International journal of pharmaceutical compounding最新文献

The relevance of antibiotic resistance in intensive care units (ICU) is of great concern because of the growing threat to patient and health care system health. The aim of the study is to comprehensively analyse the prevalence, risk factors, clinical implications and strategies to combat antibiotic resistance in sepsis. Methods include a systematic literature review and evaluation of the effectiveness of different approaches based on empirical evidence. Alarming levels of resistance to reserve-line antibiotics have been observed among Gram-negative pathogens in ICU. Irrational use of antibiotics, lack of adherence to infection control measures and limited implementation of antimicrobial stewardship programmes are key factors contributing to the development and spread of resistance. Infections caused by resistant pathogens are associated with increased mortality, risk of complications, longer hospitalization and higher treatment costs. This creates a situation where opportunities for effective antibiotic therapy become exhausted. Sepsis caused by resistant pathogens significantly complicates treatment and worsens prognosis, increasing the risk of complications and mortality. Overcoming the problem of antibiotic resistance requires a comprehensive approach that includes the development of new antibiotics, rational use of existing drugs, strengthening infection control measures, improving epidemiological surveillance and exploring alternative therapeutic strategies. Antibiotic stewardship programmes (ASPs), infection control measures and combined strategies have demonstrated the greatest effectiveness in combating the spread of resistance in ICU. This study contributes to the understanding of the magnitude of the antibiotic resistance problem and offers specific recommendations for improving clinical practice and health policy.

Immediate-use compounded sterile preparations (CSPs) pose significant sterility testing challenges because of short beyond-use dating. Traditional sterility tests, as outlined in USP <71>, require long incubation periods. USP Chapter <797> provides guidelines emphasizing aseptic technique, environmental controls, and validated sterility testing methods. Alternative rapid sterility testing methods, such as those which use cytometric or ATP bioluminescence principles, may obtain faster results and proving suitable for immediate-use CSPs, though they require rigorous validation. This review discusses the sterility testing challenges specific to immediate-use CSPs, examines USP <797> requirements, and compares traditional and alternative testing approaches. It highlights the need for validated rapid methods to enhance sterility testing procedures to improve patient safety in sterile compounding.

Amiloride is a commonly known FDA-approved diuretic used to treat hypertension and congestive heart failure. In more recent years, it has been postulated that it might also serve as an anxiolytic agent due to its agonistic effects on acid-sensing ion channels (ASIC). An intranasal administration of an extemporaneously compounded amiloride would allow for easy and rapid access to the site of action to alleviate symptoms of anxiety and other related disorders. However, compounded patient-preparations do not have the chemical stability or pre-formulation characterization that typical manufactured dosage forms have. The purpose of this study was to assess the real-time chemical, microbiological, and physical stability of extemporaneously compounded amiloride nasal spray over the course of 90 days. This was accomplished via a validated, high-performance liquid chromatography (HPLC) method at designated and appropriate time points to reveal that amiloride remained highly chemically stable over 50 days at 4 and 20 degrees Celsius and retained sufficient stability after 90 days from initial compounding. Additionally, the physical stability of the solution when combined with the preservative benzyl alcohol was confirmed via visual inspection, pH monitoring, and measuring of turbidity.

Extemporaneous oral suspensions are essential for patients who require flexible dosing or cannot swallow solid dosage forms, such as pediatric, geriatric, or immunocompromised patients. SyrSpend® SF PH4 is a preservative-free, sugar-free, and dye-free suspending vehicle designed to ensure both physical, chemical and microbiological stability in compounded formulations. This study evaluates the microbiological and physical stability of oral suspensions compounded with SyrSpend® SF PH4, containing a range of active pharmaceutical ingredients (APIs) including propranolol, domperidone, ondansetron, dexamethasone, tacrolimus, allopurinol, clopidogrel, and folic acid. The chemical stability had been assessed in a previous study, in the same laboratory. Formulations were assessed over 90 days under room temperature and refrigerated conditions. Physical parameters such as appearance and pH remained stable throughout the study period. Antimicrobial effectiveness testing (AET), conducted according to United States Pharmacopoeia guidelines, demonstrated rapid and sustained microbial reduction across all tested organisms (C. albicans, A. brasiliensis, E. coli, P. aeruginosa, and S. aureus), with counts reduced to below detectable limits by day 14 and maintained through day 28. These findings confirm the intrinsic preservative properties of SyrSpend® SF PH4 and support its use as a safe and effective vehicle for extemporaneous compounding, particularly when intended for vulnerable populations.

Background: Intravenous medications and fluids must be compatible to ensure patient safety and optimal clinical outcomes. The physical compatibility of ertapenem and meropenem has not been conclusively established in 0.45% sodium chloride and Plasma-Lyte A.

Methods: An in vitro analysis of the physical compatibility of ertapenem and meropenem at 10 mg/mL and 20 mg/mL concentrations was conducted in 0.45% sodium chloride and Plasma-Lyte A over 24 hours. Admixtures were prepared in triplicate at hours 0, 1, 5, 8, and 24 and were visually inspected, underwent spectrophotometric testing, and pH analysis.

