Novel HPTLC densitometric methods for determination of tamsulosin HCl and tadalafil in their newly formulated dosage form: Comparative study and green profile assessment.

A promising combination of tamsulosin HCl and tadalafil has recently been introduced for treating two prevalent and associated urological disorders: benign prostate hyperplasia and erectile dysfunction. Novel HPTLC methods were designed and validated for assaying the cited drugs in their challenging combined formulation. Separation was achieved using HPTLC silica gel 60 F254 plates as a stationary phase with a densitometric measurement at 280 nm. The proposed methods with two different chromatographic systems were successfully applied: a conventional mixture (method I) of ethyl acetate-toluene-methanol-ammonia (5:3:2:0.5, by volume) and a greener one (method II) with ethyl acetate-ethanol-ammonia (8:2:0.1, by volume). The two methods were evaluated through a comparative study in terms of selectivity, tailing factor, developing time and concentration ranges. The greenness profile for each method was then appraised with several green guides, namely GlaxoSmithKline solvent sustainability guide, Environmental, Health and Safety (EHS) tool, National Environmental Method Index (NEMI) and Eco-scale. Moreover, method specificity and peak homogeneity were evaluated by peak purity assessment using the winCATS® software spectral correlation tool. The methods have potential for being simple, fast, economic and selective, and the greener one could be a good option for sustainable analysis of the drugs.

Falsified vardenafil tablets available online.

It is often reported that falsified medicines have harmful effects on patients both Japan and abroad. In this study, we purchased vardenafil tablets on the internet and investigated their quality and authenticity using visual observations, authenticity investigations, non-destructive tests (handheld NIR and Raman spectroscopy), and quality analyses (active ingredient content and tablet dissolution rate). We used genuine 20-mg Levitra tablets that were sold in Japan and tablets from Bayer AG (Germany) as controls. In April 2015, we obtained 28 samples from 15 websites on the internet. Our authenticity investigations revealed that 11 (40%) were genuine products and 17 (60%) were falsified products. Handheld NIR and Raman results revealed that the falsified products had different spectra to the genuine products. Principal component analysis of the NIR and Raman spectra showed variation among the falsified products. The 11 genuine products were of good quality, and the 17 falsified products were of poor quality. The falsified products contained sildenafil (the active ingredient of Viagra) or tadalafil (the active ingredient of Cialis) instead of vardenafil. Our results show that falsified Vardenafil tablets are sold on the internet and that it is important to prevent illegal internet sales and increase consumer awareness of the presence of falsified medicines.

Smart spectrophotometric assessment of tamsulosin hydrochloride and tadalafil in their new pharmaceutical formulation for treatment of benign prostatic hyperplasia and erectile dysfunction.

A novel combination of tamsulosin hydrochloride and tadalafil is recently available for treatment of benign prostatic hyperplasia and erectile dysfunction. For the first time, four simple, accurate, smart and robust spectrophotometric methods have been suggested for their simultaneous quantification. The methods, namely; first derivative, ratio difference, derivative ratio and mean centering of ratio spectra, successfully resolved the spectral overlap of their challenging binary mixture. Calibration curves were linear at 2.0-40.0 and 2.0-55.0 µg/mL for tamsulosin hydrochloride and tadalafil, respectively. The methods were validated according to ICH guidelines and statistically compared with the official ones, revealing no considerable difference with respect to accuracy and precision. Specificity of the developed methods was assessed by evaluating various laboratory prepared mixtures. Furthermore, the methods were successfully applied for the quantification of the two drugs in their combined dosage form.

Tadalafila indicado para o tratamento da hipertensão arterial pulmonar / Tadalafil indicated for the treatment of pulmonary arterial hypertension

A hipertensão pulmonar é uma síndrome clínica e hemodinâmica, que resulta no aumento da resistência vascular na pequena circulação, elevando os níveis pressóricos na circulação pulmonar. A hipertensão arterial pulmonar (HAP) é definida como pressão arterial pulmonar média maior ou igual a 25mmHg em repouso ou maior que 30mmHg ao fazer exercícios, com pressão de oclusão da artéria pulmonar ou pressão de átrio direito menor ou igual a 15mmHg, medidas por cateterismo cardíaco. Pela diversidade de fatores etiopatogênicos, a adequada investigação diagnóstica é determinante no planejamento terapêutico. A HAP idiopática é uma doença rara, com maior ocorrência entre mulheres (1,7 mulheres para 1 homem) e incidência de aproximadamente 6 casos por milhão de habitantes por ano. Compromete principalmente indivíduos jovens. Entre as mulheres a prevalência é maior na terceira década e entre os homens na quarta década de vida. Atualmente, não existe evidência disponível que comprove superioridade de eficácia da tadalafila em relação à sildenafila. Existe um único estudo (ensaio clínico randomizado controlado duplo-cego) com tadalafila comparado a placebo para o tratamento de HAP, no qual se observou uma substancial imprecisão nos seus resultados em virtude do grande intervalo de confiança. Ademais, o custo de tratamento mensal por paciente com a tadalafila para HAP seria o dobro do com sildenafila, medicamento já incorporado ao SUS. Assim, os membros da CONITEC presentes na 8ª reunião ordinária, do dia 06/09/2012, por unanimidade, recomendaram a não incorporação da tadalafila para o tratamento da Hipertensão Arterial Pulmonar no SUS. Os membros da CONITEC presentes na reunião do plenário do dia 07/12/2012, por unanimidade, ratificaram a deliberação de não recomendar a incorporação do medicamento tadalafila para o tratamento da Hipertensão Arterial Pulmonar. A Portaria No-9, 5 de março de 2013 - Torna pública a decisão de não incorporar o medicamento tadalafila para o tratamento da hipertensão arterial pulmonar no Sistema Único de Saúde (SUS).