that a patient-centered approach is common in daily practice, but that bureaucracy is endangering quality of care. This cultural analysis, through both the application of quantitative assessment and narrative plots, provides a useful tool to improve those aspects of the system detrimental to the appropriate management of pain in Italy.

Bioequivalence of ticlopidine hydrochloride administered in single dose to healthy volunteers.

Ticlopidine hydrochloride (CAS 55142-85-3) is an inhibitor of platelet aggregation used in the management and prevention of thromboembolic disorders.A new formulation of ticlopidine hydrochloride (test) was compared to the reference Tiklid, present in the market, in order to assess their bioequivalence and to register the new formulation as a generic according to the Abbreviated New Drug Application (ANDA) procedure.Twenty-four healthy male volunteers were treated with the two formulations (one tablet containing 250mg of active ingredient) according to a single-dose, balanced, crossover, double-blind design with a washout between the two study periods. Plasma concentration of ticlopidine was assayed in timed samples over a 24h-period with a well-validated HPLC method with UV detection, which allowed 5ngml(-1) to be assayed as the lowest quantifiable concentration. The double-blind key was disclosed only after having completed the assay of unknown samples. From plasma concentrations, C(max), t(max), AUC(0-t), AUC(0- infinity ) and t(1/2) were evaluated through non-compartmental pharmacokinetic analysis. C(max) and AUCs were log(10)- transformed and statistically processed using crossover ANOVA. No statistically significant formulation, period, or sequence effect was encountered. Ninety percent confidence intervals of C(max) and AUCs were comprised in the stipulated 0.80-1.25 range. Similarly, Schuirmann's test led to statistically significant degrees on both the sides explored. Time to peak, t(max), processed with the non-parametric Kruskal-Wallis' test, did not show any statistically significant degree. According to guidelines operating in Europe, the test formulation of ticlopidine hydrochloride can be declared bioequivalent with the reference, both formulations in 250mg tablets.