Pharmaceutical composition comprising bicarbonate salt and its use as a medicine for the treatment and / or prevention of urinary lithiasis and related diseases
Solid pharmaceutical composition for oral use in the form of at least one microcompressed tablet, and the tablet consisting of a core comprising at least one bicarbonate salt as an active ingredient and at least one hydrophilic extended release matrix, and a coating that includes the less a coating agent, said composition allowing a continuous release in vivo for a period of about a quarter of an hour and up to twelve hours after taking a single dose, the composition being such that its dissolution occurs independently of pH in a dissolution medium with pH in a range of 1.3 to 7, for use as a medicine for the alkalinization of urine and / or for the treatment and / or prevention of urinary lithiasis and related diseases that manifest at a physiological pH and / or in cases of urinary acidosis in cases of hypocarbonatemia and / or in cases of hypocitraturia and / or in cases of hypercalciu ria and / or in cases of hyperoxaluria, said composition being suitable for releasing the bicarbonate salt in vitro in a solution solution buffered to pH 1.3 with a type 2 dissolution apparatus, according to the European Pharmacopoeia 2.9.3 "Dissolution test for solid pharmaceutical forms", at a rate in a range of 5% to 15% in one hour, at a rate in a range of 35% to 55% in five hours and at a rate in a range from 70% to 90% in ten hours.Composición farmacéutica sólida para uso oral en forma de al menos un microcomprimido, y estando el comprimido constituido por un núcleo que comprende al menos una sal de bicarbonato como principio activo y al menos una matriz hidrófila de liberación prolongada, y por un revestimiento que incluye al menos un agente de revestimiento, permitiendo dicha composición una liberación continua in vivo durante un plazo de aproximadamente un cuarto de hora y hasta doce horas después de la toma de una dosis única, siendo tal la composición que su disolución se produce de forma independiente del pH en un medio de disolución con pH en un intervalo de 1,3 a 7, p
