RESUMEN
Background: Gastroesophageal reflux disease (GERD) is a common clinical condition in Indian population. Antacids, which are available as over the counter (OTC) are the commonly prescribed drugs for treatment of GERD. Antacids manufactured and marketed by various multinational and local companies are available in the market. There is need for evaluating the cost effectiveness and efficacy of these antacids as a matter of public concern. Hence the present study was conducted to evaluate the cost effectiveness and efficacy of the commonly prescribed antacid gel preparations. Methods: Seven different gel formulations of antacids manufactured by different companies were evaluated. Cost effectiveness was done by calculating the cost per ml of antacid and also by palatability test. Efficacy was evaluated based on acid neutralizing capacity (ANC) of antacid preparations. Results: The highest cost was 0.305 Rs. per ml and lowest was 0.135 Rs per ml. Palatability score was high at 26.80 and low at 23.85. The antacid with lowest ANC was 20.5 mEq and the highest was 26.5 mEq. Conclusion: Cost effectiveness studies are beneficial in improving the prescribing pattern. It will be a benefit for both doctor as well as patient.
RESUMEN
Neste estudo buscou-se desenvolver formulações de comprimidos tamponados mastigáveis (CTM) de didanosina com eficiência de dissolução (ED%) e capacidade neutralizante ácida (CNA) otimizados, tendo como base o medicamento referência e especialidades farmacêuticas disponíveis no mercado nacional. Cinco formulações de CTM foram produzidas e avaliadas quanto a ED% e CNA, por meio de ensaio de dissolução e titulação ácido-base, respectivamente. Os resultados iniciais de CNA foram próximos aos encontrados para as especialidades farmacêuticas, aproximadamente 12 mEq HCl, porém distantes do medicamento referência (especialidade A, CNA = 17,93 mEq HCl). Já as formulações derivadas de CTM-4 conduziram à obtenção de comprimidos tamponados com CNA otimizada de aproximadamente 17,5 mEq HCl, o mesmo ocorrendo para ED%, (61,33% e 62,00%, CTM-4-2-1 e3, respectivamente). Esse resultado mostra-se próximo ao valor de 59,33% da especialidade A, quando utilizado o mesmo método de dissolução, indicando haver equivalência entre estas formulações e o medicamento referência para estes parâmetros.
The aim in this study was to develop chewable buffered tablets (CBT) of didanosine with optimized dissolution efficiency (DE) and acid-neutralizing capacity (ANC), using the reference medicine and other pharmaceutical didanosine products available in Brazil as models. Five CBT formulations were prepared and assessed for DE and ANC, through the dissolution test and acid-base titration, respectively. The initial ANC results fell short of those for the reference medicine (product A, ANC= 17.93 mEq HCl), but were close to those obtained for other pharmaceutical products (approximately 12 mEq HCl). The formulations derived from CBT-4 resulted in buffered tablets with an optimized ANC of 17.5 mEq HCl, approximately. The same was found for DE (61.33% and 62.00%, CBT-4-2-1 and CBT 3, respectively). This result proved to be close to that of product A (59.33%), when the same method was used for the dissolution test, indicating that both formulations and the reference medicine were equivalent with respect to these properties.