K Nosrati Gazafroudi, L K Mailänder, R Daniels, D R Kammerer, F C Stintzing
Equisetum arvense L., commonly known as horsetail, is the most prominent Equisetum species and a widely used medicinal plant in traditional and herbal medicine. This study presents a comprehensive phytochemical characterisation of various pharmaceutical extracts prepared from field horsetail according to a national pharmacopoeia, including aqueous fermented extracts, oil-based extracts and hydroalcoholic extracts. Polar constituents were analysed using HPLC-DAD-ESI-MS n. GC-MS analyses following silylation were performed to elucidate low-molecular-weight compounds. The results revealed different phytochemical compositions of the E. arvense L. extracts, with distinct profiles of compounds including hydroxycinnamic acids and flavonoids. The results of the GC-MS investigations indicated the presence of an even broader variety of compounds, comprising benzoic acids, fatty acids, sugars, and phytosterols. Additionally, chlorophyll and carotenoid contents were quantified in the oil-based extracts by UV-VIS spectroscopy. This study underlines the significant impact of the respective extraction parameters on the phytochemical profile of the corresponding pharmaceutical extracts and highlights the rich history and continuing importance of this medicinal plant in traditional and complementary medicine.
{"title":"Phytochemical characterisation of pharmaceutical extracts from <i>Equisetum arvense</i> L. by HPLC-DAD-MS<sup>n</sup> and GC-MS.","authors":"K Nosrati Gazafroudi, L K Mailänder, R Daniels, D R Kammerer, F C Stintzing","doi":"10.1691/ph.2025.5620","DOIUrl":"10.1691/ph.2025.5620","url":null,"abstract":"<p><p><i>Equisetum arvense</i> L., commonly known as horsetail, is the most prominent <i>Equisetum</i> species and a widely used medicinal plant in traditional and herbal medicine. This study presents a comprehensive phytochemical characterisation of various pharmaceutical extracts prepared from field horsetail according to a national pharmacopoeia, including aqueous fermented extracts, oil-based extracts and hydroalcoholic extracts. Polar constituents were analysed using HPLC-DAD-ESI-MS n. GC-MS analyses following silylation were performed to elucidate low-molecular-weight compounds. The results revealed different phytochemical compositions of the <i>E. arvense</i> L. extracts, with distinct profiles of compounds including hydroxycinnamic acids and flavonoids. The results of the GC-MS investigations indicated the presence of an even broader variety of compounds, comprising benzoic acids, fatty acids, sugars, and phytosterols. Additionally, chlorophyll and carotenoid contents were quantified in the oil-based extracts by UV-VIS spectroscopy. This study underlines the significant impact of the respective extraction parameters on the phytochemical profile of the corresponding pharmaceutical extracts and highlights the rich history and continuing importance of this medicinal plant in traditional and complementary medicine.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"122-131"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background and aim: To implement Clinical Pharmaceutical Services (CPS) in routine hospital care with limited resources, their use should be prioritized. We present an objectifiable approach to planning development particularly for pharmaceutical staff. Investigations: We designed a Human Resource Development Score (HRD): HRD=P-([I+F]/2) with P: prioritization score of CPS assessed by a pharmaceutical expert panel; I: intensity score of CPS currently offered in routine care; F: frequency score of CPS offered; all scores ranged from 0[min]4[max]. An HRD<0 indicates a future decrease, HRD=0 no change and HRD>0 a desirable increase in the pharmaceutical staff development. To obtain an estimated future development (ΔHRD), we multiplied HRD as a weighting factor by the proportion of current or evaluated for the start of the respective CPS pharmaceutical staff positions (n, median per hospital pharmacy) as follows: ΔHRD=HRD*n. We calculated the ΔHRD in 155 of 162 CPS for which all required data were available. Results: In the "Top-5 categories to be increased", the pharmaceutical staff positions (n) and the Human Resource Development (ΔHRD=HRD*n) were as follows (median per hospital pharmacy): 1. "Interfaces"/"Closed-loop concepts" (n: 1.850; ΔHRD: +7.400), 2. "Progress-management"/"Interdisciplinary ward-rounds" (2.000; +2.000), 3. "Progress-management"/"Nursing ward-rounds" (1.000; +2.000). 4. "Interfaces"/"Electronic-prescription and knowledge-support" (0.300; +1.200), 5. "Progress-management"/"Ward-rounds for high-risk-patients" (1.100; +1.100). The most relevant categories whose resources could potentially be decreased to support other CPS were assessed as: "Indication-related (non-patient-related) drug analysis" (0.500; -0.250) and "Oncology consultations" (0.275; -0.275). Conclusions: With the help of a weighted Human Resource Development Score based on an expert panel, proposals for Human Resource Development in CPS were calculated.
