Solubility is one of the critical physicochemical properties of drugs, and plays a key role in a variety of physical and biological processes such as absorption, removal, and dosage forms. The simplest definition of solubility is the concentration of a substance in equilibrium in a solution that contains an excess of an undissolved substance.
After the solid is added to the aqueous solution, the surface of the solid particles is moistened by the solution, and the particles on the surface of the solid lattice interact with the water molecules, leaving the lattice and entering the solution phase, and these compounds and ions that have just entered the solution phase will be briefly enriched at the solid-liquid interface, forming a "diffusion layer". The concentration of compounds and ions in this diffusion layer is higher than that of the solution phase, and this concentration gradient encourages compounds and ions to enter the solution phase.
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The effectiveness and safety of the drug depend largely on the release and dissolution of API. On the other hand, excipients have significant and complex effects on API solubility and dissolution, often affecting polycrystalline or solvate transitions. In the early stages of generic drug development, evaluating the solubility of API and excipient in RLD at multiple pH is necessary and also helps to better understand the interaction of active ingredients and excipients.
As a professional RLD reverse engineering research company, we have many years of reverse analysis and preparation research experience. We can assist generic drug manufacturers to complete a full range of RLD characterization, such as API & Excipient Crystal Form Study, API & Excipient Particle Size Study, API pKa Study, solubility study and Determination of Principal Component in RLD.
The solubility of API and excipient affects the properties and analytical methods of preparation. The quality difference between generic drugs and RLD is mainly reflected in in vitro dissolution and in vivo bioequivalence, both of which are closely related to solubility. To ensure that generic drugs are comparable to RLD in terms of quality and efficacy, API and excipient solubility must be considered. After fully understanding the solubility of API and excipient in RLD, proper considerations can be made for the prescription, process, crystal form, particle size, etc., of generic drugs.
Our company provides solubility testing services for API and excipients to accelerate the process of generic drug development with simple, fast methods and reliable data.
Our company generally tests the solubility of API of RLD by using the shaking bottle method under specified pH conditions. A solid is added to a specific aqueous solution and then oscillated at a specific temperature. The solution is taken at a specific time and the concentration of the target compound is determined by HPLC-DAD or LC/MS. It is generally necessary to measure the results of different time periods to determine whether the dissolution process has reached equilibrium.
Most of the commonly used drugs are weakly acidic drugs, and a small part are weakly alkaline drugs. To accurately determine its solubility, for weakly acidic drugs and weakly alkaline drugs, it should be determined in acidic and alkaline solutions respectively.
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We are committed to helping generic drug manufacturers complete RLD prescription process research faster and with higher quality, and helping companies successfully complete generic drug consistency evaluations.
- Full range of RLD reverse engineering services
We provide a full range of RLD reverse engineering services to generic drug manufacturing companies and researchers.
We use advanced analytical instruments and innovative technologies to bring you fast, accurate and efficient data results.
Our experts have years of experience in drug development, and we apply strong problem-solving skills to help you solve the challenges of generic drug development.
