Bovine subclinical mastitis stands out as a significant challenge in the dairy industry, leading to substantial milk losses. The issue becomes more alarming as lactating cows frequently face severe infections caused by Staphylococcus aureus bacteria, resulting in detrimental udder damage. The conventional approach of combating such infections involves prolonged antibiotic treatments, contributing to the emergence of Antimicrobial Resistance (AMR) in cows. Compounding the issue, S. aureus bacteria can undergo modifications, transforming into the formidable Methicillin-Resistant S. aureus (MRSA). Addressing this pressing concern requires exploring alternative solutions, and one promising avenue lies in the realm of medicinal plants. Leveraging the inherent antibacterial properties of phytochemicals found in various medicinal plants could offer a sustainable and effective approach to managing bovine mastitis. Not only do these botanical remedies provide a potential solution to the challenges posed by conventional antibiotic treatments, but they also offer a more environmentally friendly and holistic approach to safeguarding the health of dairy cows and preserving milk production in the industry.
{"title":"A Mini Review on Current Challenges and Opportunities in the Management of Bovine Mastitis","authors":"Bhatt Pr","doi":"10.23880/beba-16000225","DOIUrl":"https://doi.org/10.23880/beba-16000225","url":null,"abstract":"Bovine subclinical mastitis stands out as a significant challenge in the dairy industry, leading to substantial milk losses. The issue becomes more alarming as lactating cows frequently face severe infections caused by Staphylococcus aureus bacteria, resulting in detrimental udder damage. The conventional approach of combating such infections involves prolonged antibiotic treatments, contributing to the emergence of Antimicrobial Resistance (AMR) in cows. Compounding the issue, S. aureus bacteria can undergo modifications, transforming into the formidable Methicillin-Resistant S. aureus (MRSA). Addressing this pressing concern requires exploring alternative solutions, and one promising avenue lies in the realm of medicinal plants. Leveraging the inherent antibacterial properties of phytochemicals found in various medicinal plants could offer a sustainable and effective approach to managing bovine mastitis. Not only do these botanical remedies provide a potential solution to the challenges posed by conventional antibiotic treatments, but they also offer a more environmentally friendly and holistic approach to safeguarding the health of dairy cows and preserving milk production in the industry.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"391 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140455745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Will the Organic Food Phenomenon Continue or Fade Away?","authors":"Gul W","doi":"10.23880/beba-16000224","DOIUrl":"https://doi.org/10.23880/beba-16000224","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"50 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140455882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Researchers are increasingly investigating marketing assertions related to natural products and supplements. In the modern era, the study of bioavailability has gained prominence as a burgeoning scientific discipline. This comprehensive review explores the bioavailability of natural products in pharmaceutical applications, shedding light on their intrinsic challenges and innovative strategies for improvement. The assessment encompasses the limitations including poor aqueous solubility, low permeability, and instability, which collectively impede the effective absorption of natural products in the human body hinder the effective utilization of these compounds, and underscores the critical need for enhanced bioavailability to unlock their full therapeutic potential. Such challenges have spurred research into innovative approaches to overcome these limitations and optimize bioavailability. In response to these challenges, this review highlights cutting-edge strategies, including nanoparticle formulations, lipid-based delivery systems, and prodrug design, as effective means to enhance bioavailability. These approaches aim to improve solubility, stability, and overall absorption, thereby maximizing the therapeutic efficacy of natural products in pharmaceutical formulations. Moreover, the review emphasizes the importance of understanding the interplay between formulation techniques and the physicochemical properties of natural products. By integrating these innovative approaches, researchers can tailor solutions to specific compounds, providing a roadmap for overcoming bioavailability limitations and advancing the integration of natural products into mainstream pharmaceutical practice.