{"title":"Human-Resource-Development for the future provision of Clinical Pharmaceutical Services.","authors":"L Riedel, A Lange -Böhmer, T Bertsche","doi":"10.1691/ph.2025.5618","DOIUrl":"10.1691/ph.2025.5618","url":null,"abstract":"<p><p><i>Background and aim:</i> To implement Clinical Pharmaceutical Services (CPS) in routine hospital care with limited resources, their use should be prioritized. We present an objectifiable approach to planning development particularly for pharmaceutical staff. <i>Investigations:</i> We designed a Human Resource Development Score (HRD): HRD=P-([I+F]/2) with P: prioritization score of CPS assessed by a pharmaceutical expert panel; I: intensity score of CPS currently offered in routine care; F: frequency score of CPS offered; all scores ranged from 0[min]4[max]. An HRD<0 indicates a future decrease, HRD=0 no change and HRD>0 a desirable increase in the pharmaceutical staff development. To obtain an estimated future development (ΔHRD), we multiplied HRD as a weighting factor by the proportion of current or evaluated for the start of the respective CPS pharmaceutical staff positions (n, median per hospital pharmacy) as follows: ΔHRD=HRD*n. We calculated the ΔHRD in 155 of 162 CPS for which all required data were available. <i>Results:</i> In the \"Top-5 categories to be increased\", the pharmaceutical staff positions (n) and the Human Resource Development (ΔHRD=HRD*n) were as follows (median per hospital pharmacy): 1. \"Interfaces\"/\"Closed-loop concepts\" (n: 1.850; ΔHRD: +7.400), 2. \"Progress-management\"/\"Interdisciplinary ward-rounds\" (2.000; +2.000), 3. \"Progress-management\"/\"Nursing ward-rounds\" (1.000; +2.000). 4. \"Interfaces\"/\"Electronic-prescription and knowledge-support\" (0.300; +1.200), 5. \"Progress-management\"/\"Ward-rounds for high-risk-patients\" (1.100; +1.100). The most relevant categories whose resources could potentially be decreased to support other CPS were assessed as: \"Indication-related (non-patient-related) drug analysis\" (0.500; -0.250) and \"Oncology consultations\" (0.275; -0.275). <i>Conclusions:</i> With the help of a weighted Human Resource Development Score based on an expert panel, proposals for Human Resource Development in CPS were calculated.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"142-148"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R Van Der Merwe, D P Otto, W Liebenberg, H J R Lemmer, F van der Kooy
Creatine and taurine are frequently found together in sports supplements due to their performance-enhancing and metabolic benefits. However, discrepancies between label claims and actual content have raised concerns about product quality, regulatory compliance, and possible health impacts. Accurate quantification of these compounds is therefore essential. Liquid chromatography mass spectrometry (LC-MS/MS) is widely used for its ability to detect and quantify compounds with high sensitivity and specificity. Therefore, in a previous study, an LC-MS/MS method was developed and validated for the simultaneous quantification of creatine and taurine in sports supplements. While accurate and sensitive, its somewhat cumbersome sample preparation step makes it less suitable for a commercial setting, where typically large numbers of samples must be analysed for quality control purposes. In this study, we report the first application of quantitative nuclear magnetic resonance (qNMR) for the simultaneous quantification of creatine and taurine in sports supplements, offering a simpler alternative for quality control. A qNMR method was developed, validated, and applied to commercial sports supplements, and the results were compared to label claims. All validation parameters fell well within acceptable limits, and sample analysis revealed deviations from label claims of up to +65.97% for creatine and +141.52% for taurine. Batch-to-batch variation of the products showed better consistency with variability only as high as 8.49%. Overall, this study confirms qNMR as a reliable method demonstrating specificity, precision, accuracy, and suitability for quantitative analysis. Although high-field NMR systems remain more commonly used, the method developed here is directly transferable to modern cryogen-free benchtop NMR instruments. Benchtop NMR significantly reduces operational costs and complexity, and may arguably become a valuable, reliable, and affordable tool in quality control laboratories.
