RC-6/8 Dissolution Tester

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RC-6/8 Dissolution Tester

Dissolution Tester: The Ultimate FAQ Guide

This guide covers every information you need to know about dissolution tester.

It will help choose a high-performance dissolution tester hence, boosting your tablet compression business.

Keep reading to learn more.

What is Dissolution?

Dissolution is the process by which a substance will form a solution.

Why is the Dissolution Test Important?

A dissolution test is important in the pharma industries to help determine the effectiveness of pharma products.

Some of the reasons as to why it is important to conduct a dissolution test include:

  • A dissolution test is important as it will enable you to determine the rate at which a tablet or capsule dissolves.
  • It helps to determine the bioavailability of a pharma product.
  • It also assists to determine the therapeutic effectiveness of a drug.
  • It will assist in determining the stability of the solid dosages.
  • It is vital for detecting the physical changes in active pharma ingredients.
  • It also assists in determining the physical changes in product formulation.

What does Q Stand for when using a Dissolution Tester?

The quantity Q is the amount or quantity of a dissolved Active Pharmaceutical Ingredient [API].

When studying the Q value, we calculate the percentage dissolution of a product at a specific time.

A percentage value allows for easy standardization across all monographs in the USP.

It also helps to limit the statistics.

Different monographs may limit the Q in different ways according to the attributes of the active ingredients and the formulation.

What are the Features of a Dissolution Tester?

Some of the features of a dissolution tester include:

Disintegration tester

Dissolution tester

  • It can come with six baskets or paddles.
  • It comes with overheat protection, a self-test fault alarm, and other automatic prevention features.
  • The test timing can start, suspend, and be reset independently.
  • It has an accurate speed and a stable operation.
  • It consumes less energy.
  • It comes with a Human Machine Interface [HMI] and LED panel that is simple and easy to operate.
  • It comes with the ability to store the working parameters, hence no need to repeat settings on a new test.
  • It uses a high-quality stainless steel basket rod, basket, and pulp rod.
  • It has an in-built temperature sensor to ensure constant water bath temperature.
  • Operation of the head can happen using a manual or automatic method.

How does a Dissolution Tester Work?

A dissolution tester works by first placing the volume of the dissolution medium into the dissolution tester.

Make sure the dissolution medium is free from air.

Warm the dissolution medium to around 36.5 °C to 37.5 °C.

Place one unit of dosage into the apparatus making sure no air bubbles form on the surface of the dosage unit.

Allow the tablet or capsule to sink to the bottom of the cylindrical vessel before you start the rotation process.

A wire of glass helix can keep the dosage, which would otherwise float in a horizontal position.

When using a dissolution tester that has a basket, place the tablet or capsule in the dry basket.

Then you will lower the basket in the solution before you begin the rotation process.

Using the speed of rotation on the individual monograph, operate the dissolution tester instantly.

After each time interval, remove the specimen from the solution.

Make sure it is between the surface of the dissolution medium and the top part of the rotating basket or blade.

It should not be less than 10 mm from the surface of the wall of the apparatus.

Only when you are using a single sample will you add a dissolution medium.

The medium should be equal to the volume of the samples that you will withdraw.

After that, you will filter the sample solution quickly via a membrane filter disk.

The average pore size of the filter disk should not be more than 1.0 micron.

Dispose of the first ml of the filtrate that was in the test.

Analyze as shown in the individual monograph.

Repeat the process five more times.

In these tests, add two or more dosages to the apparatus.

For each test, you will calculate the number of ingredients that dissolve.

Calculate it as a percentage of each test to determine the dissolution.

What are the Different Stages that a Dissolution Tester Performs a Dissolution Test?

 Dissolution tester

 Dissolution tester

The dissolution stages allow more flexibility to the sample that is unable to pass the dissolution tests.

All regulatory bodies accept these stages.

Many firms globally accept this test method for the dissolution of solid dosages.

There are three stages that a dissolution tester can use to perform a dissolution test.

These stages are:

· Stage One

The first stage of the dissolution test is the S1 Stage.

In S1 Stage, you will use a total of 6 sample units.

The amount of each unit that dissolves in S1 Stage should not be less than Q + 5%.

The specific limit for each unit in an individual monograph should be above 5%.

If the limit of any unit is below 5%, you will conduct the S2 Stage.

· Stage Two

In the S2 Stage, the average should not be less than Q, and no individual unit should be lower than Q – 15%.

In S2 Stage, you will use a total of 12 unit samples since you will add six more units to the test.

If any unit falls below Q – 15%, or when the average of all units is below Q, you will conduct S3 Stage analysis.

· Stage Three

This is the final stage of the dissolution test.

The units in this stage should not be less than Q.

