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Lyophilized formulation sealed in glass vial

A technology for glass containers and preparations, which is used in medical containers, freeze-dried transportation, and medical preparations with inactive ingredients, etc., can solve problems such as poor appearance of vials, affecting quality inspection, etc. Effect

Pending Publication Date: 2021-03-16
CHUGAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Not only are these residues considered a significant defect, but they can also affect quality checks by visual inspection of vials or by automated devices
Also, poor vial appearance may be perceived as problematic by the patient or physician

Method used

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  • Lyophilized formulation sealed in glass vial
  • Lyophilized formulation sealed in glass vial
  • Lyophilized formulation sealed in glass vial

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0175] Example 1: Effect of Suppressing Glass Vial Atomization by Sulfur Treatment or VIST Treatment

[0176] The degree of fogging on the inner surface of the glass container was evaluated when the protein-containing drug solution was placed in sulfur-treated, VIST-treated, silicone-treated or untreated glass vials, and freeze-dried.

[0177] The vials used were as follows: vial 10 mL white bulk (material: borosilicate glass; without any treatment; manufactured by Murase Glass Co., Ltd.); vial 10 mL white sulfur bulk (material: borosilicate glass; treated with sulfur; manufactured by Murase Glass Co., Ltd.), 10 mL of VIST vial (material: borosilicate glass; VIST-treated; manufactured by Daiwa Special Glass Co., Ltd.), and 10 mL of TopLyo (registered trademark) vial (material: borosilicate glass; Silicone treatment; manufactured by SCHOTTAG). The vials were dry heat sterilized at 250°C for 120 minutes prior to use.

[0178] As a drug solution containing protein, a solution...

Embodiment 2

[0201] Example 2 No Cake Shrinkage in Sulfur-Treated Vials and VIST-Treated Vials

[0202] For the vials subjected to various surface treatments, freeze-dried preparations were prepared in the same manner as in Example 1, and the state of the cake was evaluated.

[0203] The result is as figure 2 shown. In the silicone-treated vials, the cake was found to shrink during freeze drying, creating a void between the container wall and the cake, allowing the cake to move easily in the vial. On the other hand, good cake formation was achieved without cake shrinkage in sulfur-treated and VIST-treated vials (data not shown). If the cake is easy to move, physical stress at the time of transportation, etc. may cause the cake to disintegrate, resulting in a decrease in quality. Thus, it has been demonstrated that sulfur-treated vials and VIST-treated vials inhibit aerosolization and form a good cake when freeze-dried, thus outperforming silicone-treated vials.

Embodiment 3

[0204] Example 3 Evaluation of the atomization degree of freeze-dried products obtained by sealing various chemical solutions in various surface-treated vials Score and Pie Move Ratio

[0205]

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Abstract

The present invention provides a lyophilized formulation sealed in a glass vial and containing a treatment drug and a surfactant, the invention being characterized in that the glass vial has a sulfur-treated or VIST-treated inner surface.

Description

technical field [0001] The present invention relates to a technique for suppressing fogging of glass containers used for freeze-dried preparations. Background technique [0002] Among pharmaceutical formulations, there are many pharmaceutical formulations using pharmaceutical compositions in liquid form. Liquid formulations often must be stored at low temperatures, and some medications also deteriorate during storage in liquid form. One possibility to overcome these problems is to freeze-dry its pharmaceutical composition. The pharmaceutical composition is shipped and stored in dry form and then reconstituted before use. [0003] Especially when the active agent is a protein, the freeze-drying process itself may lead to deterioration of the properties of the pharmaceutical composition. In order to prevent the activity of pharmaceutical compositions from decreasing, surfactants are usually added to pharmaceutical compositions in addition to cryoprotectants such as certain ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/05A61K9/19A61K39/395A61K47/10A61K47/18A61K47/26A61P43/00
CPCA61P43/00A61K39/395A61K47/10A61K47/26A61K9/19A61J1/065A61J1/1468A61J1/05A61J1/062A61K47/34A61K38/00A61K45/06
Inventor 山下正悟吉泽雄太
Owner CHUGAI PHARMA CO LTD
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