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Medical Products and Parenteral Formulations

a technology of parenteral formulation and medical products, which is applied in the field of medical solutions and containers, can solve the problems of increasing the risk of contamination of the final mixture, easy to break, and difficult to handle, and heat sterilization such as autoclaving can affect certain plastic materials

Inactive Publication Date: 2007-04-26
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a sterilized medical product for a pediatric patient population that includes a polymeric container with multiple chambers separated by frangible barriers. The chambers contain different nutritional formulations that can be activated by the frangible barriers to create a total nutritional formulation that provides one day of nutritional needs for a child. The nutritional formulations include carbohydrates, amino acids, electrolytes, and lipids. The activation of all the frangible barriers results in a safe and effective way to provide nutritional support for children.

Problems solved by technology

While glass containers offer many benefits such as gas impermeability and virtually complete compatibility with medical solutions, glass containers are heavy, easily broken, difficult to handle and can release aluminum into the solutions.
However such a combination method is time consuming, may give rise to errors in formulation and increases the risks of contamination of the final mixture.
A drawback of utilizing such multi-chamber containers is that one is restricted to the formulation which are provided by the supplied components and proportional amounts which are housed in the various chambers When seeking to address the needs of varying patient populations, particularly fluid restricted populations, such restriction may hinder the ability to utilize such a containers, cause use of only a portion of the contents of such a container or cause multiple versions of such containers to be stored.
Plastic containers such as those just discussed however can also present unique issues which must be addressed.
One possible issue is that heat sterilization such as autoclaving can affect certain plastic materials used to form the container and / or the heat seal separating the chambers.
Another possible issue is that certain plastic materials are permeable to atmospheric oxygen and may inadequately protect oxygen sensitive solutions or components.
Yet another is that certain fat soluble or lipophilic solutions or components may not be compatible with certain plastic materials.
For example, lipid formulations such as Lipid emulsions used in parenteral nourishment cannot be stored in certain plastics because it can leach out some plastic material from the container.
The lipid emulsion would be contaminated and the plastic containers integrity can be compromised.
Moreover, preparation of the separate components of PN formulations for premature infants, neonatal patients or small children presents unique problems.
Seeking to provide all of the desired nutritional components in such a low volume is extremely difficult.
In addition, some of the individual constituents are either interdependent or incompatible if present in certain forms and concentrations.
Furthermore, electrolytes such as calcium and phosphate may be incompatible in certain concentration levels.
Also, storing the components of a PN formulation in a single or multi-chamber plastic container for sterile mixing to form the PN formulation also presents unique problems.
As already discussed above, the lipid component is incompatible with certain plastic material.
Overwraps or overpouches are typically used to restrict the ability of oxygen to get to the multi-chamber containers; however, the overwrap may still allow a small amount of oxygen to diffuse through.
In addition, the overwrap may develop a leak which would allow an excessive amount of oxygen to be exposed to the container.
While oxygen indicators exist they appear to not be able to withstand heat sterilization and still function properly after prolonged storage.
An excessive level of hydrogen sulfide may negatively affect some of the nutritional components.
Moreover, while the all the separately stored components are mixed to form the final PN formulation prior to administration, there are circumstances when it is undesirable to include one or more of the components found in one of the chambers in the final solution.

Method used

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  • Medical Products and Parenteral Formulations

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0092] A comparison was of a 300 ml multi-chamber container of the present invention best exemplified by container 10 was compared to a currently available multi-chamber container which was the same in all respects to container 10 expect that the hanger flap extended only about half as far into the central chamber as hanger flap 36 extends into chamber 14 making the central chamber of this bag slightly larger in capacity. The same central and lateral end chambers were filled with water while the other lateral end chamber was filled with a colored solution. Additional water was added in the central chamber to compensate for the added volumetric capacity. In other words even though the central chamber of container 10 had a slightly smaller volume than the central chamber of other container they were similarly inflated with water.

[0093] Twenty operators were selected (10 male & 10 female). Each operator received 5 units of each design and the following instructions:

[0094] Instruction...

example 2

[0194] An indigo carmine indicator mixture was made as follows:

14 g indigo carmine, 60 g tetrasodium pyrophosphate, 2.75 g anhydrous dextrose, and 180 g microcrystalline cellulose were added to one liter of distilled water.

[0195] This mixture was placed in small pouches that were packed with oxygen absorber in an oxygen barrier overpouch and exposed to steam sterilization at 121° C. The samples were then stored in reduced form and the reduced form, i.e. yellow color of the indicator mixture, was still yellow after storage in a substantially oxygen free environment for 112 days at 50° C.

[0196] When similar packages were exposed to oxygen after being first placed in a reduced state as described above, the mixture changed to the oxidized form, i.e. dark blue color. The mixture remained dark blue after storage for 112 days at 50° C.

example 3

[0197] An indigo carmine indicator mixture was made as follows: 14 g indigo carmine, 60 g tetrasodium pyrophosphate, 2.00 g anhydrous dextrose and 180 g microcrystalline cellulose were added to one liter of distilled water. The results were similar to those found in Example 2 above.

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Abstract

A medical product and parenteral formulation are provided. The parenteral formulation is preferably for fluid restricted patients such as pediatric patients and can include amino acids, lipids, carbohydrates and electrolytes. The parenteral formulation can be housed in a multi-chamber container for separately storing a amino acid component, a lipid component and a carbohydrate component to provide a medical product. Frangible barriers preferably peelable seals separate the components and allow for admix to form a just prior to administration. Electrolytes can also be included in one or both of the carbohydrate and amino acid components; preferably the electrolytes are included in the amino acid component and the amino acid component includes cysteine. The multi-chamber container preferably facilitates the selective activation of the peelable seals to permit the admixing of less than all the separately stored components. The medical product can include a parenteral formulation for supplying the mean nutritional requirements for separate patient populations, such as for preterm infants, term to two year olds, and two to eighteen year olds.

Description

[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 704,555 filed on Aug. 2, 2005.BACKGROUND OF THE INVENTION [0002] The present invention is directed generally to medical solutions, containers for storing medical solutions and oxygen indicators for detecting the presence of oxygen in a medical container. More particularly, the present invention is directed to ready-to-use ternary parenteral nutritional formulations for certain patient populations, particularly fluid limited populations, the container systems for long-term storage and selective administration of such formulations and oxygen indicators for such container systems. More specifically, the present invention is directed to such formulations being stored in flexible containers having multiple chambers for isolated long-term storage of the various nutritional components of such formulations, oxygen indicators for alerting healthcare professionals of an oxygen compromised container and cont...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K36/63A61K33/42A61K33/14A61K31/70A61K33/06A61K31/198
CPCA23L1/296A61J1/1462A23L1/3006A23L1/304A23L1/305A61J1/10A61J1/2093A61J2001/2024A61K9/0019A61K31/198A61K33/00A61K36/48A61K36/63A61K45/06B32B27/08G01N21/783G01N31/225A23L1/30A61K2300/00A61J1/2024A23L33/40A23L33/10A23L33/115A23L33/16A23L33/17A61P3/02A61K31/70A61K31/195
Inventor TROUILLY, JEAN LUCDESBROSSES, FREDDYBONNOT, DENISMELIN, CHRISTIAN
Owner BAXTER INT INC
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