pH Stability Assay
Creative Animodel provides stability assays to measure the chemical stability of therapeutic candidates in a wide range of buffers at any pH. With years of experience in drug metabolism studies, our experts can afford comprehensive metabolic profiles of new drugs by delivering consistent and high-quality data with cost-efficiency that comes from a highly automated approach.
Chemical Stability Is Essential in Oral Route
Oral administration is the route of choice for new drugs, which is a convenient and cost effective route of delivery. After oral dosing, a drug is absorbed by the digestive system, enters the hepatic portal system, and reaches the rest of body through circulation. Drug candidates may be chemically unstable due to hydrolysis as a result of low pH observed in the stomach, further reducing in vivo exposure. Additionally, if the compound is unstable at pH 7.4, which is a physiological pH mimicking the in vivo situation, it usually decays rapidly from in vitro screens. Thus, understanding the chemical stability of compound at different pH is essential to predict possibility of failure in oral administration.
Figure 1. Sketch of pH conditions after oral route.
Standard Conditions of pH Stability Assay
This assay is performed to predict the stability of test compound after oral delivery. Creative Animodel provides stability studies in a wide range of buffers at any pH. Test compounds are incubated with appropriate pH buffer at 37℃ in duplicate. After incubation, the parent compound is investigated by LC-MS/MS analysis at five-time points over 120 minutes (0, 15, 30, 60 and 120 min). The percentage of parent compound remaining in plasma is plotted at each time point, and the half-life (T½) is calculated from the obtained curve.
Figure 2. Stability result from in-house laboratory in pH buffers at pH 7.4 and 3.0. Data are shown as mean ± standard deviation.
Creative Animodel, an ideal partner in the process of drug discovery and development, provides pH stability assay to specifically satisfy your needs. Customers can require for options including compound concentrations, incubation temperature, alternative time points, pH conditions and additional replicates. We are looking forward to cooperating with you.
1. Di, Li, and Edward H. Kerns. Drug-like properties: concepts, structure design and methods from ADME to toxicity optimization. Academic press, 2015.