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Copyright of ScienceRise: Pharmaceutical Science is the property of PC TECHNOLOGY CENTER and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Many reports support the use of closed system drug transfer devices (CSTDs) to protect against exposure to hazardous drugs during their preparation. However, leakage may occur if the CSTD fails to maintain hermeticity when fitted into the vial. Our aims were to devise a measure to prevent HD exposure and to develop a test method to verify CSTD function when a BD PhaSeal™ protector is used in HD preparation. Methods: We selected the BD PhaSeal™ System, which is the most commonly used CSTD device in Japan. The sealability of the BD PhaSeal™ protector and vial is considered to be due to the hermeticity of the protector and the rubber stopper of the vial. We constructed a protector with a damaged sealing rim and monitored the pressure fluctuation 10 times when the BD PhaSeal™ injector was connected to the pressurized vial. Results: The reduction in pressure of the protector in the group without a damaged sealing rim was 5%, while that in the group with the damaged sealing rim was 84.9%. Conclusion: It was suggested that leakage occurred through the gap between the protector and the rubber stopper when using a vial that was not in close contact with the sealing rim. In this study, we developed a test that can be easily used to verify the compatibility of the BD PhaSeal™ protector and a vial in the clinical setting. Thus, when new hazardous drugs are being prepared, these measures can be taken to ensure that the risk of exposure is reduced or eliminated. [ABSTRACT FROM AUTHOR]

Cocaine, heroin, methamphetamine, and hashish are the primary drugs transported by a body packer, who swallows such packages. A body pusher or stuffer transports drug packages in rectum or vagina. Plain radiography is the primary imaging modality used in the evaluation of concealed drugs and has sensitivity of 85-90%. The imaging features include well-defined opacities in the bowel with crescents of air near ovoid opacities. The imaging signs include double condom sign, halo sign, parallelism sign, and tic tac sign. A low-dose CT is an efficient noninvasive and accurate technique of locating packages internally for all types of concealment. [ABSTRACT FROM AUTHOR]

What is known and Objective: During the coronavirus disease of 2019 (COVID‐19) pandemic, there were periods when patients were not able to collect their medications from the hospital. The purpose of this study is to report on our management of the handling and delivery of biological medications to patients during periods of lockdown in the Kingdom of Saudi Arabia (KSA). Methods: A descriptive study conducted at our 380‐bed tertiary care hospital. Managing the delivery of the biological medications was organized in six phases: (1) taskforce development, (2) identification of the relevant biological medications, (3) identification of patients, (4) organization of transportation, (5) medication delivery/pickup and (6) locating patients with unidentified addresses. The study was approved by our hospital's Institutional Review Board. Results and discussion: Biological medications were delivered to 1235/1373 (90%) patients. This included 1875/2036 (92%) prescriptions. 900 prescriptions were delivered to 570 patients living in 95 cities and villages across the kingdom. 141 patients received 183 prescribed oral biological medications and 477 patients received 787 prescribed parenteral biological medications delivered with temperature control. 224 parenteral biological medication were delivered by car to 116 patients living in less accessible cities in the west of the country. The car deliveries of parenteral biological medications required particularly careful handling, packaging and temperature control. Delivering biological medications to patients during the curfew was a unique experience. However, the approach we have used ensured safe access to medications under appropriate conditions. What is new and Conclusion: Delivering biological medications to patients during the lockdown was challenging. With the possibility of a second wave of COVID‐19, hospitals should have a standardized process in‐place for delivering such medications. [ABSTRACT FROM AUTHOR]

In Japan, the mean time spent on preparing and administering medications each day for everyone in care facilities has been reported to be 163 min. Most caregivers that administer medications to the elderly in care facilities have reported that this responsibility is a burden. We developed a drug distribution support device (DDSD) for caregivers, which was then installed in a group home and a 3-month monitoring experiment was conducted. Caregivers then answered a questionnaire survey on medication management burden pre- and post-DDSD use. The caregivers reported no difficulties associated with medication distribution using DDSD. The DDSD reduced the daily dispensing duration by an average of 3.5 min. The questionnaire survey showed no differences in items related to the reduction of errors, and the Family Caregiver Medication Administration Hassles Scale showed no reduction of burden on caregivers. However, whether the DDSD reduces medication management burden remains undetermined. [ABSTRACT FROM AUTHOR]

