Contact person
Mattias P Persson
Forskare
Contact Mattias P
Dissolution testing of tablets and capsules
RISE offers dissolution analyses for formulations such as tablets and capsules under development or for GMP quality control of finished product. We perform method development, method validation and tech transfer of existing methods, we focus on robust arrangements adapted to the product, the dosage form and regulatory requirements.
Purpose
Dissolution analysis is used to show how quickly and to what extent a substance is released from, for example, a tablet under defined conditions.
The testing is used in formulation development as well as process development, and as part of quality control for the finished product.
Dissolution analyses are performed on both immediate release dosage forms and extended and delayed release dosage forms.
RISE can perform:
- dissolution testing for tablets and capsules, as well as other formulations on request
- method development and optimisation adapted to product and area of use
- method validation and tech transfer of existing methods
- support in formulation and process development
- routine analyses according to GMP
Method
Dissolution testing is performed primarily according to the pharmacopoeial method Ph. Eur. 2.9.3 and USP <711>. These are harmonised for dissolution testing of oral solid formulations. We perform analyses mainly on tablets and capsules, but other formulations are also possible.
Instrument
Our automated dissolution instrument is qualified for GMP analysis and equipped with extraction probes, temperature monitoring in all vessels and the possibility of automated filtration of release samples. The automation contributes to high reproducibility and efficient sample handling.
The analysis is done either with rotating paddles or baskets, which is most common for tablets and capsules. Samples are withdrawn at defined times. Quantification of released substance is mainly done with LC UV or LC CAD, depending on the product's properties.
Delivery
Reporting is done by agreement and can include anything from a simple performance report to a full analytical method validation report or tech transfer report. We adapt the structure and documentation to the phase of the project, the customer's needs and applicable regulatory requirements.
