Lotus Pharmaceuticals, a Chinese drug developer, announced that its wholly owned subsidiary, En Ze Jia Shi Pharmaceuticals, has been issued a patent by the State Intellectual Property Office of the People's Republic of China for controlled-release oral gliclazide. The patent covers the composition and preparation methods for the drug through 2030. Gliclazide is commonly used to control mild to moderate adult-onset Type 2 diabetes. The drug belongs to the second generation of sulfonylureas, a class of diabetes drugs that stimulate the pancreas to release more insulin.
According to the company, Lotus' controlled-release gliclazide tablet is formulated using osmotic pump technology, which encases the drug in a semi-permeable framework for a gradual, sustained release. The drug release is designed to be minimally affected by pH, gastric acid and food intake. In preclinical studies, the tablets demonstrated a similar rate of drug release in both in vitro and in vivo models.
"We believe our controlled-release gliclazide tablet will have a meaningful impact on the clinical treatment of diabetes," says Zhongyi Liu, chairman and CEO. "The drug release rate of conventional oral gliclazide is uncontrolled, which can lead to unpleasant side effects due to quick drug release. Our controlled-release formulation has the potential to provide a more stable and sustained drug delivery compared to conventional gliclazide, resulting in fewer side effects, greater efficacy and an improved safety profile."
Clinical trials are set to begin in 2012, according to the company.
- read the Lotus release