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Compositions and methods of delivery of pharmacological agents

a technology of pharmacological agents and compositions, applied in the field of pharmaceutical compositions, can solve the problems of phlebitis, burning and pain, venous irritation, parenteral use, etc., and achieve the effects of reducing one or more side effects, and inhibiting microbial growth

Inactive Publication Date: 2007-06-07
ABRAXIS BIOSCI LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010] The invention provides a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises a protein, such as albumin, more preferably human serum albumin, in an amount effective to reduce one or more side effects of administration of the pharmaceutical composition into a human, and wherein the pharmaceutically acceptable carrier comprises deferoxamine in an amount effective to inhibit microbial growth in the pharmaceutical composition. The invention also provides a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier comprises a protein, such as albumin, in an amount effective to reduce one or more side effects of administation of the pharmaceutical composition into a human, and wherein the pharmaceutically acceptable carrier comprises deferoxamine in an amount effective to inhibit oxidation m the pharmaceutical composition.
[0011] The invention provides a method for reducing one or more side effects associated with administration of a pharmaceutical composition to a human comprising (a) administering to a human a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrer, wherein the pharmaceutically acceptable carrier comprises albumin and deteroxamine. Also provided are methods for inhibiting microbial growth or for inhibiting oxidation, or for inhibiting microbial growth and oxidation in a pharmaceutical composition. These methods comprise preparing a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, wherein the pharmacutically acceptable carrier comprises deferoxamine in an amount effective for inhibiting microbial growth or an amount effective for inhibiting oxidation in the pharmaceutical composition.

Problems solved by technology

It is well recognized that many drugs for parenteral use, especially those administered intravenously, cause undesirable side effects such as venous irritation, phlebitis, burning and pain on injection, venous thrombosis, extravasation, and other administration related side effects.
Often, the free drug present in the formulation induces pain or irritation upon administration.
Another problem associated with the manufacture of drugs for injection, particularly water insoluble drugs, is the assurance of sterility.
However, such methods are time consuming and expensive.
In addition, the oxidation of drug formulations by exposure to air during manufacture or storage can lead to, for example, reduced pH, drug degradation, and discoloration, thereby destabilizing the drug formulation and / or reducing shelf life.
These formulations, however, induce other side effects (e.g., cardiovascular complications), or cause destabiliztion of propofol emulsions.
Since edetate and pentetate are metal ion chelators, however, they have the potential to be dangerous by scavenging the essential metal ions from the body system.
Moreover, the addition of sulphites to drug formulations presents potential adverse effects to the periatric population and for those in the general population who are allergic to sulphur.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0051] This example demonstrates the preparation of pharmaceutical compositions comprising paclitaxel and albumin. Preparation of paclitaxel-albumin compositions is described in U.S. Pats. 5,439,686 and 5,916,596, which are incorporated in their entirety by reference. Specifically, 30 mg of paclitaxel was dissolved in 3.0 ml methylene chloride. The solution was added to 27.0 ml of human serm albumin solution (2% w / v). Deferoxamine was added as necessary. The was homogenized for 5 mmutes at low RPM (Vitris homogenizer, model Tempest I.Q.) in order to form a crude emulsion, and then transferred into a high pressure homogenizer (Avestin). The emulification was performed at 9000-40,000 psi while recycling the emulsion for at least 5 cycles. The resulting system was transfenred into a rotary evaporator, and methylene chloride was rapidly removed at 400° C., at reduced pressure (30 mm Hg) for 20-30 minutes. The resulting dispersion was translucent, and the typical average diameter of the ...

example 2

[0053] This example demonstrates the preparation of a phmaceutical composition comprising amiodarone and albumin. 30 mg of amiodarone was dissolved in 3.0 ml methylene chloride. The solution was added to 27.0 ml of human serum albumin solution (1% w / v). Deferoxamine was added as necessary. The mixture was homogenied for 5 minutes at low RPM (Vitis homogenizer, model Tempest I.Q.) in order to form a crude emulsion, and then transferred into a high pressure homogenizer (Avestin). The emulisification was performed at 9000-40,000 psi while reycling the emulsion for at least 5 cycles. The resulting system was tansferred into a rotary evaporator, and methylene chloride was rapidly removed at 40° C., at reduced pressure (30 mm Hg) for 20-30 minutes. The resulting dispersion was translucent, and the typical average diameter of the resulting amiodarone particles was in the range 50-220 nm (Z-average, Malvern Zetasizer). The dispersion was further lyophilized for 48 hr. The resulting cake was...

example 3

[0055] This example demonstrates the preparation of pharmaceutical compositions comprising liothyronine and albumin compositions. Liothyronine (or suitable salt) was dissolved in an aqueous alcoholic solution or alkaline solution at a concentraion of 0.5-50 mg / ml. The alcoholic (or alkaline) solution was added to an albumin solution (0.1- 25% w / v) and agitated. Agitation was low shear with a stirrer or high shear using a sonicator or a homogenizer. At low concentrations of liothyronine, (5- 1000 μg / ml) clear solutions were obtained. As the concentration was increased, a milky stable suspension was obtained. These solutions or suspensions were filtered through a sterilizing filter. Organic solvents were removed by evaporation or other suitable method.

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PUM

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Abstract

The present invention relates to a pharmaceutical composition comprising a pharmaceutical agent and a pharmaceutically acceptable carrier, which carrier comprises a protein, for example, human serun albumin and / or deferoxamine. The human serum albumin is present in an amount effective to reduce one or more side effects associated with administration of the pharmaceutical composition. The invention also provides methods for reducing one or more side effects of administration of the pharmaceutical composition, methods for inhibiting microbial growth and oxidation in the pharrmaceutical composition, and methods for enhancing transport and binding of a pharmaceutical agent to a cell.

Description

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS [0001] This patent application is a continuation of patent application Ser. No. 10 / 731,224, which claims the benefit of U.S. Provisional Patent Application No. 60 / 432,317 filed December 9, 2002, U.S. Provisional Patent Application 60 / 526,544 filed Dec. 3, 2003, U.S. Provisional Patent Application 60 / 526,773 filed Dec. 4, 2003, and U.S. Provisional Patent Application 60 / 527,177 filed Dec. 5, 2003. FIELD OF THE INVENTION [0002] This invention pertains to pharmaceutical compositions comprising pharmaceutically active agents for parenteral or other internal use, which have the effect of reducing certain undesirable side effects upon administration when compared with available formulations of similar drugs. BACKGROUND OF THE INVENTION [0003] It is well recognized that many drugs for parenteral use, especially those administered intravenously, cause undesirable side effects such as venous irritation, phlebitis, burning and pain on injection, ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K47/00A61K9/00A61K9/19A61K31/00A61K47/18A61K47/48
CPCA61K9/0019A61K31/198A61K9/1075A61K9/146A61K9/19A61K31/05A61K31/16A61K31/337A61K47/18A61K47/42B82Y5/00A61K9/0078A61K31/4745A61K31/7048A61K31/164A61K31/165A61K38/13Y10S977/773Y10S977/906Y10S977/779Y10S977/911Y10S977/705A61K31/436A61K31/427A61K31/355A61K31/343A61K2300/00A61K31/00A61K9/107A61K31/24A61P19/02A61P23/00A61P29/00A61P31/04A61P35/00A61P37/06A61P39/02A61P43/00A61P9/00A61P9/04A61P9/10A61K9/51A61K47/32
Inventor DESAI, NEIL P.SOON-SHIONG, PATRICKTRIEU, VUONG
Owner ABRAXIS BIOSCI LLC
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