Applied Drug Research, Clinical Trials and Regulatory Affairs - Current Issue
Volume 9, Issue 1, 2022
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Building and Implementing a Quality Assurance/Quality Improvement Program for Clinical Research
Authors: Reva Bruns, Marietta Barton-Baxter, Roxane Poskin, Philip A. Kern and William W. StoopsBackground: A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices. Objective: One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical, and safe. Methods: The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program’s goal was to improve research design quality and, from the start of the project, “find it, fix it”, leading to improved PI education without being viewed as punitive. Results: Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth. Conclusion: A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational, and well accepted by all clinical research stakeholders.
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Formulation and Development of Nanostructured Lipid Carriers for a Poorly Water-Soluble Drug: Furosemide
Authors: Abhish B. Jadhav, Anand D. Savkare and Sachin S. GaikwadAim: Formulation, development and evaluation of solid lipid nanoparticles. Background: It was found that furosemide (FU) was a very potent drug but it fails to produce bioavailability due to its BCS class IV, so drug- cyclodextrin (CD)- nanostructured lipid carriers (NLC) will be an alternative to improve solubility and permeability as a result of this overall bioavaibility will be improved. Objective: To improve the solubility of drug by using complexation of cyclodextrin. Coating with the lipids (NLC) will improve the permeability of the drug. Methods: To generate solid Furosemide-cyclodextrin complexes (FU-CD), two distinct CDs and three different techniques were used. The co-evaporation (COE) Furosemide-β-cyclodextrinloaded NLC (FU- β-CD-COE-loaded NLC) was obtained by emulsification ultrasonic dispersion method. The selected batch was suitably characterized for particle size, polydispersity index, zeta potential, Entrapment efficiency, Drug release study, and permeability study. The crystallization of the drug in the furosemide cyclodextrin complex (FU-CD complex) and the co-evaporation Furosemide- β-cyclodextrin-loaded NLC (FU-β-CD-COE-loaded NLC) was investigated by differential scanning calorimetry (DSC). The in vitro release study was carried out. Results: The FU-β-CD-COE-loaded NLC and FU-HP-β-CD-COE-loaded NLC (Hydroxypropyl) presented a superior physicochemical property and were selected for further study. The in vitro release study of the above selected batches exhibited a higher dissolution rate in the pH 5.8 phosphate buffer than Furosemide suspension and FU-NLC. The permeability studies of abovementioned batches were compared with FU-Suspension. Conclusion: The novel formulation considerably enhanced the solubility and permeability of furosemide for oral delivery, and was successfully developed.
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Review of Modified Oral Solid Drug Delivery System and Recent Active Patents
Authors: Sachin S. Gaikwad, Shrikant K. Ainor, Narayan B. Lande and Kishor S. SalunkheBackground: A tablet is a solid dosage form containing Active Pharmaceutical Ingredients (API) and various excipients. Different procedures, such as direct compression of powder mixtures, and dry and wet granulation technologies, are used to create distinct types of tablets. Tablet development is aided by technological advancements in the form of modified-release tablets. Objective: The modified release dosage form can be manufactured to obtain a specific pharmaceutical profile, the specific site of action and reduce the number of dose administrations using a variety of coating technologies. For modified released drug delivery, various sorts of patents are explored. The review's primary goal is to provide information on modified release formulations, formulation methodologies, current active patents based on modified release, and tablet coating technologies. Conclusion: The tablet is a common and convenient pharmaceutical dosage form. Recently, modified release drug administration has largely supplanted traditional tablet drug delivery technologies. The chrono pharmaceutical drug delivery can also involve modified drug delivery. Modified release tablets are used to boost the therapeutic impact of medicine by targeting the location of action on the illness condition. Modified-release tablets are very handy, easy to create, cost-effective, and do not require high-cost equipment, and they are gaining in popularity these days. Patents for modified-release tablet dosage formulations that are currently active were also discussed.
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Safety of Soluplus® in Pediatrics
More LessThis paper provides information on the risk and acceptability of the polymeric solubilizer Soluplus® as an excipient in pediatric formulations. The assessment was performed based on safety data available from the manufacturer and publicly available data sources. Soluplus® is virtually non-toxic in rats and dogs after oral administration, consistent with its negligible systemic exposure. The non-toxic dose levels established in animals translate into a substantial Human Equivalent Dose (>300 mg/kg). Clinical safety data in adult subjects further support the presumed safe use of Soluplus® in pediatric clinical formulations. Based on existing data, additional toxicology studies in juvenile animals are not warranted. Overall, the use of Soluplus® as an excipient in pediatric oral clinical formulations in 300 mg or 30 mg/kg can be considered reasonably safe.
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Combating Childhood Cancer: Paediatric Patients Living with Neuroblastoma - Regulatory Ramifications and Roadblocks
By Manfred KurzThis paper relates to Neuroblastoma (NBL), a rare, solid cancer affecting children and aims to describe regulatory obligations to adhere to during development, marketing authorisation application (MAA) and post-authorisation stage. The focus is on European Union (EU) paediatric legislation, although essential US Food and Drug Administration (FDA) elements are briefly outlined. Practical regulatory aspects and reporting requirements, players in the therapeutic area as well as clinical management are described. The feasibility and limitations of future harmonised clinical development are pointed out.
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Novel Approaches of Self Emulsifying Drug Delivery Systems and Recent Patents: A Comprehensive Review
Authors: Rimmy Nandal, Sumit Tahlan and Aakash DeepThe main aim of the current work is to set up a revolutionary Self Nano-emulsifying drug delivery system to improve the necessary bio-availability and to boost clinical efficacy when administered orally. This study's main target is to develop a novel self-nano emulsifying drug delivery system (SNEDDS) for orally administered, poorly water-soluble medicines. SNEDDS is designed to intensify weakly water dissolvable or lipophilic drugs. SNEDDS is designed to intensify weakly water dissolvable or lipophilic drugs. It contains a micro- or nano-emulsion of oil carrying medicament that spontaneously agitates an aqueous medium. For enhancing the solubility of lipophilic medicines, SNEDDS is the most significantly used in biopharmaceutics classification system [BCS class] II and IV pharmaceuticals. The improved rate of dissolution and prevention of interfacial tension are clearly demonstrated by SNEDDS. In aqueous mediums, such as gastrointestinal fluid, SNEDDS produces a stable emulsion after dilution.
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Artificial Intelligence in Drug Regulatory Submissions in India
Authors: Vikesh K. Shukla and Manvi Kumar MittalRegulatory affairs are one of the most crucial connections between the pharmaceutical company and the other stakeholder’s or regulatory agencies such as FDA, EMA, etc. Strategies in drug approval and marketing to assure the quality, safety, and efficacy of the drug follow the guidelines and laws stated under the drug and cosmetic act 1940 and rules 1945. Their primary responsibility is to keep the company in compliance with changing guidelines, which necessitates constant monitoring of the most recent industry updates. Drug regulation is a complex process as every country has its own set of documentation that must be done while regulatory submissions. From drug development and drug approval to drug commercialisation, there is a large amount of documentation that must be completed with accuracy, which can be challenging for the professional to complete, therefore, this leads to the introduction of the concept of big data that can be incorporated which will map the regulations according to 5vs model of big data. Thus, to make it more efficient, we can work big data with artificial intelligence to ease the process using natural language processing. This concept will map all the rules and guidelines together and make a cluster of similar rules together. Now, users can use the tool to locate the data of interest in a single site in a more comprised universal language that can be accessed by any professional to complete the task in the given time schedule.
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