Pub Date : 2023-07-20DOI: 10.9734/jpri/2023/v35i197397
G. Begum, N. Anbu
Aim: The aim of this study was to explore the physicochemical, phytochemical and HPTLC analysis of the Siddha herbomineral formulation, Arputha Mathirai (AM), in tablet form, for its potential in treating PCOS (Poly Cystic Ovarian Syndrome). The objective was to analyze the tablet and assess its physicochemical properties, as well as the presence of bioactive compounds derived from plant sources. Place of Study: The physicochemical and phytochemical analysis was conducted at The Tamilnadu Dr.MGR Medical University, located at No.69, Anna Salai, Guindy, Chennai – 600 032. The High-Performance Thin Layer Chromatography (HPTLC) was carried out at Noble Research Solutions in Kolathur, Chennai – 600 099. Materials and Methods: Arputha Mathirai, the Siddha herbomineral formulation, was prepared in compliance with Good Manufacturing Practices (GMP) guidelines. The formulation underwent a thorough analysis of its physicochemical and phytochemical properties at The Tamilnadu Dr.MGR Medical university, Guindy, Chennai. The analysis was conducted following the standards set by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) in accordance with the guidelines established by AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy), the governing body for traditional health systems in India. HPTLC was peformed at Noble Research Solutions, Kolathur, Chennai – 600 099. Results: Physico-chemical analysis of AM showed 10.08% of loss on drying at 1050 C, 15.39% total ash value, 2.45% acid-insoluble ash, 12.18% water-soluble ash, 20.55% water-soluble extraction, and 8.46% alcohol-soluble extraction. According to the phytochemical analysis of AM, alkaloids, carbohydrates, saponins, flavonoids, diterpenes, gum, and mucilage were all found in the sample. Additionally, it demonstrated the absence of quinones, tannins, and phenols. HPTLC finger printing analysis of the sample revealed the presence of five prominent peaks corresponding to the presence of five versatile phytocomponents present with in it. Rf value of the peaks ranged from 0.02 to 0.56. Conclusion: The findings of this study provided a comprehensive understanding of the physicochemical properties, bio active phytochemicals and phytocomponents of Arputha Mathirai (AM). These results contribute to establishing the nature of the formulation's composition and its safety profile. Moreover, the standardization of the tablet formulation based on these parameters supports its suitability for therapeutic use in the treatment of PCOS. These outcomes validate the quality and potential effectiveness of AM in addressing PCOS, enhancing its credibility as a viable treatment option.
目的:本研究的目的是探讨西达草药制剂阿普塔·玛蒂莱(AM)片剂治疗多囊卵巢综合征(PCOS)的理化、植物化学和HPTLC分析。目的是分析片剂并评估其物理化学性质,以及来自植物来源的生物活性化合物的存在。研究地点:理化和植物化学分析在泰米尔纳德邦mgr博士医科大学进行,该大学位于No.69, Anna Salai, Guindy, Chennai - 600032。高效薄层色谱(HPTLC)在Noble Research Solutions进行,位于金奈Kolathur - 600099。材料和方法:Arputha Mathirai, Siddha草药制剂,按照良好生产规范(GMP)制备。该配方在位于金奈Guindy的泰米尔纳德邦医科大学进行了物理化学和植物化学特性的彻底分析。该分析是根据印度传统卫生系统管理机构AYUSH(阿育吠陀、瑜伽、乌纳尼、悉达、顺势疗法)制定的指南,按照印度药物药典实验室(PLIM)制定的标准进行的。HPTLC在Noble Research Solutions, Kolathur, Chennai - 600099进行。结果:AM在1050℃干燥时损失10.08%,总灰分15.39%,酸不溶灰分2.45%,水溶性灰分12.18%,水溶性萃取物20.55%,醇溶萃取物8.46%。根据AM的植物化学分析,样品中均含有生物碱、碳水化合物、皂苷、类黄酮、二萜、树胶和粘液。此外,它还证明了不含醌、单宁和酚。HPTLC指纹图谱分析显示,样品中存在五个突出的峰,对应于其中存在五种多功能植物成分。峰的Rf值在0.02 ~ 0.56之间。结论:本研究为全面了解阿普塔·马提莱(Arputha Mathirai, AM)的理化性质、生物活性化学物质和植物成分提供了基础。这些结果有助于确定配方成分的性质及其安全性。此外,基于这些参数的片剂配方的标准化支持其在多囊卵巢综合征治疗中的适用性。这些结果验证了AM治疗PCOS的质量和潜在有效性,提高了其作为可行治疗选择的可信度。
