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

Dose Recovery

Dose recovery may be defined as a fraction of the API present in the administration vehicle that is delivered to the patient upon administration using a given administration route and apparatus.

The dose recovery issue may become important early in the drug development program. For example, if animal testing is conducted using oral gavage administration of a suspension of a drug substance, dose uniformity and dose recovery should be verified.

In the course of development of an API for clinical administration, the suitability of administration vehicle and administration apparatus will be tested by measuring dose recovery. WLI can characterize the amount of active pharmaceutical ingredient delivered via any common route of administration including parenteral, oral liquid, or oral solid dosage forms. WLI has accumulated expertise in determining suitability of a formulation for co-administration with another drug. In addition, we are experienced in analyses of specialty dosage forms and devices.