Dissolution refers to the rate and extent to which the active ingredients of drugs are dissolved from preparations such as tablets, capsules, or granules under specified conditions. Dissolution is a crucial index to evaluate the quality of oral solid drug preparations, which is a simple test method in vitro that simulates the disintegration and dissolution of drug preparations in the gastrointestinal tract.
Although authoritative regulatory agencies such as FDA and NMPA recommend the use of in vivo methods to evaluate bioequivalence, because the in vitro process cannot fully represent the in vivo behavior of a drug. However, a large number of tests have shown that there is a certain correlation between the dissolution degree in vitro and bioequivalence evaluation in vivo. In vitro dissolution tests can provide data support for in vivo studies and reduce the risk of clinical trial failure. If the dissolution curves obtained from the generic drug and RLD at a variety of pH values match, the bioequivalence evaluation experiment is more likely to be the same. Therefore, in some cases, if sufficient evidence can be provided, in vitro methods can also be used to study bioequivalence evaluation.
Our Services
Alfa Chemistry provides dissolution curve determination and rapid blood drug concentration detection solutions for in vitro and in vivo bioequivalence evaluation respectively, and offers state-of-the-art innovative technology platforms and compliance data management scheme for generic drug manufacturers.
In vitro comparative dissolution studies can be used to verify the bioequivalence of oral formulations with high solubility, high permeability and rapid dissolution according to the biopharma classification. Because the dissolution and absorption of this kind of drug is not the rate-limiting step of the drug into the body. For drugs with poor solubility but high permeability, if a sufficient in vitro and in vivo correlation has been established, in vitro dissolution studies can also be used to predict in vivo dissolution, avoiding complex and time-consuming in vivo studies.
Difficulties in dissolution evaluation of generic drugs
- Numerous dissolved samples
- The amount of data obtained
- A large amount of experimental data
- There are many dissolution curves
- Formula calculation is complex
- Lots of sample reports need to be issued
- Pressed for time
Our company provides bioequivalence evaluation services for global generic pharmaceutical companies, focusing on automated, digital and efficient generic drug consistency evaluation solutions. We are equipped with industry-leading analysis and detection systems to improve the collection efficiency of dissolved samples, the detection efficiency of samples, and the efficiency of data processing.
Our Dissolution Consistency Evaluation Services
Working closely with us, we help you navigate the bioequivalence evaluation process smoothly and compliantly.
