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 effects and result

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.

Planned 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