Pub Date : 2024-02-02DOI: 10.2174/0115748855267031240102070325
Surbhi Tyagi, V. K. Shukla, Sandeep Arora
Biopharmaceuticals differ significantly from chemical drugs, and thus their CMC regulatory compliance is distinct from them. The development of biologicals, like mRNA vaccines, holds promise for preventing infectious diseases and generating an antigen-specific immune response. These vaccines are a better option than traditional vaccination methods because of their significant potency and swift and affordable manufacture. The compliance strategy is shaped by evaluating resource allocation and risk tolerance. This review examines the CMC regulatory requirements concerned with the manufacturing of biologics, particularly mRNA vaccines. The many challenges that could arise when producing biological products are also discussed in this paper, like the introduction of adventitious agents that can affect the safety of the product and the molecular designs of mRNA molecules, which may need to be optimized for higher protein expression and improved structural stability. By implementing the Quality by Design approach during the development, a better understanding of the controls and risk management should be utilized to minimize the risk and improve compliance
{"title":"CMC and QMS Regulatory Requirements and Challenges for\u0000mRNA-based Vaccines","authors":"Surbhi Tyagi, V. K. Shukla, Sandeep Arora","doi":"10.2174/0115748855267031240102070325","DOIUrl":"https://doi.org/10.2174/0115748855267031240102070325","url":null,"abstract":"\u0000\u0000Biopharmaceuticals differ significantly from chemical drugs, and thus their CMC regulatory compliance is distinct from them. The development of biologicals, like mRNA vaccines, holds\u0000promise for preventing infectious diseases and generating an antigen-specific immune response.\u0000These vaccines are a better option than traditional vaccination methods because of their significant\u0000potency and swift and affordable manufacture. The compliance strategy is shaped by evaluating resource allocation and risk tolerance. This review examines the CMC regulatory requirements concerned with the manufacturing of biologics, particularly mRNA vaccines. The many challenges that\u0000could arise when producing biological products are also discussed in this paper, like the introduction\u0000of adventitious agents that can affect the safety of the product and the molecular designs of mRNA\u0000molecules, which may need to be optimized for higher protein expression and improved structural\u0000stability. By implementing the Quality by Design approach during the development, a better understanding of the controls and risk management should be utilized to minimize the risk and improve\u0000compliance\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139869154","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 : 2024-02-02DOI: 10.2174/0115748855267031240102070325
Surbhi Tyagi, V. K. Shukla, Sandeep Arora
Biopharmaceuticals differ significantly from chemical drugs, and thus their CMC regulatory compliance is distinct from them. The development of biologicals, like mRNA vaccines, holds promise for preventing infectious diseases and generating an antigen-specific immune response. These vaccines are a better option than traditional vaccination methods because of their significant potency and swift and affordable manufacture. The compliance strategy is shaped by evaluating resource allocation and risk tolerance. This review examines the CMC regulatory requirements concerned with the manufacturing of biologics, particularly mRNA vaccines. The many challenges that could arise when producing biological products are also discussed in this paper, like the introduction of adventitious agents that can affect the safety of the product and the molecular designs of mRNA molecules, which may need to be optimized for higher protein expression and improved structural stability. By implementing the Quality by Design approach during the development, a better understanding of the controls and risk management should be utilized to minimize the risk and improve compliance
{"title":"CMC and QMS Regulatory Requirements and Challenges for\u0000mRNA-based Vaccines","authors":"Surbhi Tyagi, V. K. Shukla, Sandeep Arora","doi":"10.2174/0115748855267031240102070325","DOIUrl":"https://doi.org/10.2174/0115748855267031240102070325","url":null,"abstract":"\u0000\u0000Biopharmaceuticals differ significantly from chemical drugs, and thus their CMC regulatory compliance is distinct from them. The development of biologicals, like mRNA vaccines, holds\u0000promise for preventing infectious diseases and generating an antigen-specific immune response.