What is Tablet Dissolution Testing?
Tablet Dissolution testing is a critical and mandatory in vitro quality control procedure for solid dosage forms such as tablets, capsules and granules. Such testing confirms that a tablet has released the labelled quantity of active pharmaceutical ingredient (API) into solution within a designated time interval. It demonstrates that the API will be readily available for absorption after oral administration.
What is dissolution testing used for?
Dissolution testing has emerged as a very important tool in the generic pharmaceutical industry. It is very widely used in formulation development, in monitoring the manufacturing process and as a quality control test. It can also be used to predict the in vivo performance of certain products.
Who uses dissolution testing?
In the pharmaceutical industry, automated tablet dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.
There are three typical situations where dissolution testing plays a vital role:
- Formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.
- Equivalence decisions: during generic product development, and also when implementing post-approval process or formulation changes, similarity of in vitro dissolution profiles between the reference product and its generic or modified version are one of the key requirements for regulatory approval decisions.
- Product compliance and release decisions: during routine manufacturing, dissolution outcomes are very often one of the criteria used to make product release decisions.
How is dissolution testing automated?
- Tablet dissolution systems automation from Automated Lab Systems can be achieved by many options giving the customer the best possible choice.
- Automated UV–Visible dissolution by pumping the samples from the bath to the UV spectrophotometer and taking readings automatically at set times,
- Automated HPLC dissolution analysis is automated by pumping the samples from the dissolution tester to our ASP2000 autosampler, performing optional sample preparation of dissolution samples, injecting dissolution samples on HPLC, measuring dissolution samples by HPLC automatically by creating Sample Set / Sequence tables of the dissolution samples, acquiring results from HPLC and plotting tablet dissolution HPLC profiles.
- Automated sample preparation and UV measurement of dissolution samples analysis is automated by pumping the samples from the dissolution tester to our ASP2000 autosampler, performing optional sample preparation of dissolution samples, measuring dissolution samples on UV spectrophotometer automatically by plotting tablet dissolution profiles.
For more information about the Auto Labs Dissolution testing solutions