Preparation And Evaluation Of Soluble Micro-needle Patches For Sublingual Delivery Of Insulin

Micro-needle technology is a new type of painless minimally invasive drug delivery system,combined with the advantages of transdermal patch and injection type,can penetrate the skin stratum corneum barrier for macromolecules such as proteins,vaccines and other drugs to provide a new route of administration,to overcome the macromolecular drugs oral,transdermal absorption problems.Micro-needle technology has gradually become a hot spot in the field of medicine,beauty,microbial,and precision manufacturing.This subject combines the advantages of oral patch and micro-needle to prepare a soluble drug-loaded polymer micro-needle patch.The micro-needle patch was wet by oral saliva and was stickled on the oral mucosa.At the same time,the micro-needle array penetrates the oral mucosa and releases insulin.Insulin penetrates the mucosal keratosis disorder,into the body,through the absorption into the blood,thereby reducing blood sugar in patients with diabetes.This topic was selected to optimize the optimal prescriptions of micro-needle and backing layer.And the materials and carving technology were screened and the micro-needle mold was prepared using PTFE.Determine the appropriate patch preparation process and micro-needles by examining the preparation conditions and in conjunction with casting coating method,the micro-needles patch successfully prepared.The appearance and size of micro-needle patch were investigated by microscope,stereoscopic mirror and scanning electron microscope.Simple device was prepared simulating to determination of adhesive force method of oral patch,the adhesion of micro-needle patch was turn out to be 110 g/cm2.In order to study the hardness required for micro-needle penetration into the mucosa,the hardness of micro-needle was examined by aluminum foil puncture.The results showed that the micro-needle was qualified and had sufficient penetrability.The method of HPLC was established.The system adaptability test showed that the method had good accuracy and the content of micro-needle patch was 3.17 IU/cm.The in vivo behavior of insulin micro-needles was examined by using rats.The adhesion of the micro-needle patch was observed and was able to dissolve rapidly.The dissolution time was about 15 min.The rat model of T2DM was established by using STZ to destroy rat part of pancreatic islet cells.The effect of micro-needle patch on T2DM was evaluated.The resulting micro-needles can slowly release insulin and reduce blood glucose in diabetic rats.The efficacy of the micro-needle patch reached its maximum at 120 min and was able to effectively reduce and control rat blood glucose levels within five hours.This study has successfully developed a soluble insulin oral micro-needle patch,with hypoglycemic effect.Which provides a new dosage form and new research direction for the preparation of insulin preparations,and has certain significance for the treatment of diabetes and the development of micro-needle technique.