{"title":"Development and validation of a qNMR method for the simultaneous quantification of creatine and taurine in sports supplements.","authors":"R Van Der Merwe, D P Otto, W Liebenberg, H J R Lemmer, F van der Kooy","doi":"10.1691/ph.2025.5078","DOIUrl":"10.1691/ph.2025.5078","url":null,"abstract":"<p><p>Creatine and taurine are frequently found together in sports supplements due to their performance-enhancing and metabolic benefits. However, discrepancies between label claims and actual content have raised concerns about product quality, regulatory compliance, and possible health impacts. Accurate quantification of these compounds is therefore essential. Liquid chromatography mass spectrometry (LC-MS/MS) is widely used for its ability to detect and quantify compounds with high sensitivity and specificity. Therefore, in a previous study, an LC-MS/MS method was developed and validated for the simultaneous quantification of creatine and taurine in sports supplements. While accurate and sensitive, its somewhat cumbersome sample preparation step makes it less suitable for a commercial setting, where typically large numbers of samples must be analysed for quality control purposes. In this study, we report the first application of quantitative nuclear magnetic resonance (qNMR) for the simultaneous quantification of creatine and taurine in sports supplements, offering a simpler alternative for quality control. A qNMR method was developed, validated, and applied to commercial sports supplements, and the results were compared to label claims. All validation parameters fell well within acceptable limits, and sample analysis revealed deviations from label claims of up to +65.97% for creatine and +141.52% for taurine. Batch-to-batch variation of the products showed better consistency with variability only as high as 8.49%. Overall, this study confirms qNMR as a reliable method demonstrating specificity, precision, accuracy, and suitability for quantitative analysis. Although high-field NMR systems remain more commonly used, the method developed here is directly transferable to modern cryogen-free benchtop NMR instruments. Benchtop NMR significantly reduces operational costs and complexity, and may arguably become a valuable, reliable, and affordable tool in quality control laboratories.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"118-121"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Our understanding of pharmacists as Nazi perpetrators remains rather vague. Considerable research has examined the Nazification and transformation of German pharmaceutical research, practice, and education between 1933 and 1945. The names of several SS pharmacists who served in concentration camps are also known. Yet little is known about their actual practices and their concrete involvement in medical crimes. What tasks did pharmacists perform in the concentration camps, what scope of action did they have, and in which perpetrator networks were they embedded? This article addresses these questions through the biographical example of Herbert Siggelkow (1906-1976), chief pharmacist of the concentration camps. Drawing on extensive archival records, we reconstruct the biography of Siggelkow, who, already as a grammar school student, had joined a völkisch-nationalist paramilitary association and, in 1932, the Nazi Party and the SS. We then analyze his responsibilities, individual scope of action, and involvement in medical crimes across the various settings of his service in the Waffen-SS and within the concentration camp system. As camp pharmacist at Dachau and Sachsenhausen and as chief pharmacist of the concentration camp medical service, Siggelkow shared responsibility for both the individual and the structural medical neglect of inmates. In fact, he was among the very few who had precise knowledge of the extent of medical shortages throughout the entire camp system. Through the distribution of poisons, he facilitated the systematic killing of sick and incapacitated prisoners by injection, while the provision of drugs and equipment for the camp research stations sustained the criminal practice of coerced human experimentation. We demonstrate that, over the course of his service, Siggelkow operated within markedly varying but generally limited scopes of action. While he had initially used his individual latitude clearly to the detriment of prisoners, his demeanor shifted markedly as hopes of a German victory waned. However, as part of a multi-professional perpetrator network, he bore substantial co-responsibility for atrocious medical crimes committed in the camps.
