Increase of the pharmacological and pharmacokinetic efficacy of negatively charged polypeptide recombinant hirudin in rats via parenteral route by association with cationic liposomes

Journal of Controlled Release

Volumn 128, Issue 2, 2008, Pages 113-119

  Meng, Meng ^a   Liu, Yu ^a   Wang, Yi Bo ^a   Wang, Jian Cheng ^a   Zhang, Hua ^a   Wang, Xue Qing ^a   Zhang, Xuan ^a   Lu, Wan Liang ^a   Zhang, Qiang ^a  

^a PEKING UNIVERSITY HEALTH SCIENCE CENTER   (China)

Author keywords

Cationic liposomes; Entrapment; In vivo studies; Recombinant hirudin; Sustained release

Indexed keywords

HYDROPHILICITY; LIPIDS; LIPOSOMES; PLASMA (HUMAN); POLYPEPTIDES; RATS;

CATIONIC LIPOSOMES; ENTRAPMENT; IN VIVO STUDIES; RECOMBINANT HIRUDIN; SUSTAINED RELEASE;

PHARMACOKINETICS;

AMPHOLYTE; LIPOSOME; RECOMBINANT HIRUDIN;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; BLOOD CLOTTING TIME; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG EFFICACY; ISOELECTRIC POINT; MALE; NONHUMAN; PRIORITY JOURNAL; RAT; SUSTAINED DRUG RELEASE;

AMINES; ANIMALS; BIOLOGICAL AVAILABILITY; BLOOD COAGULATION; CATIONS; CHOLESTEROL; ELECTROSTATICS; FIBRINOLYTIC AGENTS; HIRUDINS; INFUSIONS, PARENTERAL; LECITHINS; MALE; PARTIAL THROMBOPLASTIN TIME; RATS; RATS, SPRAGUE-DAWLEY; RECOMBINANT PROTEINS; THROMBIN TIME; UNILAMELLAR LIPOSOMES;

EID: 43449100313     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2008.03.001     Document Type: Article

References (47)

