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Article ; Online: Phospholipid binding improves plasma survival of factor VIII.

Pisal, Dipak S / Balu-Iyer, Sathy V

2010 Volume 104, Issue 5, Page(s) 1073–1075

MeSH term(s)	Animals ; Area Under Curve ; Coagulants/administration & dosage ; Coagulants/pharmacokinetics ; Disease Models, Animal ; Factor VIII/administration & dosage ; Factor VIII/pharmacokinetics ; Half-Life ; Hemophilia A/blood ; Hemophilia A/drug therapy ; Metabolic Clearance Rate ; Mice ; Mice, Knockout ; Phosphatidylinositols/administration & dosage ; Phosphatidylinositols/pharmacokinetics ; Phospholipids/administration & dosage ; Phospholipids/pharmacokinetics ; von Willebrand Factor/genetics ; von Willebrand Factor/metabolism
Chemical Substances	Coagulants ; Phosphatidylinositols ; Phospholipids ; von Willebrand Factor ; Factor VIII (9001-27-8)
Language	English
Publishing date	2010-09-13
Publishing country	Germany
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1160/TH10-06-0422
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Article ; Online: Nonlinear pharmacokinetics of factor VIII and its phosphatidylinositol lipidic complex in hemophilia A mice.

Kosloski, Matthew P / Pisal, Dipak S / Mager, Donald E / Balu-Iyer, Sathy V

Biopharmaceutics & drug disposition

2014 Volume 35, Issue 3, Page(s) 154–163

Abstract: Factor VIII (FVIII) is an important cofactor in the blood coagulation cascade and its deficiency or dysfunction causes hemophilia A (HA), a bleeding disorder. Replacement with recombinant FVIII is limited by a short half-life and the development of ... ...

Abstract	Factor VIII (FVIII) is an important cofactor in the blood coagulation cascade and its deficiency or dysfunction causes hemophilia A (HA), a bleeding disorder. Replacement with recombinant FVIII is limited by a short half-life and the development of inhibitory antibodies. A phosphatidylinositol (PI) containing lipid nanoparticle was developed that, when associated with FVIII, reduces immunogenicity and prolongs circulation of the therapeutic protein in HA mice. A multiple dose level pharmacokinetic (PK) study of human free FVIII and its FVIII-PI complex over a clinically relevant range of doses (20, 40 and 200 IU/kg) was conducted in HA mice to investigate linearity of the PK and to determine if the reduced catabolism of FVIII following association with PI particles, previously only observed in the terminal phase following 400 IU/kg, could be extendable over a range of doses. The findings suggest that the disposition of FVIII is best characterized by a two-compartment model with saturable Michaelis-Menten elimination. Spontaneous complexation of FVIII with PI particles significantly increases plasma survival of the protein at 20 and 40 IU/kg doses. Human simulations at 40 IU/kg project an increase in the terminal half-life and the time to reach a minimum therapeutic threshold of 0.01 IU/ml of 5.4 h and 40 h, respectively, compared with free FVIII. Formulation with PI containing lipid particles may represent a viable delivery strategy for improving FVIII therapy.
MeSH term(s)	Animals ; Disease Models, Animal ; Dose-Response Relationship, Drug ; Factor VIII/administration & dosage ; Factor VIII/chemistry ; Factor VIII/pharmacokinetics ; Half-Life ; Hemophilia A/drug therapy ; Humans ; Lipids/chemistry ; Male ; Mice ; Mice, Inbred C57BL ; Nanoparticles ; Phosphatidylinositols/chemistry
Chemical Substances	Lipids ; Phosphatidylinositols ; Factor VIII (9001-27-8)
Language	English
Publishing date	2014-01-02
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	603014-2
ISSN	1099-081X ; 0142-2782
ISSN (online)	1099-081X
ISSN	0142-2782
DOI	10.1002/bdd.1880
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Article: Phospholipid binding lowers immunogenicity of human recombinant factor VIII in von Willebrand factor knockout mice

Pisal, Dipak S. / Balu-Iyer, Sathy V.

Thrombosis and Haemostasis

2011 Volume 105, Issue 06, Page(s) 1115–1118

Language	English
Publishing date	2011-01-01
Publisher	Schattauer GmbH
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1160/TH10-09-0628
Database	Thieme publisher's database

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Article: Phospholipid binding improves plasma survival of factor VIII

Pisal, Dipak S. / Balu-Iyer, Sathy V.

