Venlafaxine Hydrochloride Film-controlled Sustained Release Pellet Capsules

Abstract

The invention relates to a venlafaxine hydrochloride film-controlled slow-release pellet capsule. A slow-release film of the venlafaxine hydrochloride film-controlled slow-release pellet utilizes Kollicoat SR30D as a film-formation material. A pellet core of the venlafaxine hydrochloride film-controlled slow-release pellet contains low-substituted hydroxyprepyl cellulose having high expansibility, and also contains a pharmaceutically-acceptable common excipient for the slow-release pellet, wherein preferably, the excipient comprises microcrystalline cellulose, and the pellet core comprises 10 to 40wt% of low-substituted hydroxyprepyl cellulose. The slow-release film comprises Kollicoat SR30D, triethyl citrate as a plasticizer and talcum powder as an antiplastering aid, wherein preferably, a ratio of Kollicoat SR30D to triethyl citrate to talcum powder is 30: 1: 4 and a film weight increasing ratio is in a range of 21 to 39%. The venlafaxine hydrochloride film-controlled slow-release pellet comprises the pellet core containing low-substituted hydroxyprepyl cellulose having high water expansibility and thus after absorbing water, the venlafaxine hydrochloride film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the venlafaxine hydrochloride film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to a film-controlled sustained-release pellet capsule of venlafaxine hydrochloride, specifically, a film-controlled sustained-release pellet capsule of venlafaxine hydrochloride containing low-substituted hydroxypropyl cellulose in the pellet core, which belongs to medicine formulation field. Background technique [0002] Venlafaxine hydrochloride is an antidepressant that can significantly inhibit the reuptake of serotonin and norepinephrine at synaptic sites. It is used to treat various types of depression, including depression with anxiety and generalized anxiety. The basic clinical requirement for this type of drug is that it can control symptoms for a long time. [0003] The solubility of venlafaxine hydrochloride in water is very good. The earliest common preparations on the market need to be taken 2-3 times a day, and the blood drug concentration fluctuates greatly, the peak concentration is too high, and the adverse reac...

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problem of release decline caused by film aging of venlafaxine hydrochloride film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a film capable of maintaining stable release performance throughout the validity period Controlled venlafaxine hydrochloride sustained-release pellet capsules are characterized in that the core of the pellets contains low-substituted hydroxypropyl cellulose with high water-swellability, and the sustained-release coating film is deformed by water-absorbing swelling, thereby Counteracts membrane aging

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