1. Katayama K., Kato Y., Onishi H., Nagai T., and Machid Y. Double liposomes: hypoglycemic effects of liposomal insulin on normal rats. Drug Dev. Ind. Pharm. 29 7 (2003) 725-731
2. Meyenburg S., Lilie H., Panzner S., and Rudolph R. Fibrin encapsulated liposomes as protein delivery system studies on the in vitro release behavior. J. Control. Release 69 1 (2000) 159-168
3. Shew R.L., and Deamer D. A novel method for encapsulation of macromolecules in liposomes. Biochim. Biophys. Acta 816 (1985) 1-8
4. Lee K.Y., and Yuk S.H. Polymeric protein delivery systems. Prog. Polym. Sci. 32 7 (2007) 669-697
5. Haro I., Pérez S., García M., Chan W.C., and Ercill G. Liposome entrapment and immunogenic studies of a synthetic lipophilic multiple antigenic peptide bearing VP1 and VP3 domains of the hepatitis A virus: a robust method for vaccine design. FEBS Letters 540 1-3 (2003) 133-140
6. Huang Y.Y., and Wang C.H. Pulmonary delivery of insulin by liposomal carriers. J. Control. Release 113 1 (2006) 9-14
7. Yang T.Z., Wang X.T., Yan X.Y., and Zhang Q. Phospholipid deformable vesicles for buccal delivery of insulin. Chem. Pharm. Bull. 50 6 (2002) 749-753
8. Ciani L., Ristori S., Salvati A., Calamai L., and Martini G. DOTAP/DOPE and DC-Chol/DOPE lipoplexes for gene delivery: zeta potential measurements and electron spin resonance spectra. Biochim. Biophys. Acta 1664 (2004) 70-79
9. Serikawa T., Kikuchi A., Sugaya S., Suzuki N., Kikuchi H., and Tanaka K. In vitro and in vivo evaluation of novel cationic liposomes utilized for cancer gene therapy. J. Control. Release 113 (2006) 255-260
10. Stuart D.D., and Allen T.M. A new liposomal formulation for antisense oligodeoxynucleotides with small size, high incorporation efficiency and good stability. Biochim. Biophys. Acta 1463 (2000) 219-229
11. Li S.D., and Huang L. Targeted delivery of antisense oligodeoxynucleotide and small interference RNA into lung cancer cells. Mol. Pharm. 3 5 (2006) 579-588
12. Strieth S., Eichhorn M.E., Sauer B., Schulze B., Teifel M., Michaelis U., and Dellian M. Neovascular targeting chemotherapy: encapsulation of paclitaxel in cationic liposomes impairs functional tumor microvasculature. Int. J. Cancer 110 (2004) 117-124
13. Sody M.S., Strieth S., Krasnici S., Sauer B., Schulze B., Teifel M., Michaelis U., Naujoks K., and Dellian M. Neovascular targeting therapy: paclitaxel encapsulated in cationic liposomes improves antitumoral efficacy. Clin. Cancer Res. 9 (2003) 2335-2341
14. Kunstfeld R., Wickenhauser G., Michaelis U., Teife M., Umek W., Naujoks K., and Petzelbauer P. Paclitaxel encapsulated in cationic liposomes diminishes tumor angiogenesis and melanoma growth in a "humanized" SCID mouse model. J. Invest. Dermatol. 120 (2003) 476-482
15. Campbell R.B., Fukumura D., Brown E.B., Mazzola L.M., Izumi Y., Jain R.K., Torchilin V.P., and Munn L.L. Cationic charge determines the distribution of liposomes between the vascular and extravascular compartments of tumors. Cancer Res. 62 (2002) 6831-6836
16. Corvo M.L., Martins M.B., Francisco A.P., Morais J.G., Eugenia M., and Cruz M. Liposomal formulations of Cu, Zn-superoxide dismutase: physicochemical characterization and activity assessment in an inflammation model. J. Control. Release 43 (1997) 1-8
17. Zheng L., Huang X.L., Fan Z., Borowski L., and Wilson C.C. Delivery of liposome-encapsulated HIV type 1 proteins to human dendritic cells for stimulation of HIV type 1-specific memory cytotoxic T lymphocyte responses. Aids Res. Hum. Retrovir. 15 11 (1999) 1011-1020
18. Yan W., Chen W., and Huang L. Mechanism of adjuvant activity of cationic liposome: phosphorylation of a MAP kinase, ERK and induction of chemokines. Mol. Immunol. 44 15 (2007) 3672-3681
19. Vangala A., Kirby D., Rosenkrands I., Agger E.M., Andersen P., and Perrie Y. A comparative study of cationic liposome and niosome-based adjuvant systems for protein subunit vaccines: characterisation, environmental scanning electron microscopy and immunisation studies in mice. J. Pharm. Pharmacol. 58 6 (2006) 787-799
20. Lin M.F., Davolio J., and Garcia R. Cationic liposome-mediated incorporation of prostatic acid phosphatase protein into human prostate carcinoma cells. Biochem. Biophys. Res. Commun. 192 2 (1993) 413-419
21. Panico A., Pignatello R., Cardile V., and Puglisi G. Preparation of liposome formulation containing immunomodulatory peptides. Pharm. Acta Helv. 72 (1997) 1-10
22. Vitas A.I., Díaz R., and Gamazo C. Effect of composition and method of preparation of liposomes on their stability and interaction with murine monocytes infected with Brucella abortus. Antimicrob. Agents Chemother. 40 1 (1996) 146-151
23. Li S., Gao X., Son K., Sorgi F., Hofland H., and Huang L. DC-Chol lipid system in gene transfer. J. Control. Release 39 (1996) 373-381