Thrombosis and Haemostasis

2010 Volume 103, Issue 11, Page(s) 1073–1075

Language	English
Publishing date	2010-01-01
Publisher	Schattauer GmbH
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	518294-3
ISSN	2567-689X ; 0340-6245
ISSN (online)	2567-689X
ISSN	0340-6245
DOI	10.1160/TH10-06-0422
Database	Thieme publisher's database

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Article ; Online: Phosphatidylinositol induces fluid phase formation and packing defects in phosphatidylcholine model membranes.

Peng, Aaron / Pisal, Dipak S / Doty, Amy / Balu-Iyer, Sathy V

Chemistry and physics of lipids

2011 Volume 165, Issue 1, Page(s) 15–22

Abstract: Liposomes consisted of phosphatidylinositol (PI) and phosphatidylcholine (PC) have been utilized as delivery vehicle for drugs and proteins. In the present work, we studied the effect of soy PI on physical properties of 1,2-dimyristoyl-sn-glycero-3- ... ...

Abstract	Liposomes consisted of phosphatidylinositol (PI) and phosphatidylcholine (PC) have been utilized as delivery vehicle for drugs and proteins. In the present work, we studied the effect of soy PI on physical properties of 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC) liposomes such as phase state of lipid bilayer, lipid packing and phase properties using multiple orthogonal biophysical techniques. The 6-dodecanoyl-2-dimethylamino naphthalene (Laurdan) fluorescence studies showed that presence of PI induces the formation of fluid phases in DMPC. Differential scanning calorimetry (DSC), temperature dependent fluorescence anisotropy measurements, and generalized polarization values for Laurdan showed that the presence of as low as 10mol% of PI induces substantial broadening and shift to lower temperature of phase transition of DMPC. The fluorescence emission intensity of DPH labeled, PI containing DMPC lipid bilayer decreased possibly due to deeper penetration of water molecules in lipid bilayer. In order to further delineate the effect of PI on the physico chemical properties of DMPC is due to either significant hydrophobic mismatch between the acyl chains of the DMPC and that of soy PI or due to the inositol head group, we systematically replaced soy PI with PC species of similar acyl chain composition (DPPC and 18:2 (Cis) PC) or with diacylglycerol (DAG), respectively. The anisotropy of PC membrane containing soy PI showed largest fluidity change compared to other compositions. The data suggests that addition of PI alters structure and dynamics of DMPC bilayer in that it promotes deeper water penetration in the bilayer, induces fluid phase characteristics and causes lipid packing defects that involve its inositol head group.
MeSH term(s)	2-Naphthylamine/analogs & derivatives ; 2-Naphthylamine/chemistry ; Calorimetry, Differential Scanning ; Dimyristoylphosphatidylcholine/chemistry ; Laurates/chemistry ; Lipid Bilayers/chemistry ; Liposomes/chemistry ; Models, Molecular ; Phase Transition ; Phosphatidylcholines/chemistry ; Phosphatidylinositols/chemistry ; Spectrometry, Fluorescence ; Transition Temperature
Chemical Substances	Laurates ; Lipid Bilayers ; Liposomes ; Phosphatidylcholines ; Phosphatidylinositols ; 2-Naphthylamine (CKR7XL41N4) ; Dimyristoylphosphatidylcholine (U86ZGC74V5) ; laurdan (Y97FBL93VW)
Language	English
Publishing date	2011-10-17
Publishing country	Ireland
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	213869-4
ISSN	1873-2941 ; 0009-3084
ISSN (online)	1873-2941
ISSN	0009-3084
DOI	10.1016/j.chemphyslip.2011.10.002
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Article ; Online: Allometry of factor VIII and informed scaling of next-generation therapeutic proteins.

Kosloski, Matthew P / Pisal, Dipak S / Mager, Donald E / Balu-Iyer, Sathy V

Journal of pharmaceutical sciences

2013 Volume 102, Issue 7, Page(s) 2380–2394

Abstract: Allometric scaling has been applied to the pharmacokinetics (PK) of factor VIII (FVIII), but published relationships are based on relatively small subsets of available data. Numerous next-generation forms of FVIII are being developed (e.g., Fc fusion, ... ...