{"title":"Exploration of Physicochemical, Phytochemical, and HPTLC Analysis of Arputha Mathirai: A Siddha Herbo Mineral Formulation for Poly Cystic Ovarian Syndrome (PCOS)","authors":"G. Begum, N. Anbu","doi":"10.9734/jpri/2023/v35i197397","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i197397","url":null,"abstract":"Aim: The aim of this study was to explore the physicochemical, phytochemical and HPTLC analysis of the Siddha herbomineral formulation, Arputha Mathirai (AM), in tablet form, for its potential in treating PCOS (Poly Cystic Ovarian Syndrome). The objective was to analyze the tablet and assess its physicochemical properties, as well as the presence of bioactive compounds derived from plant sources. \u0000Place of Study: The physicochemical and phytochemical analysis was conducted at The Tamilnadu Dr.MGR Medical University, located at No.69, Anna Salai, Guindy, Chennai – 600 032. The High-Performance Thin Layer Chromatography (HPTLC) was carried out at Noble Research Solutions in Kolathur, Chennai – 600 099. \u0000Materials and Methods: Arputha Mathirai, the Siddha herbomineral formulation, was prepared in compliance with Good Manufacturing Practices (GMP) guidelines. The formulation underwent a thorough analysis of its physicochemical and phytochemical properties at The Tamilnadu Dr.MGR Medical university, Guindy, Chennai. The analysis was conducted following the standards set by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) in accordance with the guidelines established by AYUSH (Ayurveda, Yoga, Unani, Siddha, Homoeopathy), the governing body for traditional health systems in India. HPTLC was peformed at Noble Research Solutions, Kolathur, Chennai – 600 099. \u0000Results: Physico-chemical analysis of AM showed 10.08% of loss on drying at 1050 C, 15.39% total ash value, 2.45% acid-insoluble ash, 12.18% water-soluble ash, 20.55% water-soluble extraction, and 8.46% alcohol-soluble extraction. According to the phytochemical analysis of AM, alkaloids, carbohydrates, saponins, flavonoids, diterpenes, gum, and mucilage were all found in the sample. Additionally, it demonstrated the absence of quinones, tannins, and phenols. HPTLC finger printing analysis of the sample revealed the presence of five prominent peaks corresponding to the presence of five versatile phytocomponents present with in it. Rf value of the peaks ranged from 0.02 to 0.56. \u0000Conclusion: The findings of this study provided a comprehensive understanding of the physicochemical properties, bio active phytochemicals and phytocomponents of Arputha Mathirai (AM). These results contribute to establishing the nature of the formulation's composition and its safety profile. Moreover, the standardization of the tablet formulation based on these parameters supports its suitability for therapeutic use in the treatment of PCOS. These outcomes validate the quality and potential effectiveness of AM in addressing PCOS, enhancing its credibility as a viable treatment option.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43052646","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}
Pub Date : 2023-07-20DOI: 10.9734/jpri/2023/v35i197398
Miftah S. M. Nag, N. M. Al-Awkally, Ahmed Abouserwel, F. M. Senossi, Sara El-Warred, M. A. Ali
Background: Antibiotic resistance is a growing global public health concern because it jeopardizes the effective control and treatment of bacterial infections. The purpose of this study was to determine the bacterial profiles and susceptibility patterns to Imipenem, Augmentin, and Ceftriaxone in various clinical specimens from Al Saleem laboratory in Benghazi, Libya. Methods: Two separate studies were carried out. Each experiment lasted three months. The patients' clinical samples included wound swabs, urine, sperm, blood, high vaginal swabs, and cerebrospinal fluid. Bacterial species were isolated and identified using standard microbiological methods in each study. Kirby-Bauer disc diffusion was used to conduct antimicrobial susceptibility tests from September 2020 to November 2020. Results: There were 711 isolates obtained from 535 female and 503 male patients. The most common organisms isolated from specimens were E. coli spp, Klebsiella spp, and Staph aureus. Conclusion: Bacterial resistance levels to various antibiotics varied greatly. We found that Augmentin has less activity against gram negative bacteria isolated from clinical specimens, whereas Imipenem has a much stronger effect on isolates than Augmentin. Appropriate monitoring of prevalent pathogenic organisms and their sensitivities will assist clinicians in making appropriate antibiotic treatment choices to avoid the spread of antimicrobial resistance.
