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Freeze-dried formulation for gas-filled microvesicles

A freeze-dried, microbubble technology that is used in preparations for in vivo testing, echo/ultrasonic imaging agents, pharmaceutical formulations, etc., and can solve problems such as low percentages and vials failing to pass acceptability tests.

Pending Publication Date: 2021-01-01
BRACCO SUISSE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As the applicant has observed, if the percentage of folded chains in the polymeric material is too low, it may result in too many vials failing the acceptability test in the production batch

Method used

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  • Freeze-dried formulation for gas-filled microvesicles
  • Freeze-dried formulation for gas-filled microvesicles
  • Freeze-dried formulation for gas-filled microvesicles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Determination of the percentage of folded chains by MDSC

[0056] a. Calibration of equipment and systems

[0057] All MDSC experiments were performed on a Tzero TM technology (which allows direct measurement of heat capacity) and Option (which allows the superimposition of sinusoidal temperature fluctuations on conventional linear temperature ramps) was implemented on a DSC-Q2000 system (TA Instruments, New Castle, DE USA).

[0058] Conveniently operate from -90°C to 550°C using the Refrigerated Cooling Attachment (RCS90) with a two-stage refrigeration system.

[0059] Data acquisition and processing were performed with the help of the Universal Analysis Software package.

[0060] A Tzero aluminum crucible (ref 901683.901) and a Tzero aluminum lid (ref 901671.901) (both obtained from TAinstruments) were used to contain the sample to be examined and the crucible was sealed by a Tzero press (ref 901600.901).

[0061] The DSC system was calibrated with indium metal i...

Embodiment 2

[0086] Preparation of freeze-dried cake

[0087]The procedure for preparing the lyophilized cake essentially followed that described in the examples of WO 94 / 09829. Briefly, first dissolve DSPC, DPPG-Na and PA in a weight ratio of 4.75 / 4.75 / 1 in hexane / ethanol (8 / 2, v / v) at a concentration of about 5 g / L, and The solvent was evaporated. The residue was mixed with PEG4000 in a weight ratio of about 0.017:1, the mixture was dissolved in tert-butanol at about 60 °C, and the clear solution was filled into individual DIN8R vials (corresponding volume containing about 25 mg of the mixture). The vials were then rapidly cooled at -45°C before a final lyophilization step. At the end of lyophilization, use SF under normal pressure 6 Ambient conditions of saturated lyophilizate, and seal described vial (comprising with SF 6 solid lyophilized cake in contact).

Embodiment 3

[0090] Vial / Dry Cracker Inspection

[0091] Each batch obtained by the preparation method described in Example 2 was inspected as follows to check whether there was any substandard freeze-dried cake.

[0092] Each batch of vials was inspected using a Seidenader M10063 semi-automatic machine according to the process described above and classified as "acceptable vials" ie containing smooth dry cake (SCV, e.g. figure 1 a) or "rejected vials" that contain rough dry cake (RCV, such as figure 1 shown in b).

[0093] The inspection results implemented according to the above process are shown in Table 7 below and recorded in figure 2 middle.

[0094] Table 7: Relationship between volume of rejected vials and % folded chains in PEG4000

[0095] production batch % of defective vials PEG4000 folded chain % Batch 1 (comparative example) 16 34 batch 2 8.9 43 batch 3 5.6 49 batch 4 3.7 54

[0096] From the results shown in Table 7, it can ...

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Abstract

A freeze-dried powder composition comprising a phospholipid and a polyethylene glycol, said polyethylene glycol having a percentage of folded polymeric chains higher than a predetermined limit. The composition is suitable for preparing gasfilled microvesicles.

Description

technical field [0001] The present invention relates to the preparation of gas-filled microbubble formulations for use in contrast-enhanced ultrasound imaging. Background technique [0002] The rapid development of contrast agents in recent years has resulted in many different compositions and formulations that can be used in contrast-enhanced imaging and therapy of human or animal organs and tissues. [0003] One class of contrast agents particularly useful for contrast-enhanced ultrasound imaging ("CEUS" imaging) comprises suspensions of nano- and / or micron-sized gas bubbles dispersed in an aqueous medium. The gas is usually entrained or encapsulated in a film layer comprising, for example, emulsifiers, oils, thickeners or sugars. These stable gas bubbles (dispersed in a suitable physiological solution) are commonly referred to in the art by various terms, usually depending on the stabilizing material used for their preparation, such terms include, for example, "microsphe...

Claims

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Application Information

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IPC IPC(8): A61K49/22
CPCA61K49/223A61K2123/00
Inventor A·拉苏斯S·格戈拉特闫锋C·圭罗特J·布罗绍特
Owner BRACCO SUISSE SA
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