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Liposome composition and its production method

A technology of a liposome composition and a manufacturing method, which is applied in the directions of liposome delivery, drug delivery, pharmaceutical formulation, etc., can solve the problems of drug encapsulation amount and slow-release time that cannot be said to be sufficient.

Active Publication Date: 2016-10-12
TERUMO KK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, multivesicular liposomes (MVL) were developed as lipid-based sustained-release drug carriers for local or systemic delivery of drugs (Patent Documents 1 and 2). Sustained release time can not be said to be sufficient

Method used

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  • Liposome composition and its production method
  • Liposome composition and its production method
  • Liposome composition and its production method

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0071] In the preparation of the liposome composition of the present invention, the water-miscible solvent comprising lipid and the first internal aqueous phase solution added therein can be set as 0.7 to 2.5, preferably 1.0 to 2.0.

[0072]

[0073] In the present invention, after adding the first internal aqueous phase solution to the water-miscible solvent containing lipids to prepare the first emulsion, and then adding the second internal aqueous phase solution to the first emulsion, the second internal aqueous phase solution The aqueous phase solution is not particularly limited. Examples thereof include the same solution as the first inner water phase, HEPES solution, NaCl solution, and aqueous solutions of sugars such as glucose or sucrose, and the same solution as the first inner water phase is preferable. In addition, both the first internal water phase and the second internal water phase are most preferably aqueous ammonium sulfate. The volume ratio of the first ...

Embodiment

[0085] Next, although an Example is given and this invention is demonstrated in more detail, this invention is not limited to these Examples.

[0086] The respective concentrations and particle diameters of the drug-encapsulated liposomes prepared in each example were determined according to the following methods.

[0087] Phospholipid concentration (mg / mL): The phospholipid concentration in the liposome suspension was quantified using high performance liquid chromatography or phospholipid quantification.

[0088] Cholesterol concentration (mg / mL): Cholesterol concentration in liposome suspension quantified using high performance liquid chromatography.

[0089] Total lipid concentration (mol / L): total molar concentration (mM) of lipids as membrane constituents calculated from the above-mentioned phospholipid concentration and cholesterol concentration.

[0090] Drug concentration (mg / mL): the liposome composition obtained above is diluted with RO water (reverse osmosis membra...

preparation example 1～4

[0103] (1) Preparation of empty liposomes

[0104] In order to make HSPC / Chol = 54 / 46 (molar ratio; hereinafter the same), 1.41 g of HSPC and 0.59 g of cholesterol were weighed, respectively, and 4 mL of absolute ethanol was added and heated to dissolve. Add 100mM (preparation example 1), 150mM (preparation example 2), 250mM (preparation example 3) ammonium sulfate aqueous solution or 300mM citric acid aqueous solution (pH3.0) (preparation example 4), heated and stirred for about 10 minutes to form an emulsion. Further, 10 mL of 20 mM HEPES / 0.9% sodium chloride (pH 7.5) heated to about 70° C. was added to this emulsion, followed by heating and stirring for about 10 minutes. The liposomes after the warming was completed were quickly cooled with ice.

[0105] (2) Formation of pH gradient

[0106] Add 20mM HEPES / 0.9% sodium chloride (pH 7.5) to the liposomes obtained above and disperse, centrifuge at 3500rpm for 15 minutes to precipitate the liposomes. Thereafter, the superna...

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Abstract

The purpose of the present invention is to provide a lipid composition that can import drugs with high sealing, and clinically maintains a sufficiently effective concentration, suitable for subcutaneous administration.The lipid composition of the present invention has the first lipid body and multiple second lipids, which has an outer membrane formed by the multi -layer lipid double layer; the second lipid body containmentIn the internal area of the first lipid body defined by the outer membrane, and has an outer membrane formed by multi -layer lipid double layers, the lipid composition hasThe internal area of the dimension, and at least the internal area of the second lipid body forms an ion gradient between the outer part of the first lipid body.

Description

technical field [0001] The present invention relates to a sustained-release liposome composition containing active ingredients such as drugs. Background technique [0002] Frequent trips to and from the hospital, punctures, and other pains caused by drugs that require frequent administration are a great burden on patients. In addition, since it is difficult for patients with dysphagia to take the drug orally, administration methods other than oral administration have been sought. For patients with cognitive impairment, encephalopathy, Parkinson's disease, etc. who need a guardian, it is difficult to manage self-administration of medication, so alternatives to administration methods other than oral administration and treatment methods that do not require frequent administration are sought. Furthermore, for patients with disorders of the autonomic nervous system, such as those whose daily life is immediately hindered once the drug effect wears off, there is a need for a treat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K47/24A61K47/34B01J13/02
CPCA61K9/127B01J13/02A61K9/1271A61K9/1278A61K9/0002
Inventor 山下惠子野泽滋典
Owner TERUMO KK
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