PMID- 31415872
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR  - 20200127
IS  - 1873-3476 (Electronic)
IS  - 0378-5173 (Linking)
VI  - 569
DP  - 2019 Oct 5
TI  - Stabilization of HSV-2 viral vaccine candidate by spray drying.
PG  - 118615
LID - S0378-5173(19)30660-X [pii]
LID - 10.1016/j.ijpharm.2019.118615 [doi]
AB  - This work demonstrates that an HSV-2 candidate vaccine can be thermostabilized by 
      spray drying to reduce cold chain demands. This work is also to optimize the 
      process responses by varying spray dry parameters for pre-screened suitable 
      excipients; and to determine the validity of current prescreening techniques. 
      Vaccine activity losses were measured by in vitro plaque forming assay with Vero 
      cell line. An accelerated storage condition of 45  degrees C for 10 days was used to 
      determine spray dried sample stability. Prescreening studies demonstrated that 
      trehalose and sucrose were superior to other tested excipients spray dry thermal 
      stabilization of HSV-2. Subsequent optimization by design of experiments (DOE) of 
      activity responses to spray dry parameter changes demonstrated significant 
      differences between trehalose and sucrose for stability of the viral vaccine. 
      Model parameters included the drying conditions inlet temperature, spray gas flow 
      rate, and solids concentration for the model responses of vaccine stabilization. 
      Trehalose was an effective and robust stabilizing excipient for spray drying 
      HSV-2 vaccine. In contrast, stabilization by sucrose was greatly dependent on the 
      spray dry process parameters. These DOE differences indicated inadequate 
      excipient selection by prescreening methods and the variability demonstrated 
      current prescreening techniques may not be adequate for determining optimal 
      excipients.
CI  - Copyright (c) 2019 Elsevier B.V. All rights reserved.
FAU - LeClair, Daniel A
AU  - LeClair DA
AD  - Department of Chemical Engineering, McMaster University, Hamilton, Ontario L8S 
      4L7, Canada.
FAU - Li, Lillian
AU  - Li L
AD  - Bio-Process Research & Development Department, Sanofi-Pasteur Ltd., Toronto, 
      Ontario M2R 3T4, Canada.
FAU - Rahman, Nausheen
AU  - Rahman N
AD  - Bio-Process Research & Development Department, Sanofi-Pasteur Ltd., Toronto, 
      Ontario M2R 3T4, Canada.
FAU - Cranston, Emily D
AU  - Cranston ED
AD  - Department of Chemical Engineering, McMaster University, Hamilton, Ontario L8S 
      4L7, Canada; Department of Wood Science, University of British Columbia, 2424 
      Main Mall, Vancouver, British Columbia V6T 1Z4, Canada; Department of Chemical 
      and Biological Engineering, University of British Columbia, 2360 East Mall, 
      Vancouver, British Columbia V6T 1Z3, Canada.
FAU - Xing, Zhou
AU  - Xing Z
AD  - McMaster Immunology Research Centre & Department of Pathology and Molecular 
      Medicine, McMaster University, Hamilton, Ontario L8S 4L7, Canada.
FAU - Thompson, Michael R
AU  - Thompson MR
AD  - Department of Chemical Engineering, McMaster University, Hamilton, Ontario L8S 
      4L7, Canada. Electronic address: mthomps@mcmaster.ca.
LA  - eng
PT  - Journal Article
DEP - 20190812
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
RN  - 0 (Excipients)
RN  - 0 (Viral Vaccines)
RN  - 57-50-1 (Sucrose)
RN  - B8WCK70T7I (Trehalose)
SB  - IM
MH  - Animals
MH  - Chlorocebus aethiops
MH  - Desiccation
MH  - Drug Compounding/methods
MH  - Drug Stability
MH  - Excipients/administration & dosage
MH  - Herpesvirus 2, Human/*immunology
MH  - Sucrose/administration & dosage
MH  - Trehalose/administration & dosage
MH  - Vero Cells
MH  - Viral Vaccines/*administration & dosage
OTO - NOTNLM
OT  - DOE
OT  - Formulation
OT  - HSV-2
OT  - Optimization
OT  - Spray dry
OT  - Stabilization
OT  - Vaccine
EDAT- 2019/08/16 06:00
MHDA- 2020/01/28 06:00
CRDT- 2019/08/16 06:00
PHST- 2019/05/10 00:00 [received]
PHST- 2019/07/13 00:00 [revised]
PHST- 2019/08/12 00:00 [accepted]
PHST- 2019/08/16 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
PHST- 2019/08/16 06:00 [entrez]
AID - S0378-5173(19)30660-X [pii]
AID - 10.1016/j.ijpharm.2019.118615 [doi]
PST - ppublish
SO  - Int J Pharm. 2019 Oct 5;569:118615. doi: 10.1016/j.ijpharm.2019.118615. Epub 2019 
      Aug 12.