{"title":"Unveiling Revealing Nature's Bounty: A Comprehensive Exploration of Bioavailability in Natural Products","authors":"S. Anb","doi":"10.23880/beba-16000226","DOIUrl":"https://doi.org/10.23880/beba-16000226","url":null,"abstract":"Researchers are increasingly investigating marketing assertions related to natural products and supplements. In the modern era, the study of bioavailability has gained prominence as a burgeoning scientific discipline. This comprehensive review explores the bioavailability of natural products in pharmaceutical applications, shedding light on their intrinsic challenges and innovative strategies for improvement. The assessment encompasses the limitations including poor aqueous solubility, low permeability, and instability, which collectively impede the effective absorption of natural products in the human body hinder the effective utilization of these compounds, and underscores the critical need for enhanced bioavailability to unlock their full therapeutic potential. Such challenges have spurred research into innovative approaches to overcome these limitations and optimize bioavailability. In response to these challenges, this review highlights cutting-edge strategies, including nanoparticle formulations, lipid-based delivery systems, and prodrug design, as effective means to enhance bioavailability. These approaches aim to improve solubility, stability, and overall absorption, thereby maximizing the therapeutic efficacy of natural products in pharmaceutical formulations. Moreover, the review emphasizes the importance of understanding the interplay between formulation techniques and the physicochemical properties of natural products. By integrating these innovative approaches, researchers can tailor solutions to specific compounds, providing a roadmap for overcoming bioavailability limitations and advancing the integration of natural products into mainstream pharmaceutical practice.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"128 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140456121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The present study was designed to investigate the anticancer activity of Phyllanthus reticulatus Poir. against HeLa cell line and to predict the therapeutic potential by investigating the cytotoxicity of the extract against Vero cell line and determining the selectivity index (SI). Phytochemical screening of the ethanolic extract of Phyllanthus reticulatus Poir. was employed by using standard methods. Anticancer and cytotoxic activities were investigated from Centre for Advanced Research in Science using their commercial services. MTT assay was employed for the evaluation of the activities. The concentrations of the extract was 5 mg/ml, 2.5 mg/ml, 1.25 mg/ml and 0.625 mg/ml. From the survival rate % inhibition was calculated and graphically the IC50 value was determined by plotting the % inhibition against the concentration of the extract investigated. Finally, the selectivity index was calculated from the IC50 values of the extract against HeLa cell line and Vero cell line. Glycoside, tannin, alkaloid, flavonoid, phenol, coumarin were present in the ethanolic extract of Phyllanthus reticulatus Poir. The IC50 value of the extract against HeLa Cell and Vero Cell were 1.00 mg/ml and 8.09 mg/ml respectively. The selectivity index was 8.09. This value indicates that the cancer cell (HeLa cells) will be killed at higher rate than normal ones i.e. the extract is more toxic for cancer cells.
