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Comparative dissolution studies of 3D-printed inserts in a novel biopharmaceutical bladder model
Jhinuk Rahman-Yildir1, Raphael Wiedey2, Jörg Breitkreutz2
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Düsseldorf, Universitätsstr. 1, 40225 Düsseldorf, Germany; Drug Delivery Innovation Center (DDIC), INVITE GmbH, Chempark Building W 32, 51368 Leverkusen, Germany.
This study developed a novel bladder model to accurately assess local drug release for urinary tract disorders. The model simulates physiological conditions, revealing important concentration fluctuations for better therapeutic drug monitoring.
Area of Science:
- Pharmacology
- Biomedical Engineering
- Drug Delivery Systems
Background:
- Systemic drug therapy for urinary tract disorders causes adverse effects.
- Local drug release in the urinary bladder is a promising alternative.
- Assessing local drug release with standard methods is challenging.
Purpose of the Study:
- Develop a biorelevant dissolution model for the urinary bladder.
- Incorporate physiological conditions like urine flow and movement.
- Evaluate drug release from intravesical inserts under simulated conditions.
Main Methods:
- Developed a novel bladder model simulating physiological urine flow and agitation.
- Tested the model with 3D-printed intravesical inserts containing lidocaine hydrochloride, trospium chloride, and hydrochlorothiazide.
- Varied operating conditions to mimic physiological and pathophysiological states.
Main Results:
- The bladder model revealed periodic drug concentration fluctuations over 24-hour intervals.
- Drug concentration profiles differed significantly from compendial methods despite similar cumulative release.
- The model demonstrated the impact of changing bladder volume and agitation on drug release.
Conclusions:
- The developed biorelevant bladder model provides a more accurate assessment of local drug release for urinary tract disorders.
- This model allows for the investigation of drug release under dynamic physiological conditions.
- It aids in optimizing intravesical drug delivery systems for improved therapeutic outcomes.