In S3 Stage, you will use a total of 24 sample units since you will add twelve more samples to the test.

Only two units can be lower than Q – 15% and no particular unit should fall below Q – 25%.

This stage allows for more flexibility because the 24 units should be equal to or more than Q.

Besides, only two units may be up to Q – 25.

What is the Difference Between a Dissolution Test and a Disintegration Test?

A dissolution test will determine how a substance dissolves in a liquid medium.

A disintegration test will determine if no residue of the substance remains on the surface once it breaks down.

Disintegration tester

 Disintegration tester

A dissolution test and a disintegration test both use a liquid medium to conduct the experiments.

A disintegration test will help determine the therapeutic effectiveness of a drug.

Besides, a dissolution test will help in determining the in-vitro breakdown of solid and powder substances for quality purposes.

Furthermore, a dissolution test and a dissolution test are both important tests to determine the quality of different dosages.

A dissolution and disintegration tester has to comply with pharmacopeia standards such as USP, IP, and BP.

Dissolution tester

 Dissolution tester

A dissolution test and a disintegration test can happen both as an automatic process or a manual process.

All this depends if you have an automatic tester or a manual tester.

A dissolution test and a disintegration test both involve an arm moving in the liquid medium in the testing stage.

An automatic dissolution and disintegration testers both have a human-machine interface [HMI] and an LED panel for easy operation.

Besides, a basket assembly is available in both a dissolution test and a disintegration test.

A disintegration test and a dissolution test can both happen in one or more baskets of the machine.

Also, dissolution test uses the Q value to calculate the percentage dissolution of a product at a specific time.

A disintegration test uses time as the value for measuring the disintegration of various substances.

Moreover, a dissolution test and a disintegration test will check the consistency and conformity of several products in the pharma industries.

A disintegration test mostly applies to large solid substances.

A dissolution test mostly applies to solids, liquids, and gases.

Fillers and binders can all affect a disintegration test and a dissolution test.

What Types of Dissolution Testers are available in the Market?

There are several kinds of dissolution testers that you can use to test for dissolution.

Testing for dissolution is an important part of quality control in any pharmaceutical industry.

Drugs can only go to the consumers once it passes the dissolution test and gets approval.

Some of the dissolution apparatus in the market as per the USP include:

· Basket Dissolution Tester

The basket apparatus comes with borosilicate glass and can hold up to 1000 ml.

Also, the bottom of this basket apparatus is in a semi-hemispherical shape.

The shaft comprises quality stainless-steel.

Moreover, the basket apparatus is also known as a rotating basket.

This is because it rotates gently while adhering to the USP rotating speed.

The average speed of a basket apparatus is 100 rotations per minute [rpm].

The basket apparatus is applicable for:

  1. Capsules
  2. Tablets
  3. Delayed-release tablets
  4. Suppositories
  5. Floating dosage designs

· Paddle Dissolution Tester

The paddle apparatus has a coating that reduces the interference from stirring.

Here, the blade of the paddle apparatus will come into contact with the bottom of the shaft.

The design of the paddle is from a highly durable stainless steel.

It also comes with a platinum wire, which inhibits the capsules from floating in the liquid medium.

The average speed of the motors is usually 40 revolutions per minute [rpm].

Again, the paddle temperature is constantly at 37 °C.

Also, the position of the paddle is in line with the specific USP.

The motor speed for capsules is 50 rpm, while for suspensions is 25 rpm.

· Reciprocating Cylinder Dissolution Tester

A dissolution tester is vital for product development for the preparation of dosages.

This is vital as it assists in releasing the dosages in the gastrointestinal tract.

This apparatus exposes the dosages to many physiochemical and mechanical properties.

It easily tests the drugs as it will not cause any issues with the PH values of the liquid mediums.

A reciprocating cylinder apparatus is suitable for chewable tablets and extended-release tablets.

· Rotating Cylinder Dissolution Tester

Instead of a basket cylinder, a rotating cylinder has a vessel.

High-quality stainless steel is the material that makes up the vessel

In this system, you will place the dosage inside the cylinder then remove it from the outside into the water bath.

The drawback of this system is that the transdermal patches cannot be cut to small sizes.

This will cause a problem in dissolution testing in the pharma industries.

· Paddle Over Disc Dissolution Tester

Normally, the paddle over the disk comes with a shaft and a disk assembly.

These two components hold the product at the same level as the paddle.

Furthermore, the disk assembly holds the paddle.

The capacity of the paddle over the disc apparatus is 900 ml.

· Flow-through Cell Dissolution Tester

The flow-through cell apparatus comes in two designs: open system and closed system.

In the open system, you will pump fresh dissolution medium via the cells and then receive the fractions.

