A. Rajini, D. Jothieswari, S. R. N, N. A. Narayana
{"title":"Unravelling framework for herbal product manufacturing and approval in south India","authors":"A. Rajini, D. Jothieswari, S. R. N, N. A. Narayana","doi":"10.26452/fjphs.v4i1.552","DOIUrl":"https://doi.org/10.26452/fjphs.v4i1.552","url":null,"abstract":"This study investigates the regulatory framework for manufacturing and approving herbal products in South India, a region with increasing global demand for natural remedies. It focuses on understanding the specific guidelines and processes crucial for industry stakeholders and regulatory authorities. The research highlights the unique aspects of the South Indian regulatory environment, including botanical authenticity, safety assessments, labeling requirements, and the protection of traditional knowledge. The aim is to assist manufacturers, regulators, and policymakers in ensuring the quality, safety, and efficacy of herbal products. Methodologically, the study relies on document analysis, expert interviews, and case studies of approved herbal products. Its findings aim to enrich the understanding of herbal product regulation, promoting sustainable development and trade in this field. This research is a valuable asset for industry professionals, researchers, and policymakers in the herbal products sector. Keywords: Herbal products, regulatory framework, South India, traditional knowledge, safety assessments, authenticity. (160 words).","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"29 17","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139530717","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}
Kishore Bandarapalle, R. K. Kumarachari, Kamasani Teja Sri, Boyalapalli Neeraja, Chejarla Likhitha, Krishna Chaitanya, C. Y. Bhargavi
{"title":"A Review on regulatory affairs and regulatory requirements for drug approval","authors":"Kishore Bandarapalle, R. K. Kumarachari, Kamasani Teja Sri, Boyalapalli Neeraja, Chejarla Likhitha, Krishna Chaitanya, C. Y. Bhargavi","doi":"10.26452/fjphs.v4i1.550","DOIUrl":"https://doi.org/10.26452/fjphs.v4i1.550","url":null,"abstract":"Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of the regulatory professionals in this process as well as how crucial it is to perform and monitor the clinical and nonclinical trials of the drug before marketing the drug.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"10 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139531475","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}
Kishore Bandarapalle, R. K. Kumarachari, Kamasani Teja Sri, Boyalapalli Neeraja, Chejarla Likhitha, Krishna Chaitanya, C. Y. Bhargavi
{"title":"A comprehensive review on pilot plant scale up and platform technology","authors":"Kishore Bandarapalle, R. K. Kumarachari, Kamasani Teja Sri, Boyalapalli Neeraja, Chejarla Likhitha, Krishna Chaitanya, C. Y. Bhargavi","doi":"10.26452/fjphs.v4i1.549","DOIUrl":"https://doi.org/10.26452/fjphs.v4i1.549","url":null,"abstract":"The pharmaceutical business uses pilot plant scale-up strategies to create reliable manufacturing procedures and turn lab-scale formulas into commercial products. The place called Pilot is where the five elements Material, Man, Method, and Machine are combined to manufacture things. A tiny, basic lab scale formula will be tested on a replica of the intended plant in the pilot plant before spending a significant amount of money on a production unit. Scaling up a pilot plant provides information on formula examination, reviewing the range of pertinent processing equipment, understanding raw material specifications, production rate, and physical space requirements. It can hold accurate documentation and reports for analysis in support of the GMP procedure. This review research discusses the factors for solids, liquids, and semisolids for scaling up pilot plants. The primary goal of a pilot plant is to \"identify errors on a small scale and generate revenue on a large scale.\"","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"16 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139531109","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":"A Prospective Observational Study in a Tertiary Care Teaching Hospital on the Trends and Outcomes of Poisoning Cases","authors":"Chandu Lalitha, P. Venugopalaiah","doi":"10.26452/fjphs.v4i1.551","DOIUrl":"https://doi.org/10.26452/fjphs.v4i1.551","url":null,"abstract":"Developing countries suffer from significant morbidity and mortality making poisoning the global health problem with thousands of deaths occurring every year. In India, 70% of the land is occupied by Agriculture making farmers the worst affected which accounts for one-third of pesticide poisoning. Organophosphorus chemicals as well as purposeful self-ingestion of poison in an effort at suicide account for the majority of the significant burden of poisoning associated with morbidity and mortality. Enforcing the law correctly when it comes to the distribution and sale of addictive medications, establishing boundaries for electronic media when it comes to exposing people to harsh facts and raising societal awareness of the importance of education are essential objectives. Not only will it save countless lives, but it will also lower health budget costs by fighting and managing diseases in line with WHO targets in poor nations.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139531584","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}
