Pharmaceutical composition comprising factor VIII and neutral liposomes
First Claim
1. A pharmaceutical composition for parenteral administration comprising a therapeutically effective amount of a therapeutic protein or polypeptide and substantially neutral colloidal particles, said particles comprising approximately 1-20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer, said polymer carrying substantially no net charge,wherein said protein or polypeptide is selected from the group consisting of:
- (a) proteins or polypeptides capable of externally binding said colloidal particles; and
(b) proteins or polypeptides capable of binding polyethylene glycol, wherein said protein or polypeptide is not encapsulated in said colloidal particles and is non-covalently bound thereto, and wherein no therapeutic component is encapsulated in said colloidal particles.
3 Assignments
0 Petitions
Accused Products
Abstract
A pharmaceutical composition for parenteral administration comprising a therapeutically effective amount of a protein or polypeptide and substantially neutral colloidal particles. The particles comprise approximately 1-20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer which carriers substantially no net charge. The protein or polypeptide is capable of externally binding the colloidal particles, or is capable of binding polyethylene glycol, and is not encapsulated in the colloidal particles. A preferred protein is factor VIII, whose half-life is extended and which is protected from serum inhibitor antibodies by injecting it as a component of the composition.
10 Citations
17 Claims
-
1. A pharmaceutical composition for parenteral administration comprising a therapeutically effective amount of a therapeutic protein or polypeptide and substantially neutral colloidal particles, said particles comprising approximately 1-20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer, said polymer carrying substantially no net charge,
wherein said protein or polypeptide is selected from the group consisting of: -
(a) proteins or polypeptides capable of externally binding said colloidal particles; and
(b) proteins or polypeptides capable of binding polyethylene glycol, wherein said protein or polypeptide is not encapsulated in said colloidal particles and is non-covalently bound thereto, and wherein no therapeutic component is encapsulated in said colloidal particles. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
-
-
13. A method of administering a therapeutically effective amount of a therapeutic protein or polypeptide to a patient, comprising parenteral administration of substantially neutral colloidal particles with said therapeutic protein or polypeptide non-covalently bound thereto, wherein:
-
(1) said colloidal particles comprise approximately 1-20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer, said polymer carrying substantially no net charge;
(2) said protein or polypeptide is selected from the group consisting of;
(a) proteins or polypeptides capable of externally binding said colloidal particles; and
(b) proteins or polypeptides capable of binding polyethylene glycol, (3) said protein or polypeptide is not encapsulated in said colloidal particles, and (4) no therapeutic component is encapsulated in said colloidal particles. - View Dependent Claims (14, 15, 16, 17)
-
Specification