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Preparation of solid-state release dose including spray dried antibody
专利权人:
TILLOTTS PHARMA AG
发明人:
BRAVO GONZALEZ, ROBERTO CARLOS,OLIVEIRA VARUM, FELIPE JOSE,BRUNO, CRISTINA
申请号:
ARP180102683
公开号:
AR112825A1
申请日:
2018.09.20
申请国别(地区):
AR
年份:
2019
代理人:
摘要:
This note refers to a method for preparing individual solid particles by spray drying, including antibodies and functional fragments of these particles, as well as polymers under continuous consideration, which are suitable for treatment in the form of solid-state release dose, a. Particles selectively coated with delayed release coating and solid dosage form produced by the method;And the use of solid-state dosimetry in the treatment of patients' gastrointestinal tract Remedy 1: a method for preparing particles containing at least one antibody or functional part thereof as an active agent by spray drying, a tampon and at least one persistent release polymer; 1. Including (a) a method for preparing at least one stage of an antibody or functional part thereof, a tampon, and at least one feeding solution for the sustained release of a polymer, all of which are carried out in a water suspension state;(b) In a primary drying chamber, a liquid for producing a drop is ejected with a spout, where the drop is dispersed in a dry gas; (c) particles are formed in the dry gas by evaporating at least a part of the liquid in the drop of the dry gas; (d) The particles dispersed in the gas are used to guide the dry gas to recover the particles through a particle concentration medium. 2. Claim 2: the method according to claim 1, which is characterized in that at least one persistent release polymer is selected from the police group (ethyl acrylate),1:2:0.1 (Eudragit ® RS 30d);1. Poly (ethyl acrylate, methyl methacrylate, methyl trimethylacrylate chloride) 1:2:0.2 (e.g. Eudragit ® RL 30d);1. Poly (ethyl acrylate, methylmethylmethacrylic acid) 2:1 (e.g. Eudragit ® ne 30d, Eudragit ® ne 40d, Eudragit ® nm 30d);2. Water dispersion of ethylene monomer (such as aquacoat ® ECD and surelease ®);Polyvinyl chloride acetic acid; polyvinyl chloride hydrolysis (vinyl acetate), stabilized with sodium acetate and sodium sulfate; hydrolytic powder, consisting of about 27% polyvinyl chloride (vinyl
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