{"title":"Drug shortage and networks of medical crime: Herbert Siggelkow (1906-1976), chief pharmacist of the Nazi concentration camps.","authors":"M Ritters, D Gross, N Biermanns","doi":"10.1691/ph.2025.5076","DOIUrl":"10.1691/ph.2025.5076","url":null,"abstract":"<p><p>Our understanding of pharmacists as Nazi perpetrators remains rather vague. Considerable research has examined the Nazification and transformation of German pharmaceutical research, practice, and education between 1933 and 1945. The names of several SS pharmacists who served in concentration camps are also known. Yet little is known about their actual practices and their concrete involvement in medical crimes. What tasks did pharmacists perform in the concentration camps, what scope of action did they have, and in which perpetrator networks were they embedded? This article addresses these questions through the biographical example of Herbert Siggelkow (1906-1976), chief pharmacist of the concentration camps. Drawing on extensive archival records, we reconstruct the biography of Siggelkow, who, already as a grammar school student, had joined a völkisch-nationalist paramilitary association and, in 1932, the Nazi Party and the SS. We then analyze his responsibilities, individual scope of action, and involvement in medical crimes across the various settings of his service in the Waffen-SS and within the concentration camp system. As camp pharmacist at Dachau and Sachsenhausen and as chief pharmacist of the concentration camp medical service, Siggelkow shared responsibility for both the individual and the structural medical neglect of inmates. In fact, he was among the very few who had precise knowledge of the extent of medical shortages throughout the entire camp system. Through the distribution of poisons, he facilitated the systematic killing of sick and incapacitated prisoners by injection, while the provision of drugs and equipment for the camp research stations sustained the criminal practice of coerced human experimentation. We demonstrate that, over the course of his service, Siggelkow operated within markedly varying but generally limited scopes of action. While he had initially used his individual latitude clearly to the detriment of prisoners, his demeanor shifted markedly as hopes of a German victory waned. However, as part of a multi-professional perpetrator network, he bore substantial co-responsibility for atrocious medical crimes committed in the camps.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"175-187"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J Gabsteiger, A Paul, J Landwehr, S Landwehr, T Bertsche
Background and aim: Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. Investigations: Patients with type-2 diabetes mellitus of community pharmacies were invited to participate in a multicenter controlled trial and were randomized either to receive "basic care" (control group, CG) or "advanced pharmaceutical care" (intervention group, IG). In two home visits at t0 (status quo) and t1 ( follow-up after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. Results: Totally, 130 patients were randomized to CG or IG (median age 73 vs. 67 years, n. s., 32 vs. 27 women, n. s.). At t0, 57 gastrointestinal-AE occurred in 33 patients (CG) vs. 56/31 (IG, n. s.). At t1, 57 "unchanged persisting" gastrointestinal-AE occurred in 32 patients (CG) vs. 25/17 (IG, p=0.006) and 59 "overall persisting" gastrointestinal-AE in 33 patients (CG) vs. 39/25 (IG, n. s.). At t0, 11 hypoglycemic-AE occurred in 9 patients (CG) vs. 13/10 (IG, n. s.). At t1, 10 "unchanged persisting" hypoglycemic-AE occurred in 9 patients (CG) vs. 2/2 (IG, p=0.028) and 10 "overall persisting" hypoglycemic-AE in 9 patients (CG) vs. 5/4 (IG, n. s.). At t0, 135 DRP occurred in 36 patients (CG) vs. 147/43 (IG, n. s.). At t1, 133 DRP occurred in 34 patients (CG) vs. 41/19 (IG, p=0.005). At t0, 58 patients (CG) vs. 50 patients (IG) self-reported to be adherent (n. s.) and at t1, 60 patients (CG) vs. 59 (IG, n. s.). Conclusions: "Advanced pharmaceutical care" decreased the number of "unchanged persisting" gastroenterological- and hypoglycemic-AE and DRP.
