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Saudi Pharmaceutical Journal : SPJ :... Dec 2023India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring... (Review)
Review
India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India. The present article aims to provide an overview of the history of the IP, its standards-setting process, and the current status of monographs in the 9th edition of the IP 2022. Special focus is placed on the newly added and upgraded general chapters and monographs within the IP 2022. There are a total of 223 general chapters and 3152 drug monographs available under various categories in the IP 2022. This study also highlights a total of 92 new drug monograph additions and 412 monograph revisions in the IP 2022. It is anticipated that the standards laid down in the IP 2022 will play an imperative role in delivering quality medicines to patients within and outside India.
PubMed: 37965488
DOI: 10.1016/j.jsps.2023.101825 -
Journal of Clinical Medicine Oct 2023Intranasal adhesions (synechiae) develop as a result of improper healing of the nasal mucosa. Their incidence ranges from 6.8% to 36% of rhinosurgical procedures. The... (Review)
Review
Intranasal adhesions (synechiae) develop as a result of improper healing of the nasal mucosa. Their incidence ranges from 6.8% to 36% of rhinosurgical procedures. The aim of this study was to review the available publications and monographs dealing with intranasal adhesions-both in the context of formation and risk factors. The study used a review of the literature to determine the articles and studies available in the following medical databases: MEDLINE (National Library of Medicine's), PubMed, and Google Scholar. The following search terms were used: synechiae nasal + synechial nasal + intranasal adhesions + nasal adhesions. The time criterion of available materials was not applied. Available filters in the search engines were used to narrow down the search results. Artificial intelligence was not applied. The review indicated that the risk of intranasal adhesions correlates with the type of surgery, the surgical technique, the dressing materials, and wound care in the postoperative period. Every case requires an individualized approach. Nasal septum separators, (self-)dissolving dressings and (in selected cases) Mitomycin C were investigated thoroughly. Further studies are required which may result in a universal classification system for intranasal adhesions.
PubMed: 37959296
DOI: 10.3390/jcm12216831 -
International Journal of Pharmaceutics:... Dec 2023Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and... (Review)
Review
Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and regulatory agencies believe that the levels of amorphous content should be controlled once there is a relationship with the final product performance. This is however not an easy task. The current paper elaborates on multiple challenges and complexities that are related to the control of the amorphous content in lactose. The definition and quantification methods of amorphous lactose are reviewed, as well as challenges related to thermodynamic instability. Additionally, current monographs and recent position papers considering this parameter are discussed to provide an overview of the regulatory landscape. Development of a control strategy is recommended, provided that the amorphous content at a specific moment in the process has shown to have an impact on the performance of the dry powder inhaler.
PubMed: 37953972
DOI: 10.1016/j.ijpx.2023.100216 -
Environment International Nov 2023A World Health Organization (WHO) and International Labour Organization (ILO) systematic review reported sufficient evidence for higher risk of non-melanoma skin cancer...
Global, regional and national burdens of non-melanoma skin cancer attributable to occupational exposure to solar ultraviolet radiation for 183 countries, 2000-2019: A systematic analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury.
BACKGROUND
A World Health Organization (WHO) and International Labour Organization (ILO) systematic review reported sufficient evidence for higher risk of non-melanoma skin cancer (NMSC) amongst people occupationally exposed to solar ultraviolet radiation (UVR). This article presents WHO/ILO Joint Estimates of global, regional, national and subnational occupational exposures to UVR for 195 countries/areas and the global, regional and national attributable burdens of NMSC for 183 countries, by sex and age group, for the years 2000, 2010 and 2019.
METHODS
We calculated population-attributable fractions (PAFs) from estimates of the population occupationally exposed to UVR and the risk ratio for NMSC from the WHO/ILO systematic review. Occupational exposure to UVR was modelled via proxy of occupation with outdoor work, using 166 million observations from 763 cross-sectional surveys for 96 countries/areas. Attributable NMSC burden was estimated by applying the PAFs to WHO's estimates of the total NMSC burden. Measures of inequality were calculated.
