Dissolution Testing

Dissolution testing is one of the key steps in the drug development process. From early product development to quality control in later commercial production, the dissolution of a drug have an impact at every step. Drug dissolution testing provides drug manufacturers with valuable insight into how dosage forms affect their efficacy. The results provided by this process are critical to understanding the bioavailability and effectiveness of drugs in their current form. Given its importance throughout the drug development and manufacturing process, dissolution testing has become a key concern for regulatory agencies.

BOC Sciences is committed to providing highly accurate dissolution testing that measures the rate at which drugs are released from their dosage forms. Our team can provide fast and accurate results for your drug development, quality control, comparative studies and stability studies to determine the effects of time, temperature and humidity. Our expertise in this area is unparalleled, and we have the broadest range of instrumentation, including multiple dissolution instruments, as well as the use of HPLC systems.

Importance of Dissolution Testing

• Product Development-API characterisation, Formulation evaluation, Stability testing
• Quality control of drug products and ensuring that changes in the manufacturing process have no effect on the quality and performance of the drug product
• Bioavailability/Bioequivalence-A useful tool for establishing in vitro/in vivo correlations (IVIVC)
• Scale-Up and Post-Approval Changes– Raw materials, Formulation, Process, Manufacturing site

Dissolution Testing Methods

• USP Dissolution Meter I - Basket method

Used for testing tablets and capsules: The original acceptance criteria required 75% dissolution within a specified period. Beyond this time, particles could be small enough to pass through the basket mesh and fall to the bottom of the vessel.

• USP Dissolution Meter II - Paddle method

Suitable for testing products that release small particles e.g. tablets made by direct compression or powder-filled capsules. Also used for testing powders and suspensions.

• USP Dissolution Apparatus III - Reciprocating cylinder method
• USP Dissolution Apparatus IV - Flow-through cell
• USP Dissolution Apparatus V - Paddle over Disk

Suitable for transdermal dosage forms

• USP Dissolution Apparatus VI - Reciprocating holder apparatus

Suitable for transdermal dosage forms

BOC Sciences has the equipment, knowledge and experience that allows us to offer different wet chemical analyses. We maintain a large inventory of reagents, volumetric solutions, glassware and indicators year-round. Our team can support your dissolution testing for drug development or quality control by selecting the most suitable test method based on different factors such as the pH of the dissolution medium, the type of drug surface material, etc. Moreover, we can provide guidance for developing dissolution testing for poorly soluble compounds.

• Custom chemical analysis of drugs
• Forced degradation studies of drugs
• Stability studies
• Analytical method development and validation

Figure 1. Scheme of a biphasic dissolution-partition test system. (Xu, H.; et al. 2018)

Features of Our Dissolution Testing Services

• Our team offers complete mechanical calibration and USP Performance Verification Testing (PVT) services that meet US and EU compliance guidelines
• We fully understand dissolution testing and offer techniques that produce clear, useful and fully integrated reports that keep you in compliance throughout the process
• Our state-of-the-art UV/Visible instrumentation meets the needs of pharmaceutical and manufacturing QA/QC analysts everywhere