Long-acting colloidal insulin formulation and preparation...

Details Long-acting colloidal insulin formulation and preparation... Long-acting colloidal insulin formulation and preparation...

A - Human Necessities

61

K

A61K 38/28 (2006.01) A61K 9/10 (2006.01) A61K 9/51 (2006.01) A61K 47/42 (2006.01)

Patent

CA 2572868

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.

L'invention concerne des formulations d'insuline longue action injectables, pour le traitement des diabètes de type I et II chez l'homme et l~animal. L'objectif essentiel de l'invention est de fournir une formulation injectable d'insuline longue action sous forme de suspension colloïdale, qui soit stable, qui présente une bonne tolérance locale et une toxicité compatibles avec le traitement chronique des diabétiques et qui maintienne un effet hypoglycémiant important s'étendant sur 24 heures au moins, après une seule administration par exemple par voie sous-cutanée. Pour atteindre cet objectif, l'invention a pour objet une formulation colloïdale, aqueuse et stable de nanoparticules d'au moins un poly(Leu-bloc-Glu), chargées en insuline, dans laquelle le pH est compris entre 5,8 et 7,0, l'osmolarité O (en mOsmol) : 270 <= O <= 800 et la viscosité v (en mPa.s ) est faible, à savoir v <= 40. Les nanoparticules du poly(Leu-bloc-Glu) ont un diamètre hydrodynamique moyen Dh tel que : 15 <= Dh <= 40. L'invention concerne un médicament anti-diabétique à base de cette formulation d'insuline longue action et injectable sur aiguilles de gauge 29G, 30G ou 31G.

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