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Process for preparing microparticles

a technology of biologically active materials and microparticles, which is applied in the field of preparation of compositions can solve the problems of low yield, low recovery rate, and prior art of products containing biologically active materials, and achieve the effect of improving the recovery rate and improving the recovery ra

Inactive Publication Date: 2016-03-17
CRITICAL PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The process of the prior art can be associated with problems such as low yield.
By this we mean that use of the prior art processes can result in a lower than desirable level of recovery of a product comprising the biologically active material.
This can result in a high level of wastage of often expensive biologically active materials.
The solid products of the processes of the prior art often have an irregular shape and / or size and / or an undesirably high surface area.
This can make recovery of the product, often resulting in low yields and the use and / or the further processing of the product difficult.

Method used

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  • Process for preparing microparticles
  • Process for preparing microparticles
  • Process for preparing microparticles

Examples

Experimental program
Comparison scheme
Effect test

reference example 1

Processing in the Absence of a Processing Aid

[0107]PLGA (Mw 11 kDa, measured in THF relative to PS standards, 2.0 g) was pre mixed with Bovine Serum Albumin (0.2 g, 10 w.t. %, from Sigma Aldrich) and this mixture was loaded into the supercritical fluid PGSS processing rig. The system was sealed and pressurised with CO2. The temperature and pressure were raised to approximately 40° C. and 2000 psi rendering the CO2 a supercritical fluid. Whilst maintaining these conditions the PLGA / BSA were stirred for 60 min. The mixture was then expanded into a collection vessel using a cyclone and collected yielding a course free flowing powder. Three replicate batches were prepared.

example 1

Processing with SOLUTOL® HS15

[0108]PLGA (Mw 11 kDa, measured in THF relative to PS standards, 2.0 g) was pre mixed with SOLUTOL® HS15 (0.2 g, 10.0 w.t. %, from BASF) and Bovine Serum Albumin (0.2 g, 10 w.t. %). This mixture was loaded in to the supercritical fluid PGSS processing rig. The system was sealed and pressurised with CO2. The temperature and pressure were raised to approximately 40° C. and 2000 psi rendering the CO2 a supercritical fluid. Whilst maintaining these conditions the PLGA / SOLUTOL® HS15 / BSA were mixed for 60 min. The mixture was then expanded into a collection vessel using a cyclone and collected as a fine, free flowing white powder. Three replicate batches were prepared.

example 2

Processing with Kolidon 12

[0109]PLGA (Mw 11 kDa, measured in THF relative to PS standards, 2.00 g) was pre mixed with Kollidon 12 (0.03 g, 2 w.t. %, from BASF) and Bovine Serum Albumin (0.2 g, 10 w.t. %). This mixture was loaded in to the supercritical fluid PGSS processing rig. The system was sealed and pressurised with CO2. The temperature and pressure were raised to approximately 40° C. and 2000 psi rendering the CO2 a supercritical fluid. Whilst maintaining these conditions the PLGA / Kollidon 12 / BSA were mixed for 60 min. The mixture was then expanded into a collection vessel using a cyclone and easily collected as a course free flowing white powder. Three replicate batches were prepared.

TABLE 1Average batch yield and particle size data for three replicatesof each of Reference Example 1, Example 1 and Example 2.ProcessingIncreaseExamplePolymerBAMAidin Yield %VMDd90d50d10Ref 1PLGABSA—12624811027Average11 kDa10 wt %18271910Std dev1PLGABSASOLUTOL ®2431292799830Average11 kDa10 wt %10...

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Abstract

A process for preparing microparticles comprising a biologically active material and a polymer and having a mean particle size expressed as the volume mean diameter (VMD) of from 10 to 500 μm, wherein the biologically active material is substantially insoluble in the polymer, which process comprises: a. contacting a mixture of the biologically active material or a precursor thereof, the polymer or a precursor thereof and a processing aid with a supercritical fluid which is capable of swelling the polymer under temperature and pressure conditions necessary to maintain the fluid in a supercritical state; b. allowing the supercritical fluid to penetrate and liquefy the polymer, whilst maintaining the temperature and pressure conditions so that the fluid is maintained in a supercritical state; c. releasing the pressure to precipitate microparticles comprising the biologically active agent and the polymer.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 003,506, which is a national phase application under 35 U.S.C. §371 of International Patent Application No. PCT / GB2009 / 001711 filed Jul. 10, 2009 which claims priority to Great Britain Patent Application No. 0812742.5 filed Jul. 11, 2008. The entire text of the above-referenced disclosures are specifically incorporated herein by reference without disclaimer.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT[0002]Not ApplicableBACKGROUND OF THE INVENTION[0003]1. Field of the Invention[0004]The present invention relates to a process for preparing a composition comprising a biologically active material. More particularly, the invention relates to a process for producing microparticles comprising a biologically active material and a polymer. The microparticles produced using the process of the present invention can be used to deliver the biologically active...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/16A61K9/14A61K31/519A61K38/38
CPCA61K9/1682A61K38/385A61K9/146A61K9/145A61K31/519A61K9/1647A61K9/1694A61P7/00A61P25/18A61K47/14A61K9/16A61K47/30
Inventor NAYLOR, ANDREWLEWIS, ANDREW LESTERILLUM, LISBETH
Owner CRITICAL PHARMA LTD