{"title":"Antimicrobial Resistance Profile of Different Clinical Isolates against Augmentin, Imipenem and Ceftriaxone","authors":"Miftah S. M. Nag, N. M. Al-Awkally, Ahmed Abouserwel, F. M. Senossi, Sara El-Warred, M. A. Ali","doi":"10.9734/jpri/2023/v35i197398","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i197398","url":null,"abstract":"Background: Antibiotic resistance is a growing global public health concern because it jeopardizes the effective control and treatment of bacterial infections. The purpose of this study was to determine the bacterial profiles and susceptibility patterns to Imipenem, Augmentin, and Ceftriaxone in various clinical specimens from Al Saleem laboratory in Benghazi, Libya. \u0000Methods: Two separate studies were carried out. Each experiment lasted three months. The patients' clinical samples included wound swabs, urine, sperm, blood, high vaginal swabs, and cerebrospinal fluid. Bacterial species were isolated and identified using standard microbiological methods in each study. Kirby-Bauer disc diffusion was used to conduct antimicrobial susceptibility tests from September 2020 to November 2020. \u0000Results: There were 711 isolates obtained from 535 female and 503 male patients. The most common organisms isolated from specimens were E. coli spp, Klebsiella spp, and Staph aureus. \u0000Conclusion: Bacterial resistance levels to various antibiotics varied greatly. We found that Augmentin has less activity against gram negative bacteria isolated from clinical specimens, whereas Imipenem has a much stronger effect on isolates than Augmentin. Appropriate monitoring of prevalent pathogenic organisms and their sensitivities will assist clinicians in making appropriate antibiotic treatment choices to avoid the spread of antimicrobial resistance.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45928200","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}
Pub Date : 2023-07-15DOI: 10.9734/jpri/2023/v35i197395
N. Reddy, M. Raju, M. Mamatha, M. L. Madhuri
The goal of the current study was to identify potential bioactive components that may be responsible for Rhynchosia beddomei's antidiabetic activity through in silico docking study and to investigate potential mechanisms by which Rhynchosia beddomei may be helpful in managing diabetes and its associated complications. In vitro anti-diabetic assays showed that this plant's high efficiency to inhibit α-amylase (62.13%) and α-glucosidase (59.9%) enzymatic activity, which are well-established targets for the management of diabetes, is responsible for its anti-hyperglycaemic activity. Soxhlet extraction produced an extractive yield of 35.43%. Additionally, we hypothesised that flavonoids including rutin, lucenin, orientin, rhynchosin, and isooreintin contained in this plant may be accountable for the antidiabetic characteristics through docking experiments. The traditional usage of this herb as an antidiabetic is supported scientifically by these findings. By reducing dietary glucose intake, it may help slow the course of diabetic complications and control diabetes. The therapy of hyperglycaemia requires further screening of predicted antidiabetic compounds.
