International journal of pharmaceutical compounding最新文献

This bracketed study evaluated the physicochemical stability and microbiological safety of 12 compounded transdermal formulations containing clonazepam (1.0 and 50.0 mg/mL), diclofenac sodium (10.0 and 100.0 mg/mL), estriol (0.1 and 20.0 mg/mL), lidocaine (5.0 and 100.0 mg/mL), melatonin (0.5 and 50.0 mg/mL), and testosterone (5.0 and 100.0 mg/mL) in Pentravan®. Formulations were stored at room temperature for up to 180 days and analyzed at predefined intervals for active pharmaceutical ingredient (API) content, pH, visual characteristics, and antimicrobial effectiveness testing (AET). Most formulations maintained API content within the acceptable range of 90-110% throughout the study, with pH values demonstrating negligible fluctuations. Physical characteristics remained stable over time, with the exception of the diclofenac sodium 100.0 mg/mL formulation, which exhibited phase separation after 30 days. Antimicrobial effectiveness testing confirmed sufficient preservative efficacy for all formulations against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. The following beyond-use dates (BUDs) were established based on chemical and microbiological stability: 180 days for most APIs; 120 days for lidocaine (5.0 and 100.0 mg/mL); and 60 days for melatonin (0.5 mg/mL). These results reinforce the reliability of Pentravan® as a transdermal vehicle, demonstrating its ability to support stable and microbiologically safe formulations across a wide range of active compounds.

Background: Ensuring the integrity of intravenous medication administration is a vitally important role for pharmacists and correlates directly to patient safety and outcomes. Information about the physical compatibility of medications with intravenous fluids may be unknown or conflicting, leading to issues that may delay, complicate, or prohibit care at the bedside. The objective of this study was to determine the physical compatibility of ceftazidime and ceftazidime/avibactam in 0.45% sodium chloride (NaCl) and Plasma-Lyte A (PLA).

Methods: An in vitro analysis of ceftazidime 10 mg/mL, 20 mg/mL, and 40 mg/mL and ceftazidime/avibactam 8 mg/mL, 15 mg/mL, and 20 mg/mL was conducted in 0.45% NaCl and PLA to align with clinically utilized concentrations of the drugs. Compounded aliquots were evaluated in triplicate at hours 0, 1, 5, 8, and 24. Physical compatibility was assessed by a standardized visual inspection process, spectrophotometry, and pH analysis.

Results: While none of the admixtures had demonstrable visual or spectrophotometry changes, all samples had a demonstrable change in pH at various time points. None of the evaluated ceftazidime concentrations were physically compatible beyond initial use when mixed in 0.45% NaCl, and beyond 1 hour when mixed in PLA. Ceftazidime/avibactam at concentrations of 8 mg/mL and 15 mg/mL were physically incompatible beyond 1 hour in 0.45% NaCl and PLA, and beyond 5 hours for the 15 mg/mL concentration in both IV fluids.

Conclusions: This analysis provides new information related to the physical compatibility of ceftazidime and ceftazidime/avibactam in 0.45% NaCl and PLA. Chemical analysis of the admixtures is warranted to support these results.

This review composition explores the advancements and challenges in the use of lipid nanoparticles (LNPs) for targeted medicine delivery to the lymphatic system, with a focus on immunotherapies and vaccines. The lymphatic system's unique role in immune response and fluid regulation makes it an ideal target for nanoparticle based curatives. This review examines the impact of LNP characteristics, sizes and surface charges on their lymphatic uptake and retention. Previous studies indicated that nanoparticles with compasses under 100 nm are most effective for entering lymphatic vessels and sustaining remedial action. The review highlights the influence of surface charge on cellular uptake and bio distribution, noting that appreciatively charged nanoparticles tend to have efficient cellular uptake but may face rapid immune elimination, while negatively charged or neutral nanoparticles frequently exhibited prolonged circulation times. Also, the review addresses the contribution of microfluidic methods in the synthesis of LNPs, emphasizing their advantages in producing invariant drug delivery systems with precise size and charge parcels. By comparing traditional formulation styles with microfluidic approaches, the review identifies crucial benefits in terms of reproducibility and scalability. The review further synthesizes findings on the clinical challenges to these advancements, particularly in enhancing the efficacy of vaccines and immunotherapies through improved lymphatic targeting. Overall, the review provides a comprehensive analysis of current exploration, identifies gaps in knowledge, and suggests potential directions for optimizing LNP-based curatives for lymphatic medicine delivery.