\u0000These vaccines are a better option than traditional vaccination methods because of their significant\u0000potency and swift and affordable manufacture. The compliance strategy is shaped by evaluating resource allocation and risk tolerance. This review examines the CMC regulatory requirements concerned with the manufacturing of biologics, particularly mRNA vaccines. The many challenges that\u0000could arise when producing biological products are also discussed in this paper, like the introduction\u0000of adventitious agents that can affect the safety of the product and the molecular designs of mRNA\u0000molecules, which may need to be optimized for higher protein expression and improved structural\u0000stability. By implementing the Quality by Design approach during the development, a better understanding of the controls and risk management should be utilized to minimize the risk and improve\u0000compliance\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139809196","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 rise in age-adjusted mortality rates from hypertension and hypertensive diseases over the last several years suggests that hypertension is one of the main risk factors for heart disease. As a result, managing hypertension, both via preventive and therapeutic medicine, involves a heavy socioeconomic burden. This review paper's objective is to summarize information on chronotherapy techniques, which can make it possible for an active component to be distributed predictably and at a pace that may also minimize the patient’s illness symptoms. To incorporate published research and review papers, a comprehensive review of the literature from many sources during the past 25 years was conducted. This paper summarizes the principle and method of the chronotherapy technique. The review also throws light on different approaches that could be used to meet the need for medication for the hypertensive patient according to the circadian cycle. From the study, it was concluded that different formulation approaches are there that can work according to the principle of chronotherapy with improvement in drug bioavailability and patient compliance. To encourage future researchers to include chronotherapy in the creation of additional formulations, this review study intends to shed light on various benefits and methods of chronotherapy.
{"title":"Role of Chronotherapy in the Management of Hypertension: An Overview","authors":"Ritik Raj, Rupa Mazumder, Rakhi Mishra, Rashmi Mishra, Dileep Singh Baghel","doi":"10.2174/0115748855278395240119063324","DOIUrl":"https://doi.org/10.2174/0115748855278395240119063324","url":null,"abstract":"\u0000\u0000The rise in age-adjusted mortality rates from hypertension and hypertensive diseases over\u0000the last several years suggests that hypertension is one of the main risk factors for heart disease. As a\u0000result, managing hypertension, both via preventive and therapeutic medicine, involves a heavy socioeconomic\u0000burden. This review paper's objective is to summarize information on chronotherapy techniques,\u0000which can make it possible for an active component to be distributed predictably and at a pace\u0000that may also minimize the patient’s illness symptoms. To incorporate published research and review\u0000papers, a comprehensive review of the literature from many sources during the past 25 years was\u0000conducted. This paper summarizes the principle and method of the chronotherapy technique. The\u0000review also throws light on different approaches that could be used to meet the need for medication\u0000for the hypertensive patient according to the circadian cycle. From the study, it was concluded that\u0000different formulation approaches are there that can work according to the principle of chronotherapy\u0000with improvement in drug bioavailability and patient compliance. To encourage future researchers to\u0000include chronotherapy in the creation of additional formulations, this review study intends to shed\u0000light on various benefits and methods of chronotherapy.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139890866","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 rise in age-adjusted mortality rates from hypertension and hypertensive diseases over the last several years suggests that hypertension is one of the main risk factors for heart disease. As a result, managing hypertension, both via preventive and therapeutic medicine, involves a heavy socioeconomic burden. This review paper's objective is to summarize information on chronotherapy techniques, which can make it possible for an active component to be distributed predictably and at a pace that may also minimize the patient’s illness symptoms. To incorporate published research and review papers, a comprehensive review of the literature from many sources during the past 25 years was conducted. This paper summarizes the principle and method of the chronotherapy technique. The review also throws light on different approaches that could be used to meet the need for medication for the hypertensive patient according to the circadian cycle. From the study, it was concluded that different formulation approaches are there that can work according to the principle of chronotherapy with improvement in drug bioavailability and patient compliance. To encourage future researchers to include chronotherapy in the creation of additional formulations, this review study intends to shed light on various benefits and methods of chronotherapy.
