Abstract:
PROBLEM TO BE SOLVED: To provide solid pharmaceutical combinations for oral administration, comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in a sustained release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. SOLUTION: Provided is a pharmaceutical composition to alter lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, wherein the pharmaceutical composition contains a solid oral dosage form for once per day single dose, the dosage form contains from about 250 mg to about 3,000 mg sustained release form nicotinic acid and from about 0.1 mg to about 80 mg immediate-release statin, and after the pharmaceutical composition is ingested by an individual, almost 100% of the nicotinic acid is released in blood flow within about 4 to about 8 hr. COPYRIGHT: (C)2010,JPO&INPIT
Abstract:
The disclosure relates to solid pharmaceutical combinations for oral administration comprising nicotinic acid or a nicotinic acid compound or mixtures thereof in an extended release form and an HMG-CoA reductase inhibitor, which are useful for altering lipid levels in subjects suffering from, for example, hyperlipidemia and atherosclerosis, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis. The disclosure also relates to methods of altering serum lipids in subjects to treat, for example, hyperlipidemia in hyperlipidemics, lipidemia in normolipidemics diagnosed with or predisposed to cardiovascular disease, and atherosclerosis, by administering such oral solid pharmaceutical combinations once per day as a single dose during the evening hours, without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, or without causing in at least an appreciable number of individuals drug-induced hepatotoxicity, myopathy or rhabdomyolysis to such a level that discontinuation of such therapy would be required. More particularly, the disclosure concerns oral solid pharmaceutical combinations comprised of, for example, (1) an HMG-CoA reductase inhibitor for immediate or extended release, (2) nicotinic acid, a nicotinic acid compound or mixtures thereof, and (3) a swelling agent to form a sustained release composition for extended release of the nicotinic acid or nicotinic acid compound or mixtures thereof for nocturnal or evening dosing for reducing serum lipids and increasing HDL-cholesterol. In accordance with the disclosure, and by way of example, a composition for oral administration during the evening hours to alter serum lipids comprised of nicotinic acid and hydroxypropyl methylcellulose in the form of an extended or sustained release tablet or caplet coated with a coating comprising an HMG-CoA reductase inhibitor in immediate release form is disclosed. Also in accordance with the disclosure, the pharmaceutical combinations may include a nonsteroidal anti-inflammatory agent for reducing the capacity of nicotinic acid or nicotinic acid compounds to provoke flushing reactions in individuals. (62) Divided out of 502522
Abstract:
A pharmaceutical composition for once per day administration to alter lipids in an individual without causing drug-induced hepatotoxicity, myopathy or rhabdomyolysis, said pharmaceutical composition comprising an effective lipid-altering amount of a nicotinic acid compound or combinations of nicotinic acid compounds in an extended release form and an effective lipid-altering amount of an HMG-CoA reducatase inhibitor. (62) Divided out of 502549
Abstract:
Un constructo farmacéutico que comprende: (a) al menos una primera región del constructo que comprende un primer hidrogel superporoso que tiene un medicamento asociado con el mismo para formar una primera región asociada, (b) al menos una segunda región del constructo que comprende un segundo hidrogel superporoso, compatible con dicho primer hidrogel, superponiendo al menos una porción de dicha primera región asociada y sellando dicho medicamento asociado.
Abstract:
Un comprimido recubierto para su administración oral para alterar los lípidos en un individuo sin causar hepatotoxicidad inducida por fármaco, miopatía o rhabdomiolisis, comprendiendo dicho comprimido recubierto una cantidad modificadora de lípidos de ácido nicotínico o un compuesto metabolizado en ácido nicotínico por el cuerpo, seleccionado de tartrato de alcohol nicotínico, hexanicotinato de d-glucitol, nicotinato de aluminio, niceritrol, d, 1alfa-tocoferil nicotinata, ácido 6-OH-nicotínico, ácido nicotínico, nicotinamida, nicotinamida-N-oxido, 6-OH-nicotinamida, NAD, N-metil-2-pirridina-8-carboxamida, N-metil-nicotinamida, N-ribosil-2-piridona-5-carboxida, N-metil4-piridona-5-carboxamida, bradilian, sorbinicato, hexanicita, ronitol, y ésteres de alcoholes de metilo, etilo, propilo o butilo de ácidos nicotínicos o combinaciones de éstos, en una forma de liberación prolongada, y un recubrimiento que contiene una cantidad modificadora de los lípidos de un inhibidor de la HMG-CoA reductasaen una forma deliberación inmediata.