A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 48/00 (2006.01) C07H 1/08 (2006.01) C12N 15/10 (2006.01)
Patent
CA 2322232
A lyophilized polynucleotide composition contains at least one polynucleotide and at least one cryoprotectant, wherein the ratio of the polynucleotide to cryoprotectant is from about 0.001 to about 1.0 part by weight polynucleotide per 1.0 part by weight of the cryoprotectant. This composition also contains from about 0.5 weight percent to about (6) weight percent water, based on the total weight of the final lyophilized polynucleotide composition. The polynucleotide composition of this invention is characterized by enhanced stability, in that it retains at least 90 % supercoil over a time period of at least (10) days at a temperature of about 37 ~C. The lyophilized polynucleotide composition also has improved solubility. An improved process for lyophilization of polynucleotides employs a specific primary drying cycle, that results in the above-described stable, lyophilized polynucleotide composition.
La présente invention concerne une composition polynucléotidique lyophilisée renfermant au moins un polynucléotide et au moins un cryoprotecteur, le rapport massique polynucléotide/cryoprotecteur étant compris entre environ 0,001 et environ 1,0 en poids. Cette composition renferme également entre environ 0,5 % en poids et environ 6 % en poids d'eau, sur la base du poids total de la composition polynucléotidique lyophilisée finale. La composition lyophilisée de cette invention se caractérise par sa stabilité, sa capacité à garder au moins 90 % de sa configuration en superhélice pendant au moins 10 jours à une température d'environ 37 DEG C, et également par sa solubilité améliorée. Enfin, cette invention concerne un procédé amélioré de lyophilisation de polynucléotides utilisant un cycle de séchage primaire spécifique, permettant d'obtenir la composition polynucléotidique lyophilisée stable décrite plus haut.
Deluca Patrick P.
Musunuri Shankar
American Home Products Corporation
Smart & Biggar
Wyeth
LandOfFree
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