Abstract	Allometric scaling has been applied to the pharmacokinetics (PK) of factor VIII (FVIII), but published relationships are based on relatively small subsets of available data. Numerous next-generation forms of FVIII are being developed (e.g., Fc fusion, PEGylated, and liposomal formulations) and traditional PK scaling of these products would not incorporate the wealth of existing knowledge for current FVIII therapy in humans. We conducted a meta-analysis and developed allometric relationships of FVIII from over 100 PK studies collected from literature. Normalized Wajima curves were used to relate mean FVIII profiles between species. An "informed scaling" approach was derived for predicting first-in-human PK parameters and demonstrated with a case study for an Fc fusion FVIII. NCA values for FVIII PK were well described by the allometric equations CL = 6.59 W(0.85) and V(ss) = 65.0 W(0.97). A subset of studies characterized by two-compartment modeling showed strong linearity in scaling of total clearance (CL) and central volume, but more variability in distributional CL and peripheral volume. Wajima curves for FVIII superimposed across species and the disposition of Fc fusion FVIII in humans was well predicted by "informed scaling." This approach might be generally applicable for predicting human PK of next-generational therapeutics.
MeSH term(s)	Animals ; Coagulants/pharmacokinetics ; Computer Simulation ; Dogs ; Factor VIII/pharmacokinetics ; Haplorhini ; Humans ; Mice ; Models, Biological ; Rabbits ; Rats ; Recombinant Proteins/pharmacokinetics ; Species Specificity
Chemical Substances	Coagulants ; Recombinant Proteins ; Factor VIII (9001-27-8)
Language	English
Publishing date	2013-04-25
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1002/jps.23566
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Article ; Online: Delivery of therapeutic proteins.

Pisal, Dipak S / Kosloski, Matthew P / Balu-Iyer, Sathy V

Journal of pharmaceutical sciences

2010 Volume 99, Issue 6, Page(s) 2557–2575

Abstract: The safety and efficacy of protein therapeutics are limited by three interrelated pharmaceutical issues, in vitro and in vivo instability, immunogenicity and shorter half-lives. Novel drug modifications for overcoming these issues are under investigation ...

Abstract	The safety and efficacy of protein therapeutics are limited by three interrelated pharmaceutical issues, in vitro and in vivo instability, immunogenicity and shorter half-lives. Novel drug modifications for overcoming these issues are under investigation and include covalent attachment of poly(ethylene glycol) (PEG), polysialic acid, or glycolic acid, as well as developing new formulations containing nanoparticulate or colloidal systems (e.g., liposomes, polymeric microspheres, polymeric nanoparticles). Such strategies have the potential to develop as next generation protein therapeutics. This review includes a general discussion on these delivery approaches.
MeSH term(s)	Chemistry, Pharmaceutical ; Half-Life ; Humans ; Liposomes/pharmacokinetics ; Microspheres ; Nanoparticles/chemistry ; Polyethylene Glycols/chemistry ; Polymers/chemistry ; Proteins/administration & dosage ; Sialic Acids
Chemical Substances	Liposomes ; Polymers ; Proteins ; Sialic Acids ; polysialic acid ; Polyethylene Glycols (3WJQ0SDW1A)
Language	English
Publishing date	2010-01-04
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1002/jps.22054
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Article ; Online: Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice.

Pisal, Dipak S / Kosloski, Matthew P / Middaugh, C Russell / Bankert, Richard B / Balu-Iyer, Sathy V

Journal of pharmaceutical sciences

2012 Volume 101, Issue 6, Page(s) 2055–2065

Abstract: The administration of recombinant factor VIII (FVIII) is the first-line therapy for hemophilia A (HA), but 25%-35% of patients develop an inhibitory antibody response. In general, the presence of aggregates contributes to unwanted immunogenic responses ... ...

Abstract	The administration of recombinant factor VIII (FVIII) is the first-line therapy for hemophilia A (HA), but 25%-35% of patients develop an inhibitory antibody response. In general, the presence of aggregates contributes to unwanted immunogenic responses against therapeutic proteins. FVIII has been shown to form both native-like and nonnative aggregates. Previously, we showed that nonnative aggregates of FVIII are less immunogenic than the native protein. Here, we investigated the effect of native-like aggregates of FVIII on immunogenicity in HA and von Willebrand factor knockout (vWF(-/-)) mice. Mice immunized with native-like aggregates showed significantly higher inhibitory antibody titers than animals that received native FVIII. Following restimulation in vitro with native FVIII, the activation of CD4+ T-cells isolated from mice immunized with native-like aggregates is approximately fourfold higher than mice immunized with the native protein. Furthermore, this is associated with increases in the secretion of proinflammatory cytokines IL-6 and IL-17 in the native-like aggregate treatment group. The results indicate that the native-like aggregates of FVIII are more immunogenic than native FVIII for both the B-cell and the T-cell responses.
MeSH term(s)	Animals ; Enzyme-Linked Immunosorbent Assay ; Factor VIII/genetics ; Factor VIII/immunology ; Hemophilia A/genetics ; Mice ; von Willebrand Factor/genetics
Chemical Substances	von Willebrand Factor ; Factor VIII (9001-27-8)
Language	English
Publishing date	2012-03-02
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1002/jps.23091
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Article ; Online: Transport of surface engineered polyamidoamine (PAMAM) dendrimers across IPEC-J2 cell monolayers.

