CS254672B1

CS254672B1 - A preparation comprising immunoglobulins and a stabilizer

Info

Publication number: CS254672B1
Application number: CS854291A
Authority: CS
Inventors: Alfred Stachy; Jozef Bulik; Imrich Banda
Original assignee: Alfred Stachy; Jozef Bulik; Imrich Banda
Priority date: 1985-06-13
Filing date: 1985-06-13
Publication date: 1988-01-15
Also published as: CS429185A1

Abstract

Pripravok obsahujúci imunoglobulíny a stabilizátor obsahuje v 1 litru vodného roztoku imunoglobulínov 3,0 až 30,0 g IgG, 2,5 až 6,5 g IgA, 0,5 až 3,0 IgM a 50,0 až 100,Oj gramov maltózy. Pripravok je vhodný pro intramuskulárne podanie.The preparation containing the immunoglobulins and the stabilizer contains 3.0 to 30.0 g of IgG, 2.5 to 6.5 g of IgA, 0.5 to 3.0 IgM and 50.0 to 100, 0.1 g grams of maltose per liter of aqueous immunoglobulin solution. . The preparation is suitable for intramuscular administration.

Description

Vynález sa týka preparátov imunoglobu-línov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu, kde ako stabilizátor a kryaprotektívna látka sa používa maltóza. Z literárnych údajov je známe, že maltóza sa doporučuje ako nosné médium imunoglobulínov. (Pirofsky B., Anderson J., Bar-dana E.: Therapeutic and detrimental effect of intravenous immunoglobulin therapy v: Immunoglobulins : Charasteristics and uses of intravenous preparations, vydali Alving B., Finlayson Y. S.: Food and Drug Admi-nistration DHHS Publication No. /FDA/ — 80 — 9005, 1979, str. 245.)The invention relates to concentrated immunoglobulin preparations of the IgG, IgA, IgM type for intramuscular administration, wherein maltose is used as stabilizer and cryaprotective agent. It is known from the literature that maltose is recommended as a carrier medium for immunoglobulins. (Pirofsky B., Anderson J., Bar-dana E .: Therapeutic and Detrimental Effect of Intravenous Immunoglobulin Therapy in: Immunoglobulins: Charasteristics and Uses of Intravenous Preparations, Published by Alving, B. No. / FDA / - 80-9005, 1979, p. 245.)

Pri príprave imunoglobulínov koncentrovaného typu IgG, IgA, IgM pre intramuskulárnu aplikáciu je veľmi dôležitý problém stability, rozpustnosti a zníženia percenta agregátov a fragmentov imunoglobulínov v koncovom prípravku. Prítomnosť maltózy v prípravkoch imunoglobulínov znižuje stupeň agregácie imunoglobulínových molekúl, čo má vplyv na bezpečnosť prípravku z hľadiska recipienta. (Good R. A.: Intravenous gamma globulin therapy. J. Clin. Immunol. 1982 Apr., Vol.: 2/2 Spupl/, str. 485,. Fernan-des P. M., Lundblad J. L.: Preparation of a stabile intravenous gammaglobulin: process desing and scale up., Vox. Sang. 1980 Aug., Vol. 39/2/, str. 101 — 112, Ochs H D., ot al.: Safety and pacient acceptability of intrave nous immune globulin in 10 % maltose, Lan-cet 1980 Nov. 29, Vol.: 2/8205/, str. 1158 — 1159.) Maltóza ako uhľohydrát sa dobre uti-lizuje v organizme a je dobrým nosičom e-nergie (Gottinger E., Hagmuler K., Hellauer H.: The fate of intravenously admistreted su-gar as energy source. Wien. Klin. Wschr. 1981 Dec, 25, Vol: 93/24/, str. 755 —, 760).The problem of stability, solubility and reduction of the percentage of aggregates and fragments of immunoglobulins in the final formulation is very important in the preparation of IgG, IgA, IgM, and IgM concentrated immunoglobulins. The presence of maltose in immunoglobulin preparations decreases the degree of aggregation of immunoglobulin molecules, which affects the safety of the formulation in terms of recipient. (Good RA: Intravenous gamma globulin therapy, J. Clin. Immunol. 1982 Apr., Vol .: 2/2 Spupl /, p. 485, Fernan-des PM, Lundblad JL: Preparation of a Stabile Intravenous Gammaglobulin: Process Desing and scale up., Vox Sang, Aug. Aug., Vol. 39 (2), pp. 101-112, Ochs H D., et al .: Safety and Patient Acceptability of Intracellular Immune Globulin in 10% Maltose, Lan Nov. 29, Vol .: 2/8205 /, pages 1158 - 1159.) Maltose as a carbohydrate is well stabilized in the body and is a good carrier of allergy (Gottinger E., Hagmuler K., Hellauer H .: The fate of intravenously admistrated su-gar as energy source, Wien, Klin, Wschr, 1981 Dec, 25, Vol: 93 (24), pages 755-760.

Zvlášť u imunodeficientných pacientov, ktorým sa opakovane podávajú prípravky imunoglobulínov je dôležitá kvalita preparátu z hľadiska bezpečnosti recipienta. Maltóza použitá ako stabilizátor v značnej miere zvyšuje kvalitu imunoglobulínových prípravkov koncentrovaného typu.Especially in immunodeficient patients who are repeatedly administered immunoglobulin preparations, the quality of the recipient safety is important. Maltose used as a stabilizer greatly enhances the quality of concentrated-type immunoglobulin preparations.

Vynález sa týka prípravku obsahujúceho imunoglobulíny IgG, IgA, IgM a stabilizátor, ktorý je složený z 1 litra vodného roztoku imunoglobulínov o koncentrácii 3,0 až 30,0 gramov IgG, 2,5 až 6,5 g IgA, 0,5 až 3,0 g IgM a 50,0 až 100 g maltózy.The invention relates to a composition comprising IgG, IgA, IgM immunoglobulins and a stabilizer consisting of 1 liter of an immunoglobulin aqueous solution having a concentration of 3.0 to 30.0 grams of IgG, 2.5 to 6.5 g of IgA, 0.5 to 3 , 0 g IgM and 50.0-100 g maltose.

Príklad prevedenia K 100 ml roztoku imunoglobulínov o obsahu IgG 0,3 g, IgA 0,25 g a IgM 0,05 g sa pridá 5 g maltózy. Roztok sa homogenizuje, sterilné filtruje a rozplňuje do 20 ml peni-ciliniek po 10 ml, tieto sa namrazujú a lyo-filizujú.Embodiment Example To 100 ml of an immunoglobulin solution with IgG content of 0.3 g, IgA 0.25 g and IgM 0.05 g, add 5 g of maltose. The solution is homogenized, sterile filtered and dispensed into 20 ml of 10 ml of penicillin, frozen and lyophilized.

Takto pripravený prípravok je vhodný pre intramuskulárnu aplikáciu.The formulation thus prepared is suitable for intramuscular administration.

Claims

OBJECT OF THE INVENTION A composition comprising IgG, IgA, IgM immunoglobulins and a stabilizer characterized in that 1 liter of an immunoglobulin aqueous solution contains 3.0 to 30.0 g IgG, 2.5 to 6.5 g IgA, 0.5 to 3.0 g. IgM and 50.0-100.0 g maltose.