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Nasal insulin gel as an alternate to parenteral insulin: Formulation, preclinical, and clinical studies

机译:鼻胰岛素凝胶可替代肠胃外胰岛素:制剂,临床前和临床研究

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摘要

The objective of the present study was to formulate insulin gel for intranasal administration and to evaluate with respect to in vitro release studies and hypoglycemic activity in animal model and healthy human volunteers. The insulin gel was formulated using the combination of carbopol and hydroxypropyl methylcellulose as gelling agent. The in vivo efficacy of insulin gel administered intranasally was assessed by measuring the blood glucose levels and serum insulin levels at specified time intervals in rats and humans. The use of bioadhesive nasal gel containing insulin not only promoted the prolonged contact between the drug and the absorptive sites in the nasal cavity but also facilitated direct absorption of medicament through the nasal mucosa. Absorption of the drug through the nasal mucosa was high in the first 0.5 to 1.5 hours of the study with a sharp decline in blood sugar and rise in insulin values corresponding to that decline in blood sugar. This study further demonstrates that administration of insulin intranasally in gel form is a pleasant and painless alternative to injectable insulin.
机译:本研究的目的是配制用于鼻内给药的胰岛素凝胶,并评估动物模型和健康人类志愿者的体外释放研究和降血糖活性。使用卡波姆和羟丙基甲基纤维素的组合作为胶凝剂配制胰岛素凝胶。通过在指定的时间间隔内测量大鼠和人类的血糖水平和血清胰岛素水平,评估了鼻内给药的胰岛素凝胶的体内功效。含有胰岛素的生物粘附性鼻凝胶的使用不仅促进了药物与鼻腔吸收部位之间的长时间接触,而且还促进了药物通过鼻粘膜的直接吸收。在研究的前0.5到1.5个小时,药物通过鼻粘膜的吸收很高,血糖急剧下降,胰岛素值相应上升。这项研究进一步证明,鼻内注射凝胶形式的胰岛素是注射胰岛素的一种愉快而无痛的替代方法。

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