Preparation and Phase II Clinical Examination of Topical Dosage Form for Treatment of Carcinoma Colli Containing Bleomycin with Hydroxypropyl Cellulose

概要

論文の詳細を見る
A new topical disk-like dosage form for carcinoma colli was prepared by direct compression of the mixture of bleomycin hydrochloride (BLM) and combination of hydroxypropyl cellulose (HPC) and other water soluble polymer. After in vitro examinations regarding the water adsorption, the release and dissolution of drug and other properties, the preparations were examined clinically by applying to the voluntary patients. A combination of HPC and Carbopol 934 (CP) seemed preferable as the vehicles, and the amount of BLM released from the preparation increased remarkably with an increase in concentration of HPC. In contrast, the water absorbing property increased with an increase of CP. The preparation containing 30 mg of BLM, for which the preparative formula was designed according to the in vitro experiment, was administered to the voluntary patients of carcinoma colli of stage O to Ib. The preparation taken out of patient indicated the continuous release of BLM for longer than 24 hr. In the three of nine patients, any cancerous focus was not found after the local therapy using 90 to 195 mg of BLM in total, and remnant foci found in the other six patients were very few. Moreover, the normal mucosa was not affected by BLM, contrary to the case of usual suppositories reported. The higher per cent of cure might be expected if the therapy could be continued for the longer period.
社団法人日本薬学会の論文
1979-01-25