Antiviral Drug Stability Study
Stability testing of pharmaceutical products refers to the ability of a formulation to maintain its physical, chemical, microbiological, therapeutic, and toxicological specifications under specified storage conditions. Stability testing is performed to provide evidence on how the quality of a drug formulation changes over time under the influence of various environmental factors such as temperature, humidity, and light, and to determine the shelf life of the formulation and recommended storage conditions. In general, stability studies should include testing of those drug properties that are susceptible to change during storage and may affect quality, safety, and/or efficacy. Stability study of antiviral drugs has become an issue of great concern and is a prerequisite for the acceptance and approval of drug products in order to study their safety and efficacy throughout their shelf life. The development of a stability-indicating method is important for the detection of antiviral drugs. For example, scientists have performed accelerated stability studies of Remdesivir, a Covid-19 antiviral ester prodrug, by using reversed-phase high-performance liquid chromatography and diode array detection method. Extensive degradation tests confirmed the threatened stability of the antiviral drug at thermal and alkaline hydrolysis stress. The developed method has been fully validated and proved to be applicable for routine analysis of quality control of RDV in pharmaceutical dosage forms. In addition, there are experiments have been conducted to test the stability of antiviral drugs during release at oral therapeutic levels over long periods of time. NMR analysis indicates that the chemical structure of the drug remains stable during film casting process and release.
BOC Sciences' analytical research team has the quality control expertise to provide a comprehensive stability program for bulk antiviral drugs, in compliance with FD A and ICH guidelines. We can deliver an accurate assessment of the quality, strength, purity, potency and identity of your antiviral drug molecules to support your regulatory reporting. Our analytical development department can evaluate or develop stability-indicating methods with forced degradation studies to support shelf-life studies of your antivirals.
Figure 1. ICH guidelines for stability studies. (Revathi, S. Dhanaraju, M.D. 2019)
Comprehensive Drug Stability Study Services
- Our comprehensive services include protocol design, project management, stability sample storage and testing, data trend analysis, drug shelf life assessment and NDA/MAA filing preparation
- Stability testing to support global drug registration, experimental/exploratory stability, and stability testings of drugs after approval for market
- Stability study facility
At BOC Sciences, we provide the ideal location for stability testing at all stages of antiviral drug development. Our stability storage infrastructure includes constant temperature and humidity chambers for stability studies, multi-channel power supplies, real-time temperature and humidity monitoring, automated alarm systems, sophisticated walk-in chambers, climate cabinets, and emergency backup for power breakdown.
- Stability testings for all stage
- Long-term stability studies in accordance with ICH guidelines
- Accelerated studies
- Ongoing stability studies
- Follow-up stability studies
- Comparability studies
- Stress testing, forced degradation
- Light stability testing
- In-use testing, freeze-thaw cycles
- Excipient/API compatibility
- Interaction studies with primary packaging
- Stability protocols, reporting and interim reporting
- Stability indication method development
- Storage conditions. 40°C/75% RH, 30°C/75% RH, 30°C/65% RH, 25°C/60% RH
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing services
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
Reference
- Revathi, S. Dhanaraju, M.D. Optimization and Characterization Ezogabine-Loaded Nanosuspension for Enhancement of Bioavailability by "Bottom-Up" Technology Using 32 Factorial Design. Journal of Drug Delivery and Therapeutics. 2019. 9(3):227-237.
※ Please kindly note that our services are for research use only.