本研究的目的是调查 Phyllanthus reticulatus Poir.对 HeLa 细胞系的抗癌活性，并通过调查提取物对 Vero 细胞系的细胞毒性和确定选择性指数（SI）来预测其治疗潜力。采用标准方法对 Phyllanthus reticulatus Poir.乙醇提取物进行了植物化学筛选。利用科学高级研究中心的商业服务对其抗癌和细胞毒性活性进行了调查。采用 MTT 法评估其活性。提取物的浓度分别为 5 毫克/毫升、2.5 毫克/毫升、1.25 毫克/毫升和 0.625 毫克/毫升。根据存活率计算出抑制率，并将抑制率与所研究的提取物浓度作图，从而确定 IC50 值。最后，根据提取物对 HeLa 细胞系和 Vero 细胞系的 IC50 值计算出选择性指数。Phyllanthus reticulatus Poir 的乙醇提取物中含有糖苷、单宁、生物碱、黄酮、苯酚和香豆素。提取物对 HeLa 细胞和 Vero 细胞的 IC50 值分别为 1.00 mg/ml 和 8.09 mg/ml。选择性指数为 8.09。该值表明，癌细胞（HeLa 细胞）的致死率高于正常细胞，即该提取物对癌细胞的毒性更强。
{"title":"In Vitro Anticancer and Cytotoxic Activity of Ethanolic Extract of Phyllanthus reticulatus Poir. Against Hela Cell Line and Vero Cell Line","authors":"Shifa S","doi":"10.23880/beba-16000223","DOIUrl":"https://doi.org/10.23880/beba-16000223","url":null,"abstract":"The present study was designed to investigate the anticancer activity of Phyllanthus reticulatus Poir. against HeLa cell line and to predict the therapeutic potential by investigating the cytotoxicity of the extract against Vero cell line and determining the selectivity index (SI). Phytochemical screening of the ethanolic extract of Phyllanthus reticulatus Poir. was employed by using standard methods. Anticancer and cytotoxic activities were investigated from Centre for Advanced Research in Science using their commercial services. MTT assay was employed for the evaluation of the activities. The concentrations of the extract was 5 mg/ml, 2.5 mg/ml, 1.25 mg/ml and 0.625 mg/ml. From the survival rate % inhibition was calculated and graphically the IC50 value was determined by plotting the % inhibition against the concentration of the extract investigated. Finally, the selectivity index was calculated from the IC50 values of the extract against HeLa cell line and Vero cell line. Glycoside, tannin, alkaloid, flavonoid, phenol, coumarin were present in the ethanolic extract of Phyllanthus reticulatus Poir. The IC50 value of the extract against HeLa Cell and Vero Cell were 1.00 mg/ml and 8.09 mg/ml respectively. The selectivity index was 8.09. This value indicates that the cancer cell (HeLa cells) will be killed at higher rate than normal ones i.e. the extract is more toxic for cancer cells.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"153 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140455832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pharmacosomes are neutral colloidal, lipid vesicular drug delivery system having both negative & positive charge that enhance the bioavailability of drugs by enhacing their solubility both in aqueous as well as non-aqueous phase, additionally reduce gastrointestinal toxicity of drug. Ketoconazole is an imidazole derivative agent which is used both in the treatment of topical or systematic fungal infections with fungi static activity against dermatophytes, yeasts and other pathogenic fungi. Ketoconazole is Biopharmaceutical classification system (BCS) class II drugs that display pH dependent dissolution and absorption. In this present research work Pharmacosome of Ketoconazole was prepared in different ratios of Ketoconazole-PC complex (1:1, 1:1.5 and1:2) using conventional solvent evaporation method. FT-IR spectra showed no significant untoward interaction, Vesicles shape and morphology was carried out with Phase contrast microscopy (PCM) and Scanning electron microscopy (SEM), In-vitro permeation study and anti-fungal activity were duly examined. Drug content in the formulations (1:1) (1:1.5) and (1:2) were found 92.5%, 94.3% and 89.7% respectively. FT-IR conformed proper formation of drug- Pharmaosome complex. Particle size distribution were found to be regular and of spherical shape. In-vitro permeation study showed 78.03%, 89.05% and 55.27% drug release as per respectively formulations (KTP1, KTP2 and KTP3). Pharmacosomes of ketoconazole show improvement in antifungal activity than ketoconazole (Pure).
