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Comprehensive Reviews in Food Science... May 2024The importance of food quality and safety lies in ensuring the best product quality to meet consumer demands and public health. Advanced technologies play a crucial role... (Review)
Review
The importance of food quality and safety lies in ensuring the best product quality to meet consumer demands and public health. Advanced technologies play a crucial role in minimizing the risk of foodborne illnesses, contamination, drug residue, and other potential hazards in food. Significant materials and technological advancements have been made throughout the food supply chain. Among them, quantum dots (QDs), as a class of advanced nanomaterials with unique physicochemical properties, are progressively demonstrating their value in the field of food quality and safety. This review aims to explore cutting-edge research on the different applications of QDs in food quality and safety, including encapsulation of bioactive compounds, detection of food analytes, food preservation and packaging, and intelligent food freshness indicators. Moreover, the modification strategies and potential toxicities of diverse QDs are outlined, which can affect performance and hinder applications in the food industry. The findings suggested that QDs are mainly used in analyte detection and active/intelligent food packaging. Various food analytes can be detected using QD-based sensors, including heavy metal ions, pesticides, antibiotics, microorganisms, additives, and functional components. Moreover, QD incorporation aided in improving the antibacterial and antioxidant activities of film/coatings, resulting in extended shelf life for packaged food. Finally, the perspectives and critical challenges for the productivity, toxicity, and practical application of QDs are also summarized. By consolidating these essential aspects into this review, the way for developing high-performance QD-based nanomaterials is presented for researchers and food technologists to better capitalize upon this technology in food applications.
Topics: Food Contamination; Food Microbiology; Food Packaging; Food Quality; Quantum Dots
PubMed: 38578165
DOI: 10.1111/1541-4337.13339 -
JMIR Public Health and Surveillance Jan 2024Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on... (Review)
Review
BACKGROUND
Drug-induced suicide (DIS) is a severe adverse drug reaction (ADR). Although clinical trials have provided evidence on DIS, limited investigations have been performed on rare ADRs, such as suicide.
OBJECTIVE
We aimed to systematically review case reports on DIS to provide evidence-based drug information.
METHODS
We searched PubMed to obtain case reports regarding DIS published until July 2021. Cases resulting from drugs that are no longer used or are nonapproved, substance use, and suicidal intentions were excluded. The quality of each case report was assessed using the CASE (Case Reports) checklist. We extracted data regarding demographics, medication history, suicide symptoms, and symptom improvement and evaluated the causality of DIS using the Naranjo score. Furthermore, to identify the potential suicidal risk of the unknown drugs, we compared the results of the causality assessment with those of the approved drug labels.
RESULTS
In 83 articles, we identified 152 cases involving 61 drugs. Antidepressants were reported as the most frequent causative drugs of DIS followed by immunostimulants. The causality assessment revealed 61 cases having possible, 89 cases having probable, and 2 cases having definite relationships with DIS. For approximately 85% of suspected drugs, the risk of suicidal ADRs was indicated on the approved label; however, the approved labels for 9 drugs, including lumacaftor/ivacaftor, doxycycline, clozapine, dextromethorphan, adalimumab, infliximab, piroxicam, paclitaxel, and formoterol, did not provide information about these risks.
CONCLUSIONS
We found several case reports involving drugs without suicide risk information on the drug label. Our findings might provide valuable insights into drugs that may cause suicidal ADRs.
Topics: Humans; Doxycycline; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Suicidal Ideation; Suicide; Case Reports as Topic
PubMed: 38289650
DOI: 10.2196/49755 -
PloS One 2024Globally, millions of people have been affected by fraudulent pharmaceutical products, particularly those in developing countries. Although the problem of falsified and...
BACKGROUND
Globally, millions of people have been affected by fraudulent pharmaceutical products, particularly those in developing countries. Although the problem of falsified and substandard drugs is acknowledged, the extent of the issue is ever-changing, has a dynamic nature, and should be quantified and captured in a recent snapshot.
OBJECTIVE
This systematic review seeks to examine the data that can quantify and provide a current snapshot of the prevalence of SF antimicrobials in selected east Africa countries.
METHODS
Scientific studies on antimicrobial quality were searched in PubMed, Embase, Scopus, and Google Scholar from 2017 to February 2023. The search strategy focused on scientific articles published in peer-reviewed scientific journals written in English and the studies exclusively done in any of the selected countries of east Africa. The articles were carefully reviewed by two individuals for inclusion independently, first by title followed by abstract and the full-text retrieval. To minimize bias associated with the methodology used for data collection, the quality of the studies was assessed for quality according to the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). The reporting of this systematic review was done following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA).
