In vitro dissolution tests are to investigate the dissolution or release of the active ingredients of the drug in the formulation by exposing the drug to various conditions that mimic the human environment. In vitro dissolution is a key quality attribute of oral solid preparations and one of the evaluation indicators of bioequivalence of generic drugs.
Similar dissolution of generic drugs and RLD in vitro can greatly improve the success rate of drug consistency evaluation and provide a guarantee for the quality of generic drugs. Although the similar dissolution behavior of generic drugs and RLD does not mean that the clinical efficacy is absolutely consistent, if the dissolution behavior of generic drugs is different in vitro, the efficacy is not consistent in most cases.
Our Services
Alfa Chemistry understands that the process from project creation to approval of generic drugs can take a lot of time and effort, and we are here to solve this problem. We provide affordable one-stop services for generic drug manufacturers, including in vitro dissolution assessment services.
Our company has an experienced dissolution method development team and is equipped with advanced instrument platforms. For the establishment of dissolution methods for generic drugs, we analyze the physicochemical properties of drugs, such as solubility, permeability and pKa values, based on literature or RLD instructions. We prefer the existing and universal dissolution method of RLD. If it is not available, the test parameters are selected according to the API's physicochemical properties and the preparation process. The established dissolution test method can objectively reflect the characteristics of the preparation, and has appropriate sensitivity and specificity.
Dissolution determination process
- Place the samples into the medium and test them under the specified conditions
- Sampling at each specific time point
- Determine the samples with an HPLC or UV instrument
- Collect and process data, and calculate the dissolution
- Draw the dissolution curve
- Prepare and issue reports
Development of the dissolution method
Dissolution is the amount of drug released when it reaches a specific time in the dissolution medium. It mainly investigates whether the release of drugs at a specified time point can reach the limit specified by the standard. The factors we focus on when establishing the dissolution method include but are not limited to the following test conditions.
The basket method and paddle method are the most commonly used dissolution measurement techniques, as they are simple, durable and standardized, and suitable for most oral solid preparations. If not applicable, in vitro dissolution tests can be performed by the reciprocating cylinder method or flow cell method when necessary.
Selection of the medium
Our choice of dissolution medium was based on the nature of the drug, taking full account of the drug environment in vivo. We choose a variety of dissolution media for the dissolution test of drugs, and consider adding an appropriate amount of surfactants, enzymes and other additives when necessary.
Medium volume
Generally 500ml, 900ml or 1000ml
In general, dissolution tests of common oral preparations are performed at 37±0.5℃
The dissolution test method we developed used a moderate speed in order to make the dissolution method have better discrimination ability.
- Determination of the dissolution curve
- Selection of time points for dissolution curve determination
- Selection of cut-off time point for dissolution curve investigation
Validation of the dissolution method
After the establishment of the method, we perform the necessary verification, and the indicators to be investigated include:
- System suitability
- Specificity
- Linearity and range
- Accuracy
- Stability
- Precision
- Durability
