International journal of pharmaceutical compounding最新文献

The global increase of use of oncology drugs combined with the higher costs of these drugs raise the question of how to reduce these costs. One way to reduce the costs is to reduce spillage by extending the beyond-use date by preserving remainders in the vial of (expensive) oncology drugs instead of wasting them. Therefore, we investigated if spikes, instead of the expensive closed-system transfer devices, can be used to extend the beyond-use date of drugs both at room temperature and in the refrigerator during seven days after reconstitution and partial fluid withdrawal of a vial. Six hundred vials containing concentrated tryptic soy broth were reconstituted with 10-mL of sodium chloride 0.9%, after which approximately 3 mL were removed from the vial and discarded using a regular spike for 300 vials and a MicroSpike for the other 300 vials. Subsequently, the vials were stored either at refrigerator temperature or at room temperature for seven days. After seven days, all six hundred vials were transported and incubated at a temperature of 30°C to 35°C for fourteen days. None of the six hundred vials used showed contamination, either punctured with a MicroSpike or with a regular spike, after storage of seven days at room temperature or in the refrigerator and two weeks of incubation. Conclusively, it can be stated that hospital pharmacies play an important role in keeping the high costs of oncology drugs as low as possible. This study shows that using a spike instead of a more expensive closed-system transfer device for preservation of the remainder of oncology drugs will further reduce spillage of expensive drugs resulting in lower healthcare costs.

Described by some authors as a "black swan event . . . likened to the economic scene of World War Two," the effects of coronavirus-disease-2019 (COVID-19) and attempted techniques for its prevention and treatment have presented medical, economic, social, and (often) politicized challenges on a global scale. Caused by the highly transmissible severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 is, in many patients, associated with severe morbidity and mortality during the first few weeks after infection. At the time of this writing, estimates indicate that up to 70% of survivors may also experience "long COVID," a condition that can persist for weeks, months, or years after virus-free status has been achieved, often produces severe symptoms across multiple organ systems, and can result in a wide variety of adverse outcomes. Scientific knowledge about COVID-19 and long COVID continues to evolve at a rate insufficient to address the protean manifestations and effects of continually emerging novel SARS-CoV-2 variants. When the recovery of afflicted patients is further challenged by intolerance to ingredients in (or available doses or dosage forms of) commercially manufactured medications that could provide therapeutic support, customized formulations may offer relief and enable healing. In this article, COVID-19 is addressed as an entity (i.e., the pandemic crisis it engendered is summarized to date, the most common signs and symptoms of that disease are described, and the phenomenon of cytokine storm in infected patients is examined), SARS-CoV-2 is discussed (i.e., common nomenclature systems used to describe and track that virus are presented and the processes of viral transmission, mechanisms of action, replication, and recombination are briefly reviewed), and the efficacy of a currently underappreciated agent (low-dose naltrexone) for the treatment of COVID-19 is considered. Two compounded formulations that can be used to treat the signs, symptoms, and/or sequelae of acute COVID-19 and/or long COVID are provided for easy reference.

Intravenous admixture compounding is a common practice in most hospitals throughout the world, regardless of the country. Due to the complexity in compounding intravenous medications, there is a high potential for error, and since intravenous medications must be compounded in an aseptic environment, this poses additional issues for the compounder. Part 1 of this series of articles provides an introduction, an overview, and compounding personnel considerations of this topic. The remaining parts of this series will cover parenteral vehicle considerations; preparation procedures; physicochemical considerations; handling potential incompatibilities; endotoxin considerations; and quality control of intravenous admixtures. This introductory article in this overall series on intravenous admixture preparation presents issues related to their compounding and to medication error prevention.

Per United States Pharmacopeia Chapter <797>, effective November 1, 2023, uncovering non-conforming cleanroom microbiological conditions must be investigated thoroughly and in a timely manner. This article's objective is to outline the basic elements in investigating microbiological excursions at a sterile compounding facility, which models the use of an Ishakawa diagram to conduct a root cause investigation and discusses important concepts such as: product impact analysis, corrective and preventive action effectiveness checks, trend analysis, and investigational pitfalls to avoid. While this article focuses on investigating microbiological excursions, the concepts can be applied to investigating an out-of-range temperature, relative humidity, pressure differential, total particle count, or compounded sterile preparation failure.

