Senior Research Pharmacologist US Food and Drug Administration Silver Spring, Maryland
Intravaginal rings (IVRs) are drug-device combination delivery systems for the controlled release of drugs in the vagina. Commercial IVRs are based on the one-size-fits-all approach, where the patients receive the same drug in similar doses and frequencies, allowing no space for tailored treatment per the patient’s needs. This work reports the use of droplet deposition modeling (DDM) three-dimensional printing (3DP) to develop customized IVRs. The IVRs were manufactured varying the infill density, aspect ratio, and discharge percent. The results demonstrated that the change of these processing parameters significantly affected weight, storage, and Young’s modulus, Shore hardness, and the compression strength of the IVRs. The drug release from all IVR batches showed sustained release patterns for 25 days under accelerated release conditions. This presentation includes identifying the design space for IVR manufacturing through DDM, highlighting the technology's advantages such as design freedom, precise control over characteristics and release properties.
Learning Objectives:
Upon completion, participant will be able to develop personalized intravaginal-rings (IVR) using droplet deposition modeling, and determine critical design and process parameters for tailoring IVR for individual patients.
Upon completion, participant will be able to recognize how additive manufacturing may integrate patient-specific factors to unlock critical performance attributes essential for personalizing IVR design
Upon completion, participant will be able to identify a flexible design space for the implementation of DDM in personalizing IVR therapy for individual patient
Upon completion, participant will be able to understand the regulatory considerations and factors pivotal for the successful adoption of 3D printing in distributed manufacturing settings to produce IVR while ensuring compliance and patient safety
