I need to formulate a water dispersible tablet with an a highly potent (Dose 7mg) API which is moisture, heat and light sensitive API with poor flow properties. Please advice on the formulation, method of manufacturing and packaging
Considering such a low dose, you probably don't need to worry about the poor flow. There is no general answer for your question because you need to carry out your preformulation studies so you can understand incompatibilities of your drug but, in general, you must think in no hygroscopic excipients with no water molecules in their structure, and then do the compatibility studies. You should consider direct compression, as manufacturing method. The packaging must be a laminated PVC or alu-alu. But again, you must perform you own internal preformulation and formulation studies to assurance maximal protection without the risk of overpackaging.
- Badges
- Science topic
- Similar topics
- Clinical Pharmacology
- Dosing