Abstract
The purpose of this study was to evaluate the effect of solid dispersions of pilocarpine hydrochloride (SPC) on the salivary flow rate. Solid dispersions, including pilocarpine hydrochloride: ethylcellulos : hydroxypropylmethylcellulose phthalate (1: 9 : 10 weight ratio), showed the best sustained release behavior in the dissolution test.
Unstimulated whole saliva samples were collected immediately before drug administration at 30-minute intervals for 1 hour, and 1 hour intervals for 7 hours. Subjects, ten healthy male volunteers, took nothing by mouth for 2 hours before administration and did not eat until after the third hour of sampling. The data for the salivary flow rate was compared with that for the flow rate by unadjusted pilocarpine hydrochloride (control) .
SPC significantly increased the salivary flow rate in the subjects. An increased salivary flow was seen within 30 minutes after administration. The flow rate reached the maximum 3 hours after administration and then slowly declined for 5 hours. On the other hand, the control reached the maximum 40 minute after administration and rapidly declined for 2.5 hours. Three subjects in the control group reported an increased lachrymal flow, but there were no complaints in the SPC group. In conclusion, SPC was considered to be an effective drug as a sustained-release form of pilocarpine hydrochloride.