{"title":"Role of Chronotherapy in the Management of Hypertension: An Overview","authors":"Ritik Raj, Rupa Mazumder, Rakhi Mishra, Rashmi Mishra, Dileep Singh Baghel","doi":"10.2174/0115748855278395240119063324","DOIUrl":"https://doi.org/10.2174/0115748855278395240119063324","url":null,"abstract":"\u0000\u0000The rise in age-adjusted mortality rates from hypertension and hypertensive diseases over\u0000the last several years suggests that hypertension is one of the main risk factors for heart disease. As a\u0000result, managing hypertension, both via preventive and therapeutic medicine, involves a heavy socioeconomic\u0000burden. This review paper's objective is to summarize information on chronotherapy techniques,\u0000which can make it possible for an active component to be distributed predictably and at a pace\u0000that may also minimize the patient’s illness symptoms. To incorporate published research and review\u0000papers, a comprehensive review of the literature from many sources during the past 25 years was\u0000conducted. This paper summarizes the principle and method of the chronotherapy technique. The\u0000review also throws light on different approaches that could be used to meet the need for medication\u0000for the hypertensive patient according to the circadian cycle. From the study, it was concluded that\u0000different formulation approaches are there that can work according to the principle of chronotherapy\u0000with improvement in drug bioavailability and patient compliance. To encourage future researchers to\u0000include chronotherapy in the creation of additional formulations, this review study intends to shed\u0000light on various benefits and methods of chronotherapy.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139831254","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}
One of the classes of injective antidiabetic agents includes Glucagon-like peptide-1 receptor agonists (GLP-1RA) which ameliorate glycemia and numerous atherosclerosis-related factors in individuals prone to Type 2 diabetes mellitus (T2-DM) disorder. The review paper targeted the role of GLP-1RA in managing DM. The literature published during the last decades in several data-based searches (PubMed, Scopus, ScienceDirect) was reviewed and compiled the therapeutic uses of GLP-1 RA in the management of DM. In this review, we have discussed GLP-1RA and its role in the management of diabetes mellitus. Disrupted homeostasis marks insulin resistance and β-cell deterioration as two major indications of T2-DM. β-cells failure (~80% of functioning of β-cell) and insulin resistance in the liver and muscles are primarily susceptive to physiological defects. GLP-1RAs if administered for a prolonged period also cause a loss in weight through the activation of receptors of GLP-1 found in hypothalamic satiety centers which control appetite and decrease intake of calories. They not only assist in controlling blood glucose but also improve β- cell function and post–diabetic conditions namely hyperlipidemia, obesity, and hypertension. It was concluded that GLP-1RA has a new therapeutic approach to the management of DM. Hence, GLP-1RA provides distinctive and innovative evolution for the treatment of T2-DM.
