Dissolution Testing

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(New page: {{LSApp |name = Dissoultion Testing |image = PolymerTwinGC.png |type = Sample Prep and Inject |id = Sample |description = Dissolution testing of slow...)
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=== Overview ===
=== Overview ===
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Chemical analysis of polymers, as well as other forms of analysis such as viscosity and other tests are a necessary part of polymer development, as well as QC processes during manufacture.  Polymers are generally solids when in the final product, and thus are not amenable to such analysis unless they can be first liquefied. Preparation for analysis requires multiple stages of treatment frequently with heated reaction and cooling steps prior to introduction into a detector such as a GC. Such processes are lengthy, time-critical and labor intensive to perform manually. They frequently involve handling of caustic or toxic reagents. There is a strong case therefore, for automation of such processes.
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Dissolution testing of slow-release devices, for example small, polymer coated springs or coils which can be implanted inside the human body and release their drugs over a period of many months or even years. It is applicable to any customer who is developing or manufacturing these devices. This type of testing is a necessary part of the development and or QC process. The objective is to carefully measure the release rate of the drug from the device in-vitro over a period of time. Results are then correlated with data collected in animals.
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LEAP has broken new ground in one such application, where the complexities of this type of sample preparation have been fully automated using an HTX2H in the configuration shown below:
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=== Significant Markets  ===
=== Significant Markets  ===
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* Polymer Manufactures
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This application is ideal for those labs who wish to perform dissolution testing in small vessels. Samples or devices are normally held in vials incubated and shaken for prolonged periods and elution volumes removed and tested periodically. Elements of this application could be applied to labs requiring any type of sample treatments at timed intervals. It also involves storing data about each sample in Excel and protecting the devices from contact with the sampling needle
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* Biodiesel Blenders
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'''What is a Dissolution Testing experiment?'''<br/>
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The testing procedure is quite simple. Vials containing the devices are filled with a buffer solution. They are loaded into a special heated and shaking tray. A timer is started. At specified intervals the buffer is removed, a portion of it saved for later analysis, the rest discarded, and the vials replenished with fresh buffer.
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* Polymer Distributors
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Despite its simplicity, this process requires the manual sampling and testing of hundreds of vials at very carefully measured time intervals over a period of days. It is a very tedious operation which requires technicians to be in and out of the lab for hours doing a very mundane job – a classic candidate for automation. It was important that any automation solution did not damage the surface of the devices. There were no existing options to automate this process before the customer approached LEAP.  
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* Polymer End Users
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'''What is a Polymer experiment?'''<br/>
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The sample preparation process involves 2 heated reactions with cooldown steps in between. The first hydrolyses the solid polymer in a mixture with an internal standard at high temperature in Agitator 1. The pellets dissolve and after a quenching reaction and cooldown period, a derivitizing reagent is added followed by another heated incubation at lower temperature. The reactants are then injected onto a GC for analysis.
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A balance is used to check that a minimum weight of product is in the original vial. If not, the sample is skipped. The samples are barcoded at the time the sample list is set up. At runtime the scanned barcode is compared to the expected barcode and if there is a mis-match then the sample is also skipped. .
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LEAP Shell handles the sample scheduling of each of the 5 stages of the process, overlapping them all and filling up both agitators according to the available time between operations. It also handles barcode and weight validation as well as data logging.  
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'''LEAPS Approach'''<br/>
'''LEAPS Approach'''<br/>
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• Twin PAL control using a single sample list in LEAP Shell.<br/>
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The PAL in combination with the LEAP Shell makes a very effective and flexible workstation. We were able to design and provide a solution which met the following challenges from the customer:
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• Two heated zones for different temperature reactions.<br/>
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1. Exchanging large volumes of liquid from sealed vials. This requires overcoming vacuum/pressure differentials.
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• Direct injection to either of two GCs.<br/>
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2. Protect the slow-release devices from contact and potential damage by the sampling needle. This was achieved using a specially designed vial insert.
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• Balance integration for weighing of solid product and internal standard.<br/>
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3. Shaking and incubating a large number of sample vials (>20). We were able to source a suitable heated shaking table for their vials from a third party vendor
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• Up to 8 reactant vessels, and 32 sample vial capacity.<br/>
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4. Setting up a sampling schedule in the software which would span over several days if necessary. Only possible with the LEAP Shell.
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• Overlapped staggered processing of all samples for high throughput.<br/>
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5. Provide the flexibility to change the sample batch size and sampling intervals.
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• Barcode checking, mismatched vials are not processed.<br/>
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6. Record the actual sampling times to a data file – compare actual time with expected time and report a difference.<br/>
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• Weight checking, over or under weight vials are skipped.<br/>
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• Data reporting to log files.<br/>
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• GC failsafe mode – if GC goes down during a run, samples are still processed.<br/>
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• Integrated with Chemstation.<br/>
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'''Market potential:'''<br/>
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The success of this initial installation shows LEAP’s capability to solve complex automation challenges in areas which have previously been out of our reach. The polymer industry presents opportunities to expand these types of sales, not only for these complex sample preparation applications for solids, but for simpler applications such as viscosity testing or sample prep for NMR.<br/>
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In more general terms, this application illustrates the power of LEAP Shell and the new capabilities it provides which can be applied much more widely. Consideration should be given to the following opportunities:<br/>
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• Handling of single or multiple overlapped incubations e.g. Headspace or SPME.<br/>
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• Extensive customization of the Sample list.<br/>
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• Open access – walk-up addition of samples during a run.<br/>
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• Extensive use of the “IF” statement to manage error conditions and determine criteria for sample processing or not.<br/>
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• Output of data to log files for record keeping or for integration with data systems.<br/>
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Revision as of 04:02, 5 February 2009

