ABSTRACT
Combination of Particles and Vehicle ................................208 9.4 Excipient Selection .......................................................................................208
9.4.1 Buffering Agents ..............................................................................209 9.4.2 Isotonicity Modiers .........................................................................209 9.4.3 Preservatives (Antimicrobial Agents) ...............................................209 9.4.4 Stabilizers ......................................................................................... 210 9.4.5 Complexing Agents .......................................................................... 210 9.4.6 Other Auxiliary Agents .................................................................... 211
9.5 General Requirements for Suspension Products .......................................... 211 9.6 Testing and Optimization of Chemical, Physical, and
Microbiological Properties ........................................................................... 212
Industry trends for molecules under pharmaceutical development reect the growing importance of peptides and proteins as therapeutic candidates (Walsh, 2006). As research continues to identify and elucidate the function of new peptides and proteins and biotechnology provides the means to produce them in requisite quantities for clinical evaluation, it will ultimately become necessary to devise viable formulations and delivery modalities to allow marketing of these potential therapies. However, it is widely recognized that peptides and proteins have unique physicochemical properties limiting the formulation approaches and delivery options that can be applied to these molecules (Frokjaer and Otzen, 2005). This chapter is concerned with the formulation of peptides and proteins as parenteral suspension preparations for injection. Suspensions, in general, are perhaps the most challenging formulations to develop because of the need to balance numerous variables to achieve an acceptable product. In addition, the complexity of the molecules being considered and the type of desired formulation exacerbate the problem of developing a peptide or protein suspension.
