Dissolution refers to the rate and extent to which the active ingredient of a drug is dissolved in a preparation such as tablets, capsules or granules under specified conditions. Dissolution is a key quality attribute for evaluating the quality of oral solid preparations, and is a simple in vitro method to simulate the disintegration and dissolution of a formulation in the gastrointestinal tract.
Dissolution testing is important for evaluating the bioequivalence of drugs, which is also one of the routine testing programs for drugs. A large number of tests have proved that there is a certain correlation between in vitro dissolution and in vivo bioequivalence. Therefore, the dissolution test can provide data support for in vivo studies and reduce the risk of clinical trial failure.
Protheragen-ING Lab provides dissolution testing services to pharmaceutical companies worldwide. Our company is equipped with industry-leading analytical and detection systems that improve the efficiency of dissolution sample collection, detection, data processing, and reliability of results. Our dissolution testing can accommodate dosage form properties for all formulation types (tablet, capsule, etc.) and all release mechanisms (immediate release, modified release, extended release and delayed release).
Our Services
Dissolution Method Development
For the development of dissolution testing methods, we screen test parameters based on the physical and chemical properties of the active pharmaceutical ingredients (APIs) and the formulation process. The dissolution test methods we establish can objectively reflect the characteristics of the formulation, have appropriate sensitivity and specificity, comply with USP and ICH guidelines, and are easily transferable.
- Dissolution apparatus: usually selected according to the nature of the raw and auxiliary materials
- Dissolution media: including the choice of dissolution media type and media volume.
- Test temperature: dissolution tests for general oral preparations are performed at 37±0.5 ℃.
- Rotational speed: appropriate rotational speed can make the dissolution method have good differentiation ability.
- Determination of the dissolution curve: including the choice of sampling time and examination of the media time
Dissolution Method Validation
After the establishment of the dissolution testing method, our experienced dissolution method development team will carry out the necessary method validation, or validate the customer's existing assay. The main indicators examined during the validation of the dissolution testing method include:
- Accuracy
- Precision
- Specificity
- Linearity
- Range
- Durability
Our Dissolution Apparatus
- USP Dissolution Apparatus Ⅰ-Basket
- USP Dissolution Apparatus Ⅱ-Paddle
- USP Dissolution Apparatus Ⅲ-Reciprocating Cylinder
- USP Dissolution Apparatus IV- Flow-Through Cell
- USP Dissolution Apparatus V-Paddle over Disk
- USP Dissolution Apparatus Ⅶ-Reciprocating Holder Apparatus
Dissolution Testing Process
- Place the sample in the medium and start the test under the specified conditions.
- Samples are taken from the medium at each specific time point.
- Measurement of the sample by HPLC or UV instruments
- Collect and process the data to calculate the dissolution
- Plotting the dissolution curve
- Organize and issue a report
Dissolution testing can provide critical drug release information for drug development and quality control. Our well equipped laboratory offers comprehensive testing services according to the pharmacopoeia (e.g., USP, EP, or JP) and to your specifications.
Contact us today to learn more about our dissolution testing services or to inquire about customized testing solutions.