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Rapid reconstitution for lyophilized-pharmaceutical suspensions

a technology of lyophilized pharmaceutical actives and suspensions, applied in the field of pharmaceuticals and medical, can solve problems such as problems for medical practitioners and researchers

Inactive Publication Date: 2011-06-30
BAXTER INT INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005]Described herein, in the preferred embodiment, is a lyophilized pharmaceutical active stored under a pressure of less than 300 Torr (40 kPa) that can be rapidly reconstituted for in vivo use.

Problems solved by technology

The foaming of the lyophilized pharmaceutical active poses problems for medical practitioners and researchers.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Lyophilization and Reconstitution Studies for 5% BSA (Bovine Serum Albumin), 5 mL Fill into 10 mL Vials

[0030]The purpose of using 4 mL fill of ABRAXANE in 10 mL vials was due to the high cost of ABRAXANE. The small vial studies generated more replicates for data analysis.

[0031]The lyophilization cycle parameters are:[0032]1) Cool the shelf to −40° C. and hold for 80 minutes.[0033]2) Pull vacuum to 100 mTorr (133 Pa).[0034]3) Hold at −40° C., 100 mTorr (133 Pa) for 30 minutes.[0035]4) Ramp 0.5° C. to −20° C., 100 mTorr (133 Pa).[0036]5) Primary drying: Hold at −20° C., 100 mTorr (133 Pa) for approximately 2300 minutes.[0037]6) Ramp 1° C. / min to 30° C., 100 mTorr (133 Pa).[0038]7) Secondary drying: Hold at 30° C., 100 mTorr (133 Pa) for approximately 330 minutes.

[0039]After lyophilization, the vials were sealed at approximately 5 Torr (667 Pa). The reconstitution was performed by pointing the needle at the cake to allow water to quickly absorbed by the cake.

[0040]It was observed minim...

example 2

Lyophilization and Reconstitution Studies for Reconstituted ABRAXANE Vial (4 mL Filled into 10 mL vials) and 5% BSA (5 mL Fill into 10 mL Vials)

[0043]The purpose of the study was to investigate the lyophilization and reconstitution characteristics of the reconstituted ABRAXANE vials and the placebo vials of 5% BSA.

[0044]The lyophilization cycle parameters are:[0045]1) Cool the shelf to −40° C. and hold for 90 minutes.[0046]2) Pull vacuum to 100 mTorr (133 Pa).[0047]3) Hold at −40° C., 100 mTorr (133 Pa) for 20 minutes.[0048]4) Ramp at 0.5° C. / min to −20° C., 100 mTorr (133 Pa).[0049]5) Hold at −20° C., 100 mTorr (133 Pa) for approximately 2400 minutes.[0050]6) Ramp at 0.5° C. / min to 30° C., 100 mTorr (133 Pa).[0051]7) Hold at 30° C., 100 mTorr (133 Pa) for approximately 300 minutes.

[0052]After completion of the cycle run, the vials were sealed at approximately 4 Torr 533 Pa) and crimped. The results of reconstitution are discussed below.

[0053](1) Reconstitution Time of 4 mL of Recon...

example 3

Quick Freezing, Lyophilization and Reconstitution Studies for Reconstituted ABRAXANE Vial (4 mL filled into 10 mL Vials) and 5% BSA (5 mL Filled into 10 mL Vials)

[0058]The purpose of quick freezing was to immobilize nanoparticles from aggregation or crystallization due to the Ostwald ripening effect.

[0059]Quick Freezing Procedure:[0060]1) Placed the test-tube rack on a metal tray and placed apiece of aluminum foil on the bottom of the test tube rack and lifted the four sides of the foil to cover the bottom half of the rack for holding the liquid nitrogen.[0061]2) Placed the reconstituted vials in the slots of the test tube rack.[0062]4) Placed stoppers on the vials.[0063]5) Poured liquid nitrogen into the test tube rack to quick freeze the vials.[0064]6) Started the LyoStar II freeze dryer to precool the shelf to −40° C.

[0065]7) Loaded the frozen vials onto the shelf, and started the following cycle.

[0066]Lyophilization Cycle Parameters:[0067]1) Cool the shelf to −40° C. and hold fo...

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Abstract

A method of preparing and reconstituting a sterile, lyophilized pharmaceutical active for rapid reconstitution by evacuating a lyophilized pharmaceutical active-containing container until the pressure within the container is less than about 300 Torr and hermetically sealing the evacuated container. The sterile, lyophilized pharmaceutical active can be prepared by flash freezing a pharmaceutical active-containing composition then lyophilizing the composition. The hermetically sealed lyophilized pharmaceutical active can be reconstituted by adding at least the total volume of liquid necessary for reconstitution of the sterile, lyophilized pharmaceutical active to the sterile, lyophilized pharmaceutical active, sealed under a pressure of less than about 300 Torr, in less than about 10 seconds to yield, within about 5 minutes, an administrable pharmaceutical active-containing composition. One aspect of the herein described sterile, lyophilized pharmaceutical active is a packaged sterile pharmaceutical active comprising an evacuated, hermetically sealed container having disposed therein a sterile, lyophilized pharmaceutical active, sealed under a pressure of less than about 300 Torr.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]The benefit of U.S. Provisional Patent Application 61 / 290,998, filed Dec. 30, 2009, is hereby claimed, and the disclosure thereof is incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE[0002]The invention relates to the pharmaceutical and medical field and provides a packaged lyophilized pharmaceutical active and a method of producing the packaged lyophilized pharmaceutical active. Specifically, the invention provides for the rapid reconstitution of a lyophilized pharmaceutical active with minimal foaming.BACKGROUND[0003]Lyophilization is used to prepare pharmaceutical actives with higher stability, broader temperature tolerance, and longer shelf-life than comparable aqueous solutions. Typically, pharmaceutical actives are dried to water contents of less than 5 wt. % through sublimation and desorption.[0004]The reconstitution of lyophilized pharmaceutical actives that contain proteins or polypeptides by the addition of ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B65D85/00B65B31/00
CPCA61K9/19A61K38/38A61K31/337
Inventor KUU, WEI Y.
Owner BAXTER INT INC
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