EP 4072569 A1 20221019 - METHOD OF PREPARATION OF THE TRANSFER FACTOR MEDICINE, TRANSFER FACTOR MEDICINE, METHOD OF TESTING ITS BIOLOGICAL ACTIVITY, PHARMACEUTICAL FORM AND ITS USE
Title (en)
METHOD OF PREPARATION OF THE TRANSFER FACTOR MEDICINE, TRANSFER FACTOR MEDICINE, METHOD OF TESTING ITS BIOLOGICAL ACTIVITY, PHARMACEUTICAL FORM AND ITS USE
Title (de)
VERFAHREN ZUR HERSTELLUNG DES ARZNEIMITTELS MIT TRANSFERFAKTOR, ARZNEIMITTEL MIT TRANSFERFAKTOR, VERFAHREN ZUM TESTEN SEINER BIOLOGISCHEN AKTIVITÄT, PHARMAZEUTISCHE FORM UND SEINE VERWENDUNG
Title (fr)
PROCÉDÉ DE PRÉPARATION DE MÉDICAMENT À FACTEUR DE TRANSFERT, MÉDICAMENT À FACTEUR DE TRANSFERT, PROCÉDÉ DE TEST DE SON ACTIVITÉ BIOLOGIQUE, FORME PHARMACEUTIQUE ET SON UTILISATION
Publication
Application
Priority
- CZ 2020342 A 20200612
- CZ 2021000014 W 20210325
Abstract (en)
[origin: WO2021249581A1] Method of the transfer factor medicine preparation; transfer factor medicine; biological activity testing methodology; pharmaceutical form and its use where the Method of the medicine preparation from the peripheral blood leukocytes is based on the following individual steps, i.e. from: a) prepared leukocyte concentrate, b) dialysis and/or filtration, c) removal of salts and concentration with use of nanofiltration, d) thermal activation, e) tablet formulation and f) preparation of a lyophilised tablet, while the steps comprising removal of salts from the product and concentration of the product with use of nanofiltration are based on purifying the obtained dialysate of undesired salts and its concentration with use of nanofiltration to the required volume. A thin-film polyamide composite is used for concentration with use of nanofiltration as a membrane with the porosity allowing for permeability of up to 1,000 Da. The transfer factor active substance prepared as a Iyophilised tablet that is Iyophilised directly in the blister pocket where each pocket represents one dose of the preparation; the medicine is made of dialysate or ultrafiltrate of the peripheral blood leukocytes purified of ballast salts and comprising protein substances and nucleic acid substances whose ratio in the medicine, i.e., the absorption,index, is not under 1.7, where the molecular weight of none of the medicine substances is greater than 10,000 Daltons. The in vitro method of testing the biological activity of the transfer factor active substance is conducted through observing the transfer factor impact on the model cellular line viability after it was influenced by an immunosuppressive substance, azathioprine. Using of the transfer factor in the form of a Iyophilised tablet administered in the oral cavity where the Iyophilised tablet immediately adheres to the mucosa, which prevents its swallowing; it speedily melts on the buccal mucosa and it passes directly to the digestive system as a human or veterinary medicine or a food supplement or a prophylactic preparation.
IPC 8 full level
A61K 35/14 (2015.01); A61K 38/17 (2006.01); B01D 61/00 (2006.01)
CPC (source: CZ EP)
A61K 9/0056 (2013.01 - CZ); A61K 9/19 (2013.01 - CZ); A61K 9/20 (2013.01 - CZ); A61K 35/14 (2013.01 - EP); A61K 35/15 (2013.01 - CZ); A61K 38/17 (2013.01 - EP); A61K 38/1709 (2013.01 - CZ); A61P 37/00 (2017.12 - CZ); B01D 61/027 (2013.01 - EP); B01D 61/146 (2022.08 - CZ); B01D 61/58 (2013.01 - EP); B01D 71/56 (2013.01 - EP); G01N 33/15 (2013.01 - CZ); G01N 33/5008 (2013.01 - CZ); B01D 61/145 (2013.01 - EP); B01D 2311/10 (2013.01 - EP)
Citation (search report)
See references of WO 2021249581A1
Designated contracting state (EPC)
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated extension state (EPC)
BA ME
DOCDB simple family (publication)
WO 2021249581 A1 20211216; CZ 2020342 A3 20211222; EP 4072569 A1 20221019
DOCDB simple family (application)
CZ 2021000014 W 20210325; CZ 2020342 A 20200612; EP 21721385 A 20210325