The new excipient DDM (Dodecyl-β-D-maltoside) of Croda has obtained the Drug Master File (DMF) registration.
We are honored to announce that the Croda DDM product of Good Manufacturing Practice (GMP) grade has been successfully registered and filed in the DMF of the U.S. Food and Drug Administration (FDA). DMF Number: MF040294.
DDM, namely Dodecyl-β-D-maltoside. Alkyl glycosides exert their effects through the intranasal administration route. Their chemical structure consists of sugar molecules linked to alkyl chains. Among them, the C12 and C14 alkyl chains can achieve the optimal penetration-enhancing efficiency. C12 refers to DDM, and C14 refers to Tetradecyl-β-D-maltoside (TDM).
DDM has numerous advantages:
- DDM not only has a penetration-enhancing function but also can serve as a surfactant, which helps to stabilize the Active Pharmaceutical Ingredient (API) and reduce its aggregation.
- Meanwhile, the amphiphilic property of DDM can regulate the solubility of the API, thereby enhancing the bioavailability of the formulation.
- In current clinical and animal studies, no significant mucosal irritation or toxicity has been found.
DDM can improve the absorption of drugs through mucous membranes. In the currently marketed nasal spray preparations, many products have already used DDM, such as sumatriptan nasal spray and nalmefene nasal spray, etc.
For more information, please contact us. |
Pharma Sources Insight June 2024: Globalization on the Go