RESULTS
Globally in 2019, 1.6 billion workers (95 % uncertainty range [UR] 1.6-1.6) were occupationally exposed to UVR, or 28.4 % (UR 27.9-28.8) of the working-age population. The PAFs were 29.0 % (UR 24.7-35.0) for NMSC deaths and 30.4 % (UR 29.0-31.7) for disability-adjusted life years (DALYs). Attributable NMSC burdens were 18,960 deaths (UR 18,180-19,740) and 0.5 million DALYs (UR 0.4-0.5). Men and older age groups carried larger burden. Over 2000-2019, attributable deaths and DALYs almost doubled.
CONCLUSIONS
WHO and the ILO estimate that occupational exposure to UVR is common and causes substantial, inequitable and growing attributable burden of NMSC. Governments must protect outdoor workers from hazardous exposure to UVR and attributable NMSC burden and inequalities.
Topics: Male; Humans; Aged; Ultraviolet Rays; Cross-Sectional Studies; Occupational Exposure; Skin Neoplasms; World Health Organization; Cost of Illness; Occupational Diseases
PubMed: 37945424
DOI: 10.1016/j.envint.2023.108226 -
Neurology India 2023
Topics: Humans; Meningioma; Meningeal Neoplasms
PubMed: 37929505
DOI: 10.4103/0028-3886.388046 -
Journal of the Medical Library... Oct 2023To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information.
OBJECTIVE
To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information.
METHODS
Five electronic drug information databases: Clinical Pharmacology, Lexi-Drugs, AHFS DI (American Hospital Formulary Service Drug Information), eFacts and Comparisons, and Micromedex In-Depth Answers, were evaluated in this cross-sectional evaluation study, with data gathered from October 2021 through February 2022. Two study investigators independently extracted data (parallel extraction) from each resource. Descriptive statistics were primarily used to evaluate scope (i.e., whether the resource addresses use of the medication for treatment or prevention of COVID-19) and completeness of content (i.e., whether full information is provided related to the use of the medication for treatment or prevention of COVID-19) based on a 10-point scale. To analyze consistency among resources for scope, the Fleiss multi-rater kappa was used. To analyze consistency among resources for type of recommendation (i.e., in favor, insufficient evidence, against), a two-way mixed effects intraclass coefficient was calculated.
RESULTS
A total of 46 drug monographs, including 3 vaccination monographs, were evaluated. Use of the agents for treatment of COVID-19 was most frequently addressed in Lexi-Drugs (73.9%), followed by eFacts and Comparisons (71.7%), and Micromedex (54.3%). The highest overall median completeness score was held by AHFS DI followed by Micromedex, and Clinical Pharmacology. There was moderate consistency in terms of scope (kappa 0.490, 95% CI 0.399-0.581, p<0.001) and recommendations (intraclass correlation coefficient 0.518, 95% CI 0.385-0.651, p<0.001).
CONCLUSION
Scope and completeness results varied by resource, with moderate consistency of content among resources.
Topics: United States; Humans; Cross-Sectional Studies; Information Sources; Drug Information Services; COVID-19; Databases, Factual
PubMed: 37928123
DOI: 10.5195/jmla.2023.1662 -
JAMA Network Open Oct 2023Adjuvant stereotactic radiosurgery (SRS) enhances the local control of resected brain metastases (BrM). However, the risks of local failure (LF) and potential for...
IMPORTANCE
Adjuvant stereotactic radiosurgery (SRS) enhances the local control of resected brain metastases (BrM). However, the risks of local failure (LF) and potential for posttreatment adverse radiation effects (PTRE) after early postoperative adjuvant SRS have not yet been established.
OBJECTIVE
To evaluate whether adjuvant SRS delivered within a median of 14 days after surgery is associated with improved LF without a concomitant increase in PTRE.
DESIGN, SETTING, AND PARTICIPANTS
This prospective cohort study examines a clinical workflow (RapidRT) that was implemented from 2019 to 2022 to deliver SRS to surgical patients within a median of 14 days, ensuring all patients were treated within 30 days postoperatively. This prospective cohort was compared with a historical cohort (StanRT) of patients with BrM resected between 2013 and 2019 to assess the association of the RapidRT workflow with LF and PTRE. The 2 cohorts were combined to identify optimal SRS timing, with a median follow-up of 3.3 years for survivors.
EXPOSURE
Timing of adjuvant SRS (14, 21, and 30 days postoperatively).
