FIELD: medicine.
SUBSTANCE: invention refers to medicine, namely to endocrinology. At least one delivery device containing exenatide is implanted into a human to ensure continuous administration of exenatide from at least one delivery device wherein: (i) continuous administration comprises a first period of continuous administration of exenatide in a first dose, mcg/day, followed by a second period of continuous administration of exenatide in a second dose, mcg/day, wherein said second dose, mcg/day, greater than the first dose, mcg/day; (ii) stable delivery of exenatide in therapeutic concentrations is achieved within about 5 days after each implantation of the delivery device; (iii) stable delivery of exenatide is continuous for at least 3 months. First dose, mcg/day, followed by the second dose, mcg/day, is selected from a group consisting of: approximately 10 mcg/day followed by approximately 20 mcg/day; approximately 10 mcg/day, followed by approximately 40 mcg/day; approximately 10 mcg/day, followed by approximately 60 mcg/day; approximately 10 mcg/day, followed by approximately 80 mcg/day; approximately 20 mcg/day, followed by approximately 40 mcg/day; approximately 20 mcg/day, followed by approximately 60 mcg/day; approximately 20 mcg/day, followed by approximately 80 mcg/day; approximately 40 mcg/day, followed by approximately 60 mcg/day; approximately 40 mcg/day, followed by approximately 80 mcg/day; and approximately 60 mcg/day with subsequent approximately 80 mcg/day. In a particular case, the first period of administration in the first dose, mcg/day, is approximately 3 months with the subsequent second period of introduction in the second dose, mcg/day, equal to approximately 6 months. Device for osmotic delivery includes: impermeable reservoir including inner and outer surfaces and first and second open ends, semipermeable membrane installed with seal relative to first open end of reservoir, osmotic mechanism inside reservoir adjacent to semipermeable membrane; a piston adjacent to said osmotic mechanism, wherein said piston forms a movable seal with an inner surface of the reservoir, wherein piston divides reservoir into first chamber and second chamber, where first chamber comprises said osmotic mechanism; composition is in form of a suspension, wherein the second chamber contains said composition in form of a suspension, and a diffusion controller inserted into the second open end of the reservoir, wherein said diffusion control is adjacent to the composition in the form of a suspension.
EFFECT: method enables improving the treatment results, observing the treatment regimen in 100 % of cases, reducing the side effects and rapidly achieving or terminating, if necessary, the essential stable drug delivery.
10 cl, 21 dwg, 20 tbl, 4 ex
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Authors
Dates
2019-10-17—Published
2014-09-04—Filed