ExperimentDissolution
ExperimentDissolution[Samples]⟹Protocol
creates a Protocol that measures how quickly and completely Samples dissolve under controlled conditions. This test is used to evaluate a drug's performance.
A protocol for capturing the visual information and taking samples of a oral solid dosage being dissolved in a liquid media at a controlled temperature. The experiment is often used to determine the dissolution rate of a given formulation.
Experimental Principles
Figure 1.1: The overall dissolution process consists of (1) preheating the media, (2) adding the Oral Solid Dosage (OSD) to the media, (3) mixing the solution in the vessel and taking aliquots, and (4) stirring at a higher rate to achieve the "final" solubility of the sample. The OSD dissolution process is complex and happens at the same time as the pill is disintegrating. After the aliquots of the samples are obtained, they have to be analyzed by an analytical technique (HPLC, Absorbance, etc.), and then the data can be represented as % of the label amount of the OSD dissolved over time.
Instrumentation
Distek 2500 Bathless with Eclipse 5300 autosampler and filter changer
Figure 2.1.1: A dissolution instrument has two main components: a dissolution unit and an autosampler. The dissolution unit mixes the sample at a controlled rate and temperature, while the autosampler takes and filters aliquots from the dissolution vessels, with an option to replace the withdrawn media.
Waters Acquity UPLC Premier PDA
Figure 2.2.1: Instrument diagram for the H-Class and I-Class systems. Buffer solutions (up to 4) are steadily pumped through the instrument, consisting of a 6-port valve system, adsorbent column, detectors, and terminates at fraction collection or waste. Samples within the autosampler are loaded into the sample loop via positive displacement from the syringe. The rotation of the valve exposes the sample loop, thereby carrying the sample downstream to the column. Within the column, molecular constituents are separated by adsorption -- a function of the buffers, column, sample properties and temperature. Analytes are continuously carried downstream to the detectors, where they can elicit quantifiable peak signals.
Figure 2.2.2: Principle of PhotodiodeArray detection. Filtered light (across a range of wavelengths) passes through the flow downstream of the column. Presence of light-absorbing molecules will result in less light transmission to the recipient Diode, thereby producing a chromatographic peak for each specific wavelength.
Lunatic
Experiment Options
General
Instrument
The instrument stirs the sample in a temperature-controlled medium, taking aliquots and capturing images of the dissolution vessels at specified time points.
Default Value: Model[Instrument, DissolutionApparatus, Distek 2500 Bathless with Eclipse 5300 autosampler and filter changer]
Pattern Description: An object of type or subtype Object[Instrument, DissolutionApparatus] or Model[Instrument, DissolutionApparatus]
Programmatic Pattern: ObjectP[{Object[Instrument, DissolutionApparatus], Model[Instrument, DissolutionApparatus]}]
Medium
Medium
The buffer used to dissolve samples. This is often chosed to mimic a biologically relevant environment.
Pattern Description: An object of type or subtype Object[Sample] or Model[Sample] or a prepared sample or Model[Sample, 0.1N HCl for Dissolution], Model[Sample, Sodium Phosphate 0.05M Buffer, pH 6.80], or Model[Sample, Sodium Acetate 0.05M Buffer, pH 4.50]
Programmatic Pattern: (Model[Sample, "0.1N HCl for Dissolution"] | Model[Sample, "Sodium Phosphate 0.05M Buffer, pH 6.80"] | Model[Sample, "Sodium Acetate 0.05M Buffer, pH 4.50"]) | (ObjectP[{Object[Sample], Model[Sample]}] | _String)
MediumVolume
The volume of the medium used to dissolve the samples and from which the aliquots are taken throughout the experiment.
Default Calculation: Automatically set to the RecommendedFillVolume of the DefaultMediumVessel used for the instrument. For Model[Instrument,DissolutionApparatus,"Distek 2500 Bathless with Eclipse 5300 autosampler and filter changer"], 0.9 Liter is set.
MediumTemperature
The temperature of the medium as read by the temperature probe in the shaft that is used to dissolve the sample. The vessel is heated above the ambient temperature via a jacket on the dissolution vessel.
Mixing
MixingStrategy
The type of the stirring device used in the experiment to mix the samples. See Figure XX for a visual representation of the different shaft types.
Default Calculation: Automatically set to Basket if the SampleBuoyancy is set to Floats, otherwise set to Paddle.
