Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets

Implementation of quality by design approach in manufacturing process optimization of dry granulated, immediate release, coated tablets – a case study

Published:2017-05-23 Issue:10 Volume:43 Page:1626-1636
ISSN:0363-9045
Container-title:Drug Development and Industrial Pharmacy
language:en
Short-container-title:Drug Development and Industrial Pharmacy

Author:

Teżyk Michał¹²,Jakubowska Emilia²^ORCID,Milanowski Bartłomiej²^ORCID,Lulek Janina²

Affiliation:

1. Gedeon Richter Polska Sp. z o.o., Grodzisk Mazowiecki, Poland;

2. Department of Pharmaceutical Technology, Faculty of Pharmacy, Poznan University of Medical Sciences, Poznan, Poland

Funder

Poznan University of Medical Sciences

Publisher

Informa UK Limited

Subject

Organic Chemistry,Drug Discovery,Pharmaceutical Science,Pharmacology

Link

https://www.tandfonline.com/doi/pdf/10.1080/03639045.2017.1328431

Reference19 articles.

1. ICH. ICH Harmonised Tripartite Guideline. Pharmaceutical Development Q8(R2). 2009 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (accessed 2015/04/29)

2. ICH. ICH Harmonised Tripartite Guideline. Quality Risk Management Q9. 2008 https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf (accessed 2015/04/29)

3. ICH. ICH Harmonised Tripartite Guideline. Pharmaceutical Quality System Q10. 2008 https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf (accessed 2015/04/29)

4. Application of face centred central composite design to optimise compression force and tablet diameter for the formulation of mechanically strong and fast disintegrating orodispersible tablets

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