MAIN OUTCOMES AND MEASURES
LF and PTRE, according to modified Response Assessment in Neuro-Oncology Brain Metastases criteria.
RESULTS
There were 438 patients (265 [60.5%] female patients; 23 [5.3%] Asian, 27 [6.2%] Black, and 364 [83.1%] White patients) with a mean (SD) age of 62 (13) years; 377 were in the StanRT cohort and 61 in the RapidRT cohort. LF and PTRE rates at 1 year were not significantly different between RapidRT and StanRT cohorts. Timing of SRS was associated with radiographic PTRE. Patients receiving radiation within 14 days had the highest 1-year PTRE rate (18.08%; 95% CI, 8.31%-30.86%), and patients receiving radiation between 22 and 30 days had the lowest 1-year PTRE rate (4.10%; 95% CI, 1.52%-8.73%; P = .03). LF rates were highest for patients receiving radiation more than 30 days from surgery (10.65%; 95% CI, 6.90%-15.32%) but comparable for patients receiving radiation within 14 days, between 15 and 21 days, and between 22 and 30 days (≤14 days: 5.12%; 95% CI, 0.86%-15.60%; 15 to ≤21 days: 3.21%; 95% CI, 0.59%-9.99%; 22 to ≤30 days: 6.58%; 95% CI, 3.06%-11.94%; P = .20).
CONCLUSIONS AND RELEVANCE
In this cohort study of adjuvant SRS timing following surgical resection of BrM, the optimal timing for adjuvant SRS appears to be within 22 to 30 days following surgery. The findings of this study suggest that this timing allows for a balanced approach that minimizes the risks associated with LF and PTRE.
Topics: Humans; Female; Middle Aged; Male; Radiosurgery; Prospective Studies; Cohort Studies; Adjuvants, Immunologic; Drug-Related Side Effects and Adverse Reactions; Brain Neoplasms
PubMed: 37906192
DOI: 10.1001/jamanetworkopen.2023.40654 -
Environmental Health Perspectives Oct 2023The International Agency for Research on Cancer (IARC) Monographs program assembles expert working groups who publish a critical review and evaluation of data on agents... (Review)
Review
BACKGROUND
The International Agency for Research on Cancer (IARC) Monographs program assembles expert working groups who publish a critical review and evaluation of data on agents of interest. These comprehensive reviews provide a unique opportunity to identify research needs to address classification uncertainties. A multidisciplinary expert review and workshop held in 2009 identified research gaps and needs for 20 priority occupational chemicals, metals, dusts, and physical agents, with the goal of stimulating advances in epidemiological studies of cancer and carcinogen mechanisms. Overarching issues were also described.
OBJECTIVES
In this commentary we review the current status of the evidence for the 20 priority agents identified in 2009. We examine whether identified Research Recommendations for each agent were addressed and their potential impact on resolving classification uncertainties.
METHODS
We reviewed the IARC classifications of each of the 20 priority agents and identified major new epidemiological and human mechanistic studies published since the last evaluation. Information sources were either the published Monograph for agents that have been reevaluated or, for agents not yet reevaluated, Advisory Group reports and literature searches. Findings are described in view of recent methodological developments in Monographs evidence evaluation processes.
DISCUSSION
The majority of the 20 priority agents were reevaluated by IARC since 2009. The overall carcinogen classifications of 9 agents advanced, and new cancer sites with either "sufficient" or "limited" evidence of carcinogenicity were also identified for 9 agents. Examination of published findings revealed whether evidence gaps and Research Recommendations have been addressed and highlighted remaining uncertainties. During the past decade, new research addressed a range of the 2009 recommendations and supported updated classifications for priority agents. This supports future efforts to systematically apply findings of Monograph reviews to identify research gaps and priorities relevant to evaluation criteria established in the updated IARC Monograph Preamble. https://doi.org/10.1289/EHP12547.
