PMID- 36145563
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220928
IS  - 1999-4923 (Print)
IS  - 1999-4923 (Electronic)
IS  - 1999-4923 (Linking)
VI  - 14
IP  - 9
DP  - 2022 Aug 29
TI  - Design of Experiments as a Tool to Optimize the Process of Coating Minitablets 
      with Commercial Gastro-Resistant Coating Mixtures.
LID - 10.3390/pharmaceutics14091816 [doi]
LID - 1816
AB  - According to the Quality by Design (QbD) concept, Design of Experiment (DoE) was 
      used to indicate critical process parameters and optimize the fluid bed coating 
      of minitablets in a laboratory size batch. Full factorial design was employed to 
      increase knowledge of the process for three kinds of minitablet (MT) cores using 
      two commercial gastro-resistant coating mixtures. The statistical analysis showed 
      that different critical process parameters were indicated for the tested 
      minitablets: X3: the coating mixture flow rate for MTs with pantoprazole sodium 
      and Eudragit L; X2: the product temperature; X3 and X4: the spraying pressure for 
      MTs with pantoprazole sodium and Acryl Eze II; and X1 and X2: MTs with diclofenac 
      sodium. Such differences were the result of features, such as the sub-coat, size, 
      and mass of the cores and the core and coating mixture composition. No optimal 
      parameters were found for any of the tested MT types. Therefore, DoE should be 
      considered as a statistical tool to individually optimize the process for the 
      product, equipment, and tested parameters. However, optimization of the fluid bed 
      coating allowed us to predict the values of the process parameters necessary to 
      obtain good-quality products. Therefore, fluid bed coating may be successfully 
      used to obtain modified-release MTs of high quality after applying the 
      statistical tool DoE.
FAU - Frankiewicz, Maja
AU  - Frankiewicz M
AUID- ORCID: 0000-0002-0983-1922
AD  - Department of Pharmaceutical Technology, Medical University of Gdansk, Hallera 
      107, 80-416 Gdansk, Poland.
FAU - Sznitowska, Malgorzata
AU  - Sznitowska M
AUID- ORCID: 0000-0003-0866-0452
AD  - Department of Pharmaceutical Technology, Medical University of Gdansk, Hallera 
      107, 80-416 Gdansk, Poland.
LA  - eng
GR  - MN n 01-0367/08/510/Ministry of Science and Higher Education/
PT  - Journal Article
DEP - 20220829
PL  - Switzerland
TA  - Pharmaceutics
JT  - Pharmaceutics
JID - 101534003
PMC - PMC9505921
OTO - NOTNLM
OT  - design of experiments
OT  - enteric coating
OT  - fluid bed coating
OT  - minitablets
OT  - quality by design
COIS- The authors declare no conflict of interest.
EDAT- 2022/09/24 06:00
MHDA- 2022/09/24 06:01
PMCR- 2022/08/29
CRDT- 2022/09/23 01:42
PHST- 2022/07/26 00:00 [received]
PHST- 2022/08/21 00:00 [revised]
PHST- 2022/08/26 00:00 [accepted]
PHST- 2022/09/23 01:42 [entrez]
PHST- 2022/09/24 06:00 [pubmed]
PHST- 2022/09/24 06:01 [medline]
PHST- 2022/08/29 00:00 [pmc-release]
AID - pharmaceutics14091816 [pii]
AID - pharmaceutics-14-01816 [pii]
AID - 10.3390/pharmaceutics14091816 [doi]
PST - epublish
SO  - Pharmaceutics. 2022 Aug 29;14(9):1816. doi: 10.3390/pharmaceutics14091816.