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Packaged Iron Sucrose Products

a technology of iron sucrose and packaging, applied in the field of pharmaceutical products, can solve the problems of insufficient light obscuration technique to detect the delaminated particles in the iron sucrose formulation, the inability to easily recognize the presence of glass particulates as the result of delamination, and the greater cost of glass vials produced using this process

Inactive Publication Date: 2011-09-22
HOSPIRA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0014]A further aspect of the invention is directed to a method for storing an iron sucrose formu...

Problems solved by technology

The cost of glass vials produced using this process is greater than standard glass vials since a lower heat exposure requires increased manufacturing time.
Because iron sucrose is a dark opaque solution, the presence of glass particulate as the result of delamination is not readily recognized by visual inspection alone.
Also, the light obscuration technique is not sensitive enough to detect the delaminated particles in iron sucrose formulations due to the inherent opacity of the solution.
However, these methods of detection of glass delamination are impractical for routine inspection of commercially packaged iron sucrose solutions.

Method used

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  • Packaged Iron Sucrose Products
  • Packaged Iron Sucrose Products
  • Packaged Iron Sucrose Products

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0048]A glass delamination study was performed under accelerated stability conditions. An iron sucrose solution (20 mg elemental iron and 300 mg sucrose per ml of water) at pH 11.0 was packaged in the containers along with a control wherein delamination is expected. Four different coated containers were evaluated to determine prevention of delamination under various packaging conditions. Molded glass vials (Wheaton Science Products, Milleville, N.J.), and glass tubing vials (Schott AG). were coated with silicone by rinsing the containers with the DOW CORNING® 365 Medical Fluid and baking the containers for a predetermined time and temperature. A third container was a CARPUJECT® syringe (Hospira, Inc., Lake Forest, Ill.). The syringe has a siliconized glass surface that is prepared by spraying the DOW CORNING® 365 medical fluid on the interior of the syringe and baking. The fourth container was a container of Schott TYPE 1 PLUS® tubing glass (Schott, AG), which is prepared with a pur...

example 2

[0051]In three additional studies, samples of Iron Sucrose Injection were prepared as described above and packaged in glass CARPUJECT® syringe containers that were coated with a silicone polymer as described in Example 1. The samples were subject to both accelerated and long term stability storage. Five units of each sample were collected at various time points and analyzed for glass flakes as described above. As shown in Table 2, some delamination was found in all samples stored at accelerated 40° C. storage after 6 months. However, as shown in Table 3, no delamination was found in all samples at 25° C. and 30° C. at 12 months of storage, and minimal delamination was found after 18 months of storage.

TABLE 2Time point / Iron Sucrose InjectionStorage ConditionSample ASample BSample CInitialNo delaminationNo delaminationNo delamination1M 40° C. / 75% RHNo delaminationNo delaminationNo delamination2M 40° C. / 75% RHNo delaminationNo delaminationNo delamination3M 40° C. / 75% RHNo delaminationN...

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Abstract

A packaged iron sucrose formulation including a container with an interior glass surface that is coated with layer of material containing silicon, such as a silicone polymer or silicon dioxide. The iron sucrose formulation is packaged inside the glass vessel and in contact with the layer of material containing silicon. The packaged formulation can be stored for extended periods without glass delamination.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The invention is generally related to pharmaceutical products. The invention is more particularly related to iron sucrose products in containers having glass as a primary component.[0003]2. Description of Related Art[0004]Glass is currently the preferred material for packaging parenteral pharmaceutical solutions due to its chemical and physical inertness. While this presumption generally holds true, glass under certain conditions is both chemically and physically reactive. It has long been known that aqueous solutions can interact with glass leading to the formation of glass-based particulate matter. This process, known generally as glass delamination, is accelerated by solutions containing various anions, especially under alkaline conditions, or by exposure to high temperatures, such as those used during terminal sterilization.[0005]Manufacturers have undertaken efforts to address glass delamination. For example, lower...

Claims

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Application Information

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IPC IPC(8): B65D85/84B65B1/04
CPCB65D65/42A61J1/00A61J1/1468B65B3/003
Inventor TATA-VENKATA, SESHAGIRI R.ZHANG, XIFENGGOLDBLATT, FAYSIDDIQUI, MINHAJ
Owner HOSPIRA
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