Ceramic drug carrier for tamper resistant oral drug delivery

Purpose and goal:

Each prescription for opioids carries the inherent risk of addiction. The abuse and misuse of prescription opioids frequently serve as the starting point for a lifelong struggle with addiction, emphasizing the urgent need for multiple measures to prevent addiction and overdoses. The aim of this project is to develop a formulation and manufacturing method for mechanically strong drug loaded ceramic carriers with the intended use for either opioid use disorder or moderate to severe pain.

Expected results and effects:

The objective of this project is to develop a formulation and granulation method for producing hard ceramic granules. The project aims to document the tamper-resistant properties and drug release in a preclinical setting. These granules are intended for oral consumption of opioids to address abuse disorders or moderate to severe pain.

The goal is to achieve a product profile that ensures release of the active pharmaceutical ingredient for a minimum of 12 hours. The aim is to at the end of the project have documented the method in bench studies and a preclinical in vivo study. Approach and implementation: The project is divided into 4 work packages

WP1 Formulation and manufacturing - Manufacturing parameters will be optimized and tested to achieve a target product profile for tamper resistance and drug release characteristics.

WP2 Testing of tamper resistance - The formulation will be tested for abuse resistance and characterized in terms of mechanical properties and geometry.

WP3 Preclinical testing based upon regulatory guidance - drug release characteristics will be determined to validate plasma concentration and dose dumping resistance. WP4 Project management and reporting