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The effect of formulation on spray dried Sabin inactivated polio vaccine

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Title: The effect of formulation on spray dried Sabin inactivated polio vaccine
Authors: Kanojia, G., Have, R. ten, Brugmans, D., Soema, P.C., Frijlink, H.W., Amorij, J.P., Kersten, G.F.A.
Source: European Journal of Pharmaceutics and Biopharmaceutics. 129:21-29
Publisher Information: Elsevier BV, 2018.
Publication Year: 2018
Subject Terms: 0301 basic medicine, 0303 health sciences, Drug Compounding/methods, Drug Compounding, Poliomyelitis/prevention & control, Oral/administration & dosage, Serogroup, 3. Good health, Poliovirus Vaccine, Excipients, Poliovirus, 03 medical and health sciences, Drug Stability, Poliovirus Vaccine, Oral, Desiccation/methods, Humans, Poliovirus/immunology, Antigens, Desiccation, Powders, Viral/immunology, Antigens, Viral, Excipients/chemistry, Poliomyelitis
Description: The objective of this study was to develop a stable spray dried formulation, containing the three serotypes of Sabin inactivated polio vaccine (sIPV), aiming for minimal loss of native conformation (D-antigen) during drying and subsequent storage. The influence of atomization and drying stress during spray drying on trivalent sIPV was investigated. This was followed by excipient screening, in which monovalent sIPV was formulated and spray dried. Excipient combinations and concentrations were tailored to maximize both the antigen recovery of respective sIPV serotypes after spray drying and storage (T = 40 °C and t = 7 days). Furthermore, a fractional factorial design was developed around the most promising formulations to elucidate the contribution of each excipient in stabilizing D-antigen during drying. Serotype 1 and 2 could be dried with 98% and 97% recovery, respectively. When subsequently stored at 40 °C for 7 days, the D-antigenicity of serotype 1 was fully retained. For serotype 2 the D-antigenicity dropped to 71%. Serotype 3 was more challenging to stabilize and a recovery of 56% was attained after drying, followed by a further loss of 37% after storage at 40 °C for 7 days. Further studies using a design of experiments approach demonstrated that trehalose/monosodium glutamate and maltodextrin/arginine combinations were crucial for stabilizing serotype 1 and 2, respectively. For sIPV serotype 3, the best formulation contained Medium199, glutathione and maltodextrin. For the trivalent vaccine it is therefore probably necessary to spray dry the different serotypes separately and mix the dry powders afterwards to obtain the trivalent vaccine.
Document Type: Article
File Description: application/pdf
Language: English
ISSN: 0939-6411
DOI: 10.1016/j.ejpb.2018.05.021
Access URL: https://pubmed.ncbi.nlm.nih.gov/29787800
https://research.rug.nl/en/publications/a59ee284-0f27-48dd-976f-2edcabe563e5
https://doi.org/10.1016/j.ejpb.2018.05.021
https://hdl.handle.net/11370/a59ee284-0f27-48dd-976f-2edcabe563e5
https://www.ncbi.nlm.nih.gov/pubmed/29787800
https://www.rug.nl/research/portal/files/73800563/1_s2.0_S0939641118301966_main.pdf
https://www.sciencedirect.com/science/article/abs/pii/S0939641118301966
https://scholarlypublications.universiteitleiden.nl/access/item%3A2952953/view
https://www.sciencedirect.com/science/article/pii/S0939641118301966
https://scholarlypublications.universiteitleiden.nl/handle/1887/64264/
https://hdl.handle.net/1887/64264
Rights: CC BY
Accession Number: edsair.doi.dedup.....a79e6b9aafc8a77c45793f5ccd5fc9cd
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  Data: The effect of formulation on spray dried Sabin inactivated polio vaccine
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  Data: <searchLink fieldCode="AR" term="%22Kanojia%2C+G%2E%22">Kanojia, G.</searchLink><br /><searchLink fieldCode="AR" term="%22Have%2C+R%2E+ten%22">Have, R. ten</searchLink><br /><searchLink fieldCode="AR" term="%22Brugmans%2C+D%2E%22">Brugmans, D.</searchLink><br /><searchLink fieldCode="AR" term="%22Soema%2C+P%2EC%2E%22">Soema, P.C.</searchLink><br /><searchLink fieldCode="AR" term="%22Frijlink%2C+H%2EW%2E%22">Frijlink, H.W.</searchLink><br /><searchLink fieldCode="AR" term="%22Amorij%2C+J%2EP%2E%22">Amorij, J.P.</searchLink><br /><searchLink fieldCode="AR" term="%22Kersten%2C+G%2EF%2EA%2E%22">Kersten, G.F.A.</searchLink>
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  Data: <i>European Journal of Pharmaceutics and Biopharmaceutics</i>. 129:21-29
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  Data: Elsevier BV, 2018.