ShaftMaterial
Default Calculation: Automatically inherited from the Shaft resolved if specified, otherwise set to StainlessSteel.
Shaft
Default Calculation: Automatically set to the appropriate shaft based on the MixingStrategy, ShaftMaterial, SampleBuoyancy, and the Instrument specified.
SampleBuoyancy
This indicates if samples are expected to sink or float in the medium. This information is used to inform Automatic selection of the Sinker and MixingStrategy options for keeping the sample submerged during the experiment: either by using a Sinker to weigh down the sample or a Basket MixingStrategy to contain it. Parameters can also be selected manually if desired.
Sinker
The weighted enclosure used to keep the sample below the surface of the medium during the experiment to facilitate proper mixing.
Default Calculation: If SampleBuoyancy set to Floats, set the size-appropriate sinker based on the sample information, no sinkers are allowed is Basket MixingStrategy is used (see table XX for size restrictions of the sinkers).
Pattern Description: An object of type or subtype Object[Item, Sinker] or Model[Item, Sinker] or Null.
SinkerType
The type of sinker used to keep the sample below the surface of the medium during the experiment to facilitate proper mixing. See Figure XX for a visual representation of the different sinker types.
Default Calculation: Automatically set to the ThreeProng sinker if the SampleBuoyancy is set to Floats and the MixingStrategy is set to Paddle.
MixRate
Default Calculation: Automatically set to 100RPM for Basket MixingStrategy and 50RPM for Paddle MixingStrategy. Basket MixingStrategy is often used with lower MixRate due to the lower YYY. After the MixTime has elapsed, the MixRate is increased to InfinityMixRate to achieve the "final" saturation point.
Pattern Description: Greater than or equal to 25 revolutions per minute and less than or equal to 350 revolutions per minute.
MixTime
The duration of time the sample is mixed prior to the Infinity Mixing period during which the sampling occurs at the specified SamplingTime intervals. The Infinity Mixing period involves a higher stirring rate at the end of the protocol to obtain the final saturation point.
Default Calculation: Automatically set based on the SamplingTime. When SamplingTime is provided as a list, the duration is set to the highest value in the list. When SamplingTime is a single value, the total duration is calculated based on the NumberOfSamples. If SamplingTime and NumberOfSamples are set to Automatic, the duration set to 1 hour.
Sampling
Sampling
Indicates if samples of the dissolution media should be taken during the experiment. These samples are commonly used to determine the amount of the sample that was dissolved in the medium at a given time point.
NumberOfSamples
Default Calculation: Automatically set to the number of SamplingTime intervals if SamplingTime is set to a single value, otherwise set to the number of SamplingTime intervals that fit into MixTime. If MixTime and SamplingTIme are set to Automatic, NumberOfSamples is set to the maximum number of samples that can be taken from the dissolution medium during the experiment minus one to account for InfinityMixing.
Pattern Description: Greater than or equal to 1 and less than or equal to 12 in increments of 1 or Null.
SamplingTime
The time interval or the list of the time points for taking aliquots of the dissolution medium. For example, to take an aliquot every 5 minutes, SamplingTime can be specified as either 5 Minute or {5 Minute, 10 Minute, 15 Minute, 20 Minute..}.
Default Calculation: Automatically set so that the number of SamplingTime intervals is equal to NumberOfSamples. If NumberOfSamples and MixTime are set to Automatic, SamplingTime is set to the 5 Minutes.
Programmatic Pattern: ((RangeP[2*Minute, $MaxExperimentTime] | {RangeP[2*Minute, $MaxExperimentTime]..}) | Automatic) | Null
SamplingVolume
Pattern Description: Greater than or equal to 300 microliters and less than or equal to 2 milliliters or Null.
ContainersOut
The container type that each aliquoted sample is deposited to. The vials should have a slitted cover to be allowed on the isntrument.
Default Calculation: Automatically set to Model[Container,Vessel,"2mL HPLC clear vial, flat bottom"] if Sampling is specified.
Pattern Description: An object of type or subtype Model[Container] or Object[Container] or a prepared sample or Null.
Programmatic Pattern: ((ObjectP[{Model[Container], Object[Container]}] | _String) | Automatic) | Null
SamplingFlowRate
Default Calculation: Automatically set to the instrument default value of 8 Milliliter/Minute if Sampling is specified.
Pattern Description: Greater than or equal to 8 milliliters per minute and less than or equal to 50 milliliters per minute.
