Method for formulating large diameter synthetic membrane vesicles

A technology of atomizing nozzles and contact chambers, which is applied in the field of pharmaceutical sciences and can solve the problems of manufacturing space, cost and time, etc.

Active Publication Date: 2013-03-27
PACIRA PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, current methods to manufacture large-diameter synthetic membrane vesicles (e.g., multivesicular liposomes) on an industrial scale require substantial investments in manufacturing space, expense, and time
As such, developing stable multivesicular liposome formulations containing therapeutic agents in a cost-effective and time-efficient manner remains an ongoing challenge

Method used

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  • Method for formulating large diameter synthetic membrane vesicles
  • Method for formulating large diameter synthetic membrane vesicles
  • Method for formulating large diameter synthetic membrane vesicles

Examples

Experimental program
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Effect test

example 1

[0337] The following is one example of processing parameters and procedures using the apparatus shown in these figures. Applied to an atomizing nozzle as part of the process for forming multivesicular liposomes ( Figure 1A and Figure 1B , component 75; Figure 3A , component 310; Figure 7 , Part 7510) of the three fluids per liter have the following composition.

[0338] first fluid ( Figure 3A to Figure 3L , component 3115; Figure 5 , component 5115; Figure 7 , component 7115) is a first liquid composed of a first component having two components: an organic phase and a first aqueous phase, which are emulsified in equal volumes. The organic phase consisted of 1,2-dierucoyl-sn-glycero-3-phosphocholine (17.78 g), 1,2-dipalmitoyl-sn-glycero-3-phosphocholine (1.056 g), cholesterol (10.34 g), tricaprylin (4.32g), water (0.70g) and dichloromethane (enough to make 1L total volume of the organic phase). The first aqueous phase consisted of 0.2 molar (200 mM) phosphoric ac...

example 2

[0354] Preparation of the first component

[0355] Fill with dichloromethane connected to a high shear mixer ( Figure 1A and Figure 1B , component 25; figure 2 , part 2130) (Ross model HSM-703XS-20Sanitary Inline High Shear Mixer fitted with a 3" diameter X-5 series rotor / stator with #3 gap ring for operation to 14,400 rpm (11,300 ft / min, tip speed)) The recirculation loop on the top, thus ensuring that all air is removed from the high shear mixer. The jacket of the heat exchanger is supplied with a 5 °C coolant (water + 50% ethylene glycol) ( Figure 1A and Figure 1B , component 30; figure 2, part 2170). The mixer seal lubricant tank filled with water was also cooled with 5°C coolant (water + 50% ethylene glycol). Start the high shear mixer at a setting of 25Hz (6,000rpm), approximately 30Hz (7,200rpm), or 35Hz (8,400rpm).

[0356] After charging the high-shear mixer with dichloromethane, start the organic phase and first aqueous phase peristaltic pumps simultaneous...

example 3

[0388] Heat treatment of MVL suspension

[0389] Will Figure 1B The system is connected with an electric heater and a tube-in shell heat exchanger (such as Figure 1A described, component 90) combined with a supply of humidified rotating gas (N 2 )use together. The system was equilibrated for 10 minutes, and the discharge exiting the solvent removal vessel 50 was collected ( Figure 1B , part 130) of a 1,000 ml sample of the MVL suspension. Divide the MVL sample into two samples of 500ml each. The first 500ml MVL sample was heat treated as follows. Heat treatment was performed by rapidly adding 750 ml of 100°C dextrose solution to the first sample, raising the temperature of the mixture to approximately 63°C. After 30 seconds, 1,750 ml of +5°C brine was added quickly, thereby reducing the temperature of the mixture to near room temperature (35°C or lower). Now, the sample volume is 3,000ml. A second 500 ml sample of multivesicular liposomes was not heat-treated. The s...

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Abstract

The present invention generally relates to the field of pharmaceutical sciences. More specifically, the present invention includes apparatus and devices for the preparation of pharmaceutical formulations containing large diameter synthetic membrane vesicles, such as multivesicular liposomes, methods for preparing such formulations, and the use of specific formulations for therapeutic treatment of subjects in need thereof. Formation and use of the pharmaceutical formulations containing large diameter synthetic membrane vesicles produced by using the apparatus and devices for therapeutic treatment of subjects in need thereof is also contemplated.

Description

[0001] related application [0002] This application claims the benefit of US Provisional Application No. 61 / 322,814, filed April 9, 2010, the disclosure of which is hereby incorporated by reference in its entirety. technical field [0003] The present invention relates generally to the field of pharmaceutical sciences. More specifically, the present invention relates to pharmaceutical formulations comprising large diameter synthetic membrane vesicles such as multivesicular liposomes (MVL), methods for the preparation of such formulations, and specific formulations for therapeutic treatment The use of the subject that requires it. Background technique [0004] The following includes information that may be useful in understanding this embodiment. It is not an admission that any information presented herein is prior art or relevant to the presently described or claimed embodiments, or that any publication or document specifically or implicitly mentioned is prior art. [00...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127
CPCA61K31/4458B01F3/088A61M11/00B01F5/104A61K9/1277A61K9/127B01F3/0807B01F7/0075A61K9/4833B01J13/043B01J13/125A61K31/445A61P23/00A61P23/02B01F23/49B01F23/41B01F25/52B01F27/27B01D1/16B01F23/2132B01F35/92B01F2035/98B01F2101/22A61K9/1271
Inventor 埃内斯特·乔治·舒特罗纳德·沃伦·麦圭尔彼得·安德鲁·沃尔特斯凯瑟琳·D·A·洛斯
Owner PACIRA PHARMA INC
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