{"title":"In-vitro and In-silico Inhibitory Action of Methanol Extract of Rhynchosia beddomei Whole Plant on α-Glucosidase and α-Amylase","authors":"N. Reddy, M. Raju, M. Mamatha, M. L. Madhuri","doi":"10.9734/jpri/2023/v35i197395","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i197395","url":null,"abstract":"The goal of the current study was to identify potential bioactive components that may be responsible for Rhynchosia beddomei's antidiabetic activity through in silico docking study and to investigate potential mechanisms by which Rhynchosia beddomei may be helpful in managing diabetes and its associated complications. In vitro anti-diabetic assays showed that this plant's high efficiency to inhibit α-amylase (62.13%) and α-glucosidase (59.9%) enzymatic activity, which are well-established targets for the management of diabetes, is responsible for its anti-hyperglycaemic activity. Soxhlet extraction produced an extractive yield of 35.43%. Additionally, we hypothesised that flavonoids including rutin, lucenin, orientin, rhynchosin, and isooreintin contained in this plant may be accountable for the antidiabetic characteristics through docking experiments. The traditional usage of this herb as an antidiabetic is supported scientifically by these findings. By reducing dietary glucose intake, it may help slow the course of diabetic complications and control diabetes. The therapy of hyperglycaemia requires further screening of predicted antidiabetic compounds.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46193380","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}
Pub Date : 2023-07-10DOI: 10.9734/jpri/2023/v35i187393
Yomna Adel Gabr, G. Girgis, H. El-Sabbagh
Aims: Folate receptor (FR) is overexpressed in most cancer cells and activated macrophages entailed in rheumatoid arthritis (RA). The aim of the current study was the fabrication of FR-targeted nanocarrier loaded with methotrexate (MTX) to magnify its therapeutic efficacy and limit its toxicity. Methodology: Folic acid-chitosan (FA-CS) conjugate was synthesized and characterized. MTX loaded poly(d,l-lactide-co-glycolide) (PLGA) nanoparticles (NPs) were prepared, optimized and coated with different concentrations of FA-CS conjugate. The selected FA-CS coated MTX NPs formulation (F10) was evaluated via in vitro and in vivo studies. Results: F10 had satisfactory encapsulation efficiency (76.2%), homogenous particle size (278.6 nm) and positive zeta potential (34.0 mV) and displayed biphasic drug release pattern in different pH media. Further characterization of F10 cinched MTX incorporation in the polymeric matrix of the targeted nanocarrier. In vitro cytotoxicity assay to FR-positive and FR-negative cancer cells revealed the improved anticancer effect of F10 to FR-positive cancer cells, which was absent in FR-negative cells, compared to free MTX or uncoated MTX NPs (F2). F10 showed appropriate storage stability at refrigerated temperature up to 3 months. Moreover, oral administration of F10 in the treatment of complete Freund’s adjuvant (CFA)-induced RA in BALB/c mice conferred prodigious therapeutic outcomes and declined systemic toxicity compared to oral treatment with conventional pure MTX or commercial MTX tablets. Conclusion: The fabricated targeted nanocarrier could enhance the anticancer activity of MTX to FR-overexpressing cancer cells and could be a promising novel approach for oral administration of MTX in the treatment of RA or other inflammatory conditions associated with FR-overexpressing activated macrophages.
{"title":"Surface-Decorated Nanocarrier as a Targeted Drug Delivery Cargo to Folate Receptor-Overexpressing Cells for Enhancing Anti-cancer and Anti-inflammatory Activity","authors":"Yomna Adel Gabr, G. Girgis, H. El-Sabbagh","doi":"10.9734/jpri/2023/v35i187393","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i187393","url":null,"abstract":"Aims: Folate receptor (FR) is overexpressed in most cancer cells and activated macrophages entailed in rheumatoid arthritis (RA). The aim of the current study was the fabrication of FR-targeted nanocarrier loaded with methotrexate (MTX) to magnify its therapeutic efficacy and limit its toxicity. \u0000Methodology: Folic acid-chitosan (FA-CS) conjugate was synthesized and characterized. MTX loaded poly(d,l-lactide-co-glycolide) (PLGA) nanoparticles (NPs) were prepared, optimized and coated with different concentrations of FA-CS conjugate. The selected FA-CS coated MTX NPs formulation (F10) was evaluated via in vitro and in vivo studies. \u0000Results: F10 had satisfactory encapsulation efficiency (76.2%), homogenous particle size (278.6 nm) and positive zeta potential (34.0 mV) and displayed biphasic drug release pattern in different pH media. Further characterization of F10 cinched MTX incorporation in the polymeric matrix of the targeted nanocarrier. In vitro cytotoxicity assay to FR-positive and FR-negative cancer cells revealed the improved anticancer effect of F10 to FR-positive cancer cells, which was absent in FR-negative cells, compared to free MTX or uncoated MTX NPs (F2). F10 showed appropriate storage stability at refrigerated temperature up to 3 months. Moreover, oral administration of F10 in the treatment of complete Freund’s adjuvant (CFA)-induced RA in BALB/c mice conferred prodigious therapeutic outcomes and declined systemic toxicity compared to oral treatment with conventional pure MTX or commercial MTX tablets. \u0000Conclusion: The fabricated targeted nanocarrier could enhance the anticancer activity of MTX to FR-overexpressing cancer cells and could be a promising novel approach for oral administration of MTX in the treatment of RA or other inflammatory conditions associated with FR-overexpressing activated macrophages.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49036049","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}
Pub Date : 2023-07-10DOI: 10.9734/jpri/2023/v35i187394
Akash Sharma, Vriti Gamta, G. Luthra
In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and its impact on various aspects of the healthcare sector, including drug manufacturing, quality control, product safety, and regulatory compliance. Furthermore, the paper discusses the challenges and future perspectives of GMP implementation, emphasizing the need for ongoing advancements to meet the evolving demands of the industry. To summarize, adherence to GMP standards is crucial for the healthcare industry to produce high-quality, safe, and effective healthcare products. GMP compliance promotes patient safety, regulatory compliance, and innovation in the pharmaceutical industry.