{"title":"Development and Evaluation of Antifungal Efficacy of Ketoconazole Pharmacosome","authors":"Srivastava Sk","doi":"10.23880/beba-16000216","DOIUrl":"https://doi.org/10.23880/beba-16000216","url":null,"abstract":"Pharmacosomes are neutral colloidal, lipid vesicular drug delivery system having both negative & positive charge that enhance the bioavailability of drugs by enhacing their solubility both in aqueous as well as non-aqueous phase, additionally reduce gastrointestinal toxicity of drug. Ketoconazole is an imidazole derivative agent which is used both in the treatment of topical or systematic fungal infections with fungi static activity against dermatophytes, yeasts and other pathogenic fungi. Ketoconazole is Biopharmaceutical classification system (BCS) class II drugs that display pH dependent dissolution and absorption. In this present research work Pharmacosome of Ketoconazole was prepared in different ratios of Ketoconazole-PC complex (1:1, 1:1.5 and1:2) using conventional solvent evaporation method. FT-IR spectra showed no significant untoward interaction, Vesicles shape and morphology was carried out with Phase contrast microscopy (PCM) and Scanning electron microscopy (SEM), In-vitro permeation study and anti-fungal activity were duly examined. Drug content in the formulations (1:1) (1:1.5) and (1:2) were found 92.5%, 94.3% and 89.7% respectively. FT-IR conformed proper formation of drug- Pharmaosome complex. Particle size distribution were found to be regular and of spherical shape. In-vitro permeation study showed 78.03%, 89.05% and 55.27% drug release as per respectively formulations (KTP1, KTP2 and KTP3). Pharmacosomes of ketoconazole show improvement in antifungal activity than ketoconazole (Pure).","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139362921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The various pharmacopoeias contain descriptions of different dissolution media but these are however not predictive of bioavailability. To solve this problem, biorelevant media and different models have been developed as alternatives. The aim of this report was to highlight some of the biorelevant media and appraise their relevance to predict in vivo drug performance. It was apparent that the biorelevant media reflect contents of the gastrointestinal fluids better than the pharmacopoeial media. Also, bio-relevant dissolution methods, combined with permeability measurements and other models along with computational simulations have been used to predict the oral absorption of drug. Prediction of bioavailability from in vitro data involves the establishment of an in vitro-in vivo correlation (IVIVC) between an in vitro measurement such as dissolution rate data and the in vivo performance of the drug formulation such as the bioavailability parameters.
{"title":"Insights on Prospects of Prediction of Drug Bioavailability from in Vitro Models","authors":"Onyeji Co","doi":"10.23880/beba-16000210","DOIUrl":"https://doi.org/10.23880/beba-16000210","url":null,"abstract":"The various pharmacopoeias contain descriptions of different dissolution media but these are however not predictive of bioavailability. To solve this problem, biorelevant media and different models have been developed as alternatives. The aim of this report was to highlight some of the biorelevant media and appraise their relevance to predict in vivo drug performance. It was apparent that the biorelevant media reflect contents of the gastrointestinal fluids better than the pharmacopoeial media. Also, bio-relevant dissolution methods, combined with permeability measurements and other models along with computational simulations have been used to predict the oral absorption of drug. Prediction of bioavailability from in vitro data involves the establishment of an in vitro-in vivo correlation (IVIVC) between an in vitro measurement such as dissolution rate data and the in vivo performance of the drug formulation such as the bioavailability parameters.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139363372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This study objective was to determine the bioequivalence of Salbutamol 4 mg Tablet manufactured by PT Kimia Farma Tbk compared to Ventolin® 2x2 mg Tablet manufactured by Glaxo Wellcome Indonesia, in healthy Indonesian volunteer. The pharmacokinetic parameters calculated in this study are AUC0-24, AUC0-inf, Cmax, Tmax, and T1/2. The study was conducted in a randomized, single-dose, open-label, two-way crossover design (2 treatments, 2 periods, and 2 sequences) under fasting state with 7 (seven) days washed-out period. The number of subjects who participated in the study were 24 volunteers ((12 males and 12 females). The participants were provided with an overview of the study and signed the informed consent form. The study participants underwent a minimum 8-hour fasting period prior to receiving both the test drug and the reference drug, and blood samples were collected at 14 specified time points: 0 hours (before drug administration), minutes-20, minutes-40, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours after drug administration. Plasma concentrations of the drug were determined by LCMS/MS method. The acceptance criteria for the bioequivalence test are 80.00 - 125.00% for AUC0-t and Cmax with 90% Confidence Interval (CI) with α = 5.00%. The mean SD value of AUC0-24, AUC0-inf, Cmax, Tmax, and T1/2 respectively for test drug is 84.49 ±18.99 ng.mL-1.hour; 89.66 ±21.29 ng.mL-1.hour; 13.85 ±4.25 ng/mL; 2.00 ±0.71 hour and 5.08 ±1.27 hour. The mean SD values of AUC0-24, AUC0-inf, Cmax, Tmax, and C1/2 respectively for reference drug are 88.81 ±26.50 ng.mL-1.jam; 93.78 ±27.97 ng.mL-1.jam; 13.39 ±5.39 ng/mL; 2.63 ±1.45 hour and 5.03 ±1.16 hour. Meanwhile, the geometric mean ratio of test drug to reference drug (90% confidence interval) is 96.35% (90.55- 102.53%) for AUC0-24 and 105.39% (93.62-118.65%) for Cmax. Based on the AUC0-24 and Cmax values, Salbutamol 4 mg Tablet manufactured by PT Kimia Farma Tbk is bioequivalent to Ventolin® 2x2 mg Tablet manufactured by Glaxo Wellcome Indonesia.
