Sustained-Release Matrix Using Hydroxypropylcellulose-Ethylcellulose Complex as a Filler, and Controlling Factors of Drug Release

概要

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The effect of formulation variables on the release rate of phenylpropanolamine hydrochloride (PPA) from hydroxypropylcellulose (HPC)-ethylcellulose (EC) complex was investigated. With an increase in the weight fraction of HPC (WFH) in the filler, drug release from the solid made from a dissolved mixture of HPC and EC (SMH) tended to decrease. The major controlling factors appeared to be WFH in the filler, the HPC viscosity grade, and the PPA : filler ratio. When a low viscosity grade of HPC (HPC-L) was used, the release rates from the SMH matrix were greater than those from the physically mixed matrix at less than 50% WFH. EC particles obtained from SMH after a 6-hour dissolution test possessed a number of pores. It was assumed that after dissolving HPC-L from the SMH filler, the porous EC particles might promote drug release because the number of water channels increased. Variation in the compression pressure in the tablet manufacturing process was an insignificant factor in the drug release rate. A linear relationship was observed between the release rate and the reciprocal amount of filler. Furthermore the release rate as a function of surface area of the tablet was also in good relationship. With these relationships, the composition of the tablet can be predicted to obtain the demand release rate of the drug.
公益社団法人日本薬学会の論文
1993-08-15