Dissolution Testing - Protheragen-ING Lab

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).

Drug dissolution testing

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.

Services