ReplaceMedium
Indicates if the buffer removed for sampling is replaced with an equal volume of the fresh buffer each time an aliquot is taken.
ReplacementMedium
Default Calculation: Automatically set to the medium used in the experiment if ReplaceMedium is set to True. If several different buffers are used, the buffer with the highest frequency is used. If several buffers are used with the same frequency, the first specified buffer is used.
Pattern Description: An object of type or subtype Object[Sample] or Model[Sample] or a prepared sample or Null.
SamplingFlushVolume
Pattern Description: Greater than or equal to 0 milliliters and less than or equal to 13 milliliters or Null.
NumberOfSamplingFlushes
Pattern Description: Greater than or equal to 1 and less than or equal to 5 in increments of 1 or Null.
SamplingFlushFlowRate
Pattern Description: Greater than or equal to 8 milliliters per minute and less than or equal to 50 milliliters per minute or Null.
RecycleSamplingMedium
Indicates if the buffer removed for sample flushing is returned from the lines back to the dissolution vessel. Refer to the instrument diagram of the liquid flow path during the instrument operation for more details.
NumberOfSamplingWashCycles
Sampling Filtration
FilterSamples
Indicates if the sample of the dissolution media is filtered when transferring to the ContainerOut. When the samples are removed from the dissolution vessel, they are optionally filtered by an InLineFilter prior to entering the autosampler. Addditionally, the samples are optionally filtered by an AutosamplerFilter prior to the liquid being dispensed into the ContainerOut. The AutosamplerFilter is optionally changed for each aliquot while the InLineFilter is used for the duration of the experiment. Refer to the instrument diagram of the liquid flow path during the instrument operation for more details.
Default Calculation: Automatically set to None if Sampling is disabled. Otherwise, its value depends on the type of filtration specified: it is set to AutosamplerFiltration if only sample filtering options (AutosamplerFilter, AutosamplerFilterMaterial, AutosamplerFilterPoreSize) are provided, to InLineFiltration if only in-line options (InLineFilter, InLineFilterMaterial, InLineFilterPoreSize) are provided, and to DualFiltration if both types of filtration are used.
Programmatic Pattern: (InLineFiltration | AutosamplerFiltration | DualFiltration | None) | Automatic
AutosamplerFilterMaterial
Default Calculation: Automatically set to the match the material of the filter disks specifiedby the AutosamplerFilter option, otherwise set to PVDF when FilterSamples is set to AutosamplerFiltration or DualFiltration.
Pattern Description: Cellulose, Cotton, Polyethylene, Polypropylene, PTFE, Nylon, PES, PLUS, PVDF, GlassFiber, GHP, UHMWPE, EPDM, DuraporePVDF, GxF, ZebaDesaltingResin, NickelResin, AgaroseResin, CobaltResin, Silica, HLB, or AnoporeAlumina or Null.
AutosamplerFilterPoreSize
Default Calculation: Automatically set to the match the pore size of the filter disks specified by the AutosamplerFilter option, otherwise set to 0.45 Micron when FilterSamples is set to AutosamplerFiltration or DualFiltration.
Pattern Description: 0.008 micrometers, 0.02 micrometers, 0.1 micrometers, 0.2 micrometers, 0.22 micrometers, 0.45 micrometers, 1. micrometer, 1.1 micrometers, 2.5 micrometers, 6. micrometers, 20. micrometers, 30. micrometers, or 100. micrometers or Null.
AutosamplerFilter
The filter disks used to filter the aliquots of samples that are taken from the dissolution medium at the specified time points before the sample is dispenced into the ContainerOut. This filter is applied after the InLineFilter and is optinally changed between each aliquot.
Default Calculation: Automatically set to a Filter with the specified AutosamplerFilterMaterial and AutosamplerFilterPoreSize, if none are specified, automatically set to Model[Item, Filter, "Syringe Filter, PVDF, 0.45 µm, 33 mm"] if FilterSamples is set to AutosamplerFiltration or DualFiltration.
NumberOfFilterUses
Default Calculation: Automatically set to 1 if FilterSamples is set to AutosamplerFiltration or DualFiltration.
InLineFilterMaterial
The material of the filter that is used to remove impurities from the samples right after they are removed from the dissolution vessel and prior to the liquid entering the autosampler.
Default Calculation: Automatically set to the match the material of the filter specified by the InLineFilter option, otherwise set to UHMWPE when FilterSamples is set to InLineFiltration or DualFiltration.
