Hydroxymethylglutaryl-CoA Reductase Inhibitors (Statins) Custom Development
BOC Sciences can provide development and manufacturing services for statin Featured APIs. Statins are the most widely used and effective lipid-lowering drugs in the world. With the increase of cardiovascular and cerebrovascular diseases year by year, statins have become an indispensable part of the treatment and prevention of such diseases. Recently, the therapeutic use of statins has been increasingly recognized recently, so its economic impact on the pharmaceutical market is huge. We can provide you with the synthesis and industrial production of statin specialty APIs and key intermediates, and accelerate product launch, greatly improving your competitiveness in the industry.
Statins play an important role in regulating lipid metabolism by inhibiting the rate-limiting enzymes in the process of cholesterol synthesis in the body, while promoting the metabolism of low-density lipoprotein (LDL) and increasing the concentration of high-density lipoprotein (HDL-C). Fig. 1 shows the molecular structure of several statins. According to the chemical structure, statins can be divided into three parts. The first part is the analog of the target enzyme substrate (HMGCoA); the second part is covalent with the substrate analog. The complex hydrophobic ring structure that connects and participates in the binding of statins to reductases; the third part is the pendant group on the ring, and this part defines the solubility properties of the drugs and thus their many pharmacokinetic properties.
Fig.1 Chemical structures of the statins.
Our services include but are not limited to the following:
We employ green and sustainable biocatalytic methods to prepare statins and are able to implement different biocatalytic pathways on an industrial scale for the stereoselective preparation of side chains (with stereocenters) of superstatins. The types of biocatalysts we use include nitrilases, ketoreductases and aldolases,etc.
In addition to biocatalytic synthesis, we can also use microbial fermentation to prepare fermentation-derived statins. The microorganisms we use are mainly divided into two types of mold groups: Aspergillus and Penicillium, and the methods involved are submerged fermentation and solid-state fermentation.
Our consistency evaluation service mainly includes pharmaceutical equivalence and bioequivalence evaluation. The former is to evaluate whether the active ingredients, dosage, route of administration, and dosage form of the drug are consistent with the original drug and meet the drug quality standards; the latter verify that the absorption and metabolism of generic drug preparations in the body are consistent with the original drug.
If you are interested in our hydroxymethylglutaryl-CoA reductase inhibitors (Statins) custom development service, please contact us immediately.
- Srinivasa Rao K, et al. An Overview of Statins as Hypolipidemic Drugs[J]. International Journal of Pharmaceutical Sciences and Drug Research, 2011.
- Hoyos P, et al. Biocatalyzed Synthesis of Statins: A Sustainable Strategy for the Preparation of Valuable Drugs[J]. Catalysts, 2019.