Breakthrough in kidney stone management
MANILA, Philippines - The recently held Tascit Sci-Tech Summit titled “Cutting Edge’†unveiled the advanced technology in kidney stone management and the pioneering research and development behind Biomedis’ potassium citrate (Tascit). It was the first of its kind in the pharmaceutical and medical sector.
“As the makers of extended-release potassium citrate (Tascit) tablets, it is our commitment to make use of technology in a way that would be most helpful to our partners in the medical community and most advantageous to the Filipino patient. This is why we wanted to share with you the exciting story behind our product with the aid of advance technology,†said Albert Poblete, general manager of Biomedis Inc., a division of Unilab.
Doctors were shown high-tech presentations using holograms of Unilab senior vice president for R&D Dr. Kennie Dee and Dr. Dennis Serrano. Dr. Kennie Dee has a PhD in Chemical Engineering from Cornell University while Dr. Serrano is an active consultant in urology and kidney transplantation at St. Luke’s Medical Center Global, National Kidney Institute, and Asian Hospital.
The hologram presentation is a pioneering feature of the summit attended by over 1,500 doctors. This technology enabled the event to be beamed simultaneously to three locations: SMX Aura Convention Center in Taguig, Robinsons Summit Ridge Hotel in Tagaytay City, and Marco Polo Hotel in Cebu.
Dr. Serrano discussed the history, statistics, and technology involved in kidney stone management. According to him, an estimated 10 percent of all people will have a kidney stone at some point in their lives, with peak incidence rising between the ages of 20 and 40 years old.
He emphasized the use of potassium citrate to inhibit the growth and aggregation of calcium phosphate crystals, and treat uric acid stones that may occur concurrently with or without calcium stones. Potassium citrate can also be used to prevent the recurrence of calcium oxalate and uric acid stones, which comprise about 85 to 90 percent of kidney stones.
“For decades, we have prescribed using citrate in solution for patients with recurrent stones. But these are formulations that are both cumbersome, fraught with compliance issues and with adverse events, specifically gastrointestinal side effects and erratic serum levels,†Dr. Serrano said.
According to Dr. Serrano, what is needed is a formulation that is stable enough for constant controlled release and friendly to the gastrointestinal tract. And this, Dr. Dee cited, is why Biomedis came up with potassium citrate wax matrix extended release potassium citrate tablets.
Dr. Dee demonstrated how the potassium citrate particles in Tascit are entrapped in a waxy matrix, and then slowly released from the wax tablet. Since waxes are not water soluble, the insoluble wax matrix tablet remains intact as it passes through the gastro-intestinal tract.
“Some generics that tried to enter the US market have repeatedly been recalled because of failure to meet the critical dissolution specifications set by United States Pharmacopeia (USP),†cited Dr. Dee.
USP dissolution requirements ensure that the potassium citrate is released from the tablet gradually to allow a constant level of citrate excretion over an extended period as compared to immediate release formulations.
“We went through countless permutations to optimize the many critical parameters involved during the manufacturing process. It took us four years to finally achieve the correct combination of parameters that would produce tablets that were robust and consistent with USP dissolution specifications,†said Dr. Dee.
Biomedis’ Tascit (potassium citrate ER) is classified by the USFDA as a GRAS material, which stands for “Generally Regarded as Safe.†A GRAS classification means that potassium citrate can do no harm to humans if used in reasonable amounts.