{"title":"Clinical Analysis of Resemblance and Dissimilarities of Glucagon-like\u0000Peptide-1 Receptor Agonists: Therapeutic Approach Towards the\u0000Management of Diabetes Mellitus","authors":"Sashi, Kajal Rani, Komal Rani, Ankita, Vineet Mittal, Deepak Kaushik, Manish Dhall, Prabhjeet Kaur Bamrah, Tarun Kumar, Manisha Pandey, Neha Jain, Ashwani Arya","doi":"10.2174/0115748855276929231218053337","DOIUrl":"https://doi.org/10.2174/0115748855276929231218053337","url":null,"abstract":"\u0000\u0000One of the classes of injective antidiabetic agents includes Glucagon-like peptide-1 receptor\u0000agonists (GLP-1RA) which ameliorate glycemia and numerous atherosclerosis-related factors in\u0000individuals prone to Type 2 diabetes mellitus (T2-DM) disorder.\u0000\u0000\u0000\u0000The review paper targeted the role of GLP-1RA in managing DM. The literature published\u0000during the last decades in several data-based searches (PubMed, Scopus, ScienceDirect) was reviewed\u0000and compiled the therapeutic uses of GLP-1 RA in the management of DM. In this review,\u0000we have discussed GLP-1RA and its role in the management of diabetes mellitus.\u0000\u0000\u0000\u0000Disrupted homeostasis marks insulin resistance and β-cell deterioration as\u0000two major indications of T2-DM. β-cells failure (~80% of functioning of β-cell) and insulin resistance\u0000in the liver and muscles are primarily susceptive to physiological defects. GLP-1RAs if administered\u0000for a prolonged period also cause a loss in weight through the activation of receptors of GLP-1 found\u0000in hypothalamic satiety centers which control appetite and decrease intake of calories. They not only\u0000assist in controlling blood glucose but also improve β- cell function and post–diabetic conditions\u0000namely hyperlipidemia, obesity, and hypertension.\u0000\u0000\u0000\u0000It was concluded that GLP-1RA has a new therapeutic approach to the management of\u0000DM. Hence, GLP-1RA provides distinctive and innovative evolution for the treatment of T2-DM.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139820700","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}
One of the classes of injective antidiabetic agents includes Glucagon-like peptide-1 receptor agonists (GLP-1RA) which ameliorate glycemia and numerous atherosclerosis-related factors in individuals prone to Type 2 diabetes mellitus (T2-DM) disorder. The review paper targeted the role of GLP-1RA in managing DM. The literature published during the last decades in several data-based searches (PubMed, Scopus, ScienceDirect) was reviewed and compiled the therapeutic uses of GLP-1 RA in the management of DM. In this review, we have discussed GLP-1RA and its role in the management of diabetes mellitus. Disrupted homeostasis marks insulin resistance and β-cell deterioration as two major indications of T2-DM. β-cells failure (~80% of functioning of β-cell) and insulin resistance in the liver and muscles are primarily susceptive to physiological defects. GLP-1RAs if administered for a prolonged period also cause a loss in weight through the activation of receptors of GLP-1 found in hypothalamic satiety centers which control appetite and decrease intake of calories. They not only assist in controlling blood glucose but also improve β- cell function and post–diabetic conditions namely hyperlipidemia, obesity, and hypertension. It was concluded that GLP-1RA has a new therapeutic approach to the management of DM. Hence, GLP-1RA provides distinctive and innovative evolution for the treatment of T2-DM.
{"title":"Clinical Analysis of Resemblance and Dissimilarities of Glucagon-like\u0000Peptide-1 Receptor Agonists: Therapeutic Approach Towards the\u0000Management of Diabetes Mellitus","authors":"Sashi, Kajal Rani, Komal Rani, Ankita, Vineet Mittal, Deepak Kaushik, Manish Dhall, Prabhjeet Kaur Bamrah, Tarun Kumar, Manisha Pandey, Neha Jain, Ashwani Arya","doi":"10.2174/0115748855276929231218053337","DOIUrl":"https://doi.org/10.2174/0115748855276929231218053337","url":null,"abstract":"\u0000\u0000One of the classes of injective antidiabetic agents includes Glucagon-like peptide-1 receptor\u0000agonists (GLP-1RA) which ameliorate glycemia and numerous atherosclerosis-related factors in\u0000individuals prone to Type 2 diabetes mellitus (T2-DM) disorder.\u0000\u0000\u0000\u0000The review paper targeted the role of GLP-1RA in managing DM. The literature published\u0000during the last decades in several data-based searches (PubMed, Scopus, ScienceDirect) was reviewed\u0000and compiled the therapeutic uses of GLP-1 RA in the management of DM. In this review,\u0000we have discussed GLP-1RA and its role in the management of diabetes mellitus.\u0000\u0000\u0000\u0000Disrupted homeostasis marks insulin resistance and β-cell deterioration as\u0000two major indications of T2-DM. β-cells failure (~80% of functioning of β-cell) and insulin resistance\u0000in the liver and muscles are primarily susceptive to physiological defects. GLP-1RAs if administered\u0000for a prolonged period also cause a loss in weight through the activation of receptors of GLP-1 found\u0000in hypothalamic satiety centers which control appetite and decrease intake of calories. They not only\u0000assist in controlling blood glucose but also improve β- cell function and post–diabetic conditions\u0000namely hyperlipidemia, obesity, and hypertension.\u0000\u0000\u0000\u0000It was concluded that GLP-1RA has a new therapeutic approach to the management of\u0000DM. Hence, GLP-1RA provides distinctive and innovative evolution for the treatment of T2-DM.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139880355","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}
