Browsing by Subject "3D-tulostus"
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(2021)Lääketieteen kehittyessä yksilöllisen lääkehoidon tarpeeseen on kiinnitetty enemmän huomiota kuin aikaisemmin ja etenkin lapsille lääkkeiden tarkka annostelu on erityisen tärkeää. Kaupallisilla valmisteilla tarpeeksi pienet annokset eivät usein ole mahdollisia eikä tablettien puolittaminen takaa tarkkaa lääkkeiden annostelua. 3D-tulostamista on ajateltu mahdollisena vaihtoehtona ex tempore -lääkkeiden tuotantoon ja sen mahdollisuuksia on tutkittu laajalti viime vuosien aikana. Tämän tutkimuksen tavoitteena on selvittää, miten ekstruusiomenetelmällä tulostetut varfariinikalvot vertautuvat sairaala-apteekin käyttämiin varfariiniannosjauheisiin, sekä olisiko kyseistä menetelmää mahdollista hyödyntää sairaala-apteekeissa. Tutkimuksessa valmistettiin puolikiinteän aineen ekstruusiolla 0,1 mg:n, 0,5 mg:n ja 2 mg:n varfariinikalvoja, jotka kuivattiin 85 ℃:ssa valmistusprosessin nopeuttamiseksi. Kalvoja verrattiin saman vahvuisiin varfariinia sisältäviin sairaala-apteekin valmistamiin annosjauheisiin. Kalvoissa käytettiin hydroksipropyylimetyyliselluloosaa kalvonmuodostaja-aineena ja glyserolia tuomaan plastisuutta. Annosjauheet koostuivat kaupallisesta 5 mg:n Marevan-valmisteesta ja täyteaineena käytetystä laktoosista. Molemmista lääkevalmisteista mitattiin liukenemisnopeus ja annosyksiköiden yhdenmukaisuus. Molempien valmisteiden toimivuus nenä-mahaletkussa tutkittiin myös, sillä kalvojen on tärkeää soveltua erilaisille potilasryhmille. Kalvot olivat kovia, mikä aiheutti niiden hitaan liukenemisen. Puolikiinteän aineen valmistus ja tulostuksen toteuttaminen tavoitteiden mukaisesti osoittautui oletettua vaikeammaksi. Kalvoissa mitattiin annosjauheita tasaisempi lääkeainepitoisuus. Molempien lääkevalmisteiden kohdalla huomattiin, että kaikki varfariini ei pääse nenä-mahaletkujen läpi. Tärkein huomio oli, että hyvin yksinkertaisella formulaatiolla on mahdollista tuottaa lupaavia lääkevalmisteita. Tämä tutkimus esittelee syitä, joiden vuoksi 3D-tulostusta on hyvä tutkia mahdollisena ex tempore -valmistuksen menetelmänä.
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(2018)Marketing authorized pharmaceutical preparations that are aimed at adult use cause problems both in administration and when dosing. Over and underdosing are the most common medication errors in pediatric population. Only a fraction of medicinal products are clinically tested and evaluated for pediatric use. Children should have the right for the best achievable health, medical care and rehabilitation. The aim of this study was to determine problematic pharmaceutical preparations, formulations or excipients experienced by healthcare professionals. The another aim of this study was to comprise (?) the view of healthcare professionals about 3D-printed medicinal products by using the collected data. By using the data, the problems, challenges, targets for development and other suggestions regarding pediatric medication were identified. New 3D printed medicines suitable for children can be developed by using the observations of this study. The study was carried out as semi-structured interview. Frameworks of the themes were structured by using the subjects of a recently made semi-structured questionnaire. The semi-structured interview was carried out as a group-interview, where the participants were presented open questions according to the themes structured before. According to the study results, the prejudices of the interviewees towards the new technology were mainly positive. The adjustability of the printed medicine by the means of the patient was most highlighted property in the interviews. Accoring to the experiences of the interviewees’, the most suitable pharmaceutical preparations used are liquid preparations such as oral liquids or suspensions. When using solid oral formulations, the age of the patient was not seen as significant. The most common reason for compounding the preparation was the wrong size of the product or dose. The varying availability of pharmaceutical preparations was seen as delaying factor at the start of the medical treatment. In the interview the pharmacists recognized the most common excipients causing adverse events. The different roles of the occupational groups were identified according to their work duties.
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(2023)For pediatric patients, it is often necessary to resort to off-label use of available commercial products. This may require manual modification of the preparations, which may result in reduced dose accuracy. In the past, there have been discussions about the potential of 3D printing technologies for on-demand manufacturing of medicines in hospitals. Printing technologies can be used to tailor medicines to the individual needs of patients. This could be a possible solution to the lack of commercial products for pediatric patients, for example. Semi-solid extrusion is a printing technique that could potentially be used in the future in hospitals. This study aims to design the simplest possible excipient composition for a printing material for semi-solid extruded preparations for pediatric patients. The finished products will be examined to determine the type of products achieved with this printing method and excipient composition. In addition, the suitability of semi-solid extrusion in a hospital environment will be observed and evaluated. Printing was performed with a pneumatic bioprinter. The desired formulations could not be prepared with a printing material containing only a gel former (poloxamer 407) and a solvent (water). Therefore, a filler (microcrystalline cellulose) was added to the printing material to improve the mechanical strength of the preparations. The model drug used in the study was warfarin sodium and the target strengths of the preparations were 0.1 mg, 0.5 mg and 1.0 mg. The preparations were dried at room temperature for 22-23 hours. The tablets produced in the study were small (diameter less than 7 mm, height less than 2 mm) grid-structured preparations. The method was successful in producing tablets of uniform mass. For all strengths, the tablets passed the European Pharmacopoeia test for uniformity of content of single-dose preparations. Only the 0.5 mg strengths passed the test of uniformity of dosage units. The excipient composition should still be optimized to improve the mechanical strength of the products. The overall preparation time of the formulations should be reduced, for example by shortening the drying time, to make semi-solid extrusion suitable for extemporaneus preparations in hospitals.
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