LG Chem said it would start developing bilayer tablets of Zemiro (gemigliptin, rosuvastatin), a combination drug that simultaneously treats diabetes and dyslipidemia, for better drug stability.
Bilayer tablets have less physicochemical interactions between the two different ingredients because of the separation of the two, offering higher stability and longer storage time. LG Chem said bilayer forms would extend the shelf life of Zemiro from the current 30 months.
|LG Chem’s Zemiro (Credit: LG Chem)|
On Oct. 30, the Ministry of Food and Drug Safety approved LG Chem to test the combo drug’s bilayer form in a comparative phase-1 study.
The trial will compare pharmacokinetics, pharmacodynamics properties, safety, and tolerability of the single layer tablets (gemigliptin/rosuvastatin 50/20mg) and bilayer tablets (gemigliptin/rosuvastatin 50/20mg) in 48 healthy adult volunteers.
Currently, Zemiro comes in a single layer tablet that mixed gemigliptin and rosuvastatin. The bilayer tablet, soon to be tested, is a combo drug that combined more than two substances.
In the bilayer tablets, the ingredients are separated. Depending on techniques, the manufacturer can control the drug’s dissolving time in the body.
Zemiro is the nation’s first combo treatment for diabetes and dyslipidemia, merging Zemiglo (a dipeptidyl peptidase-4 inhibitor) with rosuvastatin. Patients can take one pill a day, which would be more convenient for them than to take the medication several times a day.
However, the tablet is large-sized. The radius of the single tablet of Zemiglo is 8mm, and that of rosuvastatin is about 7mm. However, Zemiro’s radius is 11.6mm. Pharmaceuticals try hard to reduce the size of a tablet to make patients more comfortable when swallowing the pill.
LG Chem developed Zemimet, a combo bill mixing Zemiglo with metformin, reducing the size of the tablet by 20 percent to raise patient’s convenience.
However, the company will not change the size of the bilayer tablet in the upcoming study.
“We will not change the size of the tablet in the bilayer tablet test,” an official at LG Chem said.