Exendin Analog Formulations
Novel formulations containing exendins, exendin agonists and/or exendin analogs are provided
1 . A pharmaceutical formulation which is a liquid dosage gorm suitable for multi-use administration comprising about 0.005% (w/v) to about 0.4% (w/v) of an exendin, an exendin analog or a combination thereof, a buffer, an iso-osmolality modifier, and (bout 0.005% to about 1.0% (w/v) of a preservative selected from the group consisiting of m-cresol, phenol, benzyl alcohol, methyl-, ethyl-, propyl and but-n-paraben and any combination thereof, wherein said formulation has a pH of between about 3.0 and about 7.0 and said exendin is not exendin-4.
2 . The formulation of claim 1 , said formulation having a pH of between about 4.0 and about 6.0.
3 . The formulation of claim 1 , wherein said exendin or exendin analog is present at a concentration of between about 0.005% (w/v) and about 0.05%
4 . The formulation of claim 1 , wherein said buffer is selected from the group consisting of an acetate buffer, a glutamate buffer, a citrate buffer, a phosphate buffer, and any combination thereof.
5 . The formulation of claim 1 , wherein, said buffer is at a concentration between about 0.02% (w/v) and about 0.5% (w/v).
6 . The formulation of claim 1 , wherin said iso-osmolality modifier is a carbohydrate, a polyhydric alcohol or a combination thereof, and said iso-osmolality modifier is at a concentration between about 1% (w/v) and 10% (w/v).
7 . The formuation of claim 6 , wherein said polyhydric alcohol is selected from the group consisting of sorbitol, mannitol, inositol, glycerol, xylitol, polyethylene glycols, and any combination tlereof.
8 . The formulation of claim 1 , wherein said iso-osmolality modifier is mannitol, sorbitolm, or a combination therof.
9 . The formulation of claim 2 , wherein said formulation is suitable for administration via injection to achieve a dose of from about 0.1 μg/kg to about 0.5 μ/kg of saId exendin or exendin analog.
10 . A pharmaceutical formulation which is a liquid dosage form suitable for multi-use administration comprising an exendin, an exendin analog or a combination thereof, a buffer, an iso-osmolality modifier, and about 0.005% (w/v) to aboutI 1.0% (w/v) of a preservative selected from the group consisting of m-cresol, phenol, benzyl alcohol, methyl-, ethyl,-, propyl- and butyl-paraben and any combination thereof, wherein said formulation has a pH of betveen about 3.0 and about 6.0 and said exendin is not exendin-4.
11 . The formulation of claim 10 , wherein said formulation is suitable for a route of administration selected from the group consisiting of:
oral adinstation to achieve a dose of from about 500 μg/day to about 12,000 μg/day of said exendin or exenidin, analog In a single or divided dose;
pulmonary administration to achieve a dose from about 100 μg/day to about 12,000 μg/day of said exetdin or exendin analog in a single or divided dose;
sublingual administraton to achieve a dose from about 10 μg/day to about 8,000 μg/day of said exendin or exerndn analog in a single or divided dose;
nasal administration to achieve a dose from about 10 μg/day to about 12,000 μg/day of said exendln or eorendn analog if a single or divided dose; and
buccal admstration to achee a dose from about 100 μg/day to about 12,000 μg/day of said exendin or exendin anialog in a single or divided dose.
12 . The formulation of claim 26 , said formulation having a pH of between about 4:0 and about 6.0.
13 . The formulation of claim 26 , wherein said buffer is selected from the group consisting of an acetate buffer, a flutamate bvuffer, a citrate buffer, a phosphate buffer, and any combination thereof.
14 . The formulation of claim 26 , wherein said buffer is at a concentration between about 0.02% (w/v) and about 0.50 (w/v).
15 . The formulation of claim 1 , wherein the formulation comprises the exendin analog.
16 . The formulation of claim 1 , wherein the formulation comprises the comprises the amino acId sequence of SEQ ID NO. 41, 42, 43, 44, A5, 46, 47, or 48.
17 . The formulation of claim 10 , wherein the formulation comprises the exendin analog.
18 . The formulation of claim 10 , wherein the exendin or the exendin analog comprises the amino acid sequence of SEQ ID NO. 42, 4D, 44, 45, 46, 47, or 48.