Bulking agents mannitol

Fakes et al. [1.152] evaluated the moisture sorption behavior of mannitol, anhydrous lactose, sucrose, D-(+)-trehalose, dextran 40 and povidine (PVP K24) as bulking agents. Mannitol was found to be crystalline and non-hygroscopic before and after freeze-drying with RM 0.1-0.3% w/w at 25 °C and 10-60% RH. Anhydrous lactose, sucrose and trehalose were crystalline and relatively non-hygroscopic with RM 0.86, 0.15 and 9.2% respectively. After freeze-drying they where amorphous with RM 1.6, 2.5 and 1.2%, respectively, and adsorbed moisture in an increasing RH atmosphere. Lactose adsorbed 10% water and formed its crystalline hydrate at 55% RH. 

Bulking agents mannitol, lactose, sucrose, dextran. 

Bulking agent Not applicable Used to enhance product elegance and to prevent blowout Provides structural strength to the lyo cake Examples include mannitol and glycine... 

Certain additives, salts, and bulking agents may be added primarily to improve vaccine stability upon storage (19,20). These excipients such as mannitol, glycine, and trehalose have a direct impact on the stability of the polypeptide or conjugate and are investigated for this purpose. 

A dilute solution of insulin in an appropriate aqueous medium, such as PBS (pH 7.4) or citrate buffer (pH 3 or 5), is prepared (see Note 1). Additives, such as lactose, trehalose, mannitol, or DPPC, are added as needed. These additives serve many purposes as bulking agents (4) to improve processing (4), to improve stability (6). and to increase bioavailability of the administered drug (4,7). 

Diluent To act as a bulking agent or filling material Sugars, lactose, mannitol, sorbitol, sucrose Inorganic salts, primarily calcium salts Polysaccharides, primarily microcrystalline celluloses... 

Recombinant human interleukin-1 receptor antagonist Sucrose, sorbitol, trehalose and alanine as protectants against aggregation and deamidation mannitol and glycine as bulking agent sodium citrate as buffer [25]... 

With some products, the quantity of drug per vial is extremely small. Here, bulking agents such as mannitol or glycine are used to provide product elegance (i.e., satisfactory appearance) as well as to provide sufficient... 

Freezing forms an amorphous solid of the protein and excipients with associated water in crystalline form. Annealing, an optional step, increases ice-crystal size and allows crystallization of bulking agents (such as glycine or mannitol), removing... 

Polyhydric alcohols, e.g., mannitol Stabilisation, bulking agent... 

---