Preparation

• US 10,729,661 B2
• Filed: 12/17/2015
• Issued: 08/04/2020
• Est. Priority Date: 12/19/2014
• Status: Active Grant

• Current Assignee: Sekisui Chemical Company Limited (Sekisui)
• Original Assignee: Sekisui Chemical Company Limited (Sekisui)
• Inventors: Itou, Kazushi, Akamine, Takayuki, Tone, Saori, Kawamura, Daichi, Abe, Yoshiko
• Primary Examiner(s): Pryor, Alton N
• Application Number:
  US15/532,840
• Publication Number:
  US 20170354614A1
• Time in Patent Office: 1,692 Days
• Field of Search: None
• CPC Class Codes: A61K 31/13 Amines A61K31/04 takes precedence
• CPC Class Codes: A61K 45/00 Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 9/5123 Organic compounds, e.g. fats, sugars
• CPC Class Codes: A61K 9/5161 Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
• CPC Class Codes: A61K 9/5192 Processes

Abstract

A particle comprising a first fraction containing an active ingredient and a second fraction containing a surfactant, and having a number average particle diameter of from 1 to 100 nm.

Claims

1. A method for producing a storage stable particle comprising a storage stable first fraction containing a hydrophilic active ingredient and a second fraction containing a surfactant having a weighted average of HLB value of 10 or less, wherein a portion of a surface of or a whole surface of the first fraction is coated with the second fraction, and the particle is a core-shell structured body in which the first fraction corresponds to a core portion and the second fraction corresponds to a shell portion, the method comprising:

a step of freeze-drying or vacuum-drying a W/O emulsion containing the active ingredient in, an aqueous phase,

a step of heat-treating a dried substance of the W/O emulsion, and

a step of obtaining a particle having a number average particle diameter of from 1 to 12 nm by heat-treating a dried substance of the W/O emulsion containing an active ingredient in an aqueous phase.

2. The method for production according to claim 1, wherein the particle has a water content of 20% by weight or less.

3. The method for production according to claim 1, wherein, in the heat-treating step, the heat treatment temperature is 30°

C. to 60°

C.

4. The method for production according to claim 1, wherein, in the heat-treating step, the heat treatment time is 1 day to 30 days.