Pisal, Dipak S / Yellepeddi, Venkata K / Kumar, Ajay / Palakurthi, Srinath

Drug delivery

2008 Volume 15, Issue 8, Page(s) 515–522

Abstract: The aim of our study was to prepare arginine-and ornithine-conjugated Polyamidoamine (PAMAM) dendrimers and study their permeability across IPEC-J2 cell monolayers, a new intestinal cell line model for drug absorption studies. Arginine and ornithine were ...

Abstract	The aim of our study was to prepare arginine-and ornithine-conjugated Polyamidoamine (PAMAM) dendrimers and study their permeability across IPEC-J2 cell monolayers, a new intestinal cell line model for drug absorption studies. Arginine and ornithine were conjugated to the amine terminals of the PAMAM(G4) dendrimers by Fmoc synthesis. The apical-to-basolateral (AB) and basolateral-to-apical (BA) apparent permeability coefficients (P(app)) for the PAMAM dendrimers increased by conjugating the dendrimers with both of these polyamines. The enhancement in permeability was dependent on the dendrimer concentration and duration of incubation. Correlation between monolayer permeability and the decrease in transepithelial electrical resistance (TEER) with the PAMAM dendrimers and the polyamine-conjugated dendrimers suggests that paracellular transport is one of the mechanisms of transport across the epithelial cells. Cytotoxicity of these surface-modified dendrimers was evaluated in IPEC-J2 cells by MTT (methylthiazoletetrazolium) assay. Arginine-conjugated dendrimers were insignificantly more toxic than PAMAM dendrimer as well as ornithine-conjugated dendrimers. Though investigations on the possible involvement of other transport mechanisms are in progress, results of the present study suggest the potential of dendrimer-polyamine conjugates as the carriers for antigen/drug delivery through the oral mucosa.
MeSH term(s)	Animals ; Biological Transport, Active ; Cell Line ; Cell Membrane Permeability ; Dendrimers/chemistry ; Dendrimers/pharmacokinetics ; Dendrimers/toxicity ; Drug Carriers/chemistry ; Drug Carriers/pharmacokinetics ; Drug Carriers/toxicity ; Electric Impedance ; Epithelial Cells/metabolism ; Polyamines/chemistry ; Polyamines/pharmacokinetics ; Polyamines/toxicity
Chemical Substances	Dendrimers ; Drug Carriers ; PAMAM Starburst ; Polyamines
Language	English
Publishing date	2008-07-31
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1213261-5
ISSN	1521-0464 ; 1071-7544
ISSN (online)	1521-0464
ISSN	1071-7544
DOI	10.1080/10717540802321826
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Article ; Online: A Novel Pharmacokinetic Bridging Strategy to Support a Change in the Route of Administration for Biologics.

Ji, Ping / Nikolov, Nikolay / Seymour, Sally / Glaser, Rachel / Ren, Yupeng / Li, Liang / Marathe, Anshu / Ren, Yunzhao / Chen, Jianmeng / He, Lei / Pisal, Dipak / Yapa, Shalini Wickramaratne Senarath / Wang, Yaning / Sahajwalla, Chandrahas

Journal of pharmaceutical sciences

2019 Volume 108, Issue 7, Page(s) 2490–2499

Abstract: Determination of appropriate pharmacokinetic end point to bridge different dosing regimens is often a challenge when developing a new route of administration. Trough concentrations ( ... ...

Abstract	Determination of appropriate pharmacokinetic end point to bridge different dosing regimens is often a challenge when developing a new route of administration. Trough concentrations (C
MeSH term(s)	Administration, Intravenous/methods ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/pharmacokinetics ; Arthritis, Rheumatoid/drug therapy ; Biological Products/administration & dosage ; Biological Products/pharmacokinetics ; Humans ; Injections, Subcutaneous/methods
Chemical Substances	Antirheumatic Agents ; Biological Products
Language	English
Publishing date	2019-03-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2019.02.027
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