背景与目的:研究为某些药物的降糖疗效提供了强有力的证据,但不良事件(ae)和药物相关问题(DRPs)限制了它们的有效性。调查:邀请社区药房的2型糖尿病患者参加多中心对照试验,随机分为“基础护理”组(对照组,CG)和“高级药学护理”组(干预组,IG)。在10(现状)和1(4-6周后随访)的两次家访中,患者被问及抗糖尿病患者典型的AE/DRP及其依从性。结果:总共有130例患者被随机分配到CG或IG组(中位年龄73 vs 67岁,新统计数据,32 vs 27名女性,新统计数据)。10时,消化道ae患者33例(CG), 56例(IG, n.s.s)。在t1时,32例患者(CG)中发生57例“不变持续”胃肠道ae,而25/17例(IG, p=0.006); 33例患者(CG)中发生59例“整体持续”胃肠道ae,而39/25例(IG, n. s.)。10时,9例患者发生11例低血糖- ae (CG), 13例/10例(IG, n.s.s)。t1时,9例患者(CG)发生10例“不变持续”低血糖ae, 2/2 (IG, p=0.028); 9例患者(CG)发生10例“整体持续”低血糖ae, 5/4 (IG, n. s.)。10时,36例患者发生135例DRP (CG), 147/43例(IG, n.s.s)。t1时,34例患者(CG)发生133例DRP, 41/19例(IG, p=0.005)。在10时,58例患者(CG)对50例患者(IG)自我报告粘附(n. s),在1时,60例患者(CG)对59例(IG, n. s)。结论:“先进的药学服务”降低了“不变持续”的胃肠病和低血糖ae和DRP的数量。
{"title":"A multicenter randomized controlled trial in patients with type 2 diabetes mellitus to evaluate an \"advanced pharmaceutical care\" intervention for the prevention of adverse effects and drug-related problems in a <i>follow-up</i>home visit (<i>BayPharmCareDiabetesTrail</i>).","authors":"J Gabsteiger, A Paul, J Landwehr, S Landwehr, T Bertsche","doi":"10.1691/ph.2025.5623","DOIUrl":"10.1691/ph.2025.5623","url":null,"abstract":"<p><p><i>Background and aim:</i> Studies provide strong evidence for antidiabetic efficacy of certain drugs but adverse events (AEs) and drug-related problems (DRPs) limit their effectiveness. <i>Investigations:</i> Patients with type-2 diabetes mellitus of community pharmacies were invited to participate in a multicenter controlled trial and were randomized either to receive \"basic care\" (control group, CG) or \"advanced pharmaceutical care\" (intervention group, IG). In two home visits at t0 (<i>status quo</i>) and t1 ( <i>follow-up</i> after 4-6 weeks), patients were asked about AE/DRP typical for antidiabetics and their adherence. <i>Results:</i> Totally, 130 patients were randomized to CG or IG (median age 73 vs. 67 years, n. s., 32 vs. 27 women, n. s.). At t0, 57 gastrointestinal-AE occurred in 33 patients (CG) vs. 56/31 (IG, n. s.). At t1, 57 \"unchanged persisting\" gastrointestinal-AE occurred in 32 patients (CG) vs. 25/17 (IG, p=0.006) and 59 \"overall persisting\" gastrointestinal-AE in 33 patients (CG) vs. 39/25 (IG, n. s.). At t0, 11 hypoglycemic-AE occurred in 9 patients (CG) vs. 13/10 (IG, n. s.). At t1, 10 \"unchanged persisting\" hypoglycemic-AE occurred in 9 patients (CG) vs. 2/2 (IG, p=0.028) and 10 \"overall persisting\" hypoglycemic-AE in 9 patients (CG) vs. 5/4 (IG, n. s.). At t0, 135 DRP occurred in 36 patients (CG) vs. 147/43 (IG, n. s.). At t1, 133 DRP occurred in 34 patients (CG) vs. 41/19 (IG, p=0.005). At t0, 58 patients (CG) vs. 50 patients (IG) self-reported to be adherent (n. s.) and at t1, 60 patients (CG) vs. 59 (IG, n. s.). <i>Conclusions:</i> \"Advanced pharmaceutical care\" decreased the number of \"unchanged persisting\" gastroenterological- and hypoglycemic-AE and DRP.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"149-155"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
O Pinarbasli, G P Gurbetoglu, N Sarracoglu, A A Doganay, T Ozbay
Chronopharmaceutic drug delivery systems are designed to align the release of active substances with the body's biological rhythms, offering significant advantages in diseases with time-dependent symptom patterns. Delayed-release tablets are widely used in this field to achieve controlled drug release after a defined lag time, typically by modulating the composition of excipients. However, the reliance on excipient-based control may limit the flexibility and predictability of release profiles. This study is the first in the literature to focus on the mechanistic design of chronopharmaceutical tablets by exploring how physical tablet properties-specifically tablet geometry and compression physics-can independently control delayed drug release, without relying on excipient effects. By systematically varying tablet shape, size, and compression force, we aimed to establish a new formulation approach centered on the physical characteristics of the dosage form. Prednisone was selected as a model drug due to its common use in chronotherapy, where precisely timed drug release is essential to improve therapeutic outcomes. In vitro dissolution studies demonstrated that manipulation of tablet geometry and compression parameters effectively modulated lag time and drug release kinetics, independent of excipient composition. These findings suggest that optimizing the mechanistic properties of tablets provides a valuable strategy for the design of advanced chronopharmaceutical systems, potentially enhancing drug efficacy, patient comfort, and treatment adherence.
