PMID- 22881350
OWN - NLM
STAT- MEDLINE
DCOM- 20130517
LR  - 20191210
IS  - 1097-9867 (Electronic)
IS  - 1083-7450 (Linking)
VI  - 18
IP  - 1
DP  - 2013 Feb
TI  - A quality by design approach using artificial intelligence techniques to control 
      the critical quality attributes of ramipril tablets manufactured by wet 
      granulation.
PG  - 236-45
LID - 10.3109/10837450.2012.705294 [doi]
AB  - Quality by design (QbD) is an essential part of the modern approach to 
      pharmaceutical quality. This study was conducted in the framework of a QbD 
      project involving ramipril tablets. Preliminary work included identification of 
      the critical quality attributes (CQAs) and critical process parameters (CPPs) 
      based on the quality target product profiles (QTPPs) using the historical data 
      and risk assessment method failure mode and effect analysis (FMEA). Compendial 
      and in-house specifications were selected as QTPPs for ramipril tablets. CPPs 
      that affected the product and process were used to establish an experimental 
      design. The results thus obtained can be used to facilitate definition of the 
      design space using tools such as design of experiments (DoE), the response 
      surface method (RSM) and artificial neural networks (ANNs). The project was aimed 
      at discovering hidden knowledge associated with the manufacture of ramipril 
      tablets using a range of artificial intelligence-based software, with the 
      intention of establishing a multi-dimensional design space that ensures 
      consistent product quality. At the end of the study, a design space was developed 
      based on the study data and specifications, and a new formulation was optimized. 
      On the basis of this formulation, a new laboratory batch formulation was prepared 
      and tested. It was confirmed that the explored formulation was within the design 
      space.
FAU - Aksu, Buket
AU  - Aksu B
AD  - Santa Farma Pharmaceuticals, Okmeydani, Borucicegi Sok. No:16 Sisli, Istanbul 
      Turkey. baksu@santafarma.com.tr
FAU - Paradkar, Anant
AU  - Paradkar A
FAU - de Matas, Marcel
AU  - de Matas M
FAU - Ozer, Ozgen
AU  - Ozer O
FAU - Guneri, Tamer
AU  - Guneri T
FAU - York, Peter
AU  - York P
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20120813
PL  - England
TA  - Pharm Dev Technol
JT  - Pharmaceutical development and technology
JID - 9610932
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 0 (Tablets)
RN  - L35JN3I7SJ (Ramipril)
SB  - IM
MH  - Angiotensin-Converting Enzyme Inhibitors/administration & dosage/*chemistry
MH  - Drug Compounding/*methods
MH  - *Neural Networks, Computer
MH  - Quality Control
MH  - Ramipril/administration & dosage/*chemistry
MH  - Risk Assessment
MH  - Software
MH  - Tablets
EDAT- 2012/08/14 06:00
MHDA- 2013/05/18 06:00
CRDT- 2012/08/14 06:00
PHST- 2012/08/14 06:00 [entrez]
PHST- 2012/08/14 06:00 [pubmed]
PHST- 2013/05/18 06:00 [medline]
AID - 10.3109/10837450.2012.705294 [doi]
PST - ppublish
SO  - Pharm Dev Technol. 2013 Feb;18(1):236-45. doi: 10.3109/10837450.2012.705294. Epub 
      2012 Aug 13.