抄録
We conducted a pharmaceutical study to evaluate the quality of oral dried jelly preparations,a new type of medicine for patients with dysphagia.Four kinds of acetaminophen-containing dried jelly preparations (A,B,C,D) consisting of three layers of film were produced.For Preparation A,the outer dried jelly film layers consisted of treharose and carrageenan,and the inner drug-containing film was gelatin-based.Preparations B,C,and D consisted of gelatin-based outer films and a gelatin-based drug-containing film,gelatin-based outer films and a hydroxypropyl methylcellulose-based drug-containing film,and gelatin-based outer films containing hydroxypropyl methylcellulose and a gelatin-based drug-containing film,respectively.
A content uniformity test showed that the acetaminophen content was close to 100% in all preparations,meeting the criterion of Japanese Pharmacopoeia XV.In an initial dissolution test,Preparation A had the lowest dissolution rate and Preparation B the highest.A stability test in which the preparations were stored in aluminum film packages under the conditions of 40°C and 75% RH for 8 weeks showed that the acetaminophen content was more or less stable for all of them.However,in a dissolution test performed after storage for 8 weeks,the dissolution rates for Preparations A,B,and C were significantly lower than they had been previously though most of the acetaminophen had dissolved in the test solution within 45 minutes for preparations B,C,and D.
Among the 4 preparations,Preparation D had the best quality profile as regards stability and dissolution,and our findings overall suggest that oral dried jelly preparations are suitable for clinical use as a new type of medicine.