Psoriasis is a chronic inflammatory and proliferative skin disorder characterized by redness and elevated patches covered in scaly, silvery-white skin. The National Psoriasis Foundation categorizes psoriasis into mild, moderate, and severe, impacting 2% to 5% of the global population. This article explores the types, development, and severity categories of psoriasis, delving into its pathophysiology. It also reviews both conventional and herbal topical therapies and their marketed formulations. The study aimed to contribute to the development of personalized treatment approaches for individuals with psoriasis. This article explores the types, development, and severity categories of psoriasis, delving into its pathophysiology. It also reviews both conventional and herbal topical therapies and their marketed formulations. The article relies on a comprehensive review of existing literature and research studies on psoriasis. Information on types, severity categories, pathophysiology, and available treatments, both conventional and herbal, is gathered and analyzed. The results highlight the potential advantages of incorporating herbal therapies into treatment plans for individuals with psoriasis, especially for those with severe cases. In conclusion, the article emphasizes the importance of individualized treatment plans for managing psoriasis. Both conventional and herbal topical formulations can be viable options, particularly for severe cases. By considering the safety profiles, side effects, and biological activities associated with these treatments, healthcare experts can collaborate with patients to create personalized and effective strategies for addressing the complexities of psoriasis management.
{"title":"From Pathophysiology to Personalized Treatment Strategies for Psoriasis","authors":"Aashima Barak, Anjali Sharma, Vishnu Mittal, Rohit Grover, Deepshi Arora, Akash Gupta","doi":"10.2174/0115748855279099240119110656","DOIUrl":"https://doi.org/10.2174/0115748855279099240119110656","url":null,"abstract":"\u0000\u0000Psoriasis is a chronic inflammatory and proliferative skin disorder characterized\u0000by redness and elevated patches covered in scaly, silvery-white skin. The National Psoriasis\u0000Foundation categorizes psoriasis into mild, moderate, and severe, impacting 2% to 5% of the global\u0000population. This article explores the types, development, and severity categories of psoriasis, delving\u0000into its pathophysiology. It also reviews both conventional and herbal topical therapies and their marketed\u0000formulations.\u0000\u0000\u0000\u0000The study aimed to contribute to the development of personalized treatment approaches for\u0000individuals with psoriasis.\u0000\u0000\u0000\u0000This article explores the types, development, and severity categories of psoriasis, delving\u0000into its pathophysiology. It also reviews both conventional and herbal topical therapies and their marketed\u0000formulations.\u0000\u0000\u0000\u0000The article relies on a comprehensive review of existing literature and research studies on\u0000psoriasis. Information on types, severity categories, pathophysiology, and available treatments, both\u0000conventional and herbal, is gathered and analyzed.\u0000\u0000\u0000\u0000The results highlight the potential advantages of incorporating herbal therapies into treatment\u0000plans for individuals with psoriasis, especially for those with severe cases.\u0000\u0000\u0000\u0000In conclusion, the article emphasizes the importance of individualized treatment plans\u0000for managing psoriasis. Both conventional and herbal topical formulations can be viable options,\u0000particularly for severe cases. By considering the safety profiles, side effects, and biological activities\u0000associated with these treatments, healthcare experts can collaborate with patients to create personalized\u0000and effective strategies for addressing the complexities of psoriasis management.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140478511","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 : 2024-01-30DOI: 10.2174/0115748855274979231228103038
Bhupendra G. Prajapati, Anand Bhagat, Biswajit Basu