{"title":"The Importance of Good Manufacturing Practices (GMP) in the Healthcare Industry","authors":"Akash Sharma, Vriti Gamta, G. Luthra","doi":"10.9734/jpri/2023/v35i187394","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i187394","url":null,"abstract":"In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and its impact on various aspects of the healthcare sector, including drug manufacturing, quality control, product safety, and regulatory compliance. Furthermore, the paper discusses the challenges and future perspectives of GMP implementation, emphasizing the need for ongoing advancements to meet the evolving demands of the industry. To summarize, adherence to GMP standards is crucial for the healthcare industry to produce high-quality, safe, and effective healthcare products. GMP compliance promotes patient safety, regulatory compliance, and innovation in the pharmaceutical industry.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44541236","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}
Pub Date : 2023-07-09DOI: 10.9734/jpri/2023/v35i187392
A. Soni, Muskan Sharma, C. Kumari
A novel UV-spectroscopic method, characterized by its novelty, simplicity, accuracy, precision, linearity, and sensitivity, has been successfully developed and validated for the simultaneous estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form. The method relied on the absorption factor approach, employing the analysis of isosbestic points within the zero-order absorption spectra. Specifically, the isoabsorptive points at a wavelength of 282 nm were employed for the determination of Nitrendipine and Hydrochlorothiazide. The absorbance corresponding to each compound at the isoabsorptive point of 282 nm was calculated using the absorbance factor, derived as the average absorbance of various concentrations of pure Nitrendipine utilizing the isoabsorptive point at 282 nm. Subsequently, the developed method underwent a comprehensive validation process, adhering to the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The linearity range was determined based on their respective λ max at the isoabsorptive point of 282 nm. The culmination of these results leads to the conclusion that the present research is characterized by novelty, accuracy, efficiency, precision, rapidity, reproducibility, simplicity, and sensitivity. Consequently, the proposed method is deemed suitable for the successful estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form.
{"title":"Development and Validation of a UV Spectroscopy Absorption Ratio Method for Simultaneous Estimation of Nitrendipine and Hydrochlorothiazide","authors":"A. Soni, Muskan Sharma, C. Kumari","doi":"10.9734/jpri/2023/v35i187392","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i187392","url":null,"abstract":"A novel UV-spectroscopic method, characterized by its novelty, simplicity, accuracy, precision, linearity, and sensitivity, has been successfully developed and validated for the simultaneous estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form. The method relied on the absorption factor approach, employing the analysis of isosbestic points within the zero-order absorption spectra. Specifically, the isoabsorptive points at a wavelength of 282 nm were employed for the determination of Nitrendipine and Hydrochlorothiazide. The absorbance corresponding to each compound at the isoabsorptive point of 282 nm was calculated using the absorbance factor, derived as the average absorbance of various concentrations of pure Nitrendipine utilizing the isoabsorptive point at 282 nm. Subsequently, the developed method underwent a comprehensive validation process, adhering to the guidelines established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The linearity range was determined based on their respective λ max at the isoabsorptive point of 282 nm. The culmination of these results leads to the conclusion that the present research is characterized by novelty, accuracy, efficiency, precision, rapidity, reproducibility, simplicity, and sensitivity. Consequently, the proposed method is deemed suitable for the successful estimation of Nitrendipine and Hydrochlorothiazide in pharmaceutical tablet dosage form.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48574917","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}
Pub Date : 2023-07-09DOI: 10.9734/jpri/2023/v35i187391
Akash Sharma, Vriti Gamta, G. Luthra
Healthcare regulation plays a crucial role in ensuring the quality and accessibility of healthcare services in Canada. This article provides an overview of the healthcare regulatory landscape in Canada, focusing on federal and provincial/territorial regulations. The federal level regulations, overseen by Health Canada, encompass drug and medical device regulations, health information privacy and security, and food safety and nutrition regulations. Provincial and territorial regulations, implemented by respective healthcare authorities, address licensing and regulation of healthcare professionals, healthcare facility regulation, and allocation of healthcare resources. The article discusses the importance of health information privacy and security regulations in the digital age and highlights the safeguards and best practices to protect personal health information. By understanding and navigating these healthcare regulations, stakeholders can contribute to a healthcare system that ensures quality and accessibility for all Canadians.