{"title":"Chronopharmaceutical tablet design for prednisone based on geometry and compression physics independent of excipient influence: a mechanistic approach to controlled release.","authors":"O Pinarbasli, G P Gurbetoglu, N Sarracoglu, A A Doganay, T Ozbay","doi":"10.1691/ph.2025.5065","DOIUrl":"10.1691/ph.2025.5065","url":null,"abstract":"<p><p>Chronopharmaceutic drug delivery systems are designed to align the release of active substances with the body's biological rhythms, offering significant advantages in diseases with time-dependent symptom patterns. Delayed-release tablets are widely used in this field to achieve controlled drug release after a defined lag time, typically by modulating the composition of excipients. However, the reliance on excipient-based control may limit the flexibility and predictability of release profiles. This study is the first in the literature to focus on the mechanistic design of chronopharmaceutical tablets by exploring how physical tablet properties-specifically tablet geometry and compression physics-can independently control delayed drug release, without relying on excipient effects. By systematically varying tablet shape, size, and compression force, we aimed to establish a new formulation approach centered on the physical characteristics of the dosage form. Prednisone was selected as a model drug due to its common use in chronotherapy, where precisely timed drug release is essential to improve therapeutic outcomes. In vitro dissolution studies demonstrated that manipulation of tablet geometry and compression parameters effectively modulated lag time and drug release kinetics, independent of excipient composition. These findings suggest that optimizing the mechanistic properties of tablets provides a valuable strategy for the design of advanced chronopharmaceutical systems, potentially enhancing drug efficacy, patient comfort, and treatment adherence.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"110-117"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Since many years, immunoglobulin G (IgG) substitution has been used to treat patients with primary immunodeficiencies (PID) to reduce the number of infections and the burden of disease. Nevertheless, many patients continue to suffer from persisting infections. In this SINUS study, a patient questionnaire consisting of 21 questions was used to assess the current situation in patients with PID. Of the 160 patients included, most showed a persistent tendency to infections (N=140, 87.5%). During the last 12 month, most of the patients suffered from upper and lower respiratory tract infections such as sinusitis (N=85, 60.7%), bronchitis (N=88, 62.9%), and pneumonia (N=10, 7.1%). Yet the presence of persistent infections was not inversely correlated with patient satisfaction. Therefore, the treating physicians need to carefully evaluate the infection history and additional therapeutic approaches are required for satisfying improvement in the patient's infection control. Patients are open to explore new ways to achieve this goal.
{"title":"Persisting infections under IgG substitution: Need for further improvement.","authors":"A Wartenberg-Demand, C Staiger, K Warnatz","doi":"10.1691/ph.2025.5665","DOIUrl":"10.1691/ph.2025.5665","url":null,"abstract":"<p><p>Since many years, immunoglobulin G (IgG) substitution has been used to treat patients with primary immunodeficiencies (PID) to reduce the number of infections and the burden of disease. Nevertheless, many patients continue to suffer from persisting infections. In this SINUS study, a patient questionnaire consisting of 21 questions was used to assess the current situation in patients with PID. Of the 160 patients included, most showed a persistent tendency to infections (N=140, 87.5%). During the last 12 month, most of the patients suffered from upper and lower respiratory tract infections such as sinusitis (N=85, 60.7%), bronchitis (N=88, 62.9%), and pneumonia (N=10, 7.1%). Yet the presence of persistent infections was not inversely correlated with patient satisfaction. Therefore, the treating physicians need to carefully evaluate the infection history and additional therapeutic approaches are required for satisfying improvement in the patient's infection control. Patients are open to explore new ways to achieve this goal.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"156-160"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A Koshi, R Koliqi, P Breznica Selmani, D Raka, B Koshi
Off-label drug prescribing in pediatric populations is a common practice worldwide due to the limited availability of approved formulations and clinical data for children. While often necessary, it raises concerns regarding safety, efficacy, and ethical considerations. Pharmacists play a key role in ensuring the safe use of off-label drugs; however, their perspectives in low-resource settings like Kosovo remain under-investigated. A cross-sectional, questionnaire-based survey was conducted among 296 community pharmacists across Kosovo between December 2024 and January 2025. The 27-item structured survey collected demographic data and assessed pharmacists' familiarity, practices, and perspectives on pediatric off-label use. Data were analyzed using IBM SPSS 22.0. Of the pharmacists surveyed, 49% reported moderate familiarity with pediatric off-label use, and 79% had not received formal training. Nearly all participants (99%) had encountered off-label prescriptions, most commonly involving anti-infectives and respiratory medications. Although 98% acknowledged that off-label use is sometimes necessary, many expressed concerns about safety and effectiveness. Only 21% had observed adverse drug reactions, while 96% reported no treatment failures. Communication with prescribers was rated as good by 49% of respondents, though 71% emphasized the need for stronger interdisciplinary collaboration. This study provides the first national insight into community pharmacists' perspectives on pediatric off-label prescribing in Kosovo. The findings highlight the urgent need for targeted pharmacist education, the development of standardized national guidelines, and enhanced collaboration between pharmacists and prescribers to improve medication safety in pediatric patients.