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  Data: 2018
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  Data: <searchLink fieldCode="DE" term="%220301+basic+medicine%22">0301 basic medicine</searchLink><br /><searchLink fieldCode="DE" term="%220303+health+sciences%22">0303 health sciences</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Compounding%2Fmethods%22">Drug Compounding/methods</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Compounding%22">Drug Compounding</searchLink><br /><searchLink fieldCode="DE" term="%22Poliomyelitis%2Fprevention+%26+control%22">Poliomyelitis/prevention & control</searchLink><br /><searchLink fieldCode="DE" term="%22Oral%2Fadministration+%26+dosage%22">Oral/administration & dosage</searchLink><br /><searchLink fieldCode="DE" term="%22Serogroup%22">Serogroup</searchLink><br /><searchLink fieldCode="DE" term="%223%2E+Good+health%22">3. Good health</searchLink><br /><searchLink fieldCode="DE" term="%22Poliovirus+Vaccine%22">Poliovirus Vaccine</searchLink><br /><searchLink fieldCode="DE" term="%22Excipients%22">Excipients</searchLink><br /><searchLink fieldCode="DE" term="%22Poliovirus%22">Poliovirus</searchLink><br /><searchLink fieldCode="DE" term="%2203+medical+and+health+sciences%22">03 medical and health sciences</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+Stability%22">Drug Stability</searchLink><br /><searchLink fieldCode="DE" term="%22Poliovirus+Vaccine%2C+Oral%22">Poliovirus Vaccine, Oral</searchLink><br /><searchLink fieldCode="DE" term="%22Desiccation%2Fmethods%22">Desiccation/methods</searchLink><br /><searchLink fieldCode="DE" term="%22Humans%22">Humans</searchLink><br /><searchLink fieldCode="DE" term="%22Poliovirus%2Fimmunology%22">Poliovirus/immunology</searchLink><br /><searchLink fieldCode="DE" term="%22Antigens%22">Antigens</searchLink><br /><searchLink fieldCode="DE" term="%22Desiccation%22">Desiccation</searchLink><br /><searchLink fieldCode="DE" term="%22Powders%22">Powders</searchLink><br /><searchLink fieldCode="DE" term="%22Viral%2Fimmunology%22">Viral/immunology</searchLink><br /><searchLink fieldCode="DE" term="%22Antigens%2C+Viral%22">Antigens, Viral</searchLink><br /><searchLink fieldCode="DE" term="%22Excipients%2Fchemistry%22">Excipients/chemistry</searchLink><br /><searchLink fieldCode="DE" term="%22Poliomyelitis%22">Poliomyelitis</searchLink>
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  Data: The objective of this study was to develop a stable spray dried formulation, containing the three serotypes of Sabin inactivated polio vaccine (sIPV), aiming for minimal loss of native conformation (D-antigen) during drying and subsequent storage. The influence of atomization and drying stress during spray drying on trivalent sIPV was investigated. This was followed by excipient screening, in which monovalent sIPV was formulated and spray dried. Excipient combinations and concentrations were tailored to maximize both the antigen recovery of respective sIPV serotypes after spray drying and storage (T = 40 °C and t = 7 days). Furthermore, a fractional factorial design was developed around the most promising formulations to elucidate the contribution of each excipient in stabilizing D-antigen during drying. Serotype 1 and 2 could be dried with 98% and 97% recovery, respectively. When subsequently stored at 40 °C for 7 days, the D-antigenicity of serotype 1 was fully retained. For serotype 2 the D-antigenicity dropped to 71%. Serotype 3 was more challenging to stabilize and a recovery of 56% was attained after drying, followed by a further loss of 37% after storage at 40 °C for 7 days. Further studies using a design of experiments approach demonstrated that trehalose/monosodium glutamate and maltodextrin/arginine combinations were crucial for stabilizing serotype 1 and 2, respectively. For sIPV serotype 3, the best formulation contained Medium199, glutathione and maltodextrin. For the trivalent vaccine it is therefore probably necessary to spray dry the different serotypes separately and mix the dry powders afterwards to obtain the trivalent vaccine.
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        Type: general
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      – SubjectFull: Drug Compounding/methods
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      – SubjectFull: Drug Stability
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