In this apparatus, you will remove the fractions after every 30 minutes.

In an open system, you are to conduct the test in the suitable sink conditions that are available.

In a closed system, you will pump the dissolution medium into the circle.

Also, you will not replace the dissolution medium with a fresh medium.

A closed system is suitable for drugs that show a low dosage tendency.

A closed system uses small volumes of the samples to conduct the test.

The design of a flow-through cell apparatus is like a reservoir.

Flow-through cell apparatus is mostly applicable to implants.

· Reciprocating Disc Dissolution Tester

A reciprocating disk has a cylinder that has a flat bottom.

It has a volume capacity of between 50 and 200 ml.

A disk shape holder is where you will place a reciprocating disk dissolution tester.

It has the capability of producing transdermal patches, and you will remove the dosage quantity in the water bath.

A reciprocating disk dissolution tester is suitable for small dosage samples, and you can use it for controlled release formations.

What is the Difference Between a Paddle and a Basket in a Dissolution Tester?

A paddle and a basket are the two different ways you can use to test the dissolution of substances.

Baskets are common for testing capsules or tablets floating in the media solution.

On the other hand, you will use a paddle for all kinds of dosages in the dissolution tester.

In other scenarios, you will use paddles to test the dissolution of capsules and floating tablets when you have a sinker.

In a paddle dissolution tester, you have a rotating shaft which fixes on the blade.

The blade is for stirring the mixture of the drug and the liquid medium inside the holding vessel.

Once the drug dosage settles at the bottom of the holding the vessel, you will switch on the rotating shaft.

The shaft will then mix the dosage and the liquid solution.

The drug you are testing will be on the sinker to inhibit it from attaching to the walls of the vessel.

This also ensures the drug you are testing will remain at the bottom of the rotating shaft.

A non-reactive element makes up the sinker, which inhibits it from reacting to the dosage sample it is holding.

In the basket dissolution tester, you will place a different tool at the end of the rotating shaft.

This tool is known as a basket.

It comes in a cylindrical shape and has a non-reactive mesh, which prevents any chemical reactions.

These unwanted chemical reactions may change the outcome of the dissolution test.

The pores of the basket will allow the dissolving dosage to move to the holding vessel from the basket.

This will create a uniform solution.

In the basket, you will place the dosage you need to test.

The basket firmly attaches itself to the rotating shaft.

The motor will begin to rotate the basket, which is inside the vessel, once the drug is in a secure position.

This all happens when you turn on the motor.

A basket dissolution tester is suitable for sticky tablets that contain HPMC or other similar compounds.

These compounds act as a binder.

This method is suitable since these tablets will swell in the water.

When they swell, they may stick to the walls of the dissolution tester.

The basket ensures that the dosage is inside it and will not stick.

What is the Correct Handling Technique for Baskets in a Dissolution Tester?

Basket dissolution tester

Basket dissolution tester

It is important to understand how to handle the basket in a dissolution tester to ensure accurate and reliable results.

Here are some of the correct handling techniques for baskets in a dissolution tester:

  • Never hold the mesh as it can easily deform.
  • It is advisable to hold the baskets by the rims.
  • For a durable long-lasting basket, use baskets that have sintered rigid mesh.
  • Store the basket properly, preferably in a basket rack and not a loose drawer.
  • Replace the complete shaft unit when you have shaft clips that are bent or rusty.

What is Wobbling in a Dissolution Test?

Wobbling happens when the shaft of the basket moves from the center as it rotates.

Wobbling will disrupt the flow profile in the dissolution vessel

affecting the rate of dissolution.

Measurements of the dissolution test happen on the paddle shaft or basket that is close to the basket position of the paddle blade.

In basket dissolution testers, additional measurements happen at the rim of the basket.

Dissolution measurements happen with the aid of a wobble meter.

How do you Calibrate a Dissolution Tester?

Here are some steps on how to calibrate a dissolution tester.

· RPM Calibration

Start by entering the appropriate RPM value between the range of 30 and 200.

Press the ENTER key to terminate.

The SET RPM will turn off.

An error message “Er” will show if the RPM values are not in the above range.

Go back to resetting if you see the error message.

Once you press the ENTER key and the error message “Er” shows on the RPM display, you will accept the last RPM reading.

The SET RPM LED will be put off.

To set the RPM value, press the SET-RPM key.

Then the LED will light up.

Enter the digit for the RPM value you prefer.

Press ENTER, then the SET-RPM LED will turn off, showing the value.

Record the RPM readings manually in the calibration log.

· Temperature Calibration

Start by pressing the SET key, which will light up TEMP on the SET TEMP LED.

Enter the appropriate value between the range of 30 °C and 100 °C.

