1. FLEMINGTON PHARMACEUTICAL CORPORATION Develops therapeutic entities in Lingual Spray Delivery Systems!

2. CMC for Lingual Solution Sprays The Guidance should be subdivided products that are solutions multiple phase products Lingual sprays should be added to this guidance or a separate guidance prepared.

3. CMC for Lingual Solution Sprays True solutions are simple and by nature homogeneous. Testing methods designed for suspensions or micellar “solutions” may not be needed.

4. Examples Spray Content Uniformity (SCU) No mouthpiece - sprayed directly into the mouth. Since homogenous they can be tested on weight delivered similar to other oral products. SCU through container life If no leakage or degradation, the first dose to the last dose deliver the same weight of solution and drug.

5. Examples continued Temperature cycling Cycling is not necessary in that the only change at low temperatures would be crystallization of one or more components. This phase change can more easily be tested by cooling in an ice bath for several hours and adding a seed crystal. If crystals form then the solution should be warmed to see if they dissolve.

6. Examples continued Leachables Many lingual sprays use high boiling solvents which are hard to concentrate to determine leachables. Orientations and resting Since solutions do not settle, orientation and resting will not play a role in performance of the product. The most strenuous conditions for stability testing would be those that maximize contact with the gasket and other valve components (inverted). Effect of resting time Solutions do not change on resting.