In view of an old publication date, and the recent need for new guidelines arising from inspections carried out for COVID-19 therapeutics, the World Health Organization (WHO) Prequalification Team - Inspection Services (PQT INS) raised the urgency for a revision of the WHO Good manufacturing practices for investigational pharmaceutical products for clinical trials in humans (1). The Fifty-fifth Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) concurred with this proposal. The objective of this update is to bring the guideline in line with current expectations and trends in good practices and to harmonize the text with the principles from other related international guidelines. [ABSTRACT FROM AUTHOR]

Objective: Identify disease categories in which single-item global impression (GI) scales were included in product labeling of new drugs approved by the US Food and Drug Administration (FDA) in January 2009-December 2019 and review the characteristics of GIs included in product labeling of new FDA-approved drugs (January 2017-December 2019).Methods: FDA Clinical Outcome Assessment (COA) Compendium was reviewed for drug labels that included GIs for drugs approved in 2009-2016. The indication, year of approval, ICD-10 code, and GI respondent were noted. A manual review of labels of FDA-approved drugs (2017-2019) was undertaken to identify GIs included in the labels. Corresponding drug approval packages were reviewed to identify details of any regulatory reviewer comments related to GIs. GI characteristics were noted from the drug label or the review documents, including the respondent, type of measure (static or dynamic), item wording, concept assessed, and response options.Results: Product labeling containing GIs was most common in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs were included in 30/77 (39.0%) drug labels in the four disease categories.Conclusion: In the past 10 years, GIs have been included as endpoint measures in confirmatory clinical trials and have generated evidence of treatment benefit in diseases related to the skin, nervous system, behavioral disorders, and the musculoskeletal system. GIs frequently provide important insights into the patient experience. Before GIs are included in clinical trials to assess treatment benefit, it is important to ensure that they are valid, reliable, and responsive. [ABSTRACT FROM AUTHOR]

Copyright of Al-Academy is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: Helicobacter pylori eradication therapy requires a complex prescribing schedule combining clarithromycin, amoxicillin, and a proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB, vonoprazan). To reduce the burden of complex prescribing and increase adherence, a vonoprazan triple-drug blister pack comprising all three medications was launched in June 2016. This study aimed to assess the impact of the combination blister pack on eradication success rate in Japan immediately after launch. Methods: We performed an interrupted time series analysis using a large administrative claims database of 7,300,000 insured individuals. We identified 36,570 patients who received first-line clarithromycin triple therapy from June 2015 to May 2016 (prelaunch) and 35,721 who received the same therapy from July 2016 to June 2017 (post-launch). The primary outcome was the success rate of clarithromycin triple therapy and the secondary outcomes were proportion of vonoprazan use and proportion of combination blister pack use. Results: The success rate of clarithromycin triple therapy increased by 2.44% (95% confidence interval [CI] 1.36–3.52; P < 0.0001) after the launch of the vonoprazan triple-drug blister pack. The proportion of vonoprazan use and proportion of combination blister pack use increased by 12.7% (95% CI 10.0–15.3; P < 0.0001) and 29.2% (95% CI 25.4–32.9; P < 0.0001), respectively. Conclusions: Launch of the vonoprazan triple-drug blister pack had a significant impact on the success rate of clarithromycin triple therapy, with greater proportions of vonoprazan and combination blister pack use. Introducing an easy-to-use formulation may be effective in changing prescribing practice and subsequent patient outcomes. [ABSTRACT FROM AUTHOR]

Transfer of xenobiotics from their original container to an unlabeled or secondary container is a well-identified risk factor for poisoning. Nonetheless, recent large-scale data on the practice are unavailable. The objective of this study is to describe the incidence and features of poisonings in the United States due to xenobiotics stored in a secondary container. This was a retrospective review of the National Poison Data System (NPDS) from 2007 to 2017. Non-suicidal exposures associated with the scenario "container transfer involved (product transferred from original container to unlabeled container, incorrectly labeled container, or food container for use or storage and patient accessed product from second container)" were included. Forty-five thousand five hundred and twelve cases were included. The median age of subjects was 30 years (interquartile range: 6–53); 52% were female. Cleaning products (38.2%), disinfectants (17.3%), and hydrocarbons (5.0%) were the most common xenobiotics reported. The annual incidence of cases increased over the study period. There were 9369 (20.6%) ED visits and 1856 (4.1%) hospital admissions. Most cases (72%) were deemed nontoxic or resulted in no effects; 4.4% resulted in serious outcomes (moderate effects, major effects, or death), including 23 deaths. Morbidity was highest for pesticides, prescription medications, and herbicides, with 10.3%, 9.8%, and 7.6% of cases resulting in serious outcomes, respectively. Hydrofluoric acid and herbicides were associated with the most deaths (13/23 [57%]). Transfer of xenobiotics to a secondary container is a scenario increasingly reported to U.S. poison centers. Although most exposures do not result in significant toxicity, ED visits are common and substantial morbidity can occur. This represents an opportunity for public health intervention to curb the practice. [ABSTRACT FROM AUTHOR]