{"title":"Bioequivalence Study of Salbutamol 400 mg Tablet in Healthy Indonesian Volunteers by Liquid Chromatography Tandem with Mass Spectrometry","authors":"Priyanto P","doi":"10.23880/beba-16000217","DOIUrl":"https://doi.org/10.23880/beba-16000217","url":null,"abstract":"This study objective was to determine the bioequivalence of Salbutamol 4 mg Tablet manufactured by PT Kimia Farma Tbk compared to Ventolin® 2x2 mg Tablet manufactured by Glaxo Wellcome Indonesia, in healthy Indonesian volunteer. The pharmacokinetic parameters calculated in this study are AUC0-24, AUC0-inf, Cmax, Tmax, and T1/2. The study was conducted in a randomized, single-dose, open-label, two-way crossover design (2 treatments, 2 periods, and 2 sequences) under fasting state with 7 (seven) days washed-out period. The number of subjects who participated in the study were 24 volunteers ((12 males and 12 females). The participants were provided with an overview of the study and signed the informed consent form. The study participants underwent a minimum 8-hour fasting period prior to receiving both the test drug and the reference drug, and blood samples were collected at 14 specified time points: 0 hours (before drug administration), minutes-20, minutes-40, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours after drug administration. Plasma concentrations of the drug were determined by LCMS/MS method. The acceptance criteria for the bioequivalence test are 80.00 - 125.00% for AUC0-t and Cmax with 90% Confidence Interval (CI) with α = 5.00%. The mean SD value of AUC0-24, AUC0-inf, Cmax, Tmax, and T1/2 respectively for test drug is 84.49 ±18.99 ng.mL-1.hour; 89.66 ±21.29 ng.mL-1.hour; 13.85 ±4.25 ng/mL; 2.00 ±0.71 hour and 5.08 ±1.27 hour. The mean SD values of AUC0-24, AUC0-inf, Cmax, Tmax, and C1/2 respectively for reference drug are 88.81 ±26.50 ng.mL-1.jam; 93.78 ±27.97 ng.mL-1.jam; 13.39 ±5.39 ng/mL; 2.63 ±1.45 hour and 5.03 ±1.16 hour. Meanwhile, the geometric mean ratio of test drug to reference drug (90% confidence interval) is 96.35% (90.55- 102.53%) for AUC0-24 and 105.39% (93.62-118.65%) for Cmax. Based on the AUC0-24 and Cmax values, Salbutamol 4 mg Tablet manufactured by PT Kimia Farma Tbk is bioequivalent to Ventolin® 2x2 mg Tablet manufactured by Glaxo Wellcome Indonesia.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139362956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Psoriasis (psoriasis) is a chronic disease with a number of significant comorbidities and often with a very significant impact on the quality of life of patients. Recently, a relatively large number of biological treatment products with a significant effect have entered the market, but they are also significantly more expensive than systemic conventional treatment. In the context of the published long period of inadequate treatment of patients with psoriasis in the Czech Republic, the health care system and the limited costs of center drugs, it is necessary to make the greatest possible effort at the level of the provider of this health care to effectively spend financial resources and provide highly effective treatment to the greatest possible number of patients. Method: With a model-set amount of the unit prices of the packaging of preparations according to the maximum reimbursements in the Czech Republic in 2021, a fictitiously set amount of bonuses for only two selected preparations (this is a model example that does not reflect the real state of business policy at the University Hospital Olomouc), and the conditions for reimbursement of biological treatment preparations psoriasis in the Czech Republic in 2021, a cost-effectiveness analysis (CEA) was carried out in the selected PASI 100 efficiency parameter. The analysis was carried out and processed interactively in the Excel software into the graphical form of the outputs, especially in the form of forest plot graphs (in the CER and ICER parameters) and in a two-dimensional efficient frontiers graph (costs vs. efficiency). Results: The differences in the cost-effectiveness of individual preparations according to the point values of the CER and ICER parameters are up to several times. Taking into account the 95% confidence intervals, some of the differences between the preparations are also statistically significant. With the most cost-effective sequence of treatment for a gradually more effective drug in one patient during the induction period of treatment, we can, based on the saved costs, start induction treatment with a less effective biologic in two more patients than when using the second cost-effective sequence of treatment escalation. Conclusion: The cost-effectiveness analysis (CEA) of biological drugs in the treatment of psoriasis at the level of the health service provider has great potential in the effort to make the treatment as effective as possible with limited financial resources, or in the effort to provide effective treatment to additional patients with the same limitations
