PMID- 32290729
OWN - NLM
STAT- MEDLINE
DCOM- 20210204
LR  - 20210204
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 46
IP  - 5
DP  - 2020 May
TI  - Filling of lactose-based formulations in a tamping-pin capsule filler.
PG  - 775-787
LID - 10.1080/03639045.2020.1753063 [doi]
AB  - We studied three lactose-based formulations in terms of bulk powder properties 
      and capsule-filling behavior in a tamping-pin capsule filling system, to which 
      several mechanical adaptions were made for process optimization in light of 
      future continuous production. The model formulations were thoroughly 
      characterized and filled into size 1 capsules according a well-defined design of 
      experiments (DoE). Overall, the three entirely different formulations were 
      successfully filled within the selected design space. The fill weight and fill 
      weight variability can be adjusted by fine-tuning the process settings, like the 
      pin immersion depth and the maximum compaction pressure (pneumatic or 
      spring-controlled), and by using the appropriate powder bed height and mechanical 
      adaptions. This study demonstrated that selection of process parameters and 
      mechanical adaptions could enhance the filling performance, especially in 
      continuous production, since they reduce the powder volume in the process. 
      Moreover, we showed that a tamping-pin system is capable of successfully filling 
      a broad range of powders with various material characteristics and can 
      potentially be used in a continuous production mode.
FAU - Faulhammer, Eva
AU  - Faulhammer E
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
FAU - Kruisz, Julia
AU  - Kruisz J
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
FAU - Scheibelhofer, Otto
AU  - Scheibelhofer O
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
FAU - Rehrl, Jakob
AU  - Rehrl J
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
AD  - Institute of Automation and Control, Graz University of Technology, Graz, 
      Austria.
FAU - Witschnigg, Andreas
AU  - Witschnigg A
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
FAU - Khinast, Johannes G
AU  - Khinast JG
AD  - Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
AD  - Institute of Process and Particle Engineering, Graz University of Technology, 
      Graz, Austria.
LA  - eng
PT  - Journal Article
DEP - 20200417
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Capsules)
RN  - 0 (Powders)
RN  - J2B2A4N98G (Lactose)
SB  - IM
MH  - Capsules
MH  - Chemistry, Pharmaceutical/*instrumentation/*methods
MH  - Drug Compounding/*methods
MH  - Lactose/*chemical synthesis
MH  - Powders
OTO - NOTNLM
OT  - Tamping-pin capsule filling
OT  - continuous manufacturing
OT  - lactose-based formulations
OT  - material characterization
OT  - process optimization
EDAT- 2020/04/16 06:00
MHDA- 2021/02/05 06:00
CRDT- 2020/04/16 06:00
PHST- 2020/04/16 06:00 [pubmed]
PHST- 2021/02/05 06:00 [medline]
PHST- 2020/04/16 06:00 [entrez]
AID - 10.1080/03639045.2020.1753063 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2020 May;46(5):775-787. doi: 10.1080/03639045.2020.1753063. 
      Epub 2020 Apr 17.