UV-VIS imaging-based investigation of API concentration fluctuation caused by the sticking behaviour of pharmaceutical powder blends

被引：3

作者：

Peterfi, Orsolya ^{[1
]}

Meszaros, Lilla Alexandra ^{[1
]}

Szabo-Szocs, Bence ^{[1
]}

Ficzere, Mate ^{[1
]}

Sipos, Emese ^{[2
]}

Farkas, Attila ^{[1
]}

Galata, Dorian Laszlo ^{[1
]}

Nagy, Zsombor Kristof ^{[1
]}

机构：

[1] Budapest Univ Technol & Econ, Fac Chem Technol & Biotechnol, Dept Organ Chem & Technol, Muegyetem Rkp 3, H-1111 Budapest, Hungary

[2] George Emil Palade Univ Med Pharm Sci & Technol Ta, Fac Pharm, Dept Toxicol & Biopharm, Gheorghe Marinescu St 38, Targu Mures 540142, Romania

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICS | 2024年 / 655卷

关键词：

Powder adhesion; Machine vision; UV imaging; Raman chemical imaging; Tableting; Powder homogenization; PARTICLE-SIZE; MEFENAMIC-ACID; ADHESION FORCE; SURFACE; FORMULATION; INGREDIENT; TIME;

D O I：

10.1016/j.ijpharm.2024.124010

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Surface powder sticking in pharmaceutical mixing vessels poses a risk to the uniformity and quality of drug formulations. This study explores methods for evaluating the amount of pharmaceutical powder mixtures adhering to the metallic surfaces. Binary powder blends consisting of amlodipine and microcrystalline cellulose (MCC) were used to investigate the effect of the mixing order on the adherence to the vessel wall. Elevated API concentrations were measured on the wall and within the dislodged material from the surface, regardless of the mixing order of the components. UV imaging was used to determine the particle size and the distribution of the API on the metallic surface. The results were compared to chemical maps obtained by Raman chemical imaging. The combination of UV and VIS imaging enabled the rapid acquisition of chemical maps, covering a substantially large area representative of the analysed sample. UV imaging was also applied in tablet inspection to detect tablets that fail to meet the content uniformity criteria. The results present powder adherence as a possible source of poor content uniformity, highlighting the need for 100% inspection of pharmaceutical products to ensure product quality and safety.

引用

页数：11