The purpose of this project was to provide Galderma with information regarding theabsorption processes for a selected group of active pharmaceutical ingredients andprocess materials. The acquired information can support Galderma in future decisionsfor design of process equipment and strategies for cleaning of process equipment.A UV spectrophotometric method was developed to study the absorption processesfor the three active pharmaceutical ingredients lidocaine hydriochloride, prilocainehydrochloride and mepivacaine hydrochloride in the three process materials ethylenepropylene diene monomer rubber (EPDM), silicone rubber andpolytetrafluoroethylene (PTFE). Absorption profiles for the different processes werecreated in Microsoft Excel.The observed order of absorption, from highest to lowest, in both silicone and EPDMwere lidocaine hydriochloride, prilocaine hydrochloride and mepivacainehydrochloride. An overall higher absorption in silicone than in EPDM was seen for allthree active pharmaceutical ingredients. The results also showed that the selectedtime range of the experiments were not enough to achieve equilibrium for some ofthe absorption processes. It was not possible to detect any significant absorption inPTFE for any of the substances.A hypothesis that the polarity of the active pharmaceutical ingredient might bedecisive for the order of absorption is suggested in this report. It is also proposedthat absorption might be higher in silicone because of the high free volume of thesilicone polymer compared to EPDM and PTFE. Since equilibrium was never reachedfor some of the experiments it is however possible that the results presented in thisreport do not show the true order of equilibrium absorption for the threesubstances. If so, it is possible that other properties than the polarity of the activepharmaceutical ingredient play a more significant role in the latter part of theabsorption process.The following three recommendations for how to improve the method in futurework are given in this report:- Use fresh material in all experiments.- Use material with the exact same dimensions and surface area.- Conduct experiments over a longer time range.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:uu-355655 |
| Date | January 2018 |
| Creators | Johansson, Fredrik |
| Source Sets | DiVA Archive at Upsalla University |
| Language | English |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | UPTEC X ; 18 013 |
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