Pepsin is a proteolytic enzyme which is widely used as a digestive aid. Its dose is 300 mg - 1 gm per day in divided doses. Its biological half-life is around 3.5 hrs. Pepsin is active only in the acidic pH of the stomach; its activity decreases tremendously in the basic pH. So, it is required to retain in the stomach for maximum proteolytic activity. The goal of the current effort is to develop and assess an oral controlled floating drug delivery system for pepsin that will shorten its stay in the stomach and result in a longer effect. The 12-hour sustained effect of pepsin floating microspheres was planned. This also improves the stability of the Pepsin by immobilizing them on the microsphere. Pepsin is widely used in chronic gastritis, so developing a floating drug delivery system is therefore necessary. In light of the aforementioned principles, a critical need for the creation of a dosage form to administer Pepsin in the stomach and boost the enzyme's effectiveness, enabling sustained action, was identified. The current study used a methodical strategy to create floating microspheres of Pepsin dosage forms. Optimization was done for floating ability, yield, entrapment efficiency, and release study using different concentrations of ethylcellulose & HPMC E4M. For parameter optimization and to demonstrate the significant impact of variables, 32 full factorial designs were used. The manufactured microspheres had good encapsulation rates, excellent floating, & excellent micromeritic properties as single-unit dosage forms. It has been demonstrated that pepsin prepared as floating microspheres can be used to improve proteolytic activity and extend pepsin's gastric residence.
{"title":"Preparation & Characterization of Sustained-release Floating Microsphere\u0000of Digestive Enzymes","authors":"Bhupendra G. Prajapati, Anand Bhagat, Biswajit Basu","doi":"10.2174/0115748855274979231228103038","DOIUrl":"https://doi.org/10.2174/0115748855274979231228103038","url":null,"abstract":"\u0000\u0000Pepsin is a proteolytic enzyme which is widely used as a digestive aid. Its\u0000dose is 300 mg - 1 gm per day in divided doses. Its biological half-life is around 3.5 hrs. Pepsin is\u0000active only in the acidic pH of the stomach; its activity decreases tremendously in the basic pH. So,\u0000it is required to retain in the stomach for maximum proteolytic activity. The goal of the current effort\u0000is to develop and assess an oral controlled floating drug delivery system for pepsin that will shorten\u0000its stay in the stomach and result in a longer effect.\u0000\u0000\u0000\u0000The 12-hour sustained effect of pepsin floating microspheres was planned. This also improves the stability of the Pepsin by immobilizing them on the microsphere. Pepsin is widely used in\u0000chronic gastritis, so developing a floating drug delivery system is therefore necessary. In light of the\u0000aforementioned principles, a critical need for the creation of a dosage form to administer Pepsin in\u0000the stomach and boost the enzyme's effectiveness, enabling sustained action, was identified. The current study used a methodical strategy to create floating microspheres of Pepsin dosage forms.\u0000\u0000\u0000\u0000Optimization was done for floating ability, yield, entrapment efficiency, and release study\u0000using different concentrations of ethylcellulose & HPMC E4M. For parameter optimization and to\u0000demonstrate the significant impact of variables, 32 full factorial designs were used. The manufactured\u0000microspheres had good encapsulation rates, excellent floating, & excellent micromeritic properties as\u0000single-unit dosage forms.\u0000\u0000\u0000\u0000It has been demonstrated that pepsin prepared as floating microspheres can be used to\u0000improve proteolytic activity and extend pepsin's gastric residence.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140483784","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 : 2024-01-26DOI: 10.2174/0115748855272494240109103657
Iqra Subhan, Sumbul Khan, Himanshi Varshney, K. Gaur, Y. Siddique
Geraniol is a terpene alcohol occurring in the essential oils of several aromatic plants. It is commercially used as a fragrance compound in cosmetics and several products of a household. It possesses a number of biological properties. To study the effect of geraniol on the toxicity induced by paracetamol. To study the effect of geraniol against the toxicity induced by paracetamol In the present study, geraniol at the final concentration of 0.0005, 0.0025, 0.0050 and 0.0075 M was mixed in the diet along with the 0.0075 M of paracetamol and the third instar larvae of transgenic Drosophila melanogaster (hsp70-lac Z)Bg9 were allowed to feed on it for 24 hrs. Larvae exposed to paracetamol along with the various doses of geraniol showed a dose-dependent decrease in the activity of β-galactosidase, tissue damage, oxidative stress markers, DNA damage and apoptosis. The results suggest that geraniol is potent in reducing the toxicity induced by paracetamol in the third instar larvae of transgenic Drosophila. Hence, it is concluded that paracetamol showed toxic effects in the third instar larvae of transgenic Drosophila, and geraniol is potent in reducing the toxic effects induced by paracetamol.