{"title":"Cost-Effectiveness Analysis of Biologics in the Treatment of Moderate-to-Severe Plaque Psoriasis from a Health Care Provider's Perspective","authors":"Duda J","doi":"10.23880/beba-16000218","DOIUrl":"https://doi.org/10.23880/beba-16000218","url":null,"abstract":"Introduction: Psoriasis (psoriasis) is a chronic disease with a number of significant comorbidities and often with a very significant impact on the quality of life of patients. Recently, a relatively large number of biological treatment products with a significant effect have entered the market, but they are also significantly more expensive than systemic conventional treatment. In the context of the published long period of inadequate treatment of patients with psoriasis in the Czech Republic, the health care system and the limited costs of center drugs, it is necessary to make the greatest possible effort at the level of the provider of this health care to effectively spend financial resources and provide highly effective treatment to the greatest possible number of patients. Method: With a model-set amount of the unit prices of the packaging of preparations according to the maximum reimbursements in the Czech Republic in 2021, a fictitiously set amount of bonuses for only two selected preparations (this is a model example that does not reflect the real state of business policy at the University Hospital Olomouc), and the conditions for reimbursement of biological treatment preparations psoriasis in the Czech Republic in 2021, a cost-effectiveness analysis (CEA) was carried out in the selected PASI 100 efficiency parameter. The analysis was carried out and processed interactively in the Excel software into the graphical form of the outputs, especially in the form of forest plot graphs (in the CER and ICER parameters) and in a two-dimensional efficient frontiers graph (costs vs. efficiency). Results: The differences in the cost-effectiveness of individual preparations according to the point values of the CER and ICER parameters are up to several times. Taking into account the 95% confidence intervals, some of the differences between the preparations are also statistically significant. With the most cost-effective sequence of treatment for a gradually more effective drug in one patient during the induction period of treatment, we can, based on the saved costs, start induction treatment with a less effective biologic in two more patients than when using the second cost-effective sequence of treatment escalation. Conclusion: The cost-effectiveness analysis (CEA) of biological drugs in the treatment of psoriasis at the level of the health service provider has great potential in the effort to make the treatment as effective as possible with limited financial resources, or in the effort to provide effective treatment to additional patients with the same limitations","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139362973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The goal of these two studies was to evaluate the bioequivalence of two strengths of rivaroxaban 10 mg and 20 mg. Because the food effect on the pharmacokinetics of rivaroxaban affects the strength of 20 mg and not that of 10 mg. The 20 mg strength study was conducted under fed conditions, whereas the 10 mg strength study was conducted under fasting conditions. The two studies were conducted separately with different sets of Mexican subjects of both genders using a randomized, singledose, 2-sequence, 2-period cross over design with a 7-day washout period. Blood samples from the subjects were obtained at basal conditions, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours after administration. Rivaroxaban plasma concentrations were quantified using an HPLC method coupled to a mass spectrometer. The test and reference formulations were considered to be bioequivalent if the 90% CI for the ratios (test/reference) of geometric means were within the acceptance limits of 80 to 125% for the pharmacokinetic parameters Cmax, AUC0–t and AUC0–∞. In both studies the 90% CI for all pharmacokinetic parameters were within the limits of acceptance. Therefore the conclusion of bioequivalence was reached.