Voleti Vijaya Kumar, N. M, Sreelekhaa T, Praveen A, E. S. Kumar, Srinath M, Vishwa S, Shanmugapandiyan P
{"title":"Comprehensive Review of Oro Dispersible Tablets and Co Processed Super disintegrants","authors":"Voleti Vijaya Kumar, N. M, Sreelekhaa T, Praveen A, E. S. Kumar, Srinath M, Vishwa S, Shanmugapandiyan P","doi":"10.26452/fjphs.v4i1.548","DOIUrl":"https://doi.org/10.26452/fjphs.v4i1.548","url":null,"abstract":"Due to their ease of administration, self-administration, and improved patient compliance, solid dosage forms are most popular. The most normally utilized strong dose structures are tablets and capsules, which is challenging for pediatric and geriatric patients. Considering these prerequisites endeavors have been made to foster rapid dissolving Tablets. The solid dosage form of a medicine that dissolves in a matter of seconds when swallowed is known as orodispersible tablet. The utilization of Superdisintegrants improves the crumbling season of the tablet. Fast Dissolving Tablets are generally liked because of their convenience, higher bioavailability, quick disintegration and breaking down of the medication. The various technologies utilized in the formulation of Orodispersible tablets (ODT) and their evaluation are the primary focus of this review.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139530672","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":"Deciphering the narcotic drugs and psychotropic substances act of 1985 and its enforcement guidelines in India","authors":"Dhamotharan Jothieswari, Darmi Hima Bindu, Audinarayana Nelavala","doi":"10.26452/fjphs.v3i4.535","DOIUrl":"https://doi.org/10.26452/fjphs.v3i4.535","url":null,"abstract":"This study explores the Narcotic Drugs and Psychotropic Substances Act of 1985 (NDPS Act) and its enforcement in South India. It provides a nuanced understanding of the Act's application through an analysis of legal provisions, case studies, and regional practices. The research focuses on regulatory frameworks, law enforcement strategies, and the societal impact of drug control policies in the southern states of India, highlighting the multifaceted nature of these policies. The findings emphasize the importance of context- specific approaches in drug regulation and enforcement. The NDPS Act, enacted by the Government of India, addresses the illicit trafficking and abuse of narcotic drugs and psychotropic substances. It regulates activities related to these substances, including production, manufacture, possession, sale, purchase, transport, warehousing, use, consumption, and inter-state and international trade. This comprehensive legislation plays a crucial role in shaping drug control strategies and has significant implications for both legal enforcement and social dynamics within the region.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"1 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138968024","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}
Munna Sreenivasulu, Chiramana Rama Bharathi, Y. P. Chandra
{"title":"A review on severe acute respiratory syndrome (SARS)","authors":"Munna Sreenivasulu, Chiramana Rama Bharathi, Y. P. Chandra","doi":"10.26452/fjphs.v3i4.531","DOIUrl":"https://doi.org/10.26452/fjphs.v3i4.531","url":null,"abstract":"Severe acute respiratory syndrome (SARS) is a newly arose illness that quickly spread all over the world. The ailment arose in south China including a new coronavirus (SARS-COV) was suspected of being involved as the underlying cause. The trail the said pathogen ended up taking to set up human illness abide uncertain, nevertheless initial findings said that the roots of this disease was from intermediate animal host. Hospital acquired spreading of SARS-COV has become a prominent characteristic during the pandemic. The disease is comparable to several RTI 's, even though huge percentage of victims exhibit a sharp decrease in health with airway obstruction near the 2nd week ending of infection. The Treatment methods are pretty much identical as the treatment of many other communicable lung infections however the measures for restricting the disease start taking a prominent aspect. Also, the antiviral drug action has not been proved counter to SARS-COV. One of the best striking characteristics of this disease outbreak was the rapidity for this the entire world started acting in a cohesive way to manage it. The entire review discusses the etiology, epidemiology, clinical manifestations, diagnostic methods, preventive care, pathology and pathogenesis of severe acute respiratory syndrome along with its treatment.