Wolfe Laboratories - From Concept to Creation with Confidence

Pre-Formulation
Formulation Development
Real-time and Accelerated Stability Testing
Container-closure Selection and Compatibility Studies
Dose Recovery

>	CASE STUDY 1 Parenteral dosage form development of a highly insoluble molecule
>	CASE STUDY 2 Salt form optimization and lyophilized parenteral formulation development
>	CASE STUDY 3 Oral liquid formulation development
>	CASE STUDY 4 Accelerated stability studies to support a screening IND
>	CASE STUDY 5 Lead Optimization: Solubility and formulation screen for efficacy and PK studies

Container closure selection and compatibility studies

WLI assists its clients in selecting an appropriate container closure system for a drug product. Considerations are given to the intended use of the drug product and the suitability of the container closure system for storage and transportation, including the storage and shipping container for bulk drug product, if appropriate.

Subsequently, testing is conducted to assess compatibility of the drug product with the container. Possible difficulties may be encountered with decomposition of the active pharmaceutical ingredient on contact with components of the container or its closure, contamination with plasticizers or other leachables/extractables, moisture uptake, or inadequate dose recovery.