Nova Patents
SI2561069T1

Lysosomal storage disease enzyme

Abstract

This record has no abstract on file.

Term

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16 claims: 3 independent, 13 dependent

  1. 1
    An enzyme for the treatment of lysosomal storage Patent claims Encim za bolezen lizosomskega shranjevanja Patentni zahtevki 1. A pharmaceutical formulation comprising the isolated human recombinant lysosomal acid lipase (rhLAL) in combination with a pharmaceutically acceptable carrier, diluent or excipient, wherein said rhLAL comprises one or more N-glycan structures where rhLAL N-linked glycosylated at the Asn " Asn * ®, Asn * '* ", Asn ^^^ and Asn ^" "of SEQ ID NO:2, and wherein the pharmaceutical formulation is an aqueous solution having a pH of between 5.6 and 6.2 or a pH of 5 , 9 ± 0.2. 1. Farmacevtska formulacija, ki obsega izolirano humano rekombinantno lizosomsko kislinsko lipazo (rhLAL) v kombinaciji s farmacevtsko sprejemljivim nosilcem, razredčilom ali ekscipientom, pri čemer navedena rhLAL obsega eno ali več N-glikanskih struktur, kjer je rhLAL N-vezano glikozilirana na Asn'^ Asn*®, Asn*'*”, Asn^^^ in Asn^”“ od SEQ ID NO: 2, in kjer je farmacevtska formulacija vodna raztopina, ki ima pH med 5,6 in 6,2 ali pH s 5,9 ± 0,2.
  2. 15
    Farmacevtska formulacija po katerem koli od predhodnih zahtevkov, kjer je pH farmacevtske formulacije 5,9 ± 0,2. A pharmaceutical formulation according to any of the preceding claims, wherein the pH of the pharmaceutical formulation is 5.9 ± 0.2.
  3. 16
    A pharmaceutical formulation as claimed in any one of the preceding claims, wherein said pharmaceutical formulation comprises an excipient suitable for the formulation by intravenous infusion or injection, is chosen from trisodium citrate dehydrate, citric acid and human serum albumin. 16. Farmacevtska formulacija po katerem koli od predhodnih zahtevkov, kjer farmacevtska formulacija obsega ekscipient, primeren za formulacijo za intravensko infuzijo ali injekcijo, izbrano izmed trinatrijevega citrata dehidrata, citronske kisline in humanega serumskega albumina.