Formulation expertise for better analytical development
Development projects often expend more than 50% of their overall effort on analysis. We know the analytical development process from top to bottom, employing our formulation expertise to streamline and increase efficiency for your project.
How we can help
Specific analytical solutions for complex dosage forms
Our expertise covers aspects such as the dissolution of soft capsules containing lipophilic fills or exhibiting crosslinking, migration of components, or dose-dumping of extended-release tablets.
Large network of experts
Finding experienced partners for analytical development is often the key to the project's success. With our established network of expert laboratories, we bring the right partners together from the start.
Knowledge of critical aspects of each type of dosage form
With deep expertise in softgel capsules and modified-release tablets, we make sure that the right analytical scope is selected for the characterization of the critical aspects of each dosage form.
Case study: dissolution method development for a softgel capsule with lipophilic fill
The client: A pharmaceutical company unfamiliar with softgel capsules.
The task: Develop a dissolution method for a softgel capsule with a lipophilic capsule fill and perform comparative testing to support a bioequivalence study.
The challenge: The lipophilic capsule fill was insoluble and not miscible with water, leading to potential artifacts during dissolution testing. The product was also prone to crosslinking, requiring consideration in the method.
Outcome
We selected a suitable partner laboratory with expertise in softgel testing from our network. We screened USP type 1 and type 4 apparatus; the paddle apparatus required significant speed for suitable variability, and the flow-through cell proved most appropriate within standard operating ranges.
Next, we conducted a screening of media and surfactants, defining a suitable surfactant. The method was then validated.The comparative dissolution test showed that both products released >80% of the drug within 15 minutes using the validated method.
As f1/f2-calculation was not feasible due to the fast release, an alternative statistical approach was employed, demonstrating the comparability of the two products.