| abstract |
The invention relates to long-acting insulin injectable formulations, for the treatment of diabetes of type I and II in humans and animals. The aim of the invention is to provide a long-acting injectable insulin formulation in the form of a colloidal suspension which is stable, has a good local tolerance and toxicity compatible with chronic treatment of diabetics and which maintains a significant hypoglycemic effect, extending over at least 24 hours after a single administration, for example, by the sub-cutaneous route. Said aim is achieved by means of a stable aqueous colloidal formulation of nanoparticles of at least one poly(Leu-bloc-Glu), charged with insulin, where the pH lies between 5.8 and 7.0, the osmolarity O (in mOsmol) is 270 = O = 800 and the viscosity v (in mPa.s ) is low, in other words v = 40 and the nanoparticles of poly(Leu-bloc-Glu) have a mean hydrodynamic diameter Dh of 15 = Dh = 40. The invention further relates to an anti-diabetic medicament based on said long-acting insulin formulation which may be injected with needles of 29G, 30G, or 31G gauge. |