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Compositions and methods of delivery of pharmacological agents

a technology of pharmacological agents and compositions, applied in the field of compositions of pharmaceutical products, can solve the problems of unfavorable drug safety, undesirable side effects, venous irritation, burning and pain, etc., and achieve the effects of reducing one or more side effects of administration, and inhibiting microbial growth

Inactive Publication Date: 2005-01-06
ABRAXIS BIOSCI LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention provides pharmaceutical compositions with reduced side effects and inhibited microbial growth or oxidation. The compositions comprise a pharmaceutical agent and a carrier, which can be albumin or deferoxamine. The ratio of albumin to pharmaceutical agent is about 18:1. The invention also provides methods for enhancing transport of the pharmaceutical agent to the site of infirmity in a human and increasing the transport of the pharmaceutical agent to a cell in vitro or in vivo by combining it with a protein that binds a specific cell-surface receptor.

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 destabilization 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 pediatric 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. Pat. Nos. 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 serum albumin solution (2% w / v). Deferoxamine was added as necessary. The mixture was homogenized for 5 minutes 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 emulsification was performed at 9000-40,000 psi while recycling the emulsion for at least 5 cycles. The resulting system was transferred 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 di...

example 2

[0053] This example demonstrates the preparation of a pharmaceutical 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 homogenized for 5 minutes 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 emulsification was performed at 9000-40,000 psi while recycling the emulsion for at least 5 cycles. The resulting system was transferred 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 hrs. The resulting ca...

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 concentration 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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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 serum 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 pharmaceutical 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 claims the benefit of U.S. Provisional Patent Application No. 60 / 432,317 filed Dec. 9, 2002, U.S. Provisional Patent Application (Attorney Docket No. 225519) filed Dec. 3, 2003, U.S. Provisional Patent Application (Attorney Docket No. 225549) filed Dec. 4, 2003, and U.S. Provisional Patent Application (Attorney Docket No. 225585) 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, venous thrombosis,...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/19A61K31/00A61K47/18A61K47/48
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.YANG, ANDREWDE, TAPASCI, SHERRY XIAOPEISOON-SHIONG, PATRICKTRIEU, VUONGYAO, OIANGGRIM, BRIDGET BEALS
Owner ABRAXIS BIOSCI LLC
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