title: Evaluation of the resistance of a geopolymer-based drug delivery system to tampering.
abstract: Tamper-resistance is an important property of controlled-release formulations of opioid drugs. Tamper-resistant formulations aim to increase the degree of effort required to override the controlled release of the drug molecules from extended-release formulations for the purpose of non-medical use. In this study, the resistance of a geopolymer-based formulation to tampering was evaluated by comparing it with a commercial controlled-release tablet using several methods commonly used by drug abusers. Because of its high compressive strength and resistance to heat, much more effort and time was required to extract the drug from the geopolymer-based formulation. Moreover, in the drug-release test, the geopolymer-based formulation maintained its controlled-release characteristics after milling, while the drug was released immediately from the milled commercial tablets, potentially resulting in dose dumping. Although the tampering methods used in this study does not cover all methods that abuser could access, the results obtained by the described methods showed that the geopolymer matrix increased the degree of effort required to override the controlled release of the drug, suggesting that the formulation has improved resistance to some common drug-abuse tampering methods. The geopolymer matrix has the potential to make the opioid product less accessible and attractive to non-medical users.
authors.affiliation: Division for Applied Materials Science, Department of Engineering Sciences, The Ångström Laboratory, Uppsala University, Box 534, SE-751 21 Uppsala, Sweden.
authors.forename: Bing
authors.initials: B
authors.lastname: Cai
authors.affiliation: Division for Applied Materials Science, Department of Engineering Sciences, The Ångström Laboratory, Uppsala University, Box 534, SE-751 21 Uppsala, Sweden.
authors.forename: Håkan
authors.initials: H
authors.lastname: Engqvist
authors.affiliation: Division for Applied Materials Science, Department of Engineering Sciences, The Ångström Laboratory, Uppsala University, Box 534, SE-751 21 Uppsala, Sweden. Electronic address: susanne.bredenberg@telia.com.
authors.forename: Susanne
authors.initials: S
authors.lastname: Bredenberg
mesh_terms: D000284:Administration, Oral; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000737:chemistry* / Q000302:isolation & purification; D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D004339:Drug Compounding; D055030:Drug Users; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D010098:Oxycodone / Q000008:administration & dosage / Q000737:chemistry* / Q000302:isolation & purification; D011108:Polymers / Q000737:chemistry*; D012995:Solubility; D012997:Solvents / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods; D013696:Temperature; D013997:Time Factors
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D011108:Polymers; D012997:Solvents; D013607:Tablets; D010098:Oxycodone
keywords: Abuse; Controlled release; Formulation; Opioids; Oral drug delivery; Resistance to tampering