Compatibility Assessment of Novel Orodispersible Film Vehicle for Personalized Medicine with Selected Active Pharmaceutical Ingredients

被引:0
|
作者
Polonini, Hudson C. [1 ]
Ferreira, Anderson O. [1 ]
Raposo, Nadia R. B. [2 ]
da Silva, Paulo Jose L. C. [2 ]
Brandao, Marcos Antonio F. [2 ]
机构
[1] Fagron BV, Fascinatio Blvd 350, NL-3065 WB Rotterdam, Netherlands
[2] Fed Univ Juiz De Fora UFJF, Res & Innovat Ctr Hlth Sci, Juiz De Fora, MG, Brazil
来源
JOURNAL OF PERSONALIZED MEDICINE | 2023年 / 13卷 / 11期
关键词
orodispersible films; personalizing medicine; compatibility; stability; compounding pharmacy;
D O I
10.3390/jpm13111565
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Orodispersible films (ODFs) are solid pharmaceutical forms for rapid local or systemic release of active ingredients. They are formed by a water-soluble polymer film that hydrates rapidly, adhering and dissolving immediately when placed on the tongue or in the oral cavity. In this paper, we describe the compatibility and disintegration times of compounded ODFs using OrPhylloTM, a new ready-to-use-vehicle, and APIs from different pharmacological classes, such as 5-hydroxytryptophan (5-HTP) 50 mg, bromopride 5 mg, coenzyme Q10 20 mg, melatonin 3 mg, resveratrol 5 mg, tadalafil 10 mg, vitamin B12 1 mg, or vitamin D3 2000 UI. ODFs were compounded and, subsequently, the samples were assayed using HPLC at initial (t = 0), 7 days (t = 7), 14 days (t = 14), 30 days (t = 30), 60 days (t = 60), 90 days (t = 90), 120 days (t = 120), 150 days (t = 150), and 180 days (t = 180) after compounding. Given the percentage of recovery of the APIs within the films, the beyond-use date of the final products (API + vehicle) was at least 90 days for vitamin D3, 150 days for bromopride and 5-HTP, and 180 days for coenzyme Q10, tadalafil, vitamin B12, resveratrol, and melatonin, when stored at room temperature. The average disintegration time was 46.22 s. This suggests that the OrPhylloTM vehicle is suitable for compounding ODFs with APIs from different pharmacological classes, with good compatibility and fast disintegration.
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页数:10
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