Objective: Succimer (meso-2,3-dimercaptosuccinic acid, DMSA) commercial manufacturing was discontinued for 5.5 years from 2016 to 2022. This radiopharmaceutical is used in our academic health center as standard of care for diagnosing and staging renal scarring. Our objective was to validate a method to verify the content of DMSA in a cold reaction vial, referred to hereafter as a kit, after compounding in a nuclear pharmacy.

Methods: A simplified method of DMSA kit compounding was performed by passing a saturated solution of DMSA in sterile water for injection through a 0.22-micron filter after the addition of all other kit components. To verify DMSA content, we used Ellman's Reagent, 5,5'-dithio-bis-(2-nitrobenzoic acid). This compound reacts with a free thiol group at pH - 8 to produce a yellow-colored mixed disulfide product with a strong absorbance at 412 nm. A calibration curve was prepared using DMSA solutions of known concentrations and used to determine the molar concentration of DMSA in a kit. The kits were stored frozen and DMSA content was verified over 45 days.

Results: All kits met the acceptance criteria of the USP monograph for technetium 99m succimer for administration. Statistical analysis with 0.95 power and using mean standard deviation resulted in a 95% confidence interval within ±10% of DMSA labeled content by sampling 4 vials of a batch using the Ellman's Reagent test. Kits have shown stability over 45 days frozen.

Objectives: 1. To observe the lean body mass, BMI and weight with impact of nutrition over 3 months. 2. To compare percentage increase in weight gain between regular and irregular caloric intake patients.

Materials and method: A prospective observational study was performed at Cancer Centre Hospital over six months from July to December, 2024 which includes a sample size of 197 participants. Participants were divided into regular (=2000 kcal/day) and irregular (<2000 kcal/day) caloric intake groups, with both receiving nandrolone. Weight, BMI, and lean body mass (LBM) were measured monthly for three months.

Statistical analysis: Statistical analysis was performed using SPSS. Comparative analysis was performed by applying chi-square test. Logistic regression analysis was performed to calculate odds ratios. A p value = 0.05 was considered statistically significant.

Results: Patients with regular caloric intake showed significant improvements: weight increased by 13.0% (vs. 4.3% in irregular group), BMI rose from 18.46 to 20.82 (vs. 18.47 to 19.24), and LBM increased from 83.40 to 86.16 (vs. 83.40 to 83.76). All changes were statistically significant (p<0.05). Socioeconomic status influenced adherence, with higher-income patients more likely to maintain regular intake.

Conclusion: Regular caloric intake combined with nandrolone therapy significantly enhances weight, BMI, and LBM in cancer cachexia patients. Adherence to dietary recommendations is critical for mitigating muscle wasting and improving clinical outcomes. These findings underscore the importance of integrated nutritional and pharmacological interventions in cachexia management.

Many commercial scalp solutions contain propylene glycol and high quantities of alcohols which can irritate the scalp and cause additional undesirable side effects. Foamil®, a propylene glycol-free and alcohol-reduced foam vehicle, was previously developed to reduce these side effects and increase patient compliance. Two concentrations of combined minoxidil and finasteride (5% Minoxidil/0.1% Finasteride and 12.5% Minoxidil/0.25% Finasteride) in Foamil were extemporaneously compounded and studied to evaluate chemical, physical, and microbial stability over 180 days. An HPLC analysis method was developed and validated to assess chemical stability. Additionally, pH measurement and observation of organoleptic properties was assessed throughout storage. Physical and chemical stability testing was performed at predetermined timepoints (0, 30, 60, 90, 120, and 180 days). Antimicrobial testing was conducted per USP <51> guidelines after 180 days of storage. Together, these results show that the compounded minoxidil and finasteride preparations in Foamil are considered stable for 180 days when stored at room temperature in tightly closed, light resistant plastic containers.

This study aimed to evaluate the physicochemical stability of orodispersible films (ODFs) compounded with seven active pharmaceutical ingredients (APIs): caffeine, folic acid, curcumin, pyridoxine hydrochloride, vitamin B12, 5-hydroxytryptophan (5-HTP), and dehydroepiandrosterone (DHEA), using the OrPhyllo™ film-forming base. Analytical methods were validated for specificity, linearity, precision, and accuracy, and stability was monitored over 180 days under ambient conditions. Recovery values were used to determine the beyond-use date (BUD) for each formulation, based on the last time point with recovery within the acceptable range of 90-110%, as recommended by USP <795>. The results showed that the formulations containing 5-HTP 100 mg/mL, curcumin 50 mg/mL and 100 mg/mL, DHEA 10 mg/mL, and pyridoxine hydrochloride 5 mg/mL remained stable for the full 180-day period. Formulations with 5-HTP 25 mg/mL, caffeine 20 mg/mL, folic acid 5 mg/mL, vitamin B12 0.1 mg/mL, and vitamin B12 1 mg/mL were stable for up to 150 days. Caffeine 2.5 mg/mL and DHEA 100 mg/mL showed acceptable recovery only up to 60 and 90 days, respectively. Pyridoxine hydrochloride 1 mg/mL maintained stability for 90 days, while folic acid 1 mg/mL was stable for 150 days. These findings confirm the reliability and robustness of OrPhyllo™ as a compounding base for personalized ODFs. These findings confirm the reliability and robustness of OrPhyllo™ as a compounding base for personalized ODFs. The base demonstrated consistent performance across a wide range of formulations and stability profiles, supporting extended beyond-use dates. OrPhyllo™ is currently the only film-forming base with a comprehensive stability data available, reinforcing its applicability and value in pharmaceutical compounding practices.