RESULTS
Fifteen studies that estimated the prevalence of poor-quality antimicrobial medicines in selected four east African countries were included. The overall percentage of samples of antimicrobials that failed at least one quality test was 22.6% (151/669) with each class's prevalence of 17% in antibiotics (73/432), 24% in antimalarial (41/171), and 56% in anthelmintics (37/66). Quality control parameters of API content were the most commonly examined in the included studies, accounting for 14/15 (93%) studies. Fifty (33.1%) of the failing samples failed assay API- content determination, while 26.5% (n = 40) failed the visual inspection and packaging analysis; 19.2% (29) failed dissolution; 14% (n = 21) flawed hardness or friability; 4%(n = 6) failed uniformity, as well as 3.2% (n = 5) failed disintegration test of the quality control parameter.
CONCLUSION
It was found that this review was general in these selected east African countries and was a catalyst for combating the menace of poor-quality medications that affect millions of lives.
Topics: Africa, Eastern; Antimalarials; Counterfeit Drugs; Substandard Drugs; Anti-Bacterial Agents; Anthelmintics
PubMed: 38277385
DOI: 10.1371/journal.pone.0295956 -
Journal For Immunotherapy of Cancer Jan 2024Increased understanding of how the immune system regulates tumor growth has innovated the use of immunotherapeutics to treat various cancers. The impact of such...
BACKGROUND
Increased understanding of how the immune system regulates tumor growth has innovated the use of immunotherapeutics to treat various cancers. The impact of such therapies, including programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, on the production of antidrug antibodies (ADAs) and their impact on outcomes, is poorly understood. This study aims to evaluate the clinical trial evidence on ADA incidence associated with PD-1, PD-L1, and CTLA-4 inhibitors in the treatment of cancer and to assess associations between treatment administered, ADA incidence, and treatment outcomes.
METHODS
Embase, Medline, and EBM Reviews were searched via the OVID platform on February 15, 2022. Conference proceedings, clinical trial registries, and global regulatory and reimbursement body websites were also searched. Eligible publications included clinical trials enrolling patients receiving cancer treatment with either PD-1, PD-L1, or CTLA-4 reporting outcomes including incidence or prevalence of ADAs and the impact of immunogenicity on treatment safety and efficacy. Reference lists of eligible publications were also searched. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and evidence quality assessment was conducted using the appropriate Joanna Briggs Institute Critical Appraisal tool.
RESULTS
After screening 4160 records and reviewing 97 full publications, a total of 34 publications reporting on 68 trials were included. A further 41 relevant clinical trials were identified on ClinicalTrials.gov and a further 32 from searches of packaging inserts. In total, 141 relevant trials covering 15 different checkpoint inhibitors and 16 different tumor types were included. Across the included trials, atezolizumab was associated with the highest incidence of ADAs (29.6% of 639 patients), followed by nivolumab (11.2% of 2,085 patients). Combination checkpoint inhibitor treatment appeared to increase the rate of ADAs versus monotherapy. Only 17 trials reported on the impact of ADAs on treatment outcomes with mixed results for the impact of ADAs on treatment efficacy, safety, and pharmacokinetics.
CONCLUSIONS
Checkpoint inhibitors for the treatment of cancer are immunogenic, with the incidence of treatment-emergent ADAs varying between individual therapies. It remains unclear what impact ADAs have on treatment outcomes.
Topics: Humans; Immune Checkpoint Inhibitors; CTLA-4 Antigen; B7-H1 Antigen; Programmed Cell Death 1 Receptor; Immunotherapy; Neoplasms
PubMed: 38238030
DOI: 10.1136/jitc-2023-008266 -
Research in Social & Administrative... Feb 2024Written instructive information for the patient is key in pharmaceutical care. However, the preexisting literature agrees on the discordance between the readability of...
INTRODUCTION
Written instructive information for the patient is key in pharmaceutical care. However, the preexisting literature agrees on the discordance between the readability of written medication messages intended for patients. The aim of our work was to systematically review the available evidence on the effect of pharmaceutical pictograms as elements that facilitate understanding of the text in primary or secondary medication packaging.
