tetano
Editor, Senior Moderator
AAPS PharmSciTech. 2018 Sep 26. doi: 10.1208/s12249-018-1181-2. [Epub ahead of print]
[h=1]Dry Formulations Enhanced Mucoadhesive Properties and Reduced Cold Chain Handing of Influenza Vaccines.[/h] Saengkrit N[SUP]1[/SUP], Saesoo S[SUP]1[/SUP], Woramongkolchai N[SUP]1[/SUP], Sajomsang W[SUP]1[/SUP], Phunpee S[SUP]1[/SUP], Dharakul T[SUP]2[/SUP], Ruktanonchai UR[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] To alleviate concerns in health security, emergency flu vaccine stockpiles are required for ensuring rapid availability of vaccines when needed. Cold chain preservation, at high cost and risk, is necessary to maintain vaccine efficacy. This study aimed to develop a dry, easily storable formula for influenza vaccine preparation. The formulation with mucoadhesive properties is expected to facilitate rapid delivery via nasal administration. Chitosan, a cationic polymer, was used as cryo-protectant and to promote mucoadhesion. Optimal concentrations and molecular weights of chitosan polymers were screened, with short chain chitosan (10 kDa) being most suitable. H1N1 dry powder, in different formulations, was prepared via freeze-drying. A series of cryo-protectants, trehalose (T), chitosan (C), fetal bovine serum (FBS; F), or a combination of these (TCF), were screened for their effects on prolonging vaccine shelf life. Physicochemical monitoring (particle size and zeta potential) of powders complexed with mucin revealed that the order of cryo-protectant mixing during preparation was of critical importance. Results indicated that the TCF formula retains its activity up to 1 year as indicated by TCID[SUB]50[/SUB] analysis. This approach was also successful at prolonging the shelf life of H3N2 vaccine, and has the potential for large-scale implementation, especially in developed countries where long-term storage of vaccines is problematic.
[h=4]KEYWORDS:[/h] dry formulation; influenza vaccine; mucoadhesive; nasal vaccine delivery; vaccine formulation
PMID: 30259401 DOI: 10.1208/s12249-018-1181-2
[h=1]Dry Formulations Enhanced Mucoadhesive Properties and Reduced Cold Chain Handing of Influenza Vaccines.[/h] Saengkrit N[SUP]1[/SUP], Saesoo S[SUP]1[/SUP], Woramongkolchai N[SUP]1[/SUP], Sajomsang W[SUP]1[/SUP], Phunpee S[SUP]1[/SUP], Dharakul T[SUP]2[/SUP], Ruktanonchai UR[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] To alleviate concerns in health security, emergency flu vaccine stockpiles are required for ensuring rapid availability of vaccines when needed. Cold chain preservation, at high cost and risk, is necessary to maintain vaccine efficacy. This study aimed to develop a dry, easily storable formula for influenza vaccine preparation. The formulation with mucoadhesive properties is expected to facilitate rapid delivery via nasal administration. Chitosan, a cationic polymer, was used as cryo-protectant and to promote mucoadhesion. Optimal concentrations and molecular weights of chitosan polymers were screened, with short chain chitosan (10 kDa) being most suitable. H1N1 dry powder, in different formulations, was prepared via freeze-drying. A series of cryo-protectants, trehalose (T), chitosan (C), fetal bovine serum (FBS; F), or a combination of these (TCF), were screened for their effects on prolonging vaccine shelf life. Physicochemical monitoring (particle size and zeta potential) of powders complexed with mucin revealed that the order of cryo-protectant mixing during preparation was of critical importance. Results indicated that the TCF formula retains its activity up to 1 year as indicated by TCID[SUB]50[/SUB] analysis. This approach was also successful at prolonging the shelf life of H3N2 vaccine, and has the potential for large-scale implementation, especially in developed countries where long-term storage of vaccines is problematic.
[h=4]KEYWORDS:[/h] dry formulation; influenza vaccine; mucoadhesive; nasal vaccine delivery; vaccine formulation
PMID: 30259401 DOI: 10.1208/s12249-018-1181-2