INJECTABLE SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION
Provided herein is a pre-filled injection syringe with an injectable sustained release pharmaceutical composition suitable for administration and methods of preparation thereof. The injectable sustained release pharmaceutical composition may be lanreotide acetate and have a density of 1.000 g/cm 3 to 1.015 g/cm 3 .
1 . A pre-filled injection syringe comprising an injectable sustained release pharmaceutical composition suitable for administration, the injectable sustained release pharmaceutical composition comprising lanreotide acetate, wherein the injectable sustained release pharmaceutical composition has a density of 1.000 g/cm 3 to 1.015 g/cm 3 .
2 . (canceled)
3 . The pre-filled injection syringe of claim 1 , wherein the injectable sustained release pharmaceutical composition is a homogeneous mixture and has substantially no bubbles.
4 . (canceled)
5 . The pre-filled injection syringe of claim 1 , wherein the injectable sustained release pharmaceutical composition is suitable for filling the injection syringe immediately after being mixed without requiring a phase change, is non-lyophilized, and does not need to be reconstituted prior to administration.
6 . The pre-filled injection syringe of claim 1 , wherein the injectable sustained release pharmaceutical composition within the injection syringe has a shelf life of at least 2 years.
7 . (canceled)
8 . The pre-filled injection syringe of claim 1 , wherein the injectable sustained release pharmaceutical composition is suitable for mixing without degradation and at a viscosity of up to 100,000 milPoise.
9 . (canceled)
10 . The pre-filled injection syringe of claim 1 , wherein the injection syringe is stored in a foil pouch comprising a nitrogen overlay.
11 . A non-lyophilized injectable sustained release pharmaceutical composition suitable for administration, the injectable sustained release pharmaceutical composition comprising lanreotide acetate, wherein the injectable sustained release pharmaceutical composition has a density of 1.000 g/cm 3 to 1.015 g/cm 3 .
12 . (canceled)
13 . The pharmaceutical composition of claim 11 , wherein the injectable sustained release pharmaceutical composition is a homogeneous mixture and has substantially no bubbles.
14 . (canceled)
15 . The pharmaceutical composition of claim 11 , wherein the injectable sustained release pharmaceutical composition is suitable for filling a syringe immediately after mixing without requiring a phase change and does not need to be reconstituted prior to administration.
16 . The pharmaceutical composition of claim 11 , wherein the injectable sustained release pharmaceutical composition is filled within an injection syringe and has a shelf life of at least 2 years.
17 . The pharmaceutical composition of claim 16 , wherein the injection syringe is stored in a foil pouch comprising a nitrogen overlay.
18 . (canceled)
19 . The pharmaceutical composition of claim 11 , wherein the injectable sustained release pharmaceutical composition is suitable for mixing without degradation and at a viscosity of up to 100,000 milPoise.
20 . (canceled)
21 . A method for preparing an injectable sustained release pharmaceutical composition, the method comprising:
mixing a composition comprising a somatostatin analog salt and an aqueous acid solution with water to form the injectable sustained release pharmaceutical composition; and
filling an injection syringe with the injectable sustained release pharmaceutical composition,
wherein the injectable sustained release pharmaceutical composition has a density of 1.000 g/cm 3 to 1.015 g/cm 3 .
22 . The method of claim 21 , wherein the somatostatin analog is lanreotide and the acid is acetic acid.
23 . (canceled)
24 . The method of claim 21 , wherein the injectable sustained release pharmaceutical composition comprises lanreotide acetate.
25 . (canceled)
26 . The method of claim 21 , wherein the mixing step further comprises pushing the injectable sustained release pharmaceutical composition through a plurality of orifices on an orifice plate in a static mixer using a pair of opposing pistons in the static mixer.
27 . (canceled)
28 . The method of claim 26 , wherein the plurality of orifices are angled.
29 . The method of claim 26 , wherein the plurality of orifices are arranged in concentric circles on the orifice plate and the distance between orifices in a first concentric circle is different from the distance between orifices in a second concentric circle.
30 . The method of claim 26 , wherein the mixing step further comprises removing atmospheric gasses from the static mixer and applying a vacuum.
31 . (canceled)
32 . The method of claim 26 , further comprising replacing the orifice plate with a transfer plate to fill the injection syringe.
33 . The method of claim 21 , wherein the injectable sustained release pharmaceutical composition not degraded during mixing and is suitable for mixing at a viscosity of up to 100,000 milPoise.
34 . The method of claim 21 , wherein the injectable sustained release pharmaceutical composition is a homogeneous mixture and has substantially no bubbles distributed within the composition.
35 . (canceled)
36 . The method of claim 21 , wherein the injectable sustained release pharmaceutical composition within the injection syringe has a shelf life of at least 2 years.
37 . The method of claim 21 , wherein the injectable sustained release pharmaceutical composition is not lyophilized, and does not need to be reconstituted prior to administration, and is suitable for administration immediately after mixing.
38 . (canceled)
39 . (canceled)
40 . The method of claim 21 , further comprising storing the filled injector syringe in a foil pouch comprising a nitrogen overlay.