. Author manuscript; available in PMC: 2015 Oct 1.

Published in final edited form as: Eur J Pharm Biopharm. 2014 May 21;88(2):332–341. doi: 10.1016/j.ejpb.2014.05.012

Table 5.

Apparent first-order rate constants for KGF-2 aggregation and oxidation at the surface and in the bulk glass phase of various lyophilized formulations.

Degradation type	Lyophilized Formulation	T=40°C		T=50°C		T=60°C
Degradation type	Lyophilized Formulation	k_surface, wk⁻¹	k_bulk, wk⁻¹	k_surface, wk⁻¹	k_bulk, wk⁻¹	k_surface, wk⁻¹	k_bulk, wk⁻¹
Aggregation	All disaccharide and disaccharide:HES mixtures	0.07	~0	0.39	~0	0..26	~0
Aggregation	HES	.21	.01	3.4	0.04	>10	0.05
Oxidation	All disaccharides and disaccharide:HES mixtures	0.54	0.01	1.35	0.03	>10	0.04
Oxidation	HES	0.93	0.03	1.3	0.09	>10	0.09

Reported values are combined overall best fits for all formulations that contained disaccharides, and for the HES-only formulation, which was analyzed separately.