METHODS
A parallel systematic search was conducted of the literature covering evidence of the effect of including pictograms in primary or secondary packaging on comprehension by potential users or caregivers up to April 9, 2023. The databases consulted were Scopus, MEDLINE and Web of Science. Only randomized controlled studies, whose main outcome measure was comprehension, were included.
RESULTS
Only 8 papers met our search criteria. In most of the included studies, the intervention of including pictograms improved participants' performance in comprehending instructions. A debatable methodological quality, and differences in the target population, textual complexity of the materials or the cultural affinity of the pictograms with the target population in each study, could have had a decisive influence on the results.
CONCLUSION
The heterogeneity in the design of each study poses a significant barrier to establishing commonalities and generalizing the results. This heterogeneity also prevented us from conclusively confirming the usefulness of pictograms complementary to instructional text in improving the comprehension of instructions for the rational use of medicines.
Topics: Humans; Comprehension; Drug Labeling; Drug Packaging; Health Literacy; Pharmaceutical Preparations
PubMed: 38030546
DOI: 10.1016/j.sapharm.2023.11.007 -
MAbs 2023Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging...
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due to their unique advantage of allowing subcutaneous self-administration. Technical challenges, such as physical and chemical instability, viscosity, delivery volume limitations, and product immunogenicity, can hinder successful development and commercialization of HCAPs. Such challenges can be overcome by robust formulation and process development strategies, as well as rational selection of excipients and packaging components. We compiled and analyzed data from US Food and Drug Administration-approved and marketed HCAPs that are ≥100 mg/mL to identify trends in formulation composition and quality target product profile. This review presents our findings and discusses novel formulation and processing technologies that enable the development of improved HCAPs at ≥200 mg/mL. The observed trends can be used as a guide for further advancements in the development of HCAPs as more complex antibody-based modalities enter biologics product development.
Topics: Pharmaceutical Preparations; Drug Packaging; Excipients; Viscosity
PubMed: 37243580
DOI: 10.1080/19420862.2023.2205540 -
Nutrition Research (New York, N.Y.) Mar 2023Mango has long been an attractive source of nutrition and pharmacological therapeutics. The mango plant (Mangifera indica L.) contains bioactive compounds that may have... (Review)
Review
Mango has long been an attractive source of nutrition and pharmacological therapeutics. The mango plant (Mangifera indica L.) contains bioactive compounds that may have antidiabetic properties. This systematic review investigated the evidence for antidiabetic properties of the different parts of the mango plant in managing type 2 diabetes mellitus in animal models and humans. The electronic databases PubMed, FSTA, Web of Science, CINAHL, MEDLINE, and Cochrane Library were systematically searched to identify articles with clear objectives and methodologies available in the English language with publication date limits up to December 2020. Twenty-eight of 1001 animal and human studies met the inclusion criteria that investigated antidiabetic properties of mango from leaf (31%), flesh (38%), seed-kernel (7%), peel (14%), stem-bark (7%), and by-product (3%). Results support the glucose-lowering properties of mango in both animals and human. Proposed antidiabetic mechanisms of action include inhibition of α-amylase and α-glucosidase, improved antioxidant status, improved insulin sensitivity, facilitated glucose uptake, and gene regulation of glucose transporter type 4, insulin receptor substrate 1, and phosphoinositide 3-kinase. The animal and randomized control trial findings suggest that mango may be beneficial as an antidiabetic agent. Although these studies hold promise, additional observational studies and randomized control trials are required because human studies are significantly fewer in number, use mango flesh almost exclusively, and had modest blood glucose effects. Additional research gaps include identifying the mechanisms of action for the different components of the mango plant.
Topics: Animals; Humans; Mangifera; Hypoglycemic Agents; Diabetes Mellitus, Type 2; Plant Extracts; Phosphatidylinositol 3-Kinases; Fruit; Models, Animal
PubMed: 36841190
DOI: 10.1016/j.nutres.2023.01.003 -
Infection and Drug Resistance 2022The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains. (Review)
Review
BACKGROUND
The use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains.
PURPOSE
The review aimed to provide the quality status of antimalarial drugs in East Africa.
DATA SOURCE
PubMed, Scopus, Web of Science, and Google Scholar were searched from September 5 to September 12, 2021.
STUDY SELECTION
The review included articles available as original research targeted at evaluating the quality of antimalarial drugs. For inclusion, data on at least one of the following quality control parameters were required: packaging and labeling, hardness, friability, weight variation/uniformity of weight, disintegration, dissolution, and assay/percentage purity. Mendeley citation manager version 1.19.4 was used to avoid duplication and organize references, and titles and abstracts were primarily used for screening.
