Critical tools in tableting research: Using compaction simulator and quality by design (QbD) to evaluate lubricants’ effect in direct compressible formulation
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Tarih
2021
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
AAPS PharmSciTech
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
As commonly known, the product development stage is quite complex, requires
intensive knowledge, and is time-consuming. The selection of the excipients with the proper
functionality and their corresponding levels is critical to drug product performance. The
objective of this study was to apply quality by design (QbD) principles for formulation
development and to define the desired product quality profile (QTPP) and critical quality
attributes (CQA) of a product. QbD is a risk- and science-based holistic approach for
upgraded pharmaceutical development. In this study, Ibuprofen DC 85W was used as a
model drug, Cellactose® 80 along with MicroceLac® 100 as a filler, and magnesium stearate,
stearic acid, and sodium stearyl fumarate as lubricants. By applying different formulation
parameters to the filler and lubricants, the QbD approach furthers the understanding of the
effect of critical formulation and process parameters on CQAs and the contribution to the
overall quality of the drug product. An experimental design study was conducted to
determine the changes of the obtained outputs of the formulations, which were evaluated
using the Modde Pro 12.1 statistical computer program that enables optimization by
modeling complex relationships. The results of the optimum formulation revealed that
MicroceLac® 100 was the superior filler, while magnesium stearate at 1% was the optimum
lubricant. A design space that indicates the safety operation limits for the process and
formulation variables was also created. This study enriches the understanding of the effect of
excipients in formulation and assists in enhancing formulation design using experimental
design and mathematical modeling methods in the frame of the QbD approach.
Açıklama
Anahtar Kelimeler
Quality By Design, Compaction Simulator, Lubricants, Direct Compression, Lactose-Based Fillers
Kaynak
American Association of Pharmaceutical Scientists
WoS Q Değeri
N/A
Scopus Q Değeri
N/A
Cilt
22
Sayı
4
Künye
Jiwa, N., Ozalp, Y., Yegen, G., & Aksu, B. (2021). Critical Tools in Tableting Research: Using Compaction Simulator and Quality by Design (QbD) to Evaluate Lubricants’ Effect in Direct Compressible Formulation. AAPS PharmSciTech, 22(4), 1-15.
