In the process of drug treatment, 50% of the drugs are administered in the form of salts, which plays an important role in the process of drug development. APIs usually have some sub-optimal physicochemical or biopharmaceutical properties, which can be overcome by pairing basic or acidic drug molecules with counterions to produce the salt form of the drug. This process is a simple method for overcoming the undesirable characteristics of the parent drug by changing the properties of the drug through ionizable functional groups. CD Formulation is committed to developing a variety of ways to help drugs move from the research and development stage to the commercialization stage. Salt formation is a very important and key technology in drug development. We provide services such as salt screening and testing to facilitate the development of drugs for customers.
Fig.1 Diagrammatic representation of salt formation
As a supplier of pharmaceutical preparations, CD Formulation also provides a variety of ways for drug development to promote the commercialization of drugs. We provide salt formation services including the following steps:
1. Salt selection stage in drug development. Companies tend to move the salt selection process to the research phase to make the process more foolproof. Ideally, the salt form should be chosen before conducting long-term toxicology studies (that is, at the beginning of phase I clinical trials). This time is an important factor in the early stages of new drug development, because changing the salt form at a later stage may force the duplication of toxicology, formulation, and stability studies, thereby increasing development time and costs.
2. Formation of the salt form. Various methods can be used to prepare the salt on a small scale. The formation of salts from free acids or bases is the most common method. The free acid or base of the drug substance is combined with the counterion base or acid in a suitable solvent system in a specific molar ratio. The salt form is then separated and the solid precipitate is recrystallized.
3. Salt type selection. The resulting salt form is compared with the required physicochemical and biopharmaceutical properties, which will guide the final selection of the best salt form.
4. Characterization of salt. After synthesis, the formation of salt forms must be confirmed, and then their medicinal properties must be evaluated.
In order to ensure reliability, data traceability, safety and quality, CD Formulation adopts strict quality control procedures at every step. Our products and services must be provided to you in accordance with internationally required standards.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.