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Freeze-drying of protein pharmaceuticalin vials with different character
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
2019 (English)Independent thesis Advanced level (professional degree), 20 credits / 30 HE creditsStudent thesis
Abstract [en]

Freeze-drying of protein pharmaceuticals is a procedure frequentlyused to obtain stability of the active pharmaceutical ingredientduring distribution and storage. It can be performed in pre-filledsyringes, with a lubricous coating of silicone on the inside, toenable the piston moving. The coating changes the environmentpotentially affecting the features of the freeze-dried cake sincethe wetting behavior and adhesion to the inner wall is affected.This project aimed to investigate the effect of the siliconizationof the cakes. Three different formulations were freeze-dried in nonsiliconized(NS) and siliconized vials using differentsiliconization protocols. Analysis was done using differentialscanning calorimetry (DSC), thermal gravimetric analysis (TGA),scanning electron microscopy (SEM), X-ray photoelectron spectroscopy(XPS) and an embedding method, intended to give information aboutthe cake’s shrinkage, cracking and pore-structure. The water contentin the bottom of the cakes was consistently higher than in the top,a difference decreasing over time. Increased surface hydrophobicitylead to increased shrinkage of the cake’s volume and a decrease infogging. The bottom of the protein cake in the vial siliconized witha commercial silicone emulsion consisted of pores with regularlyequal pore size and thick pore walls, a structure not seen in anyother cake. All cakes in the silicone emulsion siliconized vials hadlower water content than the cakes in the vials using the othersiliconization method. The XPS-analysis showed that the cakes in theemulsion siliconized vials contained silicon, indicating an excessof silicone when siliconizing and/or an unstable coating.

Place, publisher, year, edition, pages
2019.
Series
UPTEC K, ISSN 1650-8297 ; 19016
National Category
Other Chemical Engineering
Identifiers
URN: urn:nbn:se:uu:diva-388902OAI: oai:DiVA.org:uu-388902DiVA, id: diva2:1335804
External cooperation
Research Institutes of Sweden
Educational program
Master Programme in Chemical Engineering
Supervisors
Examiners
Available from: 2019-12-20 Created: 2019-07-08 Last updated: 2019-12-20Bibliographically approved

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CiteExportLink to record
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Citation style
  • apa
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