Background: The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study investigated the presence and role of PED in drug approval and translation into product label claims. Methods: PED reported in approval packages of the 48 drugs approved by FDA's Center for Drug Evaluation and Research in 2019 was identified and categorized. PED in the form of clinical outcome assessments (COAs) was characterized by endpoint positioning and outcome. The product labels were analyzed for PED-related claims. Results: PED was reported as relevant for 39 of 48 (81.3%) drugs approved in 2019. COAs were the predominant PED type; other PED was identified for only 9 (18.8%) drugs, and none included qualitative or patient preference studies. COAs were the only type of PED for which associated claims were identified in the product labels. 27 out of 48 (56.3%) labels contained one or more efficacy claims based on COAs; of these, patient-reported outcomes were the most prevalent with claims identified in 19 labels (39.6%). Conclusion: There are ample opportunities for incorporating PED beyond COAs to inform drug development and facilitate availability of medicines tailored to patient needs. A higher level of transparency on the role of PED in regulatory decision-making and a clear path to PED-based label claims could incentivize sponsors and enable patient empowerment in treatment decisions. [ABSTRACT FROM AUTHOR]

The relative effect of age and vision on medication management tasks (time and accuracy of entering the pharmacy phone number and interpreting dose) across four different prescription drug container shapes is examined. A mixed measures three-factor design was employed, with within-subject control. The repeated-measure independent variable of interest was container shape (four conditions), and the two between-subject independent variables were vision and age. Older age and decreased vision were found to be generally negatively associated with time and accuracy of entering the phone number and correct interpretation of dose. Container shape modified the effect of vision and age on the medication management tasks. Interactions between independent variables of age, vision, and container shape make it difficult to recommend one container shape for all participants. The results presented give credence for further examination of packing for label readability and other aspects of medication management, given the ease at which packaging can be modified. [ABSTRACT FROM AUTHOR]

Purpose: We used data from two public health surveillance systems for national estimates and detailed descriptions of insulin mix‐up errors resulting in emergency department (ED) visits and other serious adverse events to help inform prevention efforts. Methods: ED visits involving patients seeking care for insulin medication errors collected by the NEISS‐CADES project in 2012–2017 and voluntary reports of serious insulin medication errors submitted to the US Food and Drug Administration (FDA) in 2016–2017 were analyzed. National estimates of insulin product prescriptions dispensed from retail pharmacies were obtained from IQVIA National Prescription Audit. Results: Between 2012 and 2017, based on 514 NEISS‐CADES cases, there were an estimated 5636 (95% CI, 4143‐7128) ED visits annually for insulin mix‐up errors; overall, over three‐quarters (77.5%; 95% CI, 71.6%–83.3%) involved taking rapid‐acting instead of long‐acting insulin. Between 2012 and 2017, the proportion of mix‐up errors among all estimated ED visits for all insulin errors decreased by 60%; concurrently, the proportion of pens among all insulin package types dispensed increased by 50%. Among 58 voluntary reports submitted to FAERS, over one‐half (56.9%) of cases involved taking rapid‐ instead of long‐acting insulin. Among 27 cases with documented contributing factors, approximately one‐half involved patients having difficulty differentiating products. Conclusions: Among all ED visits for insulin errors collected by NEISS‐CADES in 2012–2017, the proportion involving mix‐up errors has declined. Continued reductions may require additional prevention strategies, including improving insulin distinctiveness, particularly for rapid‐ vs long‐acting insulins. Ongoing national surveillance is important for identifying the impact of interventions. [ABSTRACT FROM AUTHOR]