{"title":"Bioequivalence Studies of Rivaroxaban at Two Different Strengths: Rivaroxaban 10 mg under Fasting Conditions and Rivaroxaban 20 mg under Fed Conditions in Healthy Mexican Subjects","authors":"González-de la Parra M","doi":"10.23880/beba-16000207","DOIUrl":"https://doi.org/10.23880/beba-16000207","url":null,"abstract":"The goal of these two studies was to evaluate the bioequivalence of two strengths of rivaroxaban 10 mg and 20 mg. Because the food effect on the pharmacokinetics of rivaroxaban affects the strength of 20 mg and not that of 10 mg. The 20 mg strength study was conducted under fed conditions, whereas the 10 mg strength study was conducted under fasting conditions. The two studies were conducted separately with different sets of Mexican subjects of both genders using a randomized, singledose, 2-sequence, 2-period cross over design with a 7-day washout period. Blood samples from the subjects were obtained at basal conditions, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours after administration. Rivaroxaban plasma concentrations were quantified using an HPLC method coupled to a mass spectrometer. The test and reference formulations were considered to be bioequivalent if the 90% CI for the ratios (test/reference) of geometric means were within the acceptance limits of 80 to 125% for the pharmacokinetic parameters Cmax, AUC0–t and AUC0–∞. In both studies the 90% CI for all pharmacokinetic parameters were within the limits of acceptance. Therefore the conclusion of bioequivalence was reached.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139363325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The objective studies enhance drug release of etoricoxib by Binders, disintegrant& β- Cyclodextrin. The 2 level factorial designs employing (DOE) Design expert software; 3 independent with 3 central points. The prepared granules and tablets were subjected to flow, physical characteristics and dissolution. The optimized formulation exhibited 4 independent variables Y1 (DR 30), Y2 (DR 60), Y3 (DR 90) Y4 (T50 30), Y5 (DE10). DoE used to find response surface plots, optimization and Desirability and analysis of variance (ANOVA), p <0.005 indicates that the ANOVA of responses (dependent variables) Y1, Y2, Y3, Y4& Y5 is significant. The formulation Fa, formulated employing PVP as binder (factor A) and potato starch as disintegrant (factor B) had the highest drug release rate of 95 % in 1 h. The desirability function was 0.90170 and the predicted and experimental values had strong correlations.
{"title":"An Anti-Inflammatory and Analgesic Drug Etoricoxib Investigated by Design of Experimentation (DOE) and in Vitro Characterization","authors":"Ramarao Cht","doi":"10.23880/beba-16000212","DOIUrl":"https://doi.org/10.23880/beba-16000212","url":null,"abstract":"The objective studies enhance drug release of etoricoxib by Binders, disintegrant& β- Cyclodextrin. The 2 level factorial designs employing (DOE) Design expert software; 3 independent with 3 central points. The prepared granules and tablets were subjected to flow, physical characteristics and dissolution. The optimized formulation exhibited 4 independent variables Y1 (DR 30), Y2 (DR 60), Y3 (DR 90) Y4 (T50 30), Y5 (DE10). DoE used to find response surface plots, optimization and Desirability and analysis of variance (ANOVA), p <0.005 indicates that the ANOVA of responses (dependent variables) Y1, Y2, Y3, Y4& Y5 is significant. The formulation Fa, formulated employing PVP as binder (factor A) and potato starch as disintegrant (factor B) had the highest drug release rate of 95 % in 1 h. The desirability function was 0.90170 and the predicted and experimental values had strong correlations.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139362829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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