Lyophilization of synthetic liposomal pulmonary surfactant
Inventors
Cesco-Cancian, Sergio • HOY, Thomas • Trappler, Edward H. • Thomas, Michael S.
Assignees
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Publication Number
US-8748397-B2
Publication Date
2014-06-10
Expiration Date
Abstract
Lyophilized pulmonary surfactants having an increased specific surface area and porosity are described. Methods of making the lyophilized pulmonary surfactants are also described.
Core Innovation
A lyophilized synthetic pulmonary surfactant composition includes a synthetic peptide with SEQ ID NO:1 (KL4 polypeptide), dipalmitoyl phosphatidylcholine (DPPC), palmitoyloleoyl phosphatidylglycerol (POPG), and palmitic acid, and the lyophilized synthetic pulmonary surfactant composition has a specific surface area of at least 2.2 m2/g.
A process is provided for making a lyophilized synthetic pulmonary surfactant having reduced or eliminated cake levitation during the process. The process provides a pre-lyophilization mixture comprising DPPC, POPG, palmitic acid, and the KL4 polypeptide (SEQ ID NO:1) dispersed in a solvent with an organic solvent in the range between 3% (v/v) and 20% (v/v) of the total volume of the pre-lyophilization mixture, with a remainder being water and/or buffer, wherein the pre-lyophilization mixture is filled in a container.
The process lowers a temperature inside the lyophilizing chamber to begin chilling and solidifying the pre-lyophilization mixture in a freezing phase, and conducts an annealing phase prior to a primary drying phase, thereby reducing or eliminating cake levitation in the lyophilized synthetic pulmonary surfactant. The lyophilized synthetic pulmonary surfactant has a specific surface area of at least 2.2 m2/g.
Claims Coverage
The partial content contains two independent claims (clm-00001 and clm-00013). Across these independent claims, the inventive subject matter centers on a lyophilized composition with a specific surface area threshold and defined components, and a process that reduces or eliminates cake levitation using a specified pre-lyophilization mixture and an annealing phase prior to primary drying, also requiring a minimum specific surface area of at least 2.2 m2/g.
Process for reduced or eliminated cake levitation using low organic-solvent pre-lyophilization mixture and annealing before primary drying
A process of making a lyophilized synthetic pulmonary surfactant having reduced or eliminated cake levitation during the process, comprising providing a pre-lyophilization mixture with DPPC, palmitoyloleoyl phosphatidylglycerol (POPG), palmitic acid, and a synthetic peptide with SEQ ID NO:1 (KL4 polypeptide) dispersed in a solvent having an organic solvent between 3% (v/v) and 20% (v/v) with a remainder being water and/or buffer, lowering temperature to begin chilling and solidifying in a freezing phase, and conducting an annealing phase prior to a primary drying phase, wherein the resulting lyophilized product has a specific surface area of at least 2.2 m2/g.
Lyophilized synthetic pulmonary surfactant composition with KL4, DPPC, POPG and palmitic acid and minimum specific surface area
A lyophilized synthetic pulmonary surfactant composition comprising a synthetic peptide with SEQ ID NO:1 (KL4 polypeptide), dipalmitoyl phosphatidylcholine (DPPC), palmitoyloleoyl phosphatidylglycerol (POPG) and palmitic acid, wherein the lyophilized synthetic pulmonary surfactant composition has a specific surface area of at least 2.2 m2/g.
Overall, claim coverage is anchored by a minimum specific surface area requirement (at least 2.2 m2/g) and defined KL4 (SEQ ID NO:1), DPPC, POPG, and palmitic acid components, with the process claim further requiring a low organic-solvent fraction pre-lyophilization mixture and an annealing phase prior to primary drying to reduce or eliminate cake levitation.
Stated Advantages
Reduced or eliminated cake levitation during the process.
Documented Applications
No documented applications found
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