Faculty of Pharmacy
Recent Submissions
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(2024)Tutkimuksen tausta: Avohuollon apteekit tekivät monia toimenpiteitä varmistaakseen apteekkipalveluiden jatkuvuuden ja lääkkeiden saatavuuden COVID-19-pandemian aikana. Kriisijohtamisen prosessiteoria antaa rakenteellisen viitekehyksen kriisien ymmärtämiseen ja hallintaan. Tavoite: Tutkimuksen tavoitteena oli tutkia suomalaisten avohuollon apteekkien kriisijohtamisprosessia COVID-19-pandemian aikana käyttäen kriisijohtamisen teoriaa teoreettisena viitekehyksenä. Menetelmät: Poikkileikkauskyselytutkimus kehitettiin kriisijohtamisen prosessiteorian pohjalta ja lähetettiin suomalaisille avohuollon apteekkareille sekä yliopistoapteekkien johtaville proviisoreille toisen pandemia-aallon aikana loka–marraskuussa 2020. Logistisen regressioanalyysin avulla tutkittiin, oliko johdon riskinäkemyksellä yhteyttä kriisivalmiuteen, ja miten kriisisuunnitelmat, tiimit ja yhteistyö ulkoisten sidosryhmien kanssa olivat yhteydessä pandemian vaikutuksiin avohuollon apteekeissa. Avoimista vastauksista saatu laadullinen aineisto ryhmiteltiin samankaltaisuuksien perusteella. Tulokset: Kyselyyn vastasi yhteensä 221 apteekkaria ja johtavaa proviisoria (vastausprosentti 36,7 %). Apteekeista 79,6 %:lla oli olemassa pandemiasuunnitelma ennen kriisiä. Pandemiakriisitiimi oli nimetty 35,3 %:lla apteekeista ja 33,5 % lisäsi tai paransi yhteistyötä muiden apteekkien tai lääkehuollon toimijoiden kanssa. Kollektiivinen päätöksenteko ja ulkoisen yhteistyön lisääminen tai parantaminen olivat yhteydessä vähäisempiin negatiivisiin vaikutuksiin johdon jaksamisessa. Lisäksi kollektiivinen päätöksenteko oli yhteydessä vähäisempiin negatiivisiin vaikutuksiin organisaation taloudessa. Kirjallisuudesta poiketen olemassa olevalla pandemiasuunnitelmalla oli enemmän negatiivisia vaikutuksia organisaatioiden resursseihin. Yhteyttä apteekkarin riskinäkemyksen ja apteekkien kriisivalmiuden välillä ei havaittu. Johtopäätökset: Apteekkien tekemät toiminnalliset muutokset ja infektion ehkäisy- ja torjuntakäytännöt mahdollistivat keskeisten palvelujen tarjoamisen pandemian asettamista haasteista huolimatta. Oppimista ja sopeutumista tapahtui reaaliajassa kriisin aikana. Kollektiivisen päätöksenteon kehittäminen ja yhteistyö kollegoiden ja muiden lääkehuollon toimijoiden kanssa voivat parantaa apteekkarien jaksamista ja apteekkien taloutta tulevissa kriiseissä. Jatkotutkimuksissa voitaisiin hyödyntää laadullisia tutkimusmenetelmiä ja tutkia tarkemmin kollektiivista päätöksentekoa sekä vaikuttavan kriisisuunnitelman sisältöä avohuollon apteekkien kontekstissa.
