Effects of Some Factors on the Preparation of Spherical Particles by Extrusion-Spheronization Processing (II) : Preparation of Sustained Release Matrix-Spherical Particle

압출(壓出).구형화공정(球形化工程)에 의(依)한 구형과입제조(球形顆粒製造)의 제형향인자(諸影響因子) 검토(檢討) [제이보(第二報)] -지속성구형과입제조-

Extrusion-Spheronization Processing (ESP) was applied to preparate sustained release spherical particles as a form of matrix spherical particle (MSP). dl-methylephedrine HCI (ME) was the drug chosen and several dissolution retardants and binders were selected to estimate a relatively good formulation on this purpose. The effect of physicochemical nature, concentration, and solvents of these dissolution retardants and binders on regularity in shape of MSP and in vitro release rate was investigated. The effect of Particle size of matrix particles was also evaluated. It is, therefore, concluded that this ESP would be a relatively good preparation method of sustained release MSP of ME which has the sustained action of about 5 and 8 hours by formulating of ethylcellulose and ethylcellulose-paraffin as a dissolution retardant, respectively, and then ethylcellulose solution of 80% EtOH is recommended as a binder.