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Utility analysis of registered sucrose octadeculfite potassium and sodium sucrose octadeculfite

Time:2021-11-22

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Sucrose octadeculfate potassium salt and sucrose octadeculfate sodium salt may not be very familiar with these two products, but you should be familiar with their application, that is irinotecan liposome Onivyde®. Irinotecan liposome Onivyde® is the most generic liposome project in China. As the auxiliary material of Irinotecan liposome Onivyde®, sucrose octadeculfate potassium salt and sucrose octadeculfate sodium salt play what effect? This article let AVT xiaobian to explain the efficacy and properties of sucrose octadeculfate potassium salt and sucrose octadeculfate sodium salt.

Product name: Sucrose potassium octadeculfate 011001
Potassium Sucrose Octasulfate
CAS no. : 73264-44-5
Molecular formula: C12H14K8O35S8
Molecular weight: 1287.52
Properties: white solid powder
Purity: 99.8%
Content: 100.7%
Solubility: ≥100mg/mL (H2O)
Melting point: > 230 ℃
Registration Number: F20210000349


Product name: Sucrose sodium octadulate 011002
Sucrose octasulfate sodium salt
CAS no. : 74135-10-7
EINECS no. : 420-660-7
Molecular formula: C12H14Na8O35S8
Molecular weight: 1158.66
Properties: white solid powder
Purity: 99% or higher
Solubility: ≥100mg/mL (H2O)
Melting point: 159 ~ 164 ℃

Onivyde®, developed by Taiwan Zhiqing Company, is a liposomal drug developed by a Chinese team and successfully marketed in the United States. It was granted priority approval and orphan drug status by the FDA in 2015 and subsequently approved by the European Union in 2016 for the treatment of metastatic pancreatic cancer in combination with fluorouracil and folic acid.

Because the chemical structure of irinotecan shifts between the ester and ring-open carboxylate forms according to the pH of the environment, the two forms are in dynamic equilibrium. It is in lactone form under acidic conditions and changes to carboxylate form under physiological conditions (pH 7.4). However, lactone ring is a necessary structure for irinotecan to exert anti-tumescent liu activity, so it is necessary to find a suitable method to stabilize the active part of the structure -- lactone ring to develop its liposome preparation. Onivyde® uses a sucrose octasulfate gradient to enable irinotecan to be stably encapsulated as a precipitate in a weakly acidic aqueous phase.

Common side effects of Onivyde® include diarrhea, fatigue, vomiting, nausea, loss of appetite, stomatitis, and fever. A decrease in anti-inflammatory cells (lymphocytes and neutrophils) was also observed. The main cause of death was septicaemia caused by neutropenia.

Liposomes are complex injections, and knowing the prescription is only the first step towards a successful imitation of a product. Onivyde® phospholipid auxiliary materials DSPC, cholesterol, DSPE-MPEG2000 and sucrose octso4 X salt have completed/plan to complete CDE and DMF registration. We are willing to work together with you to overcome numerous barriers and finally achieve the smooth industrialization of Onivyde.

For more information about sucrose octadeculfate, please pay attention to Avito (Shanghai) Pharmaceutical Technology Co., LTD.
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