{"title":"Development and Characterization of Bosentan Monohydrate-loaded\nSelf-Nano Emulsifying Drug Delivery System","authors":"Dilpreet K Singh, Russel Tonjam, B. Kurmi","doi":"10.2174/2210303113666221122113514","DOIUrl":null,"url":null,"abstract":"\n\nThe present investigation aims to develop a solid Self-nano emulsifying\nDrug Delivery System for enhancing the solubility and in vitro characteristics of poorly soluble anti-hypertensive drug Bosentan Monohydrate.\n\n\n\nThe selection of formulation components on the basis of equilibrium solubility and pseudo-ternary phase titration studies revealed the suitability of Isopropyl myristate, Tween 80 and Polyethylene glycol as the lipidic excipients and their optimized concentration ranges resulted in a stable microemulsion region.\n\n\n\nThe systematic optimization of the liquid SNEDD formulations of Bosentan was performed using in vitro tests and detailed characterization studies. The results revealed that the F4\nformulation produces excellent results and satisfactory results in all the CQA of liquid SNEDDS.\nThe optimized liquid SNEDD formulations exhibited globule size of less than 100 nm, high and\nnegative values of zeta potential, quick self-emulsification rate, negligible phase separation, and a\nhigh degree of physical stability during thermodynamic evaluation studies. SEM revealed\nnanostructured particles with negligible aggregation.\n\n\n\nIn vitro dissolution studies of Bosentan in optimized liquid SNEDDS (F4) unveiled a\nmulti-fold enhancement in release profile, as compared to pure API.\n","PeriodicalId":11310,"journal":{"name":"Drug Delivery Letters","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Delivery Letters","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2174/2210303113666221122113514","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
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Abstract
The present investigation aims to develop a solid Self-nano emulsifying
Drug Delivery System for enhancing the solubility and in vitro characteristics of poorly soluble anti-hypertensive drug Bosentan Monohydrate.
The selection of formulation components on the basis of equilibrium solubility and pseudo-ternary phase titration studies revealed the suitability of Isopropyl myristate, Tween 80 and Polyethylene glycol as the lipidic excipients and their optimized concentration ranges resulted in a stable microemulsion region.
The systematic optimization of the liquid SNEDD formulations of Bosentan was performed using in vitro tests and detailed characterization studies. The results revealed that the F4
formulation produces excellent results and satisfactory results in all the CQA of liquid SNEDDS.
The optimized liquid SNEDD formulations exhibited globule size of less than 100 nm, high and
negative values of zeta potential, quick self-emulsification rate, negligible phase separation, and a
high degree of physical stability during thermodynamic evaluation studies. SEM revealed
nanostructured particles with negligible aggregation.
In vitro dissolution studies of Bosentan in optimized liquid SNEDDS (F4) unveiled a
multi-fold enhancement in release profile, as compared to pure API.
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