Medical Products and Parenteral Formulations

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...

AI Technical Summary

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.

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