Preceptor

Julie Economou
Manager, Product Development

Description

The objective of the rotation is to develop a Product Development Plan for a selected nasal spray product. A Product Development Plan is critical in the formulation and process development of a product and will define the developmental objectives for the selected product. Once a development plan has been completed, lab scale experimentation may be conducted as time permits.

The rotation will require a review of the literature with respect to chemistry, pharmaceutics, and pharmacokinetic/pharmacodynamic properties in order to accomplish the objective. A review and assessment of physical properties and in vitro performance of the reference product is required.

Objectives

1.	Demonstrate efficient literature search strategies and proficiency in the use of computerized information databases.
2.	Critcally analyze and evaluate literature on chemistry, pharmaceutics and pharmacokinetic/pharmacodynamic properties of the selected nasal spray product under development.
3.	Determine the critical physical and chemical parameters of the selected reference product. Analyze the reference product with respect to the indentified parameters and recommend a strategy for development of a product based on this analysis
4.	Generate a Product Developement Plan for the selected product.

Requirements and Activities

During the rotation, the resident will be expected to do the following activities:

1.	To be present a the site for a minimum of 40 hours per week, or at off-stie location as dictated by the nature of the work being completed and agreed upon by the preceptor and resident
2.	Interact with internal and external consultants in the pharmaceutical industry to establish a basic understanding of how formulation development of a new generic nasal spray product is implemented
3.	Attend a weekly review meeting with the preceptor to review status of the project
4.	Provide a detailed product development plan to proceed with development of the selected product
5.	If time permits, perform lab scale experimentation as described by the development plan.

Required Readings

Applicable chapters from:

1.	Lachman, L., Lieberman, H., and Kanig, J.; The Theory and Practice of Industrial Pharmacy.
2.	Understanding of PK/PD for a nasal product.
3.	Any reading on suspension theory will be helpful

Additional readings will be provided as a part of the rotation