| Autor: |
Boyce HJ; School of Pharmacy, University of Maryland, 20 N. Pine St., Baltimore, Maryland, 21201, USA., Dave VS; Wegmans School of Pharmacy, St John Fisher College, Rochester, New York, NY, USA., Scoggins M; Recro Gainesville LLC, Gainesville, Georgia, USA., Gurvich VJ; Institute for Therapeutics Discovery and Development and Department of Medicinal Chemistry, University of Minnesota, 717 Delaware St. SE, Minneapolis, Minnesota, 55414, USA.; Center of Excellence for Abuse Deterrent Opioid Technologies, National Institute for Pharmaceutical Technology and Education, 717 Delaware St. SE, Suite 482, Minneapolis, Minnesota, 55414, USA., Smith DT; College of Pharmacy, Purdue University, West Lafayette, Indiana, USA., Byrn SR; Center of Excellence for Abuse Deterrent Opioid Technologies, National Institute for Pharmaceutical Technology and Education, 717 Delaware St. SE, Suite 482, Minneapolis, Minnesota, 55414, USA.; College of Pharmacy, Purdue University, West Lafayette, Indiana, USA., Hoag SW; School of Pharmacy, University of Maryland, 20 N. Pine St., Baltimore, Maryland, 21201, USA. shoag@rx.umaryland.edu.; Center of Excellence for Abuse Deterrent Opioid Technologies, National Institute for Pharmaceutical Technology and Education, 717 Delaware St. SE, Suite 482, Minneapolis, Minnesota, 55414, USA. shoag@rx.umaryland.edu. |
| Abstrakt: |
The main goal of the presented work was to understand changes in the microstructure of tablets, as well as the properties of its main component viz. polyethylene oxide (PEO) as a function of sintering. Key polymer variables and sintering conditions were investigated, and sintering-induced increase in tablet tensile strength was evaluated. For the current study, binary-component placebo tablets comprised of varying ratios of PEO and anhydrous dibasic calcium phosphate (DCP) were prepared at two levels of tablet solid fraction. The prepared tablets were sintered in an oven at 80°C at different time points ranging from 10 to 900 min and were evaluated for pore size, tablet expansion (%), and PEO crystallinity. The results showed that for efficient sintering and a significant increase in the tablet tensile strength, a minimum of 50% w/w PEO was required. Moreover, all microstructural changes in tablets were found to occur within 60 min of sintering, with no significant changes occurring thereafter. Sintering also resulted in a decrease in PEO crystallinity, causing changes in polymer ductility. These changes in PEO ductility resulted in tablets with higher tensile strength. Formulation variables such as PEO level and PEO particle size distribution were found to be important influencers of the sintering process. Additionally, tablets with high initial solid fraction and sintering duration of 60 min were found to be optimal conditions for efficient sintering of PEO-based compacts. Finally, prolonged sintering times were not found to provide any additional benefits in terms of abuse-deterrent properties. |
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