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首页> 外文期刊>Journal of Turbulence >Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform
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Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform

机译：口服柔性平板电脑（OFT）分类患者配方：一种新型适当的配方平台

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Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed. Betadex, Eudragit E100, and polacrilex resin were evaluated as taste masking agents. Development work focused on excipient selection, formulation processing, characterization methods, stability, and palatability testing. Formulation with a cetirizine-to-polacrilex ratio of 1:2 to 1:3 showed robust physical strength with friability of 0.1% (w/w), rapid in vitro dispersion within 30 s in 2-6 ml of water, and 0.2% of total organic and elemental impurities. Polacrilex resin formulation shows immediate drug release within 30 min in gastric media, better taste masking, and acceptable stability. Hence, it is concluded that ion exchange resins can be appropriately used to develop taste-masked, rapidly dispersible, and stable tablet formulations with tailored drug release suitable for pediatrics and geriatrics. Flexible formulations can be consumed as swallowable, orally disintegrating, chewable, and as dispersible tablets. Flexibility in dose administration would improve compliance in pediatrics and geriatrics. This drug development approach using ion exchange resins can be a platform for formulating solid oral flexible drug products with low to medium doses.
机译：儿科和老年患者可口配方的开发涉及各种挑战。然而，企图，在单一制定平台中尝试了具有有益特征的创新发展。本研究的目标是开发固体口服柔性片剂（OFTS），作为儿科和老年人的平台，因为口服交付是最方便和广泛使用的药物管理模式。为此目的，根据生物制药分类系统，开发了一种柔性盐酸作为模型稳定性不稳定级别1和3种药物的柔性片剂配方。 Betadex，Eudragit E100和Polacrilex树脂被评价为味道掩蔽剂。开发工作集中在赋形剂选择，配方加工，表征方法，稳定性和可口性测试。具有1：2至1：3的十六嗪 - 脊髓灰皮曲率的配方显示出具有0.1％（w / w）的脆性的鲁棒性物理强度，在2-6毫升水中的30秒内快速体外分散，0.2％总有机和元素杂质。 Polacrilex树脂配方在胃介质中在30分钟内显示出直接药物释放，更好的味道掩蔽和可接受的稳定性。因此，得出结论，离子交换树脂可适当地用于开发味道掩盖，快速分散的和稳定的片剂配方，其适合适用于儿科和老年学科的量身定制的药物释放。柔性配方可以作为吞咽，口服崩解，可咀嚼和可分散片剂消耗。剂量给药的灵活性将改善儿科和老年教育的依从性。这种使用离子交换树脂的药物开发方法可以是用于配制具有低至中剂量的固体口服柔性药物的平台。

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