Purpose: To assess the stability of insulin detemir at controlled room temperature (RT) at 25°C in different packaging systems over 7 days. Methods: The degradation characteristics of insulin detemir were determined based on the assay results in different packaging systems (pinhole glass vial, closed glass vial, glass syringe, and plastic syringe) at RT using a reverse-phase high-performance liquid chromatography (HPLC) assay method for insulin injection. Each packaging system was compared to insulin detemir stored in the original packaged closed glass vial at 2°C to 8°C. Results: Insulin detemir stored in a closed glass vial and a glass syringe showed minor degradation at the end of day 7 (98.96% ± 1.49% and 99.78% ± 0.10%, respectively). Insulin detemir stored in plastic syringe decreased to 94.90% ± 2.50% by day 3 and to 93.52% ± 0.29% by day 7. Storage in pin-hole glass vial showed an increase in the assay (152.13% ± 0.12%) by day 7. Conclusion: Stability studies in different packaging systems demonstrated that insulin detemir remained stable for at least 7 days in a closed glass vial or glass syringe, but for only 3 days in a plastic syringe at RT. This study will allow pharmacists in the hospital setting to deliver patient-specific insulin doses into an insulin syringe with confidence in the stability. [ABSTRACT FROM AUTHOR]

Background: Glass ampoules are widely used to contain injection medications because of their properties. However, the existing literature reports that glass particle contamination is found in opening glass ampoules. To date, nursing practice standards on this issue have not gained attention in terms of the manual breaking methods generally used for opening ampoules in a clinical setting that can minimize the risk of glass particle contamination and, therefore, increase patient safety.Objective: This study aimed to compare manual breaking methods commonly used to open ampoules in clinical practice that affected the number of glass particles and to identify the factors influencing glass particle contamination.Methods: We used a comparative research design to evaluate the manual breaking methods for opening medication ampoules among 56 registered nurses from diverse clinical areas in a university hospital. Each participant broke 12 ampoules in two sizes using six methods, each method combined with wrapping material and one breaking direction. We measured the number of glass particles in five sizes for each method and the factors influencing glass particle contamination.Results: In total, 449 of 672 ampoules were contaminated with glass particles. Breaking the ampoule with a cotton ball (partial ampoule neck wrapping) from an outward direction resulted in the fewest glass particles, while breaking the ampoule with a gauze pad (entire ampoule neck wrapping) from an inward direction resulted in the most glass particles. Breaking method, ampoule size and clinical experience significantly influence glass particle contamination (P < 0.05).Conclusions: The method (wrapping technique and breaking direction) that nurses use to break ampoules affects the number of glass particles. Therefore, improving the standard guidelines for preparing medication injections and training in breaking methods for opening ampoules is essential. [ABSTRACT FROM AUTHOR]

To realize the application of xylan based film in food and drug packaging, the poor mechanical property and film-forming property of xylan based film must be overcome. Herein, a good oxygen barrier composite film with desired mechanical properties was prepared based on carboxymethly xylan (CMX), chitosan (CS), and graphene oxide (GO). The results of scanning electron microscope revealed the composite film had a dense and continuous structure, which will endow the composite film with excellent mechanical property. As expected, the composite film with the 0.5% mass fraction of GO exhibited best mechanical property, among which the tensile stress, tensile strain, and Young's modulus of the composite film reached 50.81 MPa, 47.61%, and 1.39 GPa, respectively. The oxygen barrier properties of the composite films significantly increased with the addition of graphene oxide due to the dense, stacked multilayer structure. In addition, these composite films exhibited good antibacterial properties. Therefore, these films show great promise in the field of food packaging and wound dressing due to their excellent mechanical, oxygen barrier and antibacterial properties. • Flexible composite films based on CMX, CS, and GO prepared by casting method. • Desired mechanical properties of the composite films were obtained by adding GO. • The composite films exhibit good oxygen barrier and antibacterial properties. [ABSTRACT FROM AUTHOR]

Centralized intravenous admixture service (CIVAS) centres, which are pharmaceutical departments found in Chinese hospitals, provide high-quality intravenous fluids and pharmaceutical services for patients, and errors in their working procedures can lead to adverse consequences. Pharmacists, the primary CIVAS centre personnel, play a role in risk control; however, to date, the effect of pharmacists' participation in risk management has not been reported. The main aim of this study was to evaluate the pharmacist's role in risk control and evaluate its impact. A retrospective observational study was designed to assess the principal working process in the CIVAS centre of a provincial healthcare setting. Errors in the main working process were identified, and intervention measures were formulated. The pharmacist intervention effect was evaluated by assessing the identification rate of improper prescriptions; the incidence rate of drug preparation, compounding, packaging and delivery process errors; and expenditures on wasteful drugs. There was a higher identification rate for improper prescriptions after the intervention (P < 0.05), while the incidence of drug preparation (P < 0.05), admixture (P < 0.05), and packaging and delivery errors (P < 0.01) was significantly lower; the total wasteful medication expenditure was also dramatically reduced. The potential creativity of pharmacists in error control can provide dependable intravenous drugs for patients and reduce the running expenditures for CIVAS. [ABSTRACT FROM AUTHOR]