{"title":"Off-label prescribing in the pediatric population: perceptions and practices of community pharmacists in Kosovo - a cross-sectional survey.","authors":"A Koshi, R Koliqi, P Breznica Selmani, D Raka, B Koshi","doi":"10.1691/ph.2025.5087","DOIUrl":"10.1691/ph.2025.5087","url":null,"abstract":"<p><p>Off-label drug prescribing in pediatric populations is a common practice worldwide due to the limited availability of approved formulations and clinical data for children. While often necessary, it raises concerns regarding safety, efficacy, and ethical considerations. Pharmacists play a key role in ensuring the safe use of off-label drugs; however, their perspectives in low-resource settings like Kosovo remain under-investigated. A cross-sectional, questionnaire-based survey was conducted among 296 community pharmacists across Kosovo between December 2024 and January 2025. The 27-item structured survey collected demographic data and assessed pharmacists' familiarity, practices, and perspectives on pediatric off-label use. Data were analyzed using IBM SPSS 22.0. Of the pharmacists surveyed, 49% reported moderate familiarity with pediatric off-label use, and 79% had not received formal training. Nearly all participants (99%) had encountered off-label prescriptions, most commonly involving anti-infectives and respiratory medications. Although 98% acknowledged that off-label use is sometimes necessary, many expressed concerns about safety and effectiveness. Only 21% had observed adverse drug reactions, while 96% reported no treatment failures. Communication with prescribers was rated as good by 49% of respondents, though 71% emphasized the need for stronger interdisciplinary collaboration. This study provides the first national insight into community pharmacists' perspectives on pediatric off-label prescribing in Kosovo. The findings highlight the urgent need for targeted pharmacist education, the development of standardized national guidelines, and enhanced collaboration between pharmacists and prescribers to improve medication safety in pediatric patients.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"137-141"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zolbetuximab, a monoclonal antibody against claudin-18.2 (CLDN18.2), improves outcomes in CLDN18.2-positive gastric cancer, but gastrointestinal adverse events-especially nausea and vomiting-are frequently reported. Using PMDA-JADER (April 2004-March 2025), we identified individual case safety reports (ICSRs) listing zolbetuximab as a suspected drug and defined the outcome with MedDRA-concordant preferred terms (nausea, vomiting, nausea and vomiting, retching). Within zolbetuximab reports, binary logistic regression with sex (male reference) and age (<60 years reference) showed higher adjusted odds in females (aOR 3.07; 95% CI 1.45-6.51; p=0.003) and lower odds in patients ≥60 years (aOR 0.25; 95% CI 0.10-0.61; p=0.002); model calibration was acceptable (Hosmer-Lemeshow p=1.000). Disproportionality analysis yielded a markedly elevated reporting odds ratio (ROR) for zolbetuximab versus all other reports (ROR 85.40; 95% CI 62.58-116.53), whereas immune checkpoint inhibitors showed no signal. These measures reflect reporting disproportionality within a spontaneous-reporting system and should not be interpreted as incidence or causality. These exploratory findings support proactive, guideline-based antiemetic strategies-particularly for younger female patients-and warrant prospective confirmation.