Topics: Humans; Biology; Carcinogens; Dust; Evidence Gaps; Neoplasms
PubMed: 37902675
DOI: 10.1289/EHP12547 -
Plants (Basel, Switzerland) Oct 2023L. (Asteraceae) has a long and successful tradition in Europe as herbal medicine. Arnica flowers (i.e., the flowerheads of ) are monographed in the European... (Review)
Review
L. (Asteraceae) has a long and successful tradition in Europe as herbal medicine. Arnica flowers (i.e., the flowerheads of ) are monographed in the European Pharmacopoeia (Ph. Eur.), and a European Union herbal monograph exists, in which its use as traditional herbal medicine is recommended. According to this monograph, Arnica flowers (Arnicae flos Ph. Eur.) and preparations thereof may be used topically to treat blunt injuries and traumas, inflammations and rheumatic muscle and joint complaints. The main bioactive constituents are sesquiterpene lactones (STLs) of the helenanolide type. Among these, a variety of esters of helenalin and 11α,13-dihydrohelenalin with low-molecular-weight carboxylic acids, namely, acetic, isobutyric, methacrylic, methylbutyric as well as tiglic acid, represent the main constituents, in addition to small amounts of the unesterified parent STLs. A plethora of reports exist on the pharmacological activities of these STLs, and it appears unquestioned that they represent the main active principles responsible for the herbal drug's efficacy. It has been known for a long time, however, that considerable differences in the STL pattern occur between flowers from plants growing in middle or Eastern Europe with some originating from the Iberic peninsula. In the former, Helenalin esters usually predominate, whereas the latter contains almost exclusively 11α,13-Dihydrohelenalin derivatives. Differences in pharmacological potency, on the other hand, have been reported for the two subtypes of Arnica-STLs in various instances. At the same time, it has been previously proposed that one should distinguish between two subspecies of , subsp. occurring mainly in Central and Eastern Europe and subsp. in the southwestern range of the species distribution, i.e., on the Iberian Peninsula. The question hence arises whether or not the geographic origin of flowers is of any relevance for the medicinal use of the herbal drug and the pharmaceutical quality, efficacy and safety of its products and whether the chemical/pharmacological differences should not be recognized in pharmacopoeia monographs. The present review attempts to answer these questions based on a summary of the current state of botanical, phytochemical and pharmacological evidence.
PubMed: 37895999
DOI: 10.3390/plants12203532 -
Pharmaceuticals (Basel, Switzerland) Sep 2023In Cabo Verde, several endemic species are used in traditional medicine. However, no scientific studies have been conducted on the quality, efficacy, and safety of most...
In Cabo Verde, several endemic species are used in traditional medicine. However, no scientific studies have been conducted on the quality, efficacy, and safety of most of these plants. This study focused on establishing the botanical and chemical identification parameters required for a quality monograph of Benth. aerial parts, a medicinal plant of Cabo Verde traditionally used to treat fever and muscular pain. In addition, in vitro antioxidant and antihyperglycemic activity, cytotoxicity, and genotoxicity were assessed for this medicinal plant. Optical microscopy, LC/UV-DAD-ESI/MS, and colorimetric assays were used for botanical, chemical, and biological studies, respectively. Cytotoxicity was assessed by the MTT assay with HepG2 cells, and genotoxicity by the Ames test. Microscopically, the xeromorphic leaf of presents a thick cuticle (13.6-25.5 µm), thick-walled epidermal cells, anomocytic-type stomata, glandular trichomes (stalk length = 49.4-120.8 µm), and idioblasts containing calcium oxalate microcrystals. The chemical screening of aqueous and hydroethanolic extracts of this medicinal plant revealed the presence of organic acids, iridoids, phenylethanoids, and flavonoids as the main classes of marker compounds, with malic acid, citric acid, and verbascoside being the main marker compounds identified. Both extracts showed similar LC/UV-DAD/ESI-MS qualitative profiles and DPPH radical scavenger activity (IC = 130.9 ± 1.4; 134.3 ± 3.1 µg/mL). The hydroethanolic extract inhibited both -amylase and -glucosidase enzymes in a dose-dependent manner. Both extracts showed no cytotoxicity (up to 1000 µg/mL) by the MTT assay and no genotoxic potential with or without metabolic activation up to 5 mg /plate. The results obtained are an important contribution to the monographic quality assessment of aerial parts and suggest that this medicinal plant may be safe and potentially used as an herbal drug raw material for pharmaceutical purposes.
PubMed: 37895844
DOI: 10.3390/ph16101373