Dissoultion Testing
Application Type
  Sample Prep and Inject
Application ID
  Sample
Description
  Dissolution testing of slow release drugs

Overview

Dissolution testing of slow-release devices, for example small, polymer coated springs or coils which can be implanted inside the human body and release their drugs over a period of many months or even years. It is applicable to any customer who is developing or manufacturing these devices. This type of testing is a necessary part of the development and or QC process. The objective is to carefully measure the release rate of the drug from the device in-vitro over a period of time. Results are then correlated with data collected in animals.

Significant Markets

This application is ideal for those labs who wish to perform dissolution testing in small vessels. Samples or devices are normally held in vials incubated and shaken for prolonged periods and elution volumes removed and tested periodically. Elements of this application could be applied to labs requiring any type of sample treatments at timed intervals. It also involves storing data about each sample in Excel and protecting the devices from contact with the sampling needle

What is a Dissolution Testing experiment?
The testing procedure is quite simple. Vials containing the devices are filled with a buffer solution. They are loaded into a special heated and shaking tray. A timer is started. At specified intervals the buffer is removed, a portion of it saved for later analysis, the rest discarded, and the vials replenished with fresh buffer. Despite its simplicity, this process requires the manual sampling and testing of hundreds of vials at very carefully measured time intervals over a period of days. It is a very tedious operation which requires technicians to be in and out of the lab for hours doing a very mundane job – a classic candidate for automation. It was important that any automation solution did not damage the surface of the devices. There were no existing options to automate this process before the customer approached LEAP.

LEAPS Approach
The PAL in combination with the LEAP Shell makes a very effective and flexible workstation. We were able to design and provide a solution which met the following challenges from the customer: 1. Exchanging large volumes of liquid from sealed vials. This requires overcoming vacuum/pressure differentials. 2. Protect the slow-release devices from contact and potential damage by the sampling needle. This was achieved using a specially designed vial insert. 3. Shaking and incubating a large number of sample vials (>20). We were able to source a suitable heated shaking table for their vials from a third party vendor 4. Setting up a sampling schedule in the software which would span over several days if necessary. Only possible with the LEAP Shell. 5. Provide the flexibility to change the sample batch size and sampling intervals. 6. Record the actual sampling times to a data file – compare actual time with expected time and report a difference.

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