The miniaturized SDi2 (Surface Dissolution Imaging) platform, is used to record images of the dissolution process at the surface of the compact and is able to rankorder IDR (μg/min/cm2) and visualise the dissolution of
APIs and salts during early development.
The Intrinsic Dissolution Rate (IDR) is a measure of the rate of dissolution of a pure active pharmaceutical ingredient (API) where the conditions of surface area, temperature, agitation/stirring speed, medium pH and ionic strength are all kept constant. A well-defined surface area is presented to the dissolution medium by preparing a flat tablet disc of specific size. IDR is important during the development of new drug molecules as it is possible to predict potential problems using small quantities of material. It has applications in evaluating drug solubility in accordance with the biopharmaceutics classification system (BCS), comparison of the dissolution rate during salt selection or polymorph screening to choose the best candidate, and setting specifications for particle size in order to achieve complete dissolution of the required dose within the typical gastrointestinal transfer time. IDR imaging can be applied to promising drug candidates to guide early development efforts to improve a drug’s in vivo characteristics.
Key Deliverable
A full study report is provided. Reports include: sample and customer details, the IDR (mass/time/area) for each sample for the chosen buffer system, images of the dissolution process and statement of methodology.
Benefits
- High-resolution imaging alongside drug release profiles.
- Troubleshoot or refine formulations to obtain desired release behavior.
- Gain an understanding of how the physical behavior of samples impacts drug release.
- Visualization of physical phenomena in real time.
- Compact flow cell, Raman compatible
- Dual wavelength capacity.
Flow through dissolution system with high resolution, visible, and UV imaging technology providing insight into the physical dissolution behavior of drug products
Understand the mechanism of dissolution from drug substance and full dosage forms with high-resolution imaging alongside drug release profiles. Troubleshoot or refine formulations to obtain desired release behavior and gain an understanding of how the physical behavior of samples impacts drug release.
The SDi2 simultaneously captures both ultra-violet and visible surface imaging, capturing dissolution as it happens. The SDi2 generates high-resolution 2-D videos that show these dynamic processes in real-time Reviewing the videos allows scientists to gain a full understanding of exactly what’s happening as the sample dissolves providing insights that cannot be obtained using conventional dissolution methods.
Integrated fluidics and two distinct flow cells allow the study of a range of dosage forms and sample types with automated control and switching of up to two dissolution media in a single assay.
