4.7 Article

Understanding syringeability and injectability of high molecular weight PEO solution through time-dependent force-distance profiles

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DOI: 10.1016/j.ijpharm.2022.122486

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Abuse -deterrent formulation; Syringeability; Injectability; Texture analyzer; Rheology; Opioid Abuse

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Opioid medications are widely used for treating moderate to severe pain, but they are often misused and abused through various methods such as manipulation and injection. The abuse-deterrent formulations of these drugs can affect their ease of injection, with factors such as needle gauge size, needle length, and syringe barrel size playing important roles.
Opioid medications play a vital role in treating moderate to severe pain. Unfortunately, many drug misusers and abusers attempt to alter the formulations or properties of these drugs by manipulation, (e.g., crushing, chewing, smoking, snorting, injecting). The intravenous (IV) route is most dangerous to abusers, as the drugs directly enter the circulatory system and produce intense euphoria. To obtain a full understanding of the impact of syringe factors (e.g., needle gauge size, needle length, syringe barrel size), on the ease of injection, we undertook a comprehensive assessment of syringeability and injectability of manipulated abuse-deterrent formulations (ADFs). A texture analyzer-based testing method was developed for the measurement of the resistance force of pulling, holding, and pushing phases of injections. Results showed that the finer needle gauge sizes required higher injection force to withdraw drug solutions. In addition, the syringed liquid volume was highly dependent on needle gauge size, holding time, and sample viscosity. In most cases, a lower needle gauge number and a longer holding time increased the syringed volume. Needle length was highly correlated to injection force (R2 = 0.99). Using longer needles to inject drug solution requires greater force. Furthermore, large barrel size was correlated to pushing force (R2 = 0.99); thus, increasing the difficulty of pushing the plunger of a large syringe with one hand. Finally, relationships between injection force, sample viscosity, and testing conditions were elucidated using a mathematical model, which could be used in the future to assess and predict injection force of solution samples.

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