Impact of material properties and process parameters on tablet quality in a continuous direct compression line

The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated and linked to the blending and tableting performance via multivariate models (Partial Least Squares analysis, PLS). Feeding behavior was analyzed separately, as the amount of active pharmaceutical ingredient (API) that ended into tablets was driven by random fluctuations in the API feeding behavior. The developed PLS models elucidated that formulation behavior was mainly driven by the concentration of the active pharmaceutical ingredient (API), explained by the distinct API properties. Excipient properties also had a substantial impact on formulation behavior. Generally, formulations with microcrystalline cellulose as a filler showed better compactability, lower hold-up mass, lower flowability and higher cohesion than formulations with different lactose grades. The relative performance of a formulation with different fillers differed for 1% w/w and 40% w/w drug loading. Granular and spray dried lactose grades increased in compactability ranking compared to anhydrous lactose when evaluating higher drug loading, due to the difference in morphology. It was shown that besides understanding the impact of excipients on the formulation performance, processability of ingredients is crucial for formulation design.</p

Pakolaistaustaisten kokemuksia työelämästä Suomessa – Sauma-työelämävalmennus työllistymistä tukemassa

Opinnäytetyön tarkoituksena on avata ja tarkastella työllistymistä hidastavia, haastavia sekä edistäviä tekijöitä, joita pakolaistaustaiset maahan muuttaneet saattavat kohdata Suomessa työllistymispolkunsa varrella. Tutkimusta taustoitettiin olemassa olevaa tietoa ja aikaisempia tutkimuksia hyödyntäen. Haastatteluiden avulla kerättiin pakolaistaustaisten maahanmuuttajien omia kokemuksia suomalaisesta työelämästä ja siihen pääsystä. Sauma-työelämävalmennus tukee pakolaistaustaisten maahan muuttaneiden työllistymismahdollisuuksia, ja tarjosivat aihealuetta tukevan tutkimustarpeen sekä aineistonkeruuseen tarvittavan asiakaskunnan ja toimintaympäristön. Tutkimusaineisto koostuu seitsemästä pakolaistaustaisen maahanmuuttajan haastattelusta. Haastattelut toteutettiin teemahaastatteluina ja aineiston analyysi toteutettiin temaattista sisällönanalyysin metodia hyödyntäen. Analyysia tehdessä aineistosta muodostui neljä pääluokkaa, jotka ovat: työllistymisen haasteet, työelämäkokemukset, työn merkitys sekä kokemukset työelämävalmennuksesta. Haastateltavien vastaukset olivat yhteneviä ja aineisto hyvin linjassa jo olemassa olevan tiedon ja teoriapohjan kanssa. Tuloksista voi siis päätellä, että suomalaiseen työelämään integroituminen on pakolaistaustaisille hankalaa ja he kokevat syrjintää ja eriarvoisuutta suomalaisilla työmarkkinoilla. Aihetta tulisi tutkia laajemmin, jotta pystyisimme löytämään keinoja ja tapoja näiden ongelmakohtien ratkaisemiseksi. Opinnäytetyö tuottaa Sauma-työelämävalmennukselle tietoa toiminnan vaikuttavuudesta ja asiakaskokemuksista sekä niistä nousseista kehittämisehdotuksista. Työ tarjoaa lisäksi laajan katsauksen pakolaisuuden ja työllistymisen teemoihin. Monikulttuurisuus on tänä päivänä osa sosiaalialan jokaista työkenttää. Tieto ja ymmärrys kohderyhmän tarpeista ja erityispiirteistä sekä työelämän moninaisuudesta on hyödyllistä jokaiselle sosiaalialan ammattilaiselle

Batch vs. continuous direct compression – a comparison of material processability and final tablet quality

In this study, an in-depth comparison was made between batch and continuous direct compression using similar compression set-ups. The overall material processability and final tablet quality were compared and evaluated. Correlations between material properties, process parameters and final tablet properties were made via multivariate data analyses. In total, 10 low-dosed (1% w/w) and 10 high-dosed (40% w/w) formulations were processed, using a total of 10 different fillers/filler combinations. The trials indicated that the impact of filler type, drug load or process settings was similar for batch and continuous direct compression. The main differentiator between batch and continuous was the flow dynamics in the operating system, where properties related to flow, compressibility and permeability played a crucial role. The less consistent flow throughout a batch process resulted in a significantly higher variability within the tablet press (σCF) and for the tablet quality responses (σMass, σTS). However, the better controlled blending procedure prior to batch processing was reflected in a more consistent API concentration variability. Overall, the comparison showed the benefits of selecting appropriate excipients and process settings to achieve a specific outcome, keeping in mind some key differentiators between both processes

Impact of material properties and process parameters on tablet quality in a continuous direct compression line

The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated and linked to the blending and tableting performance via multivariate models (Partial Least Squares analysis, PLS). Feeding behavior was analyzed separately, as the amount of active pharmaceutical ingredient (API) that ended into tablets was driven by random fluctuations in the API feeding behavior. The developed PLS models elucidated that formulation behavior was mainly driven by the concentration of the active pharmaceutical ingredient (API), explained by the distinct API properties. Excipient properties also had a substantial impact on formulation behavior. Generally, formulations with microcrystalline cellulose as a filler showed better compactability, lower hold-up mass, lower flowability and higher cohesion than formulations with different lactose grades. The relative performance of a formulation with different fillers differed for 1% w/w and 40% w/w drug loading. Granular and spray dried lactose grades increased in compactability ranking compared to anhydrous lactose when evaluating higher drug loading, due to the difference in morphology. It was shown that besides understanding the impact of excipients on the formulation performance, processability of ingredients is crucial for formulation design.</p

A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction

Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body of work around how lubrication via batch blender operation affects tablet critical quality attributes such as hardness and tensile strength. But, aside from being batch operations, the design of these blenders is such that they operate with low-shear, low-intensity mixing at Froude number values significantly below 0.4 (Froude number Fr being the dimensionless ratio of inertial to gravitational forces). The present work explores the performance of a mini-blender which has a fundamentally different mode of operation (static vessel with rotating blades around a mixing shaft as opposed to rotating vessel with no mixing shaft). This difference allows a substantially wider operating range in terms of speed and shear (and Fr values). The present work evaluates how its performance compares to other blenders studied in the literature. Tablet compaction data from blends produced at various intensities and regimes of mixing in the mini-blender follow a common trajectory. Model equations from literature are suitably modified by inclusion of the Froude number Fr, but only for situations where the Froude number was sufficiently high (1 < Fr). The results suggest that although a similar lubrication extent plateau is eventually reached it is the intensity of mixing (i.e. captured using the Froude number as a surrogate) which is important for the lubrication dynamics in the mini-blender, next to the number of revolutions. The degree of fill or headspace, on the other hand, is only crucial to the performance of common batch blenders. Testing using alternative formulations shows the same common trend across mixing intensities, suggesting the validity of the approach to capture lubrication dynamics for this system