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"138 30","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139003884","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":"Is Transdermal Delivery Potential Route for Sitagliptin Phosphate: The pH Control Effect","authors":"Chika J Mbah, William O Obonga, Chidinma M Ekebor","doi":"10.26452/fjphs.v3i4.532","DOIUrl":"https://doi.org/10.26452/fjphs.v3i4.532","url":null,"abstract":"The objective of this study is to predict transdermal delivery as a potential route for sitagliptin phosphate. The partition coefficient of sitagliptin phosphate was measured in a chloroform-buffer system using the shake flask method at room temperature, and the analysis was performed under different pH conditions. Established mathematical equations were employed to calculate transdermal parameters. The results indicate that the logarithm partition coefficient values of the drug at pH 2.0 (0.354) and pH 3.0 (0.293) were higher compared to the control (0.274). Statistical analysis revealed the rejection of the null hypothesis at a 95% confidence level when comparing the mean partition coefficient of the drug at pH 2.0 to the mean partition coefficient of the drug in distilled water (control). In conclusion, the results suggest that using permeability coefficient as a reliable parameter, an aqueous solution of pH 2.0 would be the preferred vehicle to formulate a potential transdermal dosage form of sitagliptin phosphate.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"18 S7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139004084","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":"A Review on Calcinosis cutis","authors":"Yeruva Mallikarjuna Reddy","doi":"10.26452/fjphs.v3i4.516","DOIUrl":"https://doi.org/10.26452/fjphs.v3i4.516","url":null,"abstract":"Calcinosis (hydroxyapatite but also calcium and phosphate particle depositions) inside the matrix proteins of both the skin and subcutaneous stroma is just a regularly attended personification like pediatric and adult immune-mediated chronic inflammatory pathogens, particularly system-wide patients with multiple, physiological conditions, mingled soft tissue illness, as well as autoimmune disorder providing the ability. Listed here, researchers overview classifying like mainly characterized, illustrate processes which may make a contribution towards the pathophysiologic like mainly characterized, but also sum up this same scientific proof trying to evaluate non - non-pharmacologic as well as pharmacodynamic intervention and prevention again for remedy like mainly characterized. calcinosis cutis has been best described even by the accumulation of irresolvable calcium ions within the epidermis as well as subcutaneous. These same symptoms seem to be kept separate into 5 subgroups: dystrophic calcification, metastatic calcification, idiopathic calcification, iatrogenic calcification, as well as calciphylaxis. dysplastic calcium deposits would seem because of municipalities' cellular damage as well as the regular calcium and phosphorus layers throughout the plasma. Distant metastasis calcified seems to be best described by such irregular potassium as well as phosphorous various metabolic, resulting in this same formation of calcium through skin lesions as well as subcutaneous. Undiagnosed calcified takes place without even any subcutaneous tissue destruction as well as a particular disease. Epidermis calcified throughout autoimmune mainly characterized syndrome is a rare is indeed a secondary effect like therapeutic. Calciphylaxis introduced for container ship calcium deposits primarily affects the vascular system of both the dermal layer as well as subcutaneous adipose. Disruptions through calcium and phosphorus biotransformation as well as congenital hypothyroidism can indeed be recognized.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"258 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135320511","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}
Likitha A, Prapurna Chandra Y, Penabaka Venugopalaiah, Yerikala Ramesh
{"title":"Adapalene Gel Therapy in Patients with Moderate to Severe Acne Vulgaris","authors":"Likitha A, Prapurna Chandra Y, Penabaka Venugopalaiah, Yerikala Ramesh","doi":"10.26452/fjphs.v3i4.515","DOIUrl":"https://doi.org/10.26452/fjphs.v3i4.515","url":null,"abstract":"Acne is a chronic inflammatory disease of pilosebaceous units. Topical Adapalene is the most effective despite the availability of various treatments. Abnormalities in plasma lipids are recognized side effects of Adapalene therapy. Minimal reports compare the lipid changes in intermittent and continuous Adapalene treatment. To evaluate the alteration in lipid profile before, during, and after constant/ intermittent topical Adapalene therapy. One hundred patients with moderate to severe acne were randomly assigned to two treatment regimens. Serum levels of lipids were measured at baseline, 4wk, 8wk, 12wk, 16wk, and at the end of the treatment. A significant increase in cholesterol, triglyceride, and LDL concentration and a decrease in HDL levels in a continuous regimen beyond the normal range but not requiring any treatment interruption compared to intermittent therapy. In intermittent therapy, the cholesterol, triglyceride, and LDL concentration increase was within the normal range. Intermittent Adapalene therapy was clinically equally effective, with lesser effects on serum lipid levels and cost than continuous Adapalene therapy.","PeriodicalId":12614,"journal":{"name":"Future Journal of Pharmaceuticals and Health Sciences","volume":"5 3-4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135272108","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}