Don Barbieri
Technical Products Manager
SPI Pharma
Wilmington, USA

Abstract

Many projects are approved by top management with very aggressive development and submission timelines. With this thought in mind, one approach that formulation teams should consider when identifying a formulation path forward is to utilize off-the shelf, coprocessed, mannitol-based excipients and drug delivery platforms.
The use of these excipients may streamline development pathways and, therefore, have the potential to expedite project completions, regulatory submissions, and product introductions.

INTRODUCTION

Formulation scientists have a difficult task. They are charged with developing high quality products in an expeditious fashion while having to meet budgetary and tight corporate timeline constraints.

Many times, a formulation team will be assigned a new development project and the critical deadlines have already be identified by senior management. This is understandable because patents are due to expire, and planned clinical, regulatory submission, and market introduction dates must be included in the overall project plan. Excipient manufacturers can be a key player in helping formulators rise to the challenge and accomplish these tasks per agreed upon (or assigned) deadlines.

When developing a formulation for an oral solid dosage form, formulators have several different manufacturing approaches from which to choose. Of course, the attributes of the drug and the intended purpose of the dosage form often dictate the type of processing that is needed. For example, aqueous based wet granulations would not be an option with moisture sensitive drugs, but solvent wet granulation, dry granulation, or direct compression may all be vi ...