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Composition for delivery of hematopoietic growth factor

a technology composition, which is applied in the direction of powder delivery, drug composition, peptide, etc., can solve the problems of multiple daily injections, fever and mild-to-moderate bone pain, and saw-toothlike effect of plasma drug levels, so as to increase the plasma half-life improve the activity of hematopoietic growth factor, and reduce the number of administrations.

Inactive Publication Date: 2005-07-07
RXKINETIX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a hematopoietic growth factor delivery composition that can sustain the delivery of hematopoietic growth factors for a longer period of time, reduce the number of administrations required, and minimize side effects. The composition exhibits reverse-thermal viscosity behavior, which allows it to be administered as a flowable medium and then convert to a higher-viscosity form in vivo. The composition includes a hematopoietic growth factor, a first biocompatible polymer, a second biocompatible polymer, and a liquid vehicle. The second biocompatible polymer helps to protect the composition from premature degradation and promotes a prolonged release of the hematopoietic growth factor. The composition can be administered as a gel form at a higher temperature, but it is in a liquid form at lower temperatures. The hematopoietic growth factor can be uniformly dispersed throughout the gel, which further enhances its activity. The invention also includes a method for manufacturing and packaging the hematopoietic growth factor delivery composition."

Problems solved by technology

One of the problems associated with the hematopoietic growth factors such as G-CSF, GM-CSF, SCF and Flt3-L, is the need for multiple daily injections.
This, in turn leads to another common disadvantage of current injectable therapies such as these, that being the creation of a saw-toothlike effect of plasma drug levels.
An additional problem with current hematopoietic growth factor therapy includes fever and mild-to-moderate bone pain in patients receiving high doses over a long period.

Method used

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  • Composition for delivery of hematopoietic growth factor
  • Composition for delivery of hematopoietic growth factor
  • Composition for delivery of hematopoietic growth factor

Examples

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example 1

Formulation of G-CSF with Pluronic™ F127

[0077] In one preferred embodiment of the present invention, the hematopoietic growth factor is G-CSF, and the delivery composition of the present invention provides a delivery system for the sustained administration of G-CSF to a human or animal host. A preferred first biocompatible polymer in this situation is a POE-POP block copolymer with reverse-thermal gelation properties.

[0078] As a specific formulation example, G-CSF can be formulated with Pluronic™ F127 (poloxamer 407), with and without hydroxypropylmethylcellulose (HPMC). Dry powder forms of Pluronic™ F 127 and HPMC are weighed, mixed together, and then reconstituted in water or physiological buffer to achieve the drug delivery matrix containing, upon addition of G-CSF, the desired concentrations of each component. More specifically, the concentration of Pluronic™ F127 is one that will achieve a final concentration (e.g., 5-30 weight %) at which it forms a semi-solid gel, along wit...

example 2

Administration of G-CCF with Pluronic™ 127

[0081] Formulations including G-CSF, Pluronic™ 127, with and without HPMC, are prepared and administered to groups of Balb / c mice to determine a) the effect of formulating G-CSF in a Pluronic™ 127 and HPMC (Invention Formulation) delivery matrix on the pharmacokinetic profile of G-CSF compared to conventionally (Buffer Formulation) formulated G-CSF and b) the effects of the Invention Formulation on hematopoietic activity compared to conventionally formulated G-CSF. The formulations are administered to mice intramuscularly (i.m.), as a single dose for pharmacokinetic analysis and as either single (for Invention Formulation) or multiple (for Buffer Formulation) doses for hematopoeitic acitivity. The compositions of the formulations are shown in Table 1.

TABLE 1Pluronic ™G-CSFHPMC (%GroupF127 (% w / w)(μg / mL)w / w)Vehicle control,000bufferVehicle control, gel1700.1 to 5G-CSF in buffer01 to 3000(BufferFormulation)G-CSF with177 to 1000.1 to 5Pluron...

example 3

Formulation of Flt3-L with Pluronic™ F127

[0090] In a preferred embodiment of the present invention, the hematopoietic growth factor is Flt3-L, and the pharmaceutical composition of the present invention provides a delivery system for the sustained administration of the Flt3-L to a human or animal. A preferred first biocompatible polymer in this situation is a POE-POP block copolymer with reverse-thermal gelation properties.

[0091] As a specific formulation example, Flt3-L can be formulated with Pluronic™ F127 (poloxamer 407), with or without hydroxypropylmethylcellulose (HPMC). Pluronic™ F127 is initially formulated in water or physiological buffer at concentrations (e.g., 5-30%) at which it forms a semi-solid gel, along with the addition of HPMC, at body temperature (37° C.). HPMC may then be added to the Pluronic™ F127 formulation at concentrations necessary to modulate the physicochemical properties of the Pluronic F127. (e.g., final concentrations of HPMC 1-5%). Alternatively, ...

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Abstract

A hematopoietic growth factor delivery composition includes a hematopoietic growth factor, a liquid vehicle, a first biocompatible polymer and a second biocompatible polymer. The composition exhibits reverse-thermal viscosity behavior, due to interaction between the first biocompatible polymer and the liquid vehicle. The second biocompatible polymer helps to protect the first biocompatible polymer from being dissolved in vivo following administration to a host.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims a priority benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 60 / 214,298 entitled “COMPOSITION AND METHOD FOR DELIVERY OF HEMATOPOIETIC GROWTH FACTOR” filed Jun. 26, 2000 and to U.S. Provisional Patent Application No. 60 / 274,891 entitled “COMPOSITION AND METHOD FOR DELIVERY OF HEMATOPOIETIC GROWTH FACTOR” filed Mar. 9, 2001, the entire contents of each of which are incorporated herein by reference as if each were set forth herein in full.FIELD OF THE INVENTION [0002] The present invention relates to compositions for delivery of hematopoietic growth factors. BACKGROUND OF THE INVENTION [0003] Functionally, hematopoietic growth factors can be considered to belong to one of three groups. The first or multilineage group includes interleukin 3 (IL-3) and granulocyte macrophage colony stimulating factor (GM-CSF) which act on early colony forming units (CFU's) including colony forming unit-granul...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/52A61K38/18A61K38/19A61K38/20A61K47/10A61K47/36A61K47/38C12N5/02
CPCA61K9/0024A61K31/505A61K38/193A61K38/2046A61K47/10A61K31/513A61K47/38A61K38/18A61K47/36A61K35/545A61K2300/00
Inventor ROSENTHAL, GARY J.ETTER, JEFFREY B.
Owner RXKINETIX
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