Scale-up from batch to flow-through wet milling process for injectable depot formulation
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F16%3A43902086" target="_blank" >RIV/60461373:22340/16:43902086 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.ejps.2016.08.043" target="_blank" >http://dx.doi.org/10.1016/j.ejps.2016.08.043</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejps.2016.08.043" target="_blank" >10.1016/j.ejps.2016.08.043</a>
Alternative languages
Result language
angličtina
Original language name
Scale-up from batch to flow-through wet milling process for injectable depot formulation
Original language description
Injectable depot formulations are aimed at providing long-term sustained release of a drug into systemic circulation, thus reducing plasma level fluctuations and improving patient compliance. The particle size distribution of the formulation in the form of suspension is a key parameter that controls the release rate. In this work, the process of wet stirred media milling (ball milling) of a poorly water-soluble substance has been investigated with two main aims: (i) to determine the parametric sensitivity of milling kinetics; and (ii) to develop scale-up methodology for process transfer from batch to flow-through arrangement. Ball milling experiments were performed in two types of ball mills, a batch mill with a 30 ml maximum working volume, and a flow-through mill with a 250 ml maximum working volume. Milling parameters were investigated in detail by methodologies of QbD to map the parametric space. Specifically, the effects of ball size, ball fill level, and rpm on the particle breakage kinetics were systematically investigated at both mills, with an additional parameter (flow-rate) in the case of the flow-through mill. The breakage rate was found to follow power-law kinetics with respect to dimensionless time, with an asymptotic d50 particle size in the range of 200?300 nm. In the case of the flow-through mill, the number of theoretical passes through the mill was found to be an important scale-up parameter. ? 2016 Elsevier B.V.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
CI - Industrial chemistry and chemical engineering
OECD FORD branch
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Result continuities
Project
<a href="/en/project/GA15-05534S" target="_blank" >GA15-05534S: Structure-property relationships and breakage dynamics of complex granular material</a><br>
Continuities
S - Specificky vyzkum na vysokych skolach
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Pharmaceutical Sciences
ISSN
0928-0987
e-ISSN
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Volume of the periodical
95
Issue of the periodical within the volume
December 2016
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
122-129
UT code for WoS article
000390505100015
EID of the result in the Scopus database
2-s2.0-84995389744