Purpose: Calcium levofolinate (CaLev) for intravenous administration is commercially available as a powder that must be reconstituted for injection or reconstituted and then diluted before administration. The lack of stability data on CaLev solutions renders necessary extemporaneous manual preparation, preventing the use of automated/semi-automated systems, with a consequent loss in terms of quality and safety. Methods: The present work assessed the chemical–physical and microbiological stability of CaLev prepared in sodium chloride 0.9%, glucose 5% and water for injections and stored in polyolefin/polyamide bags and polypropylene syringes at 2–8°C protected from light. For this purpose, we developed and validated a new rapid High Performance Liquid Chromatography with Ultra Violet Diode-Array Detection (HPLC-UV-DAD) method. Results: The samples tested were stable for 14 days, retaining >95% of their initial concentration and showing no change in colour, turbidity or pH. Microbiological tests performed on the samples were negative. Conclusions: Our results confirmed the analytical stability of CaLev in NaCl 0.9%, glucose 5% and water for injection at concentrations used in clinical practice at our institute. This enables our centralized laboratory to organize the preparation of this drug in advance and the use of robots rather than manual preparation reduces the workload and the risk of preparation errors. [ABSTRACT FROM AUTHOR]

Copyright of Farmacia is the property of Societatea de Stiinte Farmaceutice Romania and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Naltrexone extended‐release injectable (generic) – Vivitrol (brand) [ABSTRACT FROM AUTHOR]

Objective: To compare adherence one year before and after blister pack implementation in America Indian and Alaska Native (AI/AN) patients and to describe the patient population who used blister packs in the outpatient setting. Methods: A retrospective analysis of AI/AN patients receiving blister packs was performed to determine medication adherence as measured by a variable medication possession ratio (MPR). Patient characteristics and the reason for blister pack initiation were also assessed. Results: Of the 25 patients receiving blister packs, 76% were female, 56% were elderly and 60% had cognitive impairment. The three most common types of medications used were hypertension meds, vitamins and diabetes meds. The average MPR one year before blister pack implementation was 67.4% and significantly increased to 86.0% one year after. Conclusion: Blister packs significantly increased the average MPR after one year of implementation in a small group of AI/AN patients. Blister packs were utilized most commonly in patients who were female, had cognitive impairment, and who were taking numerous medications with a high pill burden in the outpatient setting. [ABSTRACT FROM AUTHOR]

The use of packaging materials is important in the pharmaceutical industry. The pharmaceutical industry uses, as primary packaging materials, glass bottles, blister packs, caps and closures, glass vials, sealed tubes. The aim of this study is to perform global component migration analyses on these types of packaging, to see if there is a possibility of migration of components from the pharmaceutical package into the drug, so as not to alter in any way its therapeutic properties. The results obtained from the processing of the extracts obtained were below the maximum limits allowed for each category of packaging, respectively, plastic, paper and cardboard, glass. [ABSTRACT FROM AUTHOR]

Objectives: To assess the incidence, types, the causes of as well as the factors associated with dispensing errors in community pharmacies in Lebanon. Methods: An observational cross-sectional study was conducted in 286 pharmacies located all over Lebanon. Data were collected by senior pharmacy students during their experiential learning placement. Collected data included information on the types of dispensing errors, the underlying causes of errors, handling approaches, and used strategies for dispensing error prevention. Data were analyzed using multiple logistic regression to determine factors that were associated with dispensing errors. Results: In the twelve thousand eight hundred sixty dispensed medications, there were 376 dispensing errors, yielding an error rate of 2.92%. Of these errors, 67.1% (252) corresponded to dispensing near-miss errors. The most common types of dispensing errors were giving incomplete/incorrect use instructions (40.9% (154)), followed by the omission of warning(s) (23.6% (89)). Work overloads/time pressures, illegible handwriting, distractions/interruptions, and similar drug naming/packaging were reported as the underlying causes in 55% (206), 23.13% (87), 15.15 % (57), and 7% (26) of the errors respectively. Besides, high prescription turnover volume, having one pharmacist working at a time, and extended working hours, were found to be independent factors that were significantly associated with dispensing errors occurrence (p<0.05). Conclusions: This study sheds light on the need to establish national strategies for preventing dispensing errors in community pharmacies to maintain drug therapy safety, considering identified underlying causes and associated factors. [ABSTRACT FROM AUTHOR]

