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Formulation of Depot Delivery Systems
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Christopher A. Rhodes, Nikita Malavia
Besides the polymeric implants and the osmotically driven systems, there are other devices which have been utilized for the delivery of highly potent drugs. SynchroMed pump from Medtronic and CODMAN® 3000 from Codman and Shurtleff are representative systems. These pumps are often used for debilitating diseases which require intrathecal administration of drug for patient care. The SynchroMed pump is an implantable, programmable, battery-powered device that stores and delivers medication according to instructions received from the programmer. The various models of the pump vary in size of the reservoir and the presence of a side catheter access port. The hold volume in the refillable pump can range from 10 to 40 mL. The CODMAN® 3000 implantable drug delivery system features an inexhaustible power supply, obviating the need for battery, and provides continuous delivery with the refillable volume ranging from 16 to 50 mL. The CODMAN® 3000 implantable pump is divided into inner and outer chambers by accordion-like bellows. The inner chamber contains the drug to be infused while the outer chamber contains propellant permanently sealed. The patient’s own body temperature warms the propellant, which exerts a constant pressure on the bellows. This causes the drug to flow out of the inner chamber through a filter and flow restrictor then slowly out of the catheter. The CODMAN 3000 implantable pump was withdrawn from the market by Johnson and Johnson in 2018.
Medical device implants for neuromodulation
Published in Ze Zhang, Mahmoud Rouabhia, Simon E. Moulton, Conductive Polymers, 2018
Implantable drug infusion pumps are electrical devices that contain and administer prescribed drugs or fluids to targeted sites in the body. Intrathecal drug delivery systems, for example, are implanted pumps that target pain relief or antispasm medication to a location on the spine that relays signals between an affected body area and the brain. Patients with chronic pain or muscle spasms may be considered for a drug infusion device if medications become ineffective or side effects become burdensome. Medications, in such systems, are released immediately into the fluid surrounding the spinal cord and reach the nerves responsible for the symptoms. By this means, lower amounts of the active ingredient are needed than when the medication is taken by tablet or intravenous infusion. One challenge in drug pumps is that the medication for chronic pain must be refilled every 6 weeks to 6 months at a doctor’s office, depending on the drug concentration and the amount of medication needed by the patient.
A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)
Published in Expert Review of Medical Devices, 2022
Jason E. Pope, Navdeep Jassal, Dawood Sayed, Denis Patterson, Gladstone McDowell, Anjum Bux, Phillip Lim, Eric Chang, Ali Nairizi, Samuel Grodofsky, Timothy R Deer
To assess the efficacy and opioid-related side effects of Intrathecal Pain Medication therapy as compared to systemic opioid therapy, the linear mixed model analysis was used to perform both an overall analysis and subgroup analysis by gender to measure the device performance/efficacy of the therapy on these treatment groups using SAS procedure Mixed for Repeated Measures with Residual Maximum Likelihood (REML) method and the default option for covariance matrix. All descriptive summary statistics were performed using SAS procedure univariate for continuous variables and SAS procedure Frequency for discrete (categorical) variables. The Global Pain Mean Score was re-accessed after collation of the final database using SAS PROC TTEST. All analyses were performed with SAS 9.4 TS Level IM7 running on Windows 10 × 64 Platform.
Mediation of PM2.5-induced cytotoxicity: the role of P2X7 receptor in NR8383 cells
Published in International Journal of Environmental Health Research, 2023
Qi Xiong, Xiang Tian, Congyue Xu, Baomiao Ma, Wenshuang Li, Yiyuan Xia, Wei Liu, Binlian Sun, Qin Ru, Xiji Shu
Stimulation of P2X7R has been viewed as an important regulator in mediating oxidative stress in macrophage under pathological state (Li et al. 2019). Munoz et al. (2017) found that intrathecal instillation of BzATP led to the generation of ROS in the spinal cord and oxidative DNA damage in dorsal horn neurons of mice. Meanwhile, the deficiency of P2X7R could also prevent oxidative damage by regulating oxidative stress marker in mice macrophage/microglia induced by the pathogenesis of age-related macular degeneration. Mitochondria are viewed as both producers and targets of ROS (Crewe et al. 2021). Of particular significance, elevated ROS production was demonstrated to be closely related to mitochondrial oxidative damage (Singh et al. 2019), these results clearly showed that PM2.5 induced the dissipation of ΔΨm, while blockade of P2X7R by oATP effectively decreased the dissipation of ΔΨm. In addition, activation of P2X7R was involved in the regulation of apoptosis in macrophage, for instance, P2X7R was proven to efficiently stimulate ATP-induced SAPK pathway, which finally contributed to cell apoptosis in BAC1 macrophages (Humphreys et al. 2000), while the blockade of P2X7R significantly alleviated HG/streptozotocin-induced apoptosis by decreasing Bax/Bcl-2 ratio in myocardial cell. The results of this study are interesting to note that SRM 2786 markedly exacerbated oxidative stress by increasing production of ROS and NO as well as the expression of iNOS in NR8383 cells, yet stimulation of P2X7R by BzATP further elevated the above parameters that aggravated oxidative stress and apoptosis. On the contrary, oATP effectively decreased oxidative damage by down-regulation of these parameters. Meanwhile, inhibition of P2X7R could also decreased PM2.5-induced cell apoptosis by reducing cell apoptosis rate, expression of Bax while increasing expression of Bcl-2 as demonstrated by the application of oATP in NR8383 cells. Therefore, P2X7R was probably involved in the regulation of oxidative damage and apoptosis in NR8383 cells post PM2.5 treatment.