| abstract |
The invention relates to long-acting injectable insulin formulations for the treatment of type I and type II diabetes in humans and animals. The essential objective of the invention is to provide a long-acting injectable formulation of insulin. action in the form of a colloidal suspension, which is stable, which has a good local tolerance and toxicity compatible with the chronic treatment of diabetics and which maintains a significant hypoglycemic effect extending over at least 24 hours, after a single administration for example by subcutaneous route. To achieve this objective, the subject of the invention is a colloidal, aqueous and stable formulation of nanoparticles of at least one poly (Leu-block-Glu), loaded with insulin, in which the pH is between 5.8 and 7. , 0, the osmolarity O (in mOsmol): 270 ≤ 0 ≤ 800 and the viscosity v (in mPa.s) is low, namely v ≤ 40. The nanoparticles of the poly (Leu-block-Glu) have a diameter Dh average hydrodynamic such that: 15 ≤ Dh ≤ 40, The invention relates to an anti-diabetic drug based on this long-acting insulin formulation and injectable on 29G, 30G or 31G gauge needles. |