Back to results
US 10,732,162 B2Granted
Method and device for determining the disintegration time of film-shaped pharmaceutical dosage forms
AssigneeHexal AG
InventorsJörg Nink, Josef Pichler, Katharina Obermüller, Alexander Wotzko
Life of this patent
Estimating the term…
Abstract
The present invention relates to a method for determining the disintegration time of a film-shaped pharmaceutical dosage form and a disintegration testing device for use in such a method.
Claims15
A method for determining a disintegration time of a film-shaped pharmaceutical dosage form, the method comprising:
- (a) placing the film-shaped pharmaceutical dosage form horizontally between a bottom side opening of an upper liquid receiving section and a top side opening of a lower liquid receiving section such that the film-shaped pharmaceutical dosage form occludes the top side opening of the lower liquid receiving section and the bottom side opening of the upper liquid receiving section, wherein the bottom side opening and the top side opening are positioned and aligned such that, but for the presence of the intact film-shaped pharmaceutical dosage form, liquid would flow under gravity from the bottom side opening through the top side opening into the lower liquid receiving section;
- (b) applying a liquid into the upper liquid receiving section;
- (c) detecting a penetration of the liquid through the film-shaped pharmaceutical dosage form, wherein the penetration of the liquid through the film-shaped pharmaceutical dosage form occurs when a first droplet detaches from the film-shaped pharmaceutical dosage form to fall into the lower liquid receiving section;
- and
- (d) determining the time between step (b) and step (c).
2 more elements
Dependencies are inferred from the claim text.