Ordinary antidiabetics for oral administration are classified into two types. The first type primarily controls postprandial blood glucose level (PBG), while the other type primarily controls fasting blood glucose level (FBG). 1,2) There is currently no oral antidiabetic capable of controlling both PBG and FBG, and such an antidiabetic is believed to be the most useful for the treatment of diabetes.The D-phenylalanine derivative, nateglinide ((Ϫ)-N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine) was developed by Ajinomoto for use as an antidiabetic (Fig. 1). Although nateglinide stimulates insulin secretion, it has a different chemical structure from sulfonylureas, 1,3) demonstrates a quick action/short duration type effect, 1,2,4) and its effect is believed to effectively control primarily PBG. Since blood glucose level inhibitory effects dissipate in a short period of time, nateglinide is expected to realize (1) avoidance of a hypoglycemic state, and (2) avoidance of b cell exhaustion following long-term administration and avoidance of secondary failure.1) Nateglinide immediate release (IR) tablets are currently available commercially in the form of Fastic ® tablets, and are used primarily for patients with mild diabetes. On the other hand, it is important to control FBG in patients with moderate and severe diabetes who exhibit elevated FBG levels. If the nateglinide oral controlled release formulation were available that is capable of controlling both PBG and FBG, it could be expected to offer the advantages of (1) improving compliance by reducing the number of administrations per day (Fastic ® tablets: 3 times per day), and (2) increasing the number of choices available for treating diabetes in moderate and severe diabetes patients.Gliclazide is an antidiabetic that is a long acting type stimulator of insulin secretion having a sulfonylurea moiety. In the case of repeated administration of gliclazide to normal rats, the blood glucose lowering action has been reported to weaken during the second administration. 5) Nateglinide is also an insulin secretion stimulator. Consequently, in the case of designing a controlled release formulation that contains nateglinide for the purpose of effectively inhibiting both PBG and FBG, there have been concerns that even if it is Nateglinide is a new quick action/short duration (QRSD) type of oral blood glucose regulator, and nateglinide immediate release tablets are used for patients with mild diabetes under the trade name of Fastic ® tablets. In this study, we attempted to determine if it was possible to control both post-prandial blood glucose level (PBG) and fasting blood glucose level (FBG) for moderate or severe diabetes through controlled release of nateglinide. Enteric coated granules were selected for the administration form for controlled release of nateglinide, and three types of enteric coated granules were prepared having dissolution pH values of 5.5, 6.5 and 7.2. The three types of enteric coated granules were each administered separately or the enteric...
Large-scale, high-density freezing of hybridomas was studied to apply frozen cells t o start high-density culture.We showed here that hybridomas can be frozen at 1.5 x lo8 cells/mL, without decrement in viability and proliferating activity. Blood transporting bags were used for large-scale freezing to store 25 mL of cell suspension with a cell density, 1.5 x lo8 cells/mL. The number of cells stored in a bag (3.0 x lo9 cells) was enough to start a high-density culture at a 10 times higher cell density (6.0 x lo6 cells/mL) than normal inoculation, and the cells proliferated to lo7 cells/mL within 2 days. These results indicate that the large-scale freezing method is useful for large-scale culture of mammalian cells.
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