香叶醇是一种萜烯醇，存在于多种芳香植物的精油中。它在商业上被用作化妆品和一些家用产品的香味化合物。To study the effect of geraniol against the toxicity induced by paracetamol.To study the effect of geraniol against the toxicity induced by paracetamolIn the present study, geraniol at the final concentration of 0.0005, 0.0025, 0.0050 and 0.0075M was mixed in the diet along with the 0.幼虫暴露于扑热息痛和不同剂量的香叶醇后，β-半乳糖苷酶活性、组织损伤、氧化应激标记物、DNA损伤和细胞凋亡均出现了剂量依赖性下降。结果表明，香叶醇能有效降低扑热息痛对转基因果蝇三龄幼虫的毒性。
{"title":"Effect of Geraniol against the Toxicity Induced by Paracetamol in the Third Instar Larvae of Transgenic Drosophila Melanogaster (hsp70-lac Z)Bg9","authors":"Iqra Subhan, Sumbul Khan, Himanshi Varshney, K. Gaur, Y. Siddique","doi":"10.2174/0115748855272494240109103657","DOIUrl":"https://doi.org/10.2174/0115748855272494240109103657","url":null,"abstract":"\u0000\u0000Geraniol is a terpene alcohol occurring in the essential oils of several aromatic\u0000plants. It is commercially used as a fragrance compound in cosmetics and several products of\u0000a household. It possesses a number of biological properties.\u0000\u0000\u0000\u0000To study the effect of geraniol on the toxicity induced by paracetamol.\u0000\u0000\u0000\u0000To study the effect of geraniol against the toxicity induced by paracetamol\u0000\u0000\u0000\u0000In the present study, geraniol at the final concentration of 0.0005, 0.0025, 0.0050 and 0.0075\u0000M was mixed in the diet along with the 0.0075 M of paracetamol and the third instar larvae of transgenic\u0000Drosophila melanogaster (hsp70-lac Z)Bg9 were allowed to feed on it for 24 hrs.\u0000\u0000\u0000\u0000Larvae exposed to paracetamol along with the various doses of geraniol showed a dose-dependent\u0000decrease in the activity of β-galactosidase, tissue damage, oxidative stress markers, DNA\u0000damage and apoptosis. The results suggest that geraniol is potent in reducing the toxicity induced by\u0000paracetamol in the third instar larvae of transgenic Drosophila.\u0000\u0000\u0000\u0000Hence, it is concluded that paracetamol showed toxic effects in the third instar larvae of\u0000transgenic Drosophila, and geraniol is potent in reducing the toxic effects induced by paracetamol.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140493418","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 : 2024-01-25DOI: 10.2174/0115748855286072240101072301
Himanshu Gupta, Jitendra Singh Chaudhary, D. Chanchal
This in-depth analysis examines the revolutionary potential of nanostructures, particularly niosomes, in boosting Clotrimazole's therapeutic effectiveness for dermatological applications. A common antifungal drug called clotrimazole suffers significant problems with solubility, bioavailability, and penetration. Niosomal gels in particular, which are nanostructured drug carriers, have emerged as ground-breaking approaches to overcome these constraints. The study opens with an explanation of the mechanisms of action of Clotrimazole and its wide range of therapeutic uses in dermatology, emphasising the limitations of standard formulations. We present and explore niosomes, lipid-based nanocarriers with diverse characteristics. They provide a viable substrate for improved Clotrimazole administration due to their biocompatibility, adjustable lipid composition, and capacity to encapsulate both hydrophilic and hydrophobic medications. The creation and development of clotrimazole- loaded niosomal gels are at the core of the review. Numerous preparation processes are investigated, and elements affecting the formation of niosomal gel, such as lipid content and optimization strategies, are reviewed. Particle size analysis and encapsulation efficiency testing are two methods for characterising these gels that are covered in depth. The effectiveness of Clotrimazoleloaded niosomal