Please complete this questionnaire to obtain start-up formulations intended to achieve immediate or extended release profiles.
All information provided is confidential and will not be shared with any third party.
* Indicates a required field
*1. Type of Formulation Request:
Immediate Release (< 1 hour) Extended/Controlled Release (> 1 hour) Delayed Release
*2. Type of Final Dosage Form:
3. What is the required release profile? Please provide all relevant time points;
*4. Active dose(s): Please specify mg;
*5. Is the solubility pH dependent?
If yes, please give details (include pKa of drug);
*6. Drug solubility in water: Solubility = mg/ml
*7. Preferred manufacturing method:
*8. What is maximum dosage form weight? (Specify per active dose, ie 250 mg for 1 dose, etc.)
9. Name of active ingredient
10. Has any formulation work already been conducted? What were the results?
11. What is the current stage of development?
Clinical Phase:
12. Please list in vitro dissolution testing conditions. Dissolution medium/media? Agitation speed? USP I II III IV
13. List any unacceptable excipients
14. Will the product be marketed as:
15. Regulatory Aspects: Target markets for the product? (eg, North America, Europe, Japan, Global)
16. What are your film coating requirements?
Aesthetic Moisture Barrier Sustained Release
High Elegance Delayed Release Taste Masking
17. Do you require a film coating sample at this time?
18. Have you chosen a desired color?
Color Guide # Pantone # Sample #
19. Any other relevant information? eg, drug sensitivity (light/heat/moisture), micronized API, etc.