{"title":"Understanding Healthcare Regulation in Canada: Strategies for Ensuring Quality and Accessibility","authors":"Akash Sharma, Vriti Gamta, G. Luthra","doi":"10.9734/jpri/2023/v35i187391","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i187391","url":null,"abstract":"Healthcare regulation plays a crucial role in ensuring the quality and accessibility of healthcare services in Canada. This article provides an overview of the healthcare regulatory landscape in Canada, focusing on federal and provincial/territorial regulations. The federal level regulations, overseen by Health Canada, encompass drug and medical device regulations, health information privacy and security, and food safety and nutrition regulations. Provincial and territorial regulations, implemented by respective healthcare authorities, address licensing and regulation of healthcare professionals, healthcare facility regulation, and allocation of healthcare resources. The article discusses the importance of health information privacy and security regulations in the digital age and highlights the safeguards and best practices to protect personal health information. By understanding and navigating these healthcare regulations, stakeholders can contribute to a healthcare system that ensures quality and accessibility for all Canadians.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49206532","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}
Pub Date : 2023-07-07DOI: 10.9734/jpri/2023/v35i187390
Akash Sharma, Vriti Gamta, G. Luthra
Regulatory compliance plays a pivotal role in the healthcare industry by ensuring patient safety, maintaining quality standards, and fostering trust between healthcare providers and patients. This research article aims to highlight the significance of regulatory compliance in healthcare, examining its impact on patient outcomes, organizational performance, and legal implications. Drawing upon existing literature and empirical evidence, this article underscores the need for robust compliance frameworks, effective monitoring systems, and continuous education to ensure adherence to regulatory requirements. By addressing key challenges and outlining best practices, this article provides valuable insights for healthcare organizations to enhance their compliance efforts and ultimately promote a safer and more reliable healthcare system.
{"title":"Ensuring Patient Safety and Trust: The Critical Importance of Regulatory Compliance in Healthcare","authors":"Akash Sharma, Vriti Gamta, G. Luthra","doi":"10.9734/jpri/2023/v35i187390","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i187390","url":null,"abstract":"Regulatory compliance plays a pivotal role in the healthcare industry by ensuring patient safety, maintaining quality standards, and fostering trust between healthcare providers and patients. This research article aims to highlight the significance of regulatory compliance in healthcare, examining its impact on patient outcomes, organizational performance, and legal implications. Drawing upon existing literature and empirical evidence, this article underscores the need for robust compliance frameworks, effective monitoring systems, and continuous education to ensure adherence to regulatory requirements. By addressing key challenges and outlining best practices, this article provides valuable insights for healthcare organizations to enhance their compliance efforts and ultimately promote a safer and more reliable healthcare system.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43754045","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}
Pub Date : 2023-07-07DOI: 10.9734/jpri/2023/v35i177388
Prakruti Amin, Manish Patel
Objective: The major goal of pre-formulation research is to create a drug delivery system that is stable, elegant, safe, and effective by determining the drug's kinetic profile, the formulation's compatibility with various excipients, and the physico-chemical characteristics of new drug molecules. This could offer crucial support for executing formulation design or the need for the molecular change. Therefore, in the current study, studies on Varenicline (VAR)'s appropriateness for oral formulation were conducted. Similar to cytisine, VAR functions as a partial nicotine receptor agonist. It blocks alpha-4-beta-2 nicotinic acetylcholine receptor subtypes and is a partial agonist. Through partial agonism, VAR reduces the urge and withdrawal symptoms associated with quitting efforts by inhibiting the dopaminergic activation brought on by smoking. It stops nicotine from stimulating the mesolimbic dopamine pathway, which is linked to nicotine addiction. Methods: The authenticity of VAR was established by DSC and FTIR spectra. A UV spectrophotometric method was employed for determination of VAR in bulk and active pharmaceutical ingredient (API). Results: The authenticity of VAR was established by DSC and FTIR spectra. For the determination of VAR in bulk API (active pharmaceutical ingredient), a UV spectrophotometric approach was used. In the concentration range of 5–40 g/ml, the UV technique was linear. The lower% CV values of intraday and interday variability indicate the proposed methodology's robustness. The higher regression coefficient value(0.999) indicates the methodology is robust. Conclusions: The outcome of the physico-chemical experiments of drug molecule indicates suitability of oral route. Additionally, at different conditions like solid as well as liquid state, the drugmoleculewasobservedstable.