24. Audouy S.A.L., Leij L.F.M.H.d., Hoekstra D., and Molema G. In vivo characteristics of cationic liposomes as delivery vectors for gene therapy. Pharm. Res. 19 11 (2002) 1599-1605
25. Templeton N.S. Cationic liposomes as in vivo delivery vehicles. Curr. Med. Chem. 10 (2003) 1279-1287
26. Hortobagyi G.N., Ueno N.T., Xia W., Zhang S., and Wolf J.K. Cationic liposome-mediated E1A gene transfer to human breast and ovarian cancer cells and its biologic effects: a phase I clinical trial. J. Clin. Oncol. 19 14 (2001) 3422-3433
27. Villaret D., Glisson B., Kenady D., Hanna E., Carey M., Gleich L., Yoo G.H., Futran N., Hung M.C., Anklesaria P., and Heald A.E. A multicenter phase II study of tgDCC-E1A for the intratumoral treatment of patients with recurrent head and neck squamous cell carcinoma. Head Neck-J. Sci. Spec. Head Neck 24 7 (2002) 661-669
28. Hui K.M., Ang P.T., Huang L., and Tay S.K. Phase I study of immunotherapy of cutaneous metastases of human carcinoma using allogeneic and xenogeneic MHC DNA-liposome complexes. Gene Ther. 4 8 (1997) 783-790
29. Markwardt F. The development of hirudin as an antithrombotic drug. Thromb. Res. 74 1 (1994) 1-23
30. Harenberg J., Hoffmann U., Huhle G., Song X.H., and Wang L.C. Treatment of an acute flush reaction caused by subcutaneous r-hirudin with pegylated hirudin. Br. J. Haematol. 108 (2000) 528-530
31. Gietz U., Arvinte T., Haner M., Aebi U., and Merkle H.P. Formulation of sustained release aqueous Zn-hirudin suspensions. Eur. J. Pharm. Sci. 11 (2000) 33-41
32. Markwardt F., Richter M., and Paintz M. Preparation of dextran-bound recombinant hirudin and its pharmacokinetic behaviour. Biomed. Biochim. Acta 49 (1990) 1103-1108
33. Mumper R.J., and Hoffman A.S. The stabilization and release of hirudin from liposomes or lipid-assemblies coated with hydrophobically modified dextran. AAPS PharmSciTech 1 (2000) E3
34. Liu Y., Lu W.L., and Zhang Q. Controlled delivery of recombinant hirudin based on thermo-sensitive Pluronic® F127 hydrogel for subcutaneous administration: in vitro and in vivo characterization. J. Control. Release 117 (2007) 387-395
35. Gao X., and Huang L. A novel cationic liposome reagent for efficient transfection of mammalian cells. Biochem. Biophys. Res. Commun. 179 (1991) 280-285
36. Bangham. Preparation and use of liposomes as models of biological membranes. Methods in Membrane Biology vol. 1 (1974), Plenum Press, New York 1-68
37. Szoka F., and Papahadjopoulos D. Procedure for preparation of liposomes with large internal aqueous space and high capture by reverse-phase evaporation. Proc. Natl. Acad. Sci. U.S.A. 75 9 (1978) 4194-4198
38. Liu Y., Lu W.L., and Zhang Q. Pharmacodynamics and pharmacokinetics of recombinant hirudin via four non-parenteral routes. Peptides 26 (2005) 423-430
39. Maurer N. Spontaneous entrapment of polynucleotides upon electrostatic interaction with ethanol-destabilized cationic liposomes. Biophys. J. 80 (2001) 2310-2326
40. Nicolazzi C., Mignet N., Figuera N.d.l., Cadet M., Ibad R.T., Seguin J., and Scherman D. Anionic polyethyleneglycol lipids added to cationic lipoplexes increase their plasmatic circulation time. J. Control. Release 88 (2003) 429-443
41. Gribach U., Stuerzebecher U., and Markwardt F. Assay of hirudin in plasma using a chromogenic thrombin substrate. Thromb. Res. 37 2 (1985) 347-350
42. Gokhale P.C., Zhang C., Newsome J.T., Pei J., Ahmad I., Rahman A., Dritschilo A., and Kasid U.N. Pharmacokinetics, toxicity, and efficacy of ends-modified raf antisense oligodeoxyribonucleotide encapsulated in a novel cationic liposome. Clin. Cancer Res. 8 (2002) 3611-3621
43. Nabel E.G., Gordon D., Yang Z.Y., Xu L., San H., Plautz G.E., Wu B.Y., Gao X., Huang L., and Nabel G.J. Gene transfer in vivo with DNA-liposome complexes: lack of autoimmunity and gonadal localization. Hum. Gene Ther. 3 (1992) 649-656
44. Nabel G.J., Nabel E.G., Yang Z.Y., Fox B.A., Plautz G.E., Gao X., Huang L., Shu S., Gordon D., and Chang A.E. Direct gene transfer with DNA-liposome complexes in melanoma: expression, biological activity and lack of toxicity in humans. Proc. Natl. Acad. Sci. U.S.A. 90 (1993) 11307-11311
45. Elouahabi A., Flamand V., Ozkan S., Paulart F., Vandenbranden M., Goldman M., and Ruysschaert J.M. Free cationic liposomes inhibit the inflammatory response to cationic lipid-DNA complex injected intravenously and enhance its transfection efficiency. Mol. Ther. 7 1 (2003) 81-88
46. Filion M.C., and Phillips N.C. Anti-inflammatory activity of cationic lipids. Br. J. Pharmacol. 122 3 (1997) 551-557
47. Iyer L., Koza M., and Iqbal O. Studies on the pharmacokinetics and pharmacodynamics of recombinant hirudin (rHV2-Lys 47) after intravenous and subcutaneous administration in dogs. Thromb. Res. 69 3 (1993) 259-269