嚥下困難患者への適応を目的とした医薬品の乾燥ゼリー製剤化に関する基礎的検討

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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℃ 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.
日本医療薬学会の論文
2007-12-10

嚥下困難患者への適応を目的とした医薬品の乾燥ゼリー製剤化に関する基礎的検討

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