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(2024)Adoptive cell therapy utilizes the patient's own immunological system in the treatment of cancer. T cells expressing the chimeric antigen receptor (CAR) are produced from the patient's own T-cells. The CAR gene is introduced into the T cells by a gene transfer vector, which results in the T cells expressing the CAR molecule that recognizes the antigen on the surface of the cancer cell. When CAR-T cells are returned to the body, they recognize the cancer cell with the CAR molecule and destroy it. CAR-T cell therapy has shown promising results in the treatment of malignant hematological cancers. The white blood cells used as starting material for CAR-T cells are collected from the patient using a specially designed leukapheresis device. The collected leukapheresis product is transported to the CAR-T cell manufacturing site as soon as possible, either fresh or frozen. The aim of this stability study of leukapheresis products was to determine the effect of storage time and temperature on the quality of fresh cell products regarding cell number, viability and composition. In addition, the goal was to determine the optimal storage temperature and the shelf life of leukapheresis product to ensure high quality cell starting material for CAR-T cell production. The study was performed by dividing the leukapheresis products into two cell bags immediately after collection, one stored at +15–25 °C and the other at +2–8 °C for five days. The leukapheresis products were examined at five different time points (0, 25, 49, 73 and 121 h) for white blood cell count, viability, apoptosis and white blood cell composition. The microbiological purity of the cell products was examined after leukapheresis. The leukocyte composition was stable, viability and cell yield over 80 % for at least 72 hours at +2–8 °C storage temperature. Although small proportions of cells were apoptotic after the 48 hours of storage +2–8 °C, the leukapheresis products contained more than 80 % viable leukocytes after 72 hours and over 70 % after 120 hours. Leukapheresis products remained stable for 48 hours at +15–25 °C, after which their leukocyte composition changed, leukocyte viabilities and yields decreased. The viabilities of the leucocytes were above 90 % for 48 hours at +15–25 °C, but at the 73 h time point, only half of the cells were viable. The optimum storage temperature for leukapheresis products was +2–8 °C, at which white blood cells remained in good quality for 72 hours. These results can be used to set quality requirements for the cell source material of CAR-T cell product and to plan the transport from the collection site of the leukapheresis to the CAR-T cell production site.
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(2024)Tablets are solid medicinal products that are produced by compressing tablet mass in a tablet press. The reproducible and reliable functionality of the manufacturing process, facilities and equipment used in the manufacturing process of medicinal products must be validated. There must be a marketing authorisation for the sale of medicinal products, and pharmaceutical companies must comply with current legislation, Good Manufacturing Practices, and other binding guidelines. After marketing authorisation, certain changes, such as significant changes related to the manufacturing process or raw materials, must be notified to the competent authority by means of a variation application. Depending on the extent of the change, a revalidation and/or a regulatory approval before implementing the change may be required, which makes manufacturing process modification slow, expensive, and laborious. However, the pressure to enhance pharmaceutical manufacturing processes and reduce costs is prevailing. In this study, Lean Six Sigma methods were applied to enhance the manufacturing process of a tablet product. The study was divided into two parts. In the first part of the study, the objective was to investigate the manufacturing process of a tablet product X and to identify improvement actions that would make the manufacturing process of the tablet product X more efficient by achieving material and time savings. In addition, improvement actions were prioritized based on the benefits achieved by the improvement actions and the difficulty of implementation. The second part of the study was based on the improvement action selected from the first part of the study. The objective of the second part of the study was to investigate the factors influencing the amount of mass loss during tableting and how the amount of mass loss can be influenced. In this study, mass loss during tableting referred to the dusty mass inside the tablet press during tableting, which is removed from the tablet press to the equipment dedusting system. The purpose of the practical experiment conducted in the tablet production, which was part of the second part of the study, was to investigate how the magnitude of the exhaust airflow and fan power of the equipment dedusting system affects the amount of mass loss generated during tableting. Based on the experiment, adjusting the power of the equipment dedusting system can affect the amount of mass loss generated during tableting. However, further studies are needed to ensure that no dusty mass remains in the piping of the dedusting system or in tablet press at low exhaust airflow and fan power values during tableting. If the results are applied to other tablet products, the effect of a different formulation on powder dusting should be considered. Adequate dedusting during tableting is important so that the dusty mass inside the tablet press is removed as intended, facilitating the cleaning of the tablet press after tableting and reducing the risk of cross-contamination and exposure of workers to dust. The conclusion of this study is that Lean Six Sigma methods can be used more extensively to enhance the manufacturing processes of both tablet products and other pharmaceutical dosage forms and to reduce loss generated during the manufacturing process without revalidation or changes to a valid marketing authorisation.
