Dissolution Testing
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Dissolution is the process in which a substance forms a solution. Active Pharmaceutical Ingredients (API) must be in solution before they are bioavailable. Bioavailability is the amount of active ingredient available for absorption into the blood to achieve the therapeutic effect. Dissolution testing is offered under the scope of Eurofins BioPharma Product Testing Services. It allows to simulate in a controlled laboratory setting how a drug will release in the body.
Elution is the process where a substance is extracted from the product to which it is attached. Typically it is associated with products such as drug coated medical devices and evaluates how the drug is released from the device. Elution testing is done under the scope of Eurofins medical device testing services.
Technical and regulatory requirements
Eurofins BioPharma Product Testing is equiped with all apparatus types needed to fulfil EP/USP/JP defaults.
Product Type and Apparatus:
(1) For products that require stronger shear forces to break apart including gelatin capsule shells, HPMC capsules, and chewable products
Basics of dissolution and drug release:
Drug Release is the process of how the API leaves the dosage form.
Dosage forms are the delivery systems of the API. Dissolution and drug release can be performed on many different types of dosage forms.
Examples: Tablets, capsules, drug coated devices, digital medicines, osmotic pumps, transdermal patches, elixirs/syrups, creams, suppositories, oral suspensions
Dosage forms determine the types of release:
The product disintegrates and the active is immediately released for absorption into the bloodstream.
Example: Acetaminophen Tablets
- Typical dissolution testing < 1 hour
- Typically 1 – 6 timepoints are tested
The active is released at a slower, more steady rate into the blood stream over a period of time
- Allows the drug to be taken at fewer intervals (2x reduction in dosing)
- Multiple sampling timepoints across extended dissolution testing times of 10+ hours are common
- More cost involved due to length of testing
- Example: Pain Management Medications
The active is released at the site where dissolution occurs
- Provides therapeutic values not offered by traditional dosage forms such as tablets or capsules
- Example: Drug Eluting Stents
Active is released at a time other than promptly after administration.
- Example: Enteric Coated Products
- Coating is resistant to stomach acids
- pH changes that occur in the GI tract break down the coating
- API is then released into the bloodstream through the intestinal wall
- Conducted as a two stage test consisting of Acid Stage and a Buffer Stage
- Mimic how the product moves the digestive system
- Example: Gastroesophageal Reflux Disease Medication
Automated Dissolution
Compendia does allow for the use of automated systems when methods are validated for their use. Automation types include:
- Automated Dissolution Sampling Stations
- On-line Dissolution UV/Vis
- Fiber Optic systems
- Fully Automated Robotic Dissolution Systems
How to run a dissolution test at the lab?
Number of determination/vessels = 6
Analysis f samples: can be manual LC or UV or UV automation)
Eurofins BioPharma Product Testing offers the following dissolutions services:
Scientific consulting involves working out concepts and full study designs, using the appropriate apparatus and type of dissolution, analyzing data and interpreting results, and compiling reports to summarize findings.
Method development of (biorelevant) dissolution methods which encompasses the development from scratch including the protocol as well as the examination of immediate, delayed, and extended release oral dosage forms, as well as any other kinds of special dosage forms.
Method validation (or transfer) in early and late phases, with attention to Immediate release, Delayed release, and Extended release oral dosage forms, as well as other Special dosage forms.
Routine, Release and stability testing:
- Analyzing Phase I, II, III and Commercial compounds for conformity to USP I and II regulations
- Examining the compounds according to any USP standards available under GMP guidelines
Troubleshooting: Identifying and resolving issues, that are not GMP-related.
Establishment of in vitro and in vivo correlations to predict the in vivo performance of a drug based on its in vitro drug release profiles
Conduction of a comparison between F1 and F2, generic and princeps, or after a change in raw material, using specific Excel sheet calculations.
Our experience is your advantage to get excellent support for your dissolution analysis
We have extensive experience in dissolution with more than 20 years at the Eurofins Centers of Excellence. This experience includes solid oral, transdermal systems, semi-solid, rectal, vaginal, and semi-solid dosage forms, as well as novel forms such as oral films, chewing gums, medical devices, nano and micro formulations, and implants. We have collaborated with the USP dissolution committee, and worked with sites all over the world.
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