Contribution information

Title Focus beam reflectance measurement probe as a tool for advanced monitoring of disintegration and dissolution in the pharmaceutical industry
Status Accepted
Final type Lecture
Final session Engineering and economy in biotechnology
Authors D., Smrcka1, J., Beránek2, O., Dammer3, P., Calta4
1 Zentiva k.s., Prague, Czechia
2 Zentiva, k.s. U Kabelovny 130, 102 37, Prague, Czechia
3 Zentiva k.s., Prague, Czechia
4 Zentiva k.s., Prague, Czechia
Uploaded abstract link
Brief content This work consists of the development of the robust method in order to achieve good data repeatability and at the same time keep the method discriminative, which was mostly implemented by optimization of the vessel volume, impeller speed and probe position. Consequently the different grades of microcrystalline cellulose (MCC) were investigated and distinguished in the tablets prepared thereof, which could be beneficial for backward engineering. The methodology was tested on the model tablets with fixed content of Ibuprofen, where effect of different disintegrant concentration and different ratios of lactose:MCC was investigated. It was shown as an increasing disintegrant concentration enhanced the disintegration speed and further reduced the size of a primary disintegration product. MCC primary particles and Ibuprofen could be distinguished from bigger agglomerates. The method was also applied on the original drug based on the lipid formulation, where in the FaSSIF media the oversaturation with consequent precipitation was observed and precipitation kinetic was properly recorded and described by evolution of CLD while amount of precipitated API was analyzed offline by UV spectrophotometry. Mentioned case studies served as an illustration of possible applications, which are, in fact, much wider. FBRM probe was found to be useful tool for proper description of the disintegration process and controlling in-vitro performance of the product behind the boundaries of the common dissolution testing.
ID 171