Dissolution of Tartaric Acid Pellets

In this application note the dissolution of Tartaric Acid Pellets is presented. Data first have been created and published by Kállai-Szabó et al. [1].

The movie below shows the time dependent effect of pH 1.2 HCl dissolution medium on starter cores made of tartaric acid (TAP). Experimental setup employed for pellet disintegration/dissolution test: Microfluidic dissolution tester by Laki Technology (BioMicrofluidicsLab PPKE ITK), Pump (KF Technology, NE1000) Flow: 4000 µL/h, Nikon SMZ 1000 Optics 1x, Magn: 3x; NIS Elements Imaging Software.

At initial condition, the pellet is freely floating in the dissolution media. After 30 seconds, the dynamic process has obviously started, and the pellet shrinks in size. Within the first 90 seconds the starter core is entirely dissolved.

The dissolution of the TAP starter core is compulsory when using BSC class IV drugs. By dissolving, tartaric acid is provided and the pellet functions as an acidic pH-level provider, assisting the dissolution and bioavailability of the drug in the human gastro intestine tract (GIT).

Having said, that the dissolution takes place within the time frame of some minutes, smart drug release solutions are needed. With the perfect drug formulation, the pharmaceutical active is released at the desired point in the GIT. Therefore, starter beads are coated and layered not only with the drug, but additionally with functional excipients, protecting the drug from acidic environment in the stomach, defining modified release characteristics, or increasing the consumers’ compliance by taste-masking or color brand.

In line with the optimized drug release profile and drug concentration, the pharmaceutical formulation seems to be tricky. With the expert partner in pellet technologies and solid drug formulations, solutions are easy. Get more information on pellet technologies, enhanced dissolution profiles and CDMO services. Contact us here.

Acknowledgement

We gratefully acknowledge the Department of Pharmaceutics Semmelweis University, Microfluidic Workgroup. The pictures were taken by Miléna Lengyel.

Tartaric acid pellets (TAP) were sponsored by HARKE Pharma.

[1] Kállai-Szabó N, Lengyel M, Farkas D, Barna ÁT, Fleck C, Basa B, Antal I. Review on Starter Pellets: Inert and Functional Cores. Pharmaceutics. 2022 Jun 18;14(6):1299. doi: 10.3390/pharmaceutics14061299. PMID: 35745872; PMCID: PMC9227027.