Press the ENTER key to terminate.

The SET TEMP will turn off.

An error message “Er” will show if the TEMP values are not in the above range.

Go back to resetting if you see the error message.

Once you press the ENTER key and the error message shows on the TEMP display, you will accept the last correct TEMP reading.

The SET TEMP LED will be put off.

Set the temperature, then measure the temperature of the bowl with a thermometer.

Record the readings.

Press the SET TEMP key to view the set temperatures, and the TEMP DISPLAY will show the set temperature in °C.

If the calibration is not within the limits, inform the quality control head.

How does an Automatic Dissolution Tester compare to a Manual Dissolution Tester?

An automatic dissolution tester is more accurate and reliable than a manual dissolution tester.

It is easy to operate an automatic dissolution tester than a manual dissolution tester.

A manual dissolution tester is more affordable than an automatic dissolution tester.

An automatic dissolution tester has more in-built automation than a manual dissolution tester.

A manual dissolution tester may cause inconsistencies in the final results.

An automatic dissolution tester is time-saving than a manual dissolution tester.

Data capture and documentation is easy on an automatic dissolution tester.

What is a Dissolution Rate?

Dissolution rate is the measure of the actual release rate of the dosage at a particular particle size.

Why is it Important to know the Dissolution Rate?

It is vital to know the dissolution rate since it impacts the bioavailability and the delivery aspects of a drug.

How does Dissolution Affect Absorption?

When a substance has a high dissolution rate, the body will rapidly absorb it.

This means the surface area is large for absorption to take place.

This means it will have its effect on the body in a short time than substances with a low dissolution rate.

What are the Parts of a Dissolution Tester?

Here are the parts of a dissolution tester:

· Water Bath

This is the container that holds the heated water.

· Media

This is the liquid that resembles the one in the human stomach.

· Vessels

This is the glass container that holds the drugs and test media.

· Drive Head

The drive head will provide power to paddles and shaft for rotation to happen.

· Test Stations

This is the place that holds the vessels.

It influences the number of tests you can do at the same time.

· Sinkers

Sinkers assist in keeping floating tablets inside the vessel.

· Heaters

Heaters produce heat to the water bath hence creating a constant testing environment.

· Paddles and Shafts

These are the handles and movers that assists in the dissolution process.

What is the difference between Dissolution and Solubility?

Dissolution is the process in which a solute dissolves in a solvent to form a solution.

Solubility is the maximum concentration that can dissolve in a solvent at a specific temperature.

Can you Test Chewable Tablets using a Dissolution Tester?

Yes, a dissolution tester is vital for testing the dissolution of chewable tablets.

Some patients may swallow the tablets without chewing.

What are the Different Dissolution Equipment Systems?

Some of the dissolution equipment systems include:

  • Online system
  • Offline system
  • Online/Offline system
  • Semi-automatic systems
  • Automatic systems

What Kind of Products can you Test with a Dissolution Tester?

Tablet dissolution tester

Tablets dissolution tester

There are various products you can test using a dissolution tester:

Some of these products include:

  • Tablets
  • Capsules
  • Suspensions
  • Powders
  • Coated beads
  • Granules
  • Creams
  • Gels
  • Chewing gums
  • Inhalation powders
  • Wound care products
  • Bone cement
  • Pastes
  • Lotions
  • Transdermal patches

What are the Qualification Standards of a Dissolution Tester?

Some of the qualification standards of a dissolution tester include:

  • Current Good Manufacturing Practices [cGMP]
  • USP <1058>
  • Design Qualifications
  • Installation Qualifications
  • Operational Qualifications
  • Performance Qualifications

What are Some of the Common Causes of Failure in a Dissolution Tester?

Some common causes of failure in a dissolution tester include:

Procedural Failures

Examples include:

  1. Inaccurate dispensing
  2. Improper degassing
  3. Poor sampling techniques

Equipment Failures

Examples include:

  1. Vibrations
  2. Substandard vessels
  3. Poor alignment

What are the Mechanical Qualifications of a Dissolution Tester?

Some of the mechanical standards include:

  • Physical inspection
  • Operational checks
  • Maintenance procedures

What are the Best Environmental Conditions for using a Dissolution Tester?

The lighting should be enough for visual observation.

Besides, the environment should be vibration-free.

The media degassing equipment should be suitable.

Each apparatus should have specific vessels and shafts.

A large room for the personnel and equipment.

What is the Cost of a Dissolution Tester?

Depending on the capacity and materials, a dissolution tester can cost between 100 US Dollars to 12,000 US Dollars.

At SaintyCo, we design and manufacture a range lab instruments.

Contact us now for all your dissolution tester needs.