{"title":"Preformulation Studies of Varenicline for Formulation and Development of a Novel Orally Disintegrating Film","authors":"Prakruti Amin, Manish Patel","doi":"10.9734/jpri/2023/v35i177388","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i177388","url":null,"abstract":"Objective: The major goal of pre-formulation research is to create a drug delivery system that is stable, elegant, safe, and effective by determining the drug's kinetic profile, the formulation's compatibility with various excipients, and the physico-chemical characteristics of new drug molecules. This could offer crucial support for executing formulation design or the need for the molecular change. Therefore, in the current study, studies on Varenicline (VAR)'s appropriateness for oral formulation were conducted. Similar to cytisine, VAR functions as a partial nicotine receptor agonist. It blocks alpha-4-beta-2 nicotinic acetylcholine receptor subtypes and is a partial agonist. Through partial agonism, VAR reduces the urge and withdrawal symptoms associated with quitting efforts by inhibiting the dopaminergic activation brought on by smoking. It stops nicotine from stimulating the mesolimbic dopamine pathway, which is linked to nicotine addiction. \u0000Methods: The authenticity of VAR was established by DSC and FTIR spectra. A UV spectrophotometric method was employed for determination of VAR in bulk and active pharmaceutical ingredient (API). \u0000Results: The authenticity of VAR was established by DSC and FTIR spectra. For the determination of VAR in bulk API (active pharmaceutical ingredient), a UV spectrophotometric approach was used. In the concentration range of 5–40 g/ml, the UV technique was linear. The lower% CV values of intraday and interday variability indicate the proposed methodology's robustness. The higher regression coefficient value(0.999) indicates the methodology is robust. \u0000Conclusions: The outcome of the physico-chemical experiments of drug molecule indicates suitability of oral route. Additionally, at different conditions like solid as well as liquid state, the drugmoleculewasobservedstable.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48067150","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}
Pub Date : 2023-07-07DOI: 10.9734/jpri/2023/v35i177389
Akash Sharma, Vriti Gamta, G. Luthra
This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.
{"title":"Regulatory Compliance in the United States: A Comprehensive Analysis of USFDA Guidelines and Implementation Strategies","authors":"Akash Sharma, Vriti Gamta, G. Luthra","doi":"10.9734/jpri/2023/v35i177389","DOIUrl":"https://doi.org/10.9734/jpri/2023/v35i177389","url":null,"abstract":"This research paper aims to provide a comprehensive analysis of regulatory compliance in the United States, with a specific focus on the guidelines set forth by the United States Food and Drug Administration (USFDA). Regulatory compliance plays a crucial role in ensuring the safety and efficacy of pharmaceutical products, medical devices, and food and beverages in the US market. This paper discusses the regulatory framework, key requirements, challenges faced by companies, and effective implementation strategies to achieve and maintain compliance with USFDA regulations. The findings of this research provide valuable insights for businesses operating in regulated industries and contribute to the understanding of the importance of regulatory compliance in the US.","PeriodicalId":16718,"journal":{"name":"Journal of Pharmaceutical Research International","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46937711","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}