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Research Report
An In-Depth Analysis of 1,2-Distearoylphosphatidylcholine (DSPC): From Physicochemical Properties to Advanced Pharmaceutical Applications
Executive Summary
1,2-Distearoylphosphatidylcholine (DSPC) is a fully saturated, synthetic phospholipid that has emerged as an indispensable excipient in the field of advanced drug delivery. While its primary role is to serve as a structural component in lipid-based nanocarriers, such as liposomes and lipid nanoparticles (LNPs), its function extends far beyond that of an inert scaffold. This report provides a comprehensive analysis of DSPC, synthesizing data on its chemical identity, physicochemical characteristics, pharmacological activity, and regulatory standing to present a holistic view of its significance in modern medicine.
The defining feature of DSPC is its high main phase transition temperature () of approximately 55°C. This property ensures that at physiological temperature (37°C), DSPC-based lipid bilayers exist in a highly ordered, rigid "gel" phase. This physical state confers exceptional structural stability and low permeability to drug delivery systems, minimizing premature drug leakage and extending the shelf-life of pharmaceutical products. These characteristics have made DSPC a cornerstone lipid in formulations requiring long systemic circulation times and controlled release kinetics. Its utility is exemplified by its inclusion in several clinically approved products, most notably as a critical structural component in the LNP formulations for the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines, where it provides the necessary stability to protect the fragile mRNA payload.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2024/09/19 | Phase 1 | Not yet recruiting | |||
2024/05/06 | Phase 3 | Not yet recruiting | |||
2024/03/26 | Phase 1 | Not yet recruiting | |||
2023/07/24 | Early Phase 1 | Recruiting | |||
2022/11/14 | Phase 1 | Completed | |||
2022/10/06 | Phase 1 | Recruiting | |||
2021/01/22 | Phase 1 | Completed | |||
2020/09/30 | Phase 4 | Completed | |||
2019/05/17 | Early Phase 1 | Completed | |||
2018/08/31 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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