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Lipophilic microparticles containing protein drug or antigen and formulation comprising same

A lipophilic, protein-based technology, applied in the field of lipophilic substance-coated particles, can solve problems such as the instability of liposome particle structure

Inactive Publication Date: 2001-05-02
LG CHEM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] However, the only effective oral vaccine formulation successfully developed is the polio vaccine in the presence of enteric receptors, and the liposomal microparticles are structurally unstable

Method used

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  • Lipophilic microparticles containing protein drug or antigen and formulation comprising same
  • Lipophilic microparticles containing protein drug or antigen and formulation comprising same
  • Lipophilic microparticles containing protein drug or antigen and formulation comprising same

Examples

Experimental program
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Effect test

Embodiment 1

[0038] Lecithin was added to 10 mM phosphate buffered saline (PBS) at a concentration of 2% (w / v) and fully hydrated. Recombinant hepatitis B surface antigen (HBsAg, LG Chemical Ltd.) was added thereto to make the concentration 0.5 mg / ml, and then the resulting solution was sent into a spray dryer (Buchi 191), solid particles (particle 1) were obtained. In this step, the inflow air temperature was 70°C and the outflow air temperature was 50°C. The particles thus obtained have a particle size between 0.1-5 μm. Example 2: Preparation of lipophilic microparticles

Embodiment 2

[0038] Lecithin was added to 10 mM phosphate buffered saline (PBS) at a concentration of 2% (w / v) and fully hydrated. Recombinant hepatitis B surface antigen (HBsAg, LG Chemical Ltd.) was added thereto to make the concentration 0.5 mg / ml, and then the resulting solution was sent into a spray dryer (Buchi 191), solid particles (particle 1) were obtained. In this step, the inflow air temperature was 70°C and the outflow air temperature was 50°C. The particles thus obtained have a particle size between 0.1-5 μm. Example 2: Preparation of lipophilic microparticles

[0039] Recombinant HBsAg was dissolved in 10 mM PBS to a concentration of 0.5 mg / ml, and then carboxymethylcellulose was added thereto to a concentration of 3% (w / v). The resulting solution was fed into a spray dryer (Buchi 191) at a low flow rate of 0.55 ml / min to obtain primary granules. In this step, the inflow air temperature was 70°C and the outflow air temperature was 50°C.

[0040] An ethanol solution conta...

Embodiment 3

[0041] Carboxymethylcellulose was dissolved in 10 mM PBS to make the concentration 3% (w / v). To this was added lecithin to a concentration of 2% (w / v) and fully hydrated. Then, recombinant HBsAg was added thereto to make the concentration 0.5 mg / ml. The resulting solution was fed into a spray drier (Buchi 191) at a flow rate of 0.55 ml / min to obtain solid microparticles (microparticle 3). In this step, the inflow air temperature was 70°C and the outflow air temperature was 50°C. The particle size thus obtained is between 0.1-5 μm. Examples 4-9: Preparation of lipophilic microparticles

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Abstract

A lipophilic microparticle with an average particle size ranging from 0.1 to 200 μm, which contains lipophilic substances and active ingredients selected from protein or peptide drugs and antigens, the microparticles retain all the activity of the active ingredients, and when formulated into oil dispersion After liquid or oil-in-water emulsion, it releases the active ingredient into the in vivo environment in a controlled release manner over a long period of time.

Description

field of invention [0001] The present invention relates to microparticles coated with a lipophilic substance, which contain protein drugs or antigens, and sustained-release formulations thereof for effective delivery of said drugs or antigens in vivo. Background of the invention [0002] It is well known that protein drugs or antigens have denaturation problems due to heat, organic solvents and / or unsuitable pH (Weiqi Lu et al., PDA J. Pharm. Sci. Tech_49, 13-19 (1995)). They are usually administered by injection; however, since their in vivo activity lasts only a short time after administration, repeated administration is necessary if long-term treatment is desired. For example, for the treatment of pituitary-deficient childhood short stature, daily or bi-day injections of human growth hormone (hGH) are necessary for 6 months or more. Therefore, much effort has been expended to develop effective sustained-release formulations of protein drugs or antigens. [0003] For exa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K9/00A61K9/10A61K9/107A61K9/113A61K9/12A61K9/16A61K9/50A61K38/00A61K38/21A61K38/22A61K38/27A61K38/28A61K38/46A61K39/00A61K39/008A61K39/04A61K39/09A61K39/095A61K39/10A61K39/102A61K39/104A61K39/106A61K39/108A61K39/112A61K39/12A61K39/13A61K39/135A61K39/145A61K39/165A61K39/175A61K39/205A61K39/235A61K39/29A61K39/39A61K47/18A61K47/34A61K47/42A61K47/44A61P5/50A61P31/04A61P31/06A61P31/10A61P31/14A61P31/16A61P31/20A61P33/02
CPCA61K9/1652A61K9/5015A61K9/1658A61K9/1617A61K38/212A61K38/27A61K9/113A61K39/39A61K9/10A61P31/04A61P31/06A61P31/10A61P31/14A61P31/16A61P31/20A61P33/02A61P5/50
Inventor 金明珍金善镇权奎灿金浚
Owner LG CHEM LTD
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