Abstract
Mixing and formulation of drugs with very low dose is a brutal challenge to formulators sometimes due to all kinds of difficulties like segregation, content uniformity and physicochemical stability issues. A careful consideration of all related factors is essential during manufacturing of very low dose drug products. The aim of this study is to evaluate the quality control of ultra-low dose drugs of different companies available in local Iraqi and their compliance with regulatory weight variation test. Quantitative analysis conducted to five drugs using weight variation technique with 20 randomly selected tablets for each drug. All of these drugs passed the test. The variations amongst the tablet weights can be attributed to factors like the powder flowing properties, tableting machine speed, compression force and pressure and the type of machinery used for tableting process. These factors can affect tablet weight. However, the most important two causes of weight variation are differences in bulk densities of powder mixture ingredients and particle size distribution in tablet compression. Further investigation is required to assess the content of these drugs using content uniformity technique with UV spectrophotometer.
Recommended Citation
Younis, Yousif K.
()
"Evaluation of the Compliance of Ultra-Low Dose Drugs Available in Local Iraqi Markets with Regulatory Weight Variation Test,"
Al-Mustaqbal Journal of Pharmaceutical and Medical Sciences: Vol. 4
:
Iss.
1
, Article 6.
Available at:
https://doi.org/10.62846/3006-5909.1043
