Design of an orally disintegrating tablet formulation containing metoprolol tartrate in the context of quality by design approach
Yükleniyor...
Tarih
2021
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Marmara University Press
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
Orally Disintegrating Tablets (ODTs) are solid dosage forms that rapidly disintegrate or dissolve to release
the drug upon contact with saliva in the mouth. As these tablets require special attention during formulation design, it
is necessary to use advanced control and formulation design techniques to increase the quality. Quality by Design (QbD)
was defined as an approach including better scientific understanding of critical process and product attributes,
designing controls and tests based on scientific understanding limits during development stage and used to work in an
environment for continuous improvement of information obtained during the product lifecycle. The aim of the study
was to develop an ODT formulation containing Metoprolol tartrate with appropriate features via QbD approach with
the help of artificial intelligence programs to enlight the multivariate relations between critical parameters and quality
attributes of on final product and to obtain an optimum formulation. Physical and chemical tests were conducted on
tablets prepared by direct compression according to the designated formulation and process variables. Then,
experimental data was evaluated with modeling programs use artificial intelligence technique, FormRules V3.32 to
understand the relationship between independent input variables and the critical quality attributes; later with INForm
V5.1 for optimization. The optimized formula was prepared and according to test results tablets shows compliance with
the pharmacopoeia limits. The adoption of QbD approach and usage of artificial intelligence programs has increased
the efficiency of the formulation development process with better understanding of the product and process.
Açıklama
Anahtar Kelimeler
Artificial Intelligence, Orally Disintegrating Tablet, Quality By Design, Metoprolol Tartrate
Kaynak
Journal of Research in Pharmacy
WoS Q Değeri
N/A
Scopus Q Değeri
Q3
Cilt
25
Sayı
5
Künye
Yeğen, G., Aksu, B., Cevher, E. (2021). Design of an orally disintegrating tablet formulation containing metoprolol tartrate in the context of quality by design approach. Journal of Research in Pharmacy, 728-737.