DATA EXTRACTION
The sample collection site, drug name, and the quality control parameters tested were retrieved from the selected studies.
DATA SYNTHESIS
Totally, 300 antimalarial drug samples from Ethiopia, Kenya and Tanzania were included in this review. No antimalarial drug tested failed the identification and disintegration test. However, 15.93% (36/226), 5.00% (15/300), and 1.90% (3/158) of antimalarial samples failed the dissolution, assay and mass uniformity test, respectively. Moreover, amodiaquine and sulfadoxine/pyrimethamine samples failed dissolution and assay tests. In addition, amodiaquine samples failed the mass uniformity test. However, artemether/lumefantrine and quinine passed all quality control parameters tested. Overall, 19.67% (59/300) of antimalarial drug samples did not meet at least one quality control parameter. And the higher faller rate was reported for sulfadoxine/pyrimethamine accounting for 52.86% (37/70).
CONCLUSIONS
An unneglected amount of antimalarial drug failed to meet at least one quality control parameter. Strengthening pharmaceutical management systems, including post-marketing surveillance, and providing the resources required for medication quality assurance, are recommended.
PubMed: 36277242
DOI: 10.2147/IDR.S373059 -
Age and Ageing Oct 2022Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality...
Difficulty opening medication packaging can have serious consequences that can lead to patient harm via medication mismanagement or poor adherence. However, the quality of literature pertaining to these issues has yet to be collated and critiqued. This systematic review examined cross-sectional studies that objectively examined the ability of participants to open different medication packaging. Of the 8,692 studies identified, 12 met the inclusion criteria, all of which were direct observational studies given that prior research has identified a mismatch between self-report and actual ability. Scoring via the Appraisal Tool for Cross Sectional Studies revealed that the methodological quality of included studies was typically low. Study samples mostly consisted of older adults. All studies reported a non-negligible proportion of participants unable to open packaging, with the most difficulty associated with child-resistant containers. Several studies examined associations; however, no factor was consistently found to be significantly associated with the ability to open packaging. Despite these studies spanning >40 years, the packaging types examined remained largely the same. This suggests that, despite decades of research demonstrating that packaging is problematic, there has been a stagnation in medication packaging development. Whether this is attributed to a paucity of high-quality research, and therefore a lack of strong evidence that change is needed, is unclear. Future research should strive for better methodological quality, with generalisable cohorts assessed via observation in their home. If the problems identified in prior research persist, this may provide the impetus for change that is overdue in the medication packaging industry.
Topics: Humans; Aged; Cross-Sectional Studies; Drug Packaging; Medication Adherence
PubMed: 36273346
DOI: 10.1093/ageing/afac225 -
Journal of Pharmaceutical and... Jan 2023Assessment of extractables and leachables (E&L) released from the pharmaceutical container closure systems (CCS), single-use polymeric processing materials (PPM), and...
A Systematic Analysis of the Effect of Extraction Solvents on the Chemical Composition of Extraction Solutions and the Analytical Implications in Extractables and Leachables Studies.
Assessment of extractables and leachables (E&L) released from the pharmaceutical container closure systems (CCS), single-use polymeric processing materials (PPM), and medical devices is one of regulatory requirements in the submission and approval of pharmaceutical products and medical devices. The analytical activities involved in E&L studies are the solvent extraction of test articles, followed by instrumental analysis to determine both concentration and identities. Most E&L publications today are centered around the latter part, and the effect of extraction solvents on the chemical composition of extracts in the number, concentration and molecular weight (M) has not been systematically delineated and conceptualized to the best of our knowledge. The focus of this study is on a systematic review and analysis of the effect of solvents on the composition of extracts based on an extensive collection and study of relevant publications. The details of the discussions include: (1) the solvent extraction processes; (2) the degree of solvent-material interactions; (3) the material swelling and diffusion rate of material constituents; (4) the M impact from swelling; and (5) finally, the conclusion of the dependency of chemical compositions in final extracts on solvent. Experimental data have also been collected and presented to support the conclusions of the study. The implications of the solvent-dependent chemical composition on analytical measurements of E&L by using both chromatography-based and gravimetric methods are briefly and critically discussed at the end.
Topics: Drug Packaging; Drug Contamination; Solvents; Polymers; Pharmaceutical Preparations
PubMed: 36244085
DOI: 10.1016/j.jpba.2022.115081