Ramya Krishna Nakkala, Balaji Maddiboyina, Shanmukha Chakravarthi Bolisetti, Harekrishna Roy
{"title":"盐酸度洛西汀肠溶微丸缓释胶囊:处方与评价","authors":"Ramya Krishna Nakkala, Balaji Maddiboyina, Shanmukha Chakravarthi Bolisetti, Harekrishna Roy","doi":"10.1080/23080477.2023.2191496","DOIUrl":null,"url":null,"abstract":"ABSTRACT The primary purpose of this study is to develop and evaluate an effective and reliable delayed-release dosage form of Duloxetine hydrochloride enteric-coated pellets in capsules. Duloxetine hydrochloride dissolves in an acidic environment, yet pellets maintain their enteric coating due to the Wurster expansion process for the Fluidized Bed Processor. Four distinct layers comprise enteric-coated pellets: a pharmaceutical layer, a barrier layer, an enteric layer, and a coating on the inert core pellets. A suspension layering approach protects the acidic environment from the drug by coating it with an enteric layer composed of hydroxyl propyl methyl cellulose phthalate HP55. We also determined the bulk and tapped densities, Hausner’s ratio, compressibility index, and moisture content of all formulations. The produced pellets are being evaluated for in-vitro release tests using UV-Visible spectroscopy. The zero-order model, the first-order model, and Higuchi’s square root equation, Hixson-Crowell, Korsemeyer peppas, and the Weibull model were used to evaluate the released kinetics models. Investigations using FT-IR (infrared spectroscopy) are still being undertaken to determine the drug’s compatibility with various excipients. Formulation ‘F7’ exhibited highest similarity factor of 56.1. Stability tests conducted over a three-month period under accelerated settings established that the optimized formulation is stable. GRAPHICAL ABSTRACT","PeriodicalId":53436,"journal":{"name":"Smart Science","volume":null,"pages":null},"PeriodicalIF":2.4000,"publicationDate":"2023-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Duloxetine hydrochloride enteric-coated pellets in capsules with delayed release: formulation and evaluation\",\"authors\":\"Ramya Krishna Nakkala, Balaji Maddiboyina, Shanmukha Chakravarthi Bolisetti, Harekrishna Roy\",\"doi\":\"10.1080/23080477.2023.2191496\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"ABSTRACT The primary purpose of this study is to develop and evaluate an effective and reliable delayed-release dosage form of Duloxetine hydrochloride enteric-coated pellets in capsules. Duloxetine hydrochloride dissolves in an acidic environment, yet pellets maintain their enteric coating due to the Wurster expansion process for the Fluidized Bed Processor. Four distinct layers comprise enteric-coated pellets: a pharmaceutical layer, a barrier layer, an enteric layer, and a coating on the inert core pellets. A suspension layering approach protects the acidic environment from the drug by coating it with an enteric layer composed of hydroxyl propyl methyl cellulose phthalate HP55. We also determined the bulk and tapped densities, Hausner’s ratio, compressibility index, and moisture content of all formulations. The produced pellets are being evaluated for in-vitro release tests using UV-Visible spectroscopy. The zero-order model, the first-order model, and Higuchi’s square root equation, Hixson-Crowell, Korsemeyer peppas, and the Weibull model were used to evaluate the released kinetics models. Investigations using FT-IR (infrared spectroscopy) are still being undertaken to determine the drug’s compatibility with various excipients. Formulation ‘F7’ exhibited highest similarity factor of 56.1. Stability tests conducted over a three-month period under accelerated settings established that the optimized formulation is stable. GRAPHICAL ABSTRACT\",\"PeriodicalId\":53436,\"journal\":{\"name\":\"Smart Science\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2023-03-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Smart Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/23080477.2023.2191496\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MULTIDISCIPLINARY SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Smart Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/23080477.2023.2191496","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}
Duloxetine hydrochloride enteric-coated pellets in capsules with delayed release: formulation and evaluation
ABSTRACT The primary purpose of this study is to develop and evaluate an effective and reliable delayed-release dosage form of Duloxetine hydrochloride enteric-coated pellets in capsules. Duloxetine hydrochloride dissolves in an acidic environment, yet pellets maintain their enteric coating due to the Wurster expansion process for the Fluidized Bed Processor. Four distinct layers comprise enteric-coated pellets: a pharmaceutical layer, a barrier layer, an enteric layer, and a coating on the inert core pellets. A suspension layering approach protects the acidic environment from the drug by coating it with an enteric layer composed of hydroxyl propyl methyl cellulose phthalate HP55. We also determined the bulk and tapped densities, Hausner’s ratio, compressibility index, and moisture content of all formulations. The produced pellets are being evaluated for in-vitro release tests using UV-Visible spectroscopy. The zero-order model, the first-order model, and Higuchi’s square root equation, Hixson-Crowell, Korsemeyer peppas, and the Weibull model were used to evaluate the released kinetics models. Investigations using FT-IR (infrared spectroscopy) are still being undertaken to determine the drug’s compatibility with various excipients. Formulation ‘F7’ exhibited highest similarity factor of 56.1. Stability tests conducted over a three-month period under accelerated settings established that the optimized formulation is stable. GRAPHICAL ABSTRACT
期刊介绍:
Smart Science (ISSN 2308-0477) is an international, peer-reviewed journal that publishes significant original scientific researches, and reviews and analyses of current research and science policy. We welcome submissions of high quality papers from all fields of science and from any source. Articles of an interdisciplinary nature are particularly welcomed. Smart Science aims to be among the top multidisciplinary journals covering a broad spectrum of smart topics in the fields of materials science, chemistry, physics, engineering, medicine, and biology. Smart Science is currently focusing on the topics of Smart Manufacturing (CPS, IoT and AI) for Industry 4.0, Smart Energy and Smart Chemistry and Materials. Other specific research areas covered by the journal include, but are not limited to: 1. Smart Science in the Future 2. Smart Manufacturing: -Cyber-Physical System (CPS) -Internet of Things (IoT) and Internet of Brain (IoB) -Artificial Intelligence -Smart Computing -Smart Design/Machine -Smart Sensing -Smart Information and Networks 3. Smart Energy and Thermal/Fluidic Science 4. Smart Chemistry and Materials