Wolfe Laboratories - Formulation Development

Analytical Method Development
Protein Characterization
Solid-State Characterization
Stability-Indicating Analytical Methods
Dose Recovery
Identification of Impurities and Degradation Products
Additional Analytical Applications

>	CASE STUDY 1 Advancement of an Early Development Candidate to Phase IIb Trials
>	CASE STUDY 2 Development of a Parenteral Formulation of a Cytotoxic Natural Product
>	CASE STUDY 3 Oral Formulation Development for Proof-of-Concept Animal Toxicology Studies
>	CASE STUDY 4 cGMP Analytical Release Testing of a Cytotoxic Drug, as Well as Other Analytical and Bioanalytical Services
>	CASE STUDY 5 Parenteral Dosage Form Development of a Highly Insoluble Molecule

Dose Recovery

Dose recovery may be defined as a fraction of the active pharmaceutical ingredient (API) present in the administration vehicle that is delivered to the patient upon administration using a given administration formulation, 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 suspension dosage forms. For oral gavage suspensions with methyl cellulose or other suitable excipient, which are used frequently for pre-clinical dosing, dose uniformity is an important issue, and must be determined. 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.

WLI performs dose recovery and dose uniformity studies with a variety of drug substances and their formulations, including small molecules, peptides, proteins, oligonucleotides, and cytotoxic materials.