26. March 2017

Background Starchy products have been widely used in the food, paper, textile, plastic, cosmetics, adhesives, and pharmaceutical industries. To meet specific requirements of their applications, different modification techniques, such as physical, chemical, and enzymatic methods, have been employed to enhance or inhibit their inherent properties or to endow specific properties of starch. Scope and approach Debranched starch (DBS), modified by pullulanase or isoamylase, acquires remarkable new...

02. August 2016

ABSTRACT Introduction: Many abuse-deterrent formulations (ADFs) rely on being crush resistant and extraction resistant in order to provide deterrence to abuse by insufflation and injection, respectively. High molecular weight polymers such as poly(ethylene oxide) are commonly used to provide this deterrence. However, these polymers suffer from slow dissolution kinetics, and are susceptible to variety of abuse conditions. Objective: This study was aimed to determine if selected superabsorbent...

17. July 2016

Abstract Objectives: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies. Methods: We investigated...

15. June 2016

Abstract Over the past decade, the abuse of prescription opioid drugs has become a national health crisis in the United States. Pharmaceutical companies, the Food and Drug Administration, and other government agencies are confronting opioid abuse by developing and commercializing various abuse-deterrent drug delivery technologies. To deter opioid abuse, various strategies including physical barriers, chemical barriers, antagonists, aversive agents, and prodrugs have been investigated. A number...

12. March 2016

Evonik has developed a formulation technology, which offers a novel approach to developing alcohol resistant oral drug products with delayed or sustained release profiles. EUDRATEC™ ADD delivers a solution to the problem of alcohol-induced dose dumping of modified release dosage forms and enables the pharmaceutical industry to be in accordance with the sharpened requirements of the US-FDA. If patients take oral drugs, designed with a modified release (MR) profile, together with alcohol, the...

29. December 2014

Consultation on the Draft Guidance Document: Tamper-resistant Formulations of Opioid Drug Product Submissions Opioid drugs are subject to the Food and Drugs Act. An opioid drug may be sold in Canada following a decision by Health Canada that the scientific evidence submitted by its manufacturer meets established standards for safety, efficacy and quality for the drug under the recommended conditions of use…....