Interest in minitablets (MTs) has grown exponentially over the last 20 years and especially the last decade, as evidenced by the number of publications cited in Scopus and PubMed. MTs offer significant opportunities for personalized medicine, dose titration and flexible dosing, taste masking, and customizing drug delivery systems. Advances in specialized MT tooling, manufacturing, and characterization instrumentation have overcome many of the earlier development issues. Breakthrough MT swallowability, acceptability, and palatability research have challenged the long-standing idea that only liquids are acceptable dosage forms for infants and young children. MTs have been shown to be a highly acceptable dosage form for infants, small children, and geriatric patients who have difficulty swallowing. This review discusses the current state of MT applications, acceptability in pediatric and geriatric populations, medication adherence, manufacturing processes such as tableting and coating, running powder and tablet characterization, packaging and MT dispensing, and regulatory considerations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

For the majority of cytotoxic drug preparations, such as bortezomib, the unit dose information is not available. In addition, there is a lack of information on the physicochemical stability of the pharmaceutical preparation after opening; this information is crucial for its administration to patients in successive visits, and the per-patient cost can be affected. The purpose of our proposed physicochemical stability study is to determine the shelf life of the reconstituted liquid product under refrigeration and clinical practice conditions. This evaluation was extended to both vials and ready-to-use syringes prefilled with the contents of the open vial. The stability test design includes the specified storage conditions and the critical physicochemical parameters of reconstituted injectable bortezomib. Furthermore, this approach includes the determination of impurities, the monitoring of the purity of the mean peak using a photodiode array, the control of the mass balance, the monitoring of subvisible particles using a laser diffraction analyser, and the setting of stability specifications. For the chemical stability study, the amount of bortezomib and its degradation products were determined using a stability-indicating HPLC method. The physical inspection of the samples was performed throughout the stability study, and their pH values were also monitored. Bortezomib (2.5 mg/mL) in 0.9% sodium chloride remained stable for 7 days when stored in both polypropylene syringes and vials at 5 ± 3 °C (refrigeration) and shielded from light. Additionally, it exhibits stability for 24 h under storage conditions simulating clinical use (20-30 °C and protected from light). The proposed protocol provides the stability in the vials once reconstituted and in prefilled refrigerated syringes; this protocol can be used to reduce waste and increase cost savings., (© 2024. The Author(s).)

Leachables are substances that are leached from a medical device during its clinical use and are important due to the patient health-related effects they may have. Thus, medical devices are profiled for leachables (and/or extractables as probable leachables) to assess their potential impact on patient health and safety. This profiling is accomplished by screening extracts or leachates of the medical device for released organic substances via non-targeted analysis (NTA) employing chromatographic methods coupled with mass spectrometric detection. Chromatographic mass spectral response factors (RFs) for extractables and leachables vary significantly from compound to compound, complicating the quantitation of these compounds and the application of assessment strategies such as the Analytical Evaluation Threshold (AET). The analytical uncertainty resulting from response factor variation can be expressed in terms of an uncertainty factor (UF), which estimates the magnitude of response factor variation. This manuscript discusses the concept and impact of analytical uncertainty and provides best practice recommendations for the calculation and use of the uncertainty factor, UF., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

For liquid drug products, e.g., solutions or suspensions for oral or parenteral dosing, stability needs to be demonstrated in primary packaging during storage and in dosing devices during in-use periods per quality guidelines from the International Conference on Harmonisation (ICH) and the European Agency for the Evaluation of Medicinal Products (EMEA). One aspect of stability testing for liquid drug products is in-use stability, which typically includes transferring the liquid samples into another container for further sample preparation with extraction diluent and necessary agitation. Samples are then analyzed with traditional chromatography methods, which are laborious, prone to human errors, and time-consuming, especially when this process needs to be repeated multiple times during storage and in-use periods. Being able to analyze the liquid samples non-destructively would significantly improve testing efficiency. We investigated different Raman techniques, including transmission Raman (TRS) and back scatter Raman with a non-contact optic (NCO) probe, as alternative non-destructive tools to the UHPLC method for API quantitation in in-use liquid samples pulled into plastic dosing syringes. The linearity of the chemometric methods for these two techniques was demonstrated by cross-validation sample sets at three levels over an API concentration range of 60 to 80 mg/mL. The accuracy of the chemometric models was demonstrated by the accurate prediction of the API concentrations in independent samples from four different pilot plant batches manufactured at different sites. Both techniques were successful in measuring a signal through a plastic oral dosing syringe, and predicting the suspension API concentration to within 4% of the UHPLC-measured value. For future work, there are opportunities to improve the methodology by exploring additional probes or to expand the range of applications by using different sample presentations (such as prefilled syringes) or formulation matrices for solutions and suspensions., (© 2024. AbbVie Inc., under exclusive licence to American Association of Pharmaceutical Scientists.)

