RU97103563A - COMPOSITIONS FOR LONG-TERM RELEASE OF VENLAFAXIN HYDROCHLORIDE, COMPOSITION OF FILM COATING, METHOD FOR PROVIDING THERAPEUTICALLY ACTIVE CONCENTRATION OF VENLAFXIN AND METHOD FOR EXCLUDING CURREN CURRENCY - Google Patents

Claims (10)

1. An encapsulated composition for prolonged release of venlafaxine hydrochloride comprising a hard gelatin capsule containing a therapeutically effective amount of spheroidal particles including venlafaxine hydrochloride, microcrystalline cellulose and hydroxypropyl methyl cellulose coated with ethyl cellulose and hydroxypropyl methyl cellulose.  2. The composition according to p. 1, characterized in that the spheroidal particles consist of about 37.3 wt.% Venlafaxine hydrochloride, about 0.5 wt.% Hydroxypropyl methylcellulose 2208 and about 62.17 wt.% Microcrystalline cellulose.  3. The composition according to p. 1, characterized in that the film coating consists of ethyl cellulose (4.81% of the total weight) and hydroxypropyl methylcellulose (0.85% of the total weight).  4. The composition according to p. 1, characterized in that the film coating consists of ethyl cellulose (4.04% of the total weight) and hydroxypropyl methylcellulose (0.714% of the total weight).  5. The composition according to claim 1, characterized in that the film coating consists of ethyl cellulose (2.48% of the total weight) and hydroxypropyl methylcellulose (0.437% of the total weight).  6. A film coating composition consisting of ethyl cellulose (15% of the total weight) having an ethoxy content of 44.0-51.0%, and hydroxypropyl methylcellulose (85% of the total weight) having a methoxy content of 28.0-30, 0% and the content of hydroxypropoxy groups 7.0-12.0%.  7. The composition of the sustained release of venlafaxine hydrochloride for a single daily administration, which includes spheroidal particles containing 37.3% venlafaxine, 62.17% microcrystalline cellulose and 0.5% hydroxypropyl methylcellulose type 2208, coated with an amount of a mixture comprising 15% ethyl cellulose type NG 2834 and 85% hydroxypropylmethyl cellulose type 2910, sufficient to impart a solubility profile to the particles to achieve the desired release rate over a 24-hour period.  8. The composition according to p. 7, characterized in that it provides lower peak serum levels of up to 150 ng / ml and prolonged therapeutically effective plasma levels for 24 hours  9. A method of providing a therapeutically effective concentration of venlafaxine in blood plasma over a 24-hour period while reducing effects such as nausea and vomiting, which includes oral administration to a patient in need of such treatment, an encapsulated composition of prolonged release, providing a peak level of venlafaxine in plasma blood over a period of time from about 4 to about 8 hours, wherein said composition includes venlafaxine hydrochloride as an active ingredient.  10. A method for eliminating zero and peak concentrations of a drug in a patient’s blood plasma characteristic of therapeutic metabolism of multiple daily dosed administration, which includes oral administration to a patient in need of such treatment, an encapsulated composition of prolonged release, which provides a peak level of venlafaxine in blood plasma after a period time from about 4 to about 8 hours, with the specified composition includes venlafaxine hydrochloride as an active ingredient.