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(2024)The potential of extracellular vesicles (EVs) as diagnostic markers and drug delivery vehicles has been studied increasingly in recent years. One of the challenges in this field has been the isolation of EVs from complex biological fluids such as blood. The methods widely used for the isolation process include for example size exclusion chromatography (SEC) and ultracentrifugation (UC). As these methods use size and density of the particle, the have not been efficient enough in isolating EVs from certain particles such as lipoproteins. Due to the challenges related to these methods, other isolation methods have been sought to improve the efficiency of EV isolation. One of these methods is ion-exchange chromatography (IEC). From the two forms of IEC, anion-exchange chromatography has been studied more in EV isolation due to the negative net charge on EV particles. However, in this study the functionality and efficiency of cation-exchange chromatography (CEC) in EV isolation was studied as very little research has been done on this method. In this study, two CEC-resins were studied to define their applicability in EV isolation. A standard strong cation-exchange chromatographic resin SP Sepharose Fast Flow was compared to a strong tentacle-type resin. In addition to this, we studied the possibility to use a magnesium gradient to separate different forms of lipoproteins from EVs through dextran-sulfite precipitation. Tentacle-type CEC-resin was found to be more efficient in capturing EVs compared to the standard-type resin without magnesium. These EVs could then be eluted from the column with sodium chloride. The use of magnesium gradient allowed the separation of apolipoproteins in the samples. Higher concentrations of magnesium also reduced the number of lipoproteins in the samples altogether but resulted in the loss of EVs as well. These results were promising and showed that cation-exchange chromatography can be used in EV isolation. Tentacle-type resin seemed to be most efficient in removing impurities and capturing EVs. While more research is needed before these findings can be applied to clinical use, these results prove that cation-exchange chromatography can be used in EV isolation as a new, efficient and up scalable method.
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(2024)To develop a closed-loop medication management process, monitoring the effects of medication should be integrated into patient information systems through structured recording methods. Sufficient documentation of medication monitoring is a prerequisite for implementing effective medication management and ensuring good quality, individualized care for patients. Medication management for patients with intellectual disabilities on the autism spectrum can be extremely challenging. The characteristics of intellectual disabilities and autism spectrum disorders, comorbidities, and polypharmacy make medication management and monitoring challenging. This study focused on patients with difficult behavioural symptoms. The study aimed to identify the most important symptoms to monitor in assessing the effects of medication in patients with intellectual disabilities on the autism spectrum. Additionally, it defined the time points from the initiation of medication when the effects should be assessed. The study was conducted as a two-round study using the Delphi consensus method in January-February 2024. The expert panel consisted of 12 experts in intellectual disabilities, autism spectrum disorders or in the field of medicine. Lists of behavioural symptoms, other symptoms, and monitoring time points were compiled for the study based on literature and the expertise of the research group. Experts were presented with a list of symptoms, and in the first round, symptoms that exceeded a consensus threshold of 50% proceeded to the second round. In the second round, experts ranked symptoms based on their importance for monitoring using Likert-scale questions. The data were analysed using quantitative and qualitative methods. Experts considered 9 behavioural symptoms and 22 other symptoms as highly important or important to monitor. The experts identified severe symptoms indicating self-harm or harm to others as the most critical behavioural symptoms to monitor. The most important other monitored symptoms included common comorbidities and symptoms within the patient group or adverse effects of medication. The effects of medication should be evaluated regularly, at least at the 4-week mark after initiating medication and after 3 months evaluations should be conducted at intervals of every 6 months. Monitoring the effects of medication was perceived to pose many challenges, and monitoring is not always carried out at a sufficient level. Many different symptoms should be monitored because patients are individual and present a variety of symptoms. It is essential to have a good understanding of the patient's condition before starting medication to assess the medication's impact on the patient's behaviour or other symptoms. The study highlighted the lack of structured monitoring forms and the need for monitoring tools.