Results: All ertapenem admixtures were found to be physically compatible over 24 hours. Meropenem 10 mg/mL had demonstrable changes in pH and was found to be physically incompatible beyond 8 hours in 0.45% sodium chloride and Plasma-Lyte A. Meropenem 20 mg/mL was found to be physically incompatible beyond 5 hours when mixed in 0.45% sodium chloride.

Conclusions: Our results are the first that have demonstrated physical compatibility for ertapenem 10 mg/mL and 20 mg/mL in 0.45% sodium chloride and Plasma-Lyte A. The findings of this meropenem analysis confirm a previous report that evaluated simulated Y-site samples at 1 hour but expanded upon those findings to show physical compatibility at 8 hours and 5 hours for the 10 mg/mL in both fluids and 20 mg/mL in 0.45% sodium chloride concentrations, respectively. Previously published reports of the stability of meropenem indicating a concentration and temperature-dependent are confirmed by this analysis. Chemical stability studies should be undertaken to support these results.

Background: The physical compatibility of orphenadrine citrate has only been reported in 0.9% sodium chloride in combination with diclofenac. The objective of this study was to investigate the physical compatibility of orphenadrine citrate mixed with 0.45% Sodium Chloride (0.45% NaCl), Lactated Ringer's (LR), and Plasma-Lyte A (PLA).

Methods: Triplicate samples at 0.24 mg/mL, 0.6 mg/mL, and 1.2 mg/mL orphenadrine were mixed in each study fluid. Physical compatibility was assessed through visual observation, spectrophotometric absorbance, and pH analysis. Samples were assessed at hours 0, 1, 5, 8, and 24.

Results: In all test samples, there were no changes observed or measured regarding visual inspection and spectrophotometric analysis. The pH measurements remained stable in 0.45% sodium chloride through 24 hours and through 1 hour with LR at the 0.24 mg/mL concentration. In all samples containing PLA, changes greater than 0.1 unit from baseline across all studied concentrations of drug were recorded from 1 hour onwards.

Conclusions: Orphenadrine citrate is physically compatible with 0.45% NaCl for up to 24 hours. LR and PLA were classified as physically incompatible beyond 1 hour due to significant changes in pH. An evaluation of chemical stability is needed to support these findings.

Background: Lozenge formulations are typically used for local effects on mouth and throat tissue or for systemic drug delivery, which is particularly beneficial for elderly patients with dysphagia. Given that gabapentin is a widely prescribed medication, especially among older adults, an extemporaneous formulation of gabapentin lozenges would offer a valuable alternative for these patients.

Objective: To formulate gabapentin lozenges in three different bases and evaluate which base provides a physically stable extemporaneous compounded formulation.

Method: An experimental design was employed. Three gabapentin lozenge formulations were prepared using different bases: sorbitol, PEG, and gelatin, representing hard, soft, and chewable lozenges, respectively. The resulting formulations were tested for physical stability, including appearance, weight variation, and dissolution, at different temperatures (4°C and 25°C) over a period of 8 consecutive weeks. Retention of original physical properties during the testing period was indicative of physical stability.

Results: The results obtained show that gabapentin is physically stable in soft (PEG) and chewable (gelatin) lozenge bases at room temperature (25 ± 2 °C) and in hard (sorbitol) and soft (PEG) bases at refrigerator temperature (4 ± 2 °C).

Conclusion: The findings suggest that the physically stable gabapentin lozenge formulations obtained in this study: soft and chewable at room temperature, and hard and soft at refrigerator temperature, can be considered viable new dosage forms.

Sterile compounding demands precision, consistency, and an unwavering commitment to safety. For pharmacists and technicians working with Compounded Sterile Products (CSPs), USP General Chapter <797> is a familiar reference point. Yet each review often reveals new considerations, making it essential to revisit the standards regularly - especially now that the latest updates are fully in effect. With inspections always on the horizon, this is the ideal time to ensure your Primary Engineering Controls (PECs) and Containment Primary Engineering Controls (C-PECs) meet both regulatory expectations and best practice standards.

Over the last three years, a combination of wildly growing demand and near-constant shortages have provided both compounding pharmacies and outsourcing facilities with strong financial incentives to move aggressively into the production and sale of semaglutide and tirzepatide. Although for simplicity's sake, we focus on semaglutide, broadly similar remarks apply to tirzepatide. This lucrative market has also proved very tempting to physicians working in the weight loss space. The fact that the predominant use of these drugs-to aid weight loss-is not typically covered by insurance, has sweetened the proverbial pot. Because reimbursement is not typically tied to federal health care programs, there is less risk from the attendant federal legal prohibitions on kickbacks and physician self-referral. Nevertheless, both compounders and clinical practices currently face significant legal risks from avoiding the branded products in favor of compounding and selling analogous drugs. We review some of the relevant history for semaglutide, including the regulatory framework and an overview of the additional risks of this novel trend in the compounding space. We should note at the outset that the following is only a cursory overview of the risks, which vary significantly and evolve rapidly. If you are considering compounding these drugs, you should seek jurisdiction specific advice from competent legal counsel.