Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have demonstrated their impact on disease-free survival (DFS) and overall survival (OS) of patients with peritoneal metastases (PM). However, prior literature lacks evidence regarding any follow-up beyond 5 years. In this study, we analyse long-term OS and DFS (more than 10 years of follow-up) of patients undergoing CRS + HIPEC in a specialized unit. We conducted a retrospective study that included only patients who underwent CRS + HIPEC from January 2001 to May 2012. Data collection was conducted by reviewing medical records and telephone calls to patients or relatives. A total of 86 patients were included. The mean PCI was nine (range 0–39) and complete cytoreduction (CC-0) was reached in 80% of patients. Postoperative complications Clavien–Dindo III-IV occurred in 27.9% of patients and the 30-day mortality rate was 2.3%. After 10 years of actual follow-up, OS was 33.7% and DFS was 31.4%. Considering the historical context in which the standard of care for patients with PM was palliation, the results obtained show that CRS + HIPEC was a valid option, with morbimortality comparable to other major abdominal surgeries and encouraging survival results, since, after 10 years of follow-up, almost one-third of patients are still alive and disease-free.
Background/Objectives: Meropenem is a broad-spectrum carbapenem antibiotic with demonstrated efficacy against multidrug-resistant Gram-negative pathogens. Although its use as an ophthalmic formulation is off-label, growing clinical evidence supports its application in severe ocular infections such as keratitis and endophthalmitis. However, the intrinsic instability of meropenem in aqueous solutions and the absence of standardized ophthalmic preparations limit its routine use. Furthermore, no stability studies are currently available for meropenem 50 mg/mL eye drops stored in polypropylene (PP) dropper bottles under freezing and subsequent refrigerated conditions. The aim of this study was to evaluate the physicochemical and microbiological stability of a 50 mg/mL meropenem ophthalmic solution prepared in a hospital pharmacy using a commercial meropenem pharmaceutical product, and packaged in PP containers. Methods: Eye drops were aseptically prepared from a commercially available pharmaceutical product, containing 1g de meropenem and anhydrous sodium carbonate as an excipient. After preparation, the drops were stored at −20 ± 2 °C for up to 42 days, followed by refrigerated storage (5 ± 3 °C) after thawing for up to 7 days. Chemical stability was assessed using a validated stability-indicating HPLC method in accordance with ICH guidelines and was defined as 90–110% recovery of the initial concentration. Physical stability (appearance, pH, particulate matter) and microbiological stability were also evaluated under simulated in-use conditions. Results: The HPLC method demonstrated excellent linearity, precision, and accuracy. Meropenem concentrations remained within the predefined acceptance limits throughout the 42-day study period under freezing conditions, with no significant changes in pH, color, or particulate formation. After thawing, a progressive decrease in drug concentration was observed under refrigerated conditions, falling below 90% of the initial concentration within 24–48 h. A concomitant color change from colorless to yellow was also detected, consistent with β-lactam ring hydrolysis. Despite this degradation, no significant changes in physical parameters other than color were observed, and microbiological testing confirmed sterility for up to 7 days under refrigerated conditions. Conclusions: Meropenem drops 50 mg/mL in PP dropper bottles are physicochemically and microbiologically stable for 43 days (42 days under frozen conditions plus 1 day, in-use conditions, after opening and under refrigeration).
Background/ Objectives: Oseltamivir is a widely used antiviral agent indicated for the treatment of influenza and plays a central role in pandemic preparedness strategies. Although an extemporaneously prepared 15 mg/mL oral suspension is recognized in formularies, preparing large volumes during a pandemic requires extended storage options. However, no stability studies are currently available for an oseltamivir 15 mg/mL oral suspension stored under freezing and subsequent refrigerated conditions for the duration of a standard treatment. The aim of this study was to evaluate the physicochemical and microbiological stability of a 15 mg/mL oseltamivir oral suspension prepared from the active pharmaceutical ingredient (API) and packaged in amber glass containers. Methods: The oral suspension was formulated using oseltamivir phosphate API, sodium benzoate as a preservative, and purified water, and then packaged in 125 mL Type II amber glass bottles allowing for thermal expansion. The samples were stored at −20 ± 2 °C for up to 75 days, followed by refrigerated storage (5 ± 3 °C) after thawing for up to 10 days. Chemical stability was assessed using a validated HPLC method in accordance with ICH guidelines and was defined as 90–110% recovery of the initial concentration. Physical stability (color, pH, particulate matter, crystallization, and homogeneity) and microbiological stability were also evaluated. Results: The HPLC method demonstrated excellent linearity, precision, and accuracy. Oseltamivir concentrations remained within the predefined acceptance limits throughout the 75-day study period under freezing conditions, with no significant changes in pH, color, or particulate formation. After thawing, the drug concentration continued to remain fully stable and within the required limits for up to 10 days under refrigerated conditions. Despite the prolonged storage and phase changes, no significant changes in physical parameters were observed, and microbiological testing confirmed the absence of aerobic, anaerobic, and fungal microorganisms on the final day of the study. Conclusions: Oseltamivir 15 mg/mL oral suspension in amber glass bottles is physicochemically and microbiologically stable for up to 85 days (75 days under frozen conditions plus 10 days under refrigeration after thawing).
Background/ Objectives: Meropenem is a broad-spectrum carbapenem antibiotic with demonstrated efficacy against multidrug-resistant Gram-negative pathogens. Alt-hough its use as an ophthalmic formulation is off-label, growing clinical evidence sup-ports its application in severe ocular infections such as keratitis and endophthalmitis. However, the intrinsic instability of meropenem in aqueous solutions and the absence of standardized ophthalmic preparations limit its routine use. Furthermore, no stability studies are currently available for meropenem 50 mg/mL eye drops stored in polypro-pylene (PP) dropper bottles under freezing and subsequent refrigerated conditions. The aim of this study was to evaluate the physicochemical and microbiological stability of a 50 mg/mL meropenem ophthalmic solution prepared in hospital pharmacy and packaged in PP containers. Methods: Eye drops were aseptically prepared and stored at −20 ± 2 °C for up to 42 days, followed by refrigerated storage (5 ± 3 °C) after thawing for up to 7 days. Chemical stability was assessed using a validated stability-indicating HPLC method in accordance with ICH guidelines and was defined as 90–110% recovery of the initial concentration. Physical stability (appearance, pH, particulate matter) and micro-biological stability were also evaluated under simulated in-use conditions. Results: The HPLC method demonstrated excellent linearity, precision, and accuracy. Meropenem concentrations remained within the predefined acceptance limits throughout the 42-day study period under freezing conditions, with no significant changes in pH, color, or par-ticulate formation. After thawing, a progressive decrease in drug concentration was ob-served under refrigerated conditions, falling below 90% of the initial concentration within 24–48 hours. A concomitant color change from colorless to yellow was also detected, consistent with β-lactam ring hydrolysis. Despite this degradation, no significant changes in physical parameters other than color were observed, and microbiological testing con-firmed sterility for up to 7 days under refrigerated conditions. Conclusions: Meropenem drops 50 mg/mL in PP dropper bottles is physicochemically and microbiologically stable for 43 days (42 days under frozen conditions plus 1 day, in-use conditions, after opening and under refrigeration).
About Me
Hospital Pharmacy Specialist
Specialist in the analysis and control of medicines and drugs
Hospital Pharmacy Specialist
Specialist in the analysis and control of medicines and drugs