Residual volumes of infusion solutions vary greatly due to container and dimensional variances. Manufacturers use overfill to compensate, but the exact amounts vary significantly. This variability in overfill - when carrier solutions are used to dilute other parenteral preparations - may lead to variable concentrations and dosing, hence, potential risk for patients. We analyzed the overfill and residual volume of 22 pre-filled infusion containers and evaluated the impact on the (simulated) dosing accuracy of a therapeutic drug product for different handling scenarios. In addition, compendial properties of the diluents (i.e. sub-visible particles, pH, color and opalescence) were assessed. The overfill and residual volume between different containers for the same diluent varied. As container size increased, the relative volume of overfill decreased while the residual volume remained constant. The design and material of the containers (e.g. port systems) defined the residual volume. Different handling scenarios led to differences in dosing accuracy. As a result, no universal approach applicable for all containers can be defined. To ensure the right dose, it is recommended to pre-select the preferred diluent, evaluate fill volumes of carrier solutions, and assess in-use compatibility of the product solution with its diluent in terms of concentration and volume., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. This research was funded by and conducted at Lonza AG (Lonza), Basel. M. W. was supported by a grant from Lonza. V. L., A. B. and A. S. S. were employed at Lonza, Basel at the time of this work. HC. M. and J. H. are not affiliated with Lonza. The authors have not received any additional benefits., (Copyright © 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)

In this study, a multi-functional packaging film was fabricated, utilizing the natural polysaccharide chitosan (CS) as the base material, integrating natural blueberry anthocyanin (AN) as pH-responsive indicator, and reinforced with cellulose nanocrystals (CNCs). The implications of addition levels of CNCs on the characteristics of the films were systematically investigated, resulting in that CS-AN-CNCs 9 % film exhibited optimal performance. Specifically, the film showed a substantial enhancement in maximum tensile strength from 15 MPa to 35 MPa; On the other hand, the swelling degree properties, the oxygen permeability and water vapor permeability decreased from 159.2 % to 92.0 %, from 51.7 g/(m 2 d) to 12.2 g/(m 2 d), from 31.6 × 10 -12  g/(m·s·Pa) to 1.6 × 10 -12  g/(m·s·Pa), respectively. Moreover, the CS-AN-CNCs 9 % film exhibited antioxidant, antibacterial, coupled with a color metrically responsive to pH variations, displaying great potential in indicating the shrimp freshness and delaying spoilage. Another notable advantage of the-prepared packaging material lies in its completely biodegradability, therefore meeting the requirement of environmental protection. Therefore, the prepared CS-AN-CNCs film as an intelligent packaging solution with potential applications in food preservation and freshness monitoring applications., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Among the common natural biomolecules, the excellent properties of proteins have attracted extensive attention from researchers for functional applications, however, in native form proteins have many limitations in the performance of their functional attribute. However, with the deepening of research, it has been found that the combination of natural active substances such as polyphenols, polysaccharides, etc. with protein molecules will make the composite system have stronger functional properties, while the utilization of pH-driven method, ultrasonic treatment, heat treatment, etc. not only provides a guarantee for the overall protein-based composite system, but also gives more possibilities to the protein-composite system. Protein composite systems are emerging in the fields of novel active packaging, functional factor delivery systems and gel systems with high medical value. The products of these protein composite systems usually have high functional properties, mainly due to the interaction of the remaining natural active substances with protein molecules, which can be broadly categorized into covalent interactions and non-covalent interactions, and which, despite the differences in these interactions, together constitute the cornerstone for the stability of protein composite systems and for in-depth research., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hao Zhang reports article publishing charges and equipment, drugs, or supplies were provided by National Natural Science Foundation of China. Hao Zhang reports a relationship with National Natural Science Foundation of China that includes: funding grants., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Antidepressant drugs play a crucial role in the treatment of mental health disorders, but their efficacy and safety can be compromised by drug degradation. Recent reports point to several drugs found in concentrations ranging from the limit of detection (LOD) to hundreds of ng/L in wastewater plants around the globe; hence, antidepressants can be considered emerging pollutants with potential consequences for human health and wellbeing. Understanding and implementing effective degradation strategies are essential not only to ensure the stability and potency of these medications but also for their safe disposal in line with current environment remediation goals. This review provides an overview of degradation pathways for amitriptyline, a typical tricyclic antidepressant drug, by exploring chemical routes such as oxidation, hydrolysis, and photodegradation. Connex issues such as stability-enhancing approaches through formulation and packaging considerations, regulatory guidelines, and quality control measures are also briefly noted. Specific case studies of amitriptyline degradation pathways forecast the future perspectives and challenges in this field, helping researchers and pharmaceutical manufacturers to provide guidelines for the most effective degradation pathways employed for minimal environmental impact.

