Diabetes is a disease recognized by elevation in some blood factors like glucose, amino acids, free fatty acids etc, some impairment in insulin secretion or resistance to insulin etc. There are mainly two types of diabetes: type 1, in which there is an abnormal absence of insulin secretion, and type 2, which primarily is due to resistance to insulin while its receptors are normal or more than its amount. After some time pancreas won’t be able to secrete enough insulin which causes post prandial hyper glycemia and after a while hyper glycemia would be an ever present sign, not just after meals. Insulin injection is necessary in this step. Many diabetics require up to four insulin injections per day, which can be quite inconvenient. The formulation of dietary insulin capable of eluding proteolytic digestion has proven to be challenging. In addition, the drug must pass through the stomach; thus, a synthetic pH-sensitive tablet would be helpful. More specifically, the insulin-containing tablet should be stable in the acidic environment of the stomach, but it should release its contents in the basic environment of the duodenum. We propose to design a bilayer tablet composed of an outer layer containing Antiproteases to neutralize the effect of pancreatic proteases and an inner layer of insulin. As the outer layer is revealed after encountering a basic environment, the Antiproteases start to be released and neutralize the surrounding digestive proteases. This neutralization allows sustained release of insulin from the inner layer of the tablet. The measured release of the drug allows for better absorption in more distal parts of the small intestine.
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