Background: In advance preparation of solutions containing morphine and ketamine can reduce the risk of error, lower costs, and reduce nursing workload, thereby improving the quality of care. However, data on the stability of morphine hydrochloride and ketamine hydrochloride admixture in polypropylene syringes stored at room temperature are lacking.

Objective: To assess the physical and chemical stability of a morphine hydrochloride (2.0 mg/mL) and ketamine hydrochloride (3.3 mg/mL) admixture in polypropylene syringes, stored at room temperature and protected from light, for up to 49 days.

Methods: Five syringes containing the admixture were prepared under aseptic conditions and analyzed periodically over 49 days. Physical stability was assessed visually, microscopically, and through turbidity measurements. Chemical stability was evaluated using ultra-high-performance liquid chromatography (UHPLC).

Results: No visual precipitation, color change, or significant turbidity increase was observed. The pH remained stable. UHPLC analysis showed that both morphine and ketamine concentrations remained above 90% of initial values at day 49.

Conclusion: The admixture of morphine hydrochloride (2.0 mg/mL) and ketamine hydrochloride (3.3 mg/mL) is physically and chemically stable for at least 49 days in polypropylene syringes stored at room temperature and protected from light. This allows for the in advance preparation of the admixture by centralized intravenous admixture services, improving efficiency and potentially reducing errors.

The purpose of this study was to investigate the principal characteristics of allergic diseases caused by common allergenic metals. For this, a thorough search of relevant information presented for 2018-2023 in the Embase, PubMed, Scopus, and Web of Science databases was conducted. The study found that one third of the world's population suffers from allergies, and 20% of them are diagnosed with metal allergies. To date, 45 metals have been identified as causing allergic reactions. The main routes of exposure to metals are inhalation, contact, oral, and parenteral. The following diseases develop as a result of metal exposure: various types of contact dermatitis, urticaria, anaphylactic reactions, conjunctivitis, rhinitis, ulcerative colitis, arthralgia, stomatitis, gingivitis, and bronchial asthma. The main diagnostic method is the patch test. Allergy treatment depends on the type of allergic reaction. In case of immediate allergic reactions, emergency treatment with epinephrine is required. For diseases that develop as delayed allergic reactions, the use of corticosteroids and antihistamines is effective. Allergenic metals should be avoided to prevent the onset and development of allergies. For this, it is advisable to use gloves, protective creams, and masks. It is essential to carefully read the composition of the products used and individually select alternative non-allergenic materials. The prescription of a diet aimed at correcting the content of metals in the body improves the general condition of patients and reduces the severity of symptoms. Thus, metal allergy is a common pathology that causes the development of a wide range of diseases of varying severity.

SyrSpend® SF PH4 is a preservative-free oral suspending vehicle widely used in extemporaneous compounding. While its chemical stability has been previously demonstrated for various active pharmaceutical ingredients (APIs), microbiological stability data remain limited. This study aimed to evaluate the microbiological stability of oral suspensions containing dapsone, griseofulvin, levofloxacin, terbinafine, indometacin, naproxen, and paracetamol in SyrSpend® SF PH4, under both room temperature and refrigerated conditions. Formulations were assessed over 90 days for physical appearance and pH. Antimicrobial effectiveness testing (AET) was conducted according to USP <51> against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. All formulations maintained stable pH and appearance throughout the study. AET results showed a reduction of microbial counts to below detectable levels (log 1.0) by day 14, sustained through day 28, meeting USP <51> acceptance criteria. SyrSpend® SF PH4 effectively preserved the microbiological integrity of all tested formulations without added preservatives. These findings complement existing chemical stability data and support the use of SyrSpend® SF PH4 as a safe and effective vehicle for extemporaneous oral suspensions, particularly in populations requiring preservative-free formulations.