Lyophilized cake in straight-walled vial
A system including a vial and methods of its use to provide a lyophilized cake removable from the vial without cracking or breaking.
1 . A straight-walled vial system ( 10 ) comprising:
a straight-walled vial ( 14 ); and
a solid lyophilized vaccine composition within the straight-walled vial ( 14 ), wherein the solid lyophilized vaccine composition comprises an antigen and a stabilizer, wherein the stabilizer comprises i SGGK3, and
wherein the solid lyophilized vaccine composition is a cake ( 20 ).
2 . The straight-walled vial system ( 10 ) of claim 1 , wherein the straight-walled vial ( 14 ) comprises a bottom wall ( 143 ), a side wall ( 141 ) connected to and extending from the bottom wall ( 143 ), and a collar ( 145 ) extending radially outwardly from the side wall at an open end of the side wall, opposite the bottom wall.
3 . The straight-walled vial system ( 10 ) of claim 1 , further comprising a stopper ( 12 ) insertable through the open end.
4 . The straight-walled vial system ( 10 ) of claim 3 , further comprising a seal ( 16 ), wherein the seal ( 16 ) is plastic or aluminum.
5 . The straight-walled vial system ( 10 ) of claim 1 , wherein the antigen source is animal, human, fish, bird, microorganism, parasite, protozoal, spirochete, bacterial, viral, vector, recombinant, or combination thereof; and
the antigen is a nucleic acid, protein, peptide, or combination thereof.
6 . The straight-walled vial system ( 10 ) of claim 1 , wherein the antigen source is Bordetella bronchiseptica.
7 . The straight-walled vial system ( 10 ) of claim 1 , wherein the antigen source is selected from the group consisting of Bordetella bronchiseptica (Bb), Rabies Virus, Canine Influenza Virus (CIV), Canine Adenovirus-2 (CAV2), Canine Adenovirus-1 (CAV1), Canine Distemper Virus (CDV), Canine Parainfluenza Virus (CPiV), Canine Parvo Virus (CPV), Feline Calicivirus (FCV), Feline Herpes Virus (FHV), Feline Panleukopenia Virus (FPL), Feline leukemia Virus (FeLV), Borrelia, Ehrlichia , and Giardia.
8 . The straight-walled vial system ( 10 ) of claim 1 , wherein the composition further comprises an adjuvant, an immunoadjuvant, an immunomodulator, or a combination thereof.
9 . The straight-walled vial system ( 10 ) of claim 1 , wherein the stabilizer further comprises mannitol, xanthan gum, a bulking agent, or any combination thereof.
10 . The straight-walled vial system ( 10 ) of claim 1 , wherein the solid lyophilized vaccine composition further comprises a blending diluent comprised of MEM Powder, Sodium Bicarbonate, HEPES Acid, and purified water.
11 . The straight-walled vial system ( 10 ) of claim 1 , wherein the cake is configured to be removed from the straight-walled vial ( 14 ) without cracking or breaking.
12 . The straight-walled vial system ( 10 ) of claim 1 , wherein the straight-walled vial ( 14 ) is a glass vial.
13 . The straight-walled vial system ( 10 ) of claim 1 , wherein the stabilizer further comprises i) a mucoadhesive agent, ii) an agent that enhances mucosal permeability, or iii) a combination thereof.
14 . A method for preparing a solid lyophilized vaccine composition, the method comprising:
combining an antigen and a stabilizer to obtain a blend, wherein the stabilizer comprises SGGK3;
filling a straight-walled vial ( 14 ) with the blend;
lyophilizing the blend in the straight-walled vial ( 14 ) to form a solid lyophilized vaccine composition; and
removing the solid lyophilized vaccine composition from the straight-walled vial ( 14 ).
15 . The method of claim 14 , wherein the solid lyophilized vaccine composition is for use in a human, fish, bird, cow, pig, cat, dog, horse, rabbit, or wild animal.
16 . The method of claim 14 , wherein the antigen is Bordetella bronchiseptica and the solid lyophilized vaccine composition is for use in a dog, cat, or rabbit.
17 . The method of claim 14 , further comprising adding mannitol to the blend of antigen and stabilizer and further comprising annealing the blend at −25° C. prior to removing the solid lyophilized vaccine composition.
18 . The method of claim 14 , wherein the solid lyophilized vaccine composition has a smaller diameter than the inner surface ( 142 ) of the straight-walled vial ( 14 ).
19 . The method of claim 14 , wherein the solid lyophilized vaccine composition is removed without cracking or breaking.