Pattern Description: Cellulose, Cotton, Polyethylene, Polypropylene, PTFE, Nylon, PES, PLUS, PVDF, GlassFiber, GHP, UHMWPE, EPDM, DuraporePVDF, GxF, ZebaDesaltingResin, NickelResin, AgaroseResin, CobaltResin, Silica, HLB, or AnoporeAlumina or Null.
InLineFilterPoreSize
The pore size of the filter that is used to remove impurities from the samples right after they are removed from the dissolution vessel and prior to the liquid entering the autosampler.
Default Calculation: Automatically set to the match the pore size of the filter specified by the InLineFilter option, otherwise set to 0.2 Micron when FilterSamples is set to InLineFiltration or DualFiltration.
Pattern Description: 0.008 micrometers, 0.02 micrometers, 0.1 micrometers, 0.2 micrometers, 0.22 micrometers, 0.45 micrometers, 1. micrometer, 1.1 micrometers, 2.5 micrometers, 6. micrometers, 20. micrometers, 30. micrometers, or 100. micrometers or Null.
InLineFilter
The filter that is used to remove impurities from the samples right after they are removed from the dissolution vessel and prior to the liquid entering the autosampler for optinal secondary filtration.
Default Calculation: Automatically set to a Filter with the specified InLineFilterMaterial and InLineFilterPoreSize, if none are specified, automatically set to Model[Item,Filter,XXX] if FilterSamples is set to InLineFiltration or DualFiltration.
InfinityMixing
InfinityMix
Indicates if additional mixing at higher rotational speed will be performed at the end of the MixTime. The Infinity Mixing period is used to achieve the final saturation point.
InfinityMixRate
The frequency of rotation used by the dissolution instrument at the end of the experiment to achieve final dissolution condition. This is typically set to a higher value than the MixRate to achieve the final saturation point.
Default Calculation: Automatically set to MixRate + 50RPM (up to the maximum rotation rate supported by the instrument) if InfinityMix is set to True.
Pattern Description: Greater than or equal to 25 revolutions per minute and less than or equal to 350 revolutions per minute or Null.
InfinityMixTime
Duration of time for which the samples will be mixed at InfinityMixRate after MixTime to achieve the final saturation point.
Post Experiment
SamplesInStorageCondition
The non-default conditions under which the SamplesIn of this experiment should be stored after the protocol is completed. If left unset, SamplesIn will be stored according to their current StorageCondition.
Pattern Description: {AmbientStorage, EnclosedAmbientStorage, Refrigerator, Freezer, DeepFreezer, CryogenicStorage, YeastIncubation, YeastShakingIncubation, BacterialIncubation, BacterialShakingIncubation, MammalianIncubation, ViralIncubation, CrystalIncubation, AcceleratedTesting, IntermediateTesting, LongTermTesting, UVVisLightTesting} or Disposal or Null.
SamplesOutStorageCondition
The non-default conditions under which any new samples generated by this experiment should be stored after the protocol is completed. If left unset, the new samples will be stored according to their Models' DefaultStorageCondition.
Pattern Description: {AmbientStorage, EnclosedAmbientStorage, Refrigerator, Freezer, DeepFreezer, CryogenicStorage, YeastIncubation, YeastShakingIncubation, BacterialIncubation, BacterialShakingIncubation, MammalianIncubation, ViralIncubation, CrystalIncubation, AcceleratedTesting, IntermediateTesting, LongTermTesting, UVVisLightTesting} or Disposal or Null.
Sample Prep Options
Sample Preparation
PreparatoryUnitOperations
Specifies a sequence of transferring, aliquoting, consolidating, or mixing of new or existing samples before the main experiment. These prepared samples can be used in the main experiment by referencing their defined name. For more information, please reference the documentation for ExperimentSamplePreparation.
Protocol Options
Organizational Information
Template
A template protocol whose methodology should be reproduced in running this experiment. Option values will be inherited from the template protocol, but can be individually overridden by directly specifying values for those options to this Experiment function.
Pattern Description: An object of type or subtype Object[Protocol] or an object of type or subtype of Object[Protocol] with UnresolvedOptions, ResolvedOptions specified or Null.
Programmatic Pattern: (ObjectP[Object[Protocol]] | FieldReferenceP[Object[Protocol], {UnresolvedOptions, ResolvedOptions}]) | Null
Name
Warnings and Errors
-
Messages
Last modified on Thu 14 Aug 2025 02:14:24