The objective of this study was to compare residual volume and time to prepare and reconstitute cefazolin using 3 different reconstitution devices while observing for use errors, participant feedback, and particulate after reconstitution. After demonstrations on the use of each device and practicing twice with each device, participants performed reconstitutions 3 times per device while being timed and observed on device preparation and assembly, mixing the drug with intravenous fluid into vials, and transfer of vial contents into the intravenous bags. Participants completed surveys to assess perceptions on use of each device. Intravenous bags were then hung for 60 minutes and observed for residual fluid and particulate matter. Residual vial volumes ranged from 0.05 mL to 2.6 mL: >0.3 mL in Device 2 (16.7%), Device 1 (55.6%), and Device 3 (81.1%). Most participants (83%) had experience with Device 1. Mean (standard deviation) total time in seconds to reconstitute medication significantly differed between devices (P<0.001): Device 1, 70.98 (15.72), Device 2, 99.11 (14.87), Device 3, 103.7 (18.99). Device assembly took the longest time and significantly differed between devices (P<0.001): Device 1, 18.76 (8.13), Device 2, 36.09 (8.05), and Device 3, 31.21 (7.75). Survey results (60=max score) were significantly different (P<0.001): Device 1, 54.5 (5.3), Device 2, 44 (13.1), Device 3, 37.1 (9.1). Nurses ranked Device 1 the highest (79%) and pharmacy technicians favored Device 2 (60%). No particulates were found (n = 270). Potentially significant residual vial volume was found and use errors were concerning in Device 2 and Device 3, potentially resulting in incomplete medication dosing. Mean times for reconstitution were <104 seconds, with Device 1 being the fastest and most favored.

A postmenopausal female patient was suffering from vulvovaginal symptoms such as dryness and irritation, which were affecting her relationship with her partner and her overall quality of life. The patient was instructed to apply an estriol 0.1% vaginal ointment (PCCA Ellage Anhydrous Vaginal) for a duration of three months. The safety and efficacy of the compounded treatment were evaluated using an online data collection form, which included the validated Vulvovaginal Symptom Questionnaire. Post-treatment results show that the vulvovaginal symptoms were no longer bothersome, and that the patient's relationship was no longer affected. There were no reports of undesirable effects as a result of the compounded treatment. This case study reinforces the benefits and convenience of using topical hormone replacement therapy in postmenopausal women.

The objective of this study was to prepare and evaluate ibuprofen nanocrystals using isopropyl alcohol and stabilizer sodium lauryl sulphate by way of the precipitation method. The nanocrystals were prepared by the bottom-up approach of the precipitation technique. This technique involves the use of an organic phase, which is completely miscible in the external aqueous phase. The ratio used for organic solvent-to-aqueous solvent was 1:50. The Fourier Transform Infrared Spectroscopy analyses confirmed that the drug and excipients were compatible, and the differential scanning calorimetry results indicated that the precipitation method led to no change in the crystalline structure of the drug. Scanning electron microscopy analysis of ibuprofen nanocrystals showed the promising size reduction of pure drug ibuprofen. Differential light scattering technique showed significant decrease in particle size and good stability of ibuprofen nanocrystals. Ibuprofen nanocrystals increased 20% to 25% of the saturation solubility of ibuprofen nanocrystals. Ibuprofen nanocrystals showed 90% drug release in the dissolution medium within 1 hour, while the pure drug and market product were dissolved only up to 58% and 63%, respectively. Ibuprofen nanocrystals increased the saturation solubility and in vitro dissolution of the drug as compared to conventional market product.

This article discusses a new method for the preparation of extemporaneous ibuprofen-based suspensions for use in paediatric patients. This method allows the preparation of extemporaneous suspensions up to concentrations of 200 mg/5 mL by using a liquid base named "Wagner." A comprehensive physicochemical stability study was conducted on the formulation at a drug concentration of 200 mg/5 mL by performing high-pressure liquid chromatography and Turbiscan analyses. Chromatographic analyses of the samples demonstrated the chemical stability of the active pharmaceutical ingredient in the base for more than 90 days when the formulations were stored at 4°C and 25°C. Visual and optical analyses evidenced a reversible, slightly creaming phenomenon when the formulations were stored at 4°C or 25°C restoring the initial suspension by simply shaking.

Whether sterile compounds are prepared in a brand new state-of-the-art cleanroom suite or in an aging space, compounders rely heavily on their primary and secondary engineering controls when sterilizing or maintaining sterility of the final preparation. With the release of the latest revision to United States Pharmacopeia Chapter <797>, organizations that prepare sterile compounds must now sample and test each classified area for the presence of microbiological contaminants at a higher frequency. Facilities that are not purpose-built, as well as those that do not operate within a state of control, are predicted to repeatedly exceed action levels as set by the United States Pharmacopeia Convention, Inc. Before the United States Pharmacopeia revision becomes active and enforceable, it is advised that sterile compounding practice sites undergo an environmental-baseline study to gather statistically significant data to demonstrate how the cleanroom(s) perform and to assess whether or not dynamic operations increase the levels of bioburden.