gels is validated in large part by in vitro and in vivo tests. The review explores in vitro drug release investigations, studies of skin permeability and penetration, and comparisons with conventional formulations. When accessible, preclinical and clinical trial insights provide crucial clinical context. The benefits of clotrimazole-loaded niosomal gels, such as greater patient compliance and improved drug delivery, are also covered in the article. It solves difficulties including stability issues and regulatory issues. The review's conclusion emphasises the essential role that nanostructures and niosomes have played in developing Clotrimazole medicines for dermatological usage. It provides a thorough review of current developments, exciting new approaches, and the wider effects of this ground-breaking medication delivery strategy.
{"title":"Nanostructures and Niosomes: A Quantum Leap in Clotrimazole Therapeutics","authors":"Himanshu Gupta, Jitendra Singh Chaudhary, D. Chanchal","doi":"10.2174/0115748855286072240101072301","DOIUrl":"https://doi.org/10.2174/0115748855286072240101072301","url":null,"abstract":"\u0000\u0000This in-depth analysis examines the revolutionary potential of nanostructures, particularly\u0000niosomes, in boosting Clotrimazole's therapeutic effectiveness for dermatological applications. A\u0000common antifungal drug called clotrimazole suffers significant problems with solubility, bioavailability,\u0000and penetration. Niosomal gels in particular, which are nanostructured drug carriers, have\u0000emerged as ground-breaking approaches to overcome these constraints. The study opens with an explanation\u0000of the mechanisms of action of Clotrimazole and its wide range of therapeutic uses in dermatology,\u0000emphasising the limitations of standard formulations. We present and explore niosomes,\u0000lipid-based nanocarriers with diverse characteristics. They provide a viable substrate for improved\u0000Clotrimazole administration due to their biocompatibility, adjustable lipid composition, and capacity\u0000to encapsulate both hydrophilic and hydrophobic medications. The creation and development of clotrimazole-\u0000loaded niosomal gels are at the core of the review. Numerous preparation processes are\u0000investigated, and elements affecting the formation of niosomal gel, such as lipid content and optimization\u0000strategies, are reviewed. Particle size analysis and encapsulation efficiency testing are two\u0000methods for characterising these gels that are covered in depth. The effectiveness of Clotrimazoleloaded\u0000niosomal gels is validated in large part by in vitro and in vivo tests. The review explores in\u0000vitro drug release investigations, studies of skin permeability and penetration, and comparisons with\u0000conventional formulations. When accessible, preclinical and clinical trial insights provide crucial\u0000clinical context. The benefits of clotrimazole-loaded niosomal gels, such as greater patient compliance\u0000and improved drug delivery, are also covered in the article. It solves difficulties including stability\u0000issues and regulatory issues. The review's conclusion emphasises the essential role that\u0000nanostructures and niosomes have played in developing Clotrimazole medicines for dermatological\u0000usage. It provides a thorough review of current developments, exciting new approaches, and the wider\u0000effects of this ground-breaking medication delivery strategy.\u0000","PeriodicalId":11004,"journal":{"name":"Current Drug Therapy","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2024-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140495492","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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