{"title":"Risk factors for zolbetuximab-associated nausea and vomiting: a pharmacovigilance analysis using the Japanese Adverse Drug Event Report (JADER) database.","authors":"T Nagase, K Shinozaki","doi":"10.1691/ph.2025.5660","DOIUrl":"10.1691/ph.2025.5660","url":null,"abstract":"<p><p>Zolbetuximab, a monoclonal antibody against claudin-18.2 (CLDN18.2), improves outcomes in CLDN18.2-positive gastric cancer, but gastrointestinal adverse events-especially nausea and vomiting-are frequently reported. Using PMDA-JADER (April 2004-March 2025), we identified individual case safety reports (ICSRs) listing zolbetuximab as a suspected drug and defined the outcome with MedDRA-concordant preferred terms (nausea, vomiting, nausea and vomiting, retching). Within zolbetuximab reports, binary logistic regression with sex (male reference) and age (<60 years reference) showed higher adjusted odds in females (aOR 3.07; 95% CI 1.45-6.51; p=0.003) and lower odds in patients ≥60 years (aOR 0.25; 95% CI 0.10-0.61; p=0.002); model calibration was acceptable (Hosmer-Lemeshow p=1.000). Disproportionality analysis yielded a markedly elevated reporting odds ratio (ROR) for zolbetuximab versus all other reports (ROR 85.40; 95% CI 62.58-116.53), whereas immune checkpoint inhibitors showed no signal. These measures reflect reporting disproportionality within a spontaneous-reporting system and should not be interpreted as incidence or causality. These exploratory findings support proactive, guideline-based antiemetic strategies-particularly for younger female patients-and warrant prospective confirmation.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"166-169"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Y Yamamoto, N Orito, N Watanabe, H Hayashi, T Fukuoka, M Ando, M Kawahara, Y Deguchi
Purpose: Pemetrexed causes renal impairment. However, few studies have investigated the risk factors associated with pemetrexed-induced renal impairment. This study aimed to investigate the incidence of nephrotoxicity in patients receiving pemetrexed in combination with carboplatin and to identify the associated risk factors. Methods: This single-center retrospective study included patients with lung cancer (including malignant mesothelioma) who underwent pemetrexed-based treatment between May 2019 and August 2022. Nephrotoxicity incidence was evaluated according to the Kidney Disease Improving Global Outcomes diagnostic criteria, and risk factors for nephrotoxicity during pemetrexed treatment were identified using logistic regression analysis. Results: Renal impairment occurred in 17 of 108 patients (15.7 %), with many experiencing irreversible renal function decline after its onset. The risk factors for nephrotoxicity during pemetrexed-based treatment were identified as the total number of cycles (≥ 10) (odds ratio: 7.94, p < 0.01) and its combination with any two non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEIs/ARBs), or diuretics (odds ratio: 6.30, p < 0.01). Conclusion: Patients receiving pemetrexed treatment are at risk of developing renal impairment, with risk potentially increasing with the number of treatment cycles and concomitant use of NSAIDs, ACEIs/ARBs, or diuretics. However, further studies are required to confirm these findings.
{"title":"Nephrotoxicity and associated risk factors in patients treated with pemetrexed.","authors":"Y Yamamoto, N Orito, N Watanabe, H Hayashi, T Fukuoka, M Ando, M Kawahara, Y Deguchi","doi":"10.1691/ph.2025.5661","DOIUrl":"10.1691/ph.2025.5661","url":null,"abstract":"<p><p><i>Purpose:</i> Pemetrexed causes renal impairment. However, few studies have investigated the risk factors associated with pemetrexed-induced renal impairment. This study aimed to investigate the incidence of nephrotoxicity in patients receiving pemetrexed in combination with carboplatin and to identify the associated risk factors. <i>Methods:</i> This single-center retrospective study included patients with lung cancer (including malignant mesothelioma) who underwent pemetrexed-based treatment between May 2019 and August 2022. Nephrotoxicity incidence was evaluated according to the Kidney Disease Improving Global Outcomes diagnostic criteria, and risk factors for nephrotoxicity during pemetrexed treatment were identified using logistic regression analysis. <i>Results:</i> Renal impairment occurred in 17 of 108 patients (15.7 %), with many experiencing irreversible renal function decline after its onset. The risk factors for nephrotoxicity during pemetrexed-based treatment were identified as the total number of cycles (≥ 10) (odds ratio: 7.94, p < 0.01) and its combination with any two non-steroidal anti-inflammatory drugs (NSAIDs), angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEIs/ARBs), or diuretics (odds ratio: 6.30, p < 0.01). <i>Conclusion:</i> Patients receiving pemetrexed treatment are at risk of developing renal impairment, with risk potentially increasing with the number of treatment cycles and concomitant use of NSAIDs, ACEIs/ARBs, or diuretics. However, further studies are required to confirm these findings.</p>","PeriodicalId":20145,"journal":{"name":"Pharmazie","volume":"80 11","pages":"170-174"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145906321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}