Miglitol-PMO nanoparticles, an alpha-glucosidase inhibitor, has prolonged action on blood glucose level in diabetic rats

Preclinical and clinical evaluations of nanodrugs are important to support approval. Preclinical studies involve ex vivo, in vitro, and in vivo approaches to evaluate the efficacy, toxicity, and biophysical and biochemical properties of nanomedicines. Clinical studies, also involving human trials, represent a crucial stage to translate nanomedicines from product to treatment before marketing them. However, there are currently no standard preclinical and clinical protocols to facilitate the development of nanomedicines. In the case of diabetes, few nanoformulations have received approval for controlled delivery of insulin. Standard preclinical and clinical approaches to evaluate the toxicity and antidiabetic properties of nanomedicines are required to support the introduction of a wide range of diabetes nanodrugs to the marketplace. This chapter discusses various preclinical assays that are used to evaluate the antidiabetic properties of nanomedicines. Clinical evaluation of the antidiabetic efficacy of nanomedicines for regulatory approval is also discussed. 

Preclinical and clinical evaluation of nanodrugs for diabetes treatment

Diabetes mellitus is a group of metabolic disorder characterized by a complete lack of insulin, a relative lack of insulin, or insulin resistance  In response to the need for better control of diabetes, several new classes antidiabetic drugs were introduced Among these are Alpha Glucosidase Inhibitors which are used to treat the Type II Diabetes mellitus by inhibiting the Alpha Glucosidase enzymes in the small intestine The biological half-life of Miglitol is 2 Hrs and by conventional dosage form it requires oral administration of three times daily Hence to overcome this problem, we developed controlled release formulation of Miglitol loaded nanoparticles will help to release the drug in continuously for 12 Hrs The effect of newly formulated Miglitol loaded nanoparticles was studied in diabetic rates   Diabetes was induced by streptozotocin in Wistar rats At first, Maltose was administered orally to all the groups Along with maltose, the newly formulated Miglitol loaded nanoparticles and marketed conventional release tablets was administered in diabetic rates and Blood glucose was measured at predefined interval After the initial Maltose load, in the interval of 6 Hrs, Maltose load to the animal was repeated for two more times After administration of the first maltose load, there was steady attenuation in the plasma glucose values after the same time point in the groups treated with Miglitol formulations After initial administration of drug, the pharmacological actions are similar for marketed conventional release dosage form and Nanoparticle However, the conventional release dosage form could not control the peak postprandial plasma glucose after second & third loading of maltose Whereas, the Nanoparticle formulation significantly (P<0001) controlled the peak postprandial plasma glucose after second & third loading of maltose

Evaluation of antidiabetic activity of Miglitol nanoparticles in Streptozotocin induced diabetic rats

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Evaluation of antidiabetic activity of Miglitol nanoparticles in Streptozotocin induced diabetic rats