Performant sample preparation is mandatory in any leachable study to clean and preconcentrate analytes within the sample to offer the best possible extraction recovery as well the best precision for any given substance. The aim consists in developing a sample preparation method for hospital pharmacy-prepared drug products such as long-term storage prefilled syringes, vials and IV bags for the screening of leachable compounds. The Quality Control Laboratory of the Pharmacy of the Lausanne University Hospital (Switzerland) has developed a time- and cost-effective, highly sensitive, robust, and fast method using liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS) for the analysis of 205 plastic additives. An innovative setup, based on postcolumn infusion (PCI) using 2% ammonium hydroxide in methanol was used to boost the signal intensity of the analytes in MS detection. A database for extractable and leachable trace assessment (DELTA) was built to assist in the screening process of 205 plastic packaging-related compounds. The development of the sample preparation was based on 33 plastic additive candidates in different hospital pharmacy compounding solutions, and their extraction recovery rates as well as their relative standard deviation were taken into consideration. In conclusion, the developed DLLME was assigned with ultrasound assistance and triple extraction, which brought about extraction recovery rates between 67% and 92%, a good RSD <10%, and a preconcentration factor of 50×. Therefore, DLLME could be considered suitable for the semiquantitative screening of leachable additives in simple hospital pharmacy-prepared prefilled drug products.

Plastic components are essential in the pharmaceutical industry, encompassing container closure systems, laboratory handling equipment, and single-use systems. As part of their material qualification process, studies on interactions between plastic contact materials and process solutions or drug products are conducted. The assessment of single-use systems includes their potential impact on patient safety, product quality, and process performance. This is particularly crucial in cell and gene therapy applications since interactions with the plastic contact material may result in an adverse effect on the isolated therapeutic human cells. We utilized the cell painting assay (CPA), a non-targeted method, for profiling the morphological characteristics of U2OS human osteosarcoma cells in contact with chemicals related to plastic contact materials. Specifically, we conducted a comprehensive analysis of 45 common plastic extractables, and two extracts from single-use systems. Results of the CPA are compared with a standard cytotoxicity assay, an osteogenesis differentiation assay, and in silico toxicity predictions. The findings of this feasibility study demonstrate that the device extracts and most of the tested compounds do not evoke any measurable biological changes on the cells (induction  ≤ 5%) among the 579 cell features measured at concentrations  ≤ 50 µM. CPA can serve as an important assay to reveal unique information not accessible through quantitative structure-activity relationship analysis and vice versa. The results highlight the need for a combination of in vitro and in silico methods in a comprehensive assessment of single-use equipment utilized in advanced therapy medicinal products manufacturing., (© 2024. The Author(s).)

Background: Food and drug packaging materials are an integral part of our everyday life.  Noxious elements can inadvertently be included in packaging materials in various stages of their production. Adulterants, adhesives, colorants and heavy metal interference are the common sources of contamination in food packaging materials. Heavy metal toxicity has far-reaching ill effects on living organisms. The present study aimed at qualitatively and quantitatively analysing heavy metal content of various materials that are used for food and drug packaging in India., Methods: The qualitative detection was done by rapid assay and heavy metals were quantified with the help of inductively coupled plasma-optical emission spectrometry (ICP-OES). A total of thirteen types of food and drug packaging materials were procured from local market and analysed for four heavy metals viz. arsenic (As), vanadium (V), mercury (Hg) and cadmium (Cd). The concentration of each heavy metal in the samples was compared with the permissible values published by the European Council., Results: Heavy metals were qualitatively detected in ten out of thirteen samples. Among the ten samples mercury and arsenic were detected the most followed by cadmium and vanadium. Quantitative estimation by ICP-OES showed presence of vanadium and cadmium in ten samples and arsenic and mercury in all the thirteen samples above the permissible range., Conclusions: The notable elevation in mercury concentration, followed by cadmium, arsenic and vanadium registering the least, presents a potential health hazard to consumers and compromises the food quality., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Mukhi S et al.)