WebMeyer JD, Nayar R, Manning MC (2009) Impact of bulking agents on the stability of a lyophilized monoclonal antibody. Eur J Pharm Biopharm 38(1):29–38 ... Lyophilizatin cycle development for a high-concentration monoclonal antibody formulation lacking a crystalline bulking agent. J Pharm Sci 96(6):1598–1608 Microcrystalline cellulose (MCC) is a term for refined wood pulp and is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production. The most common form is used in vitamin supplements or tablets. It is also used in plaque assays for counting viruses, as an alternative to carboxymethylcellulose.
Excipient selection in biologics and vaccines formulation development
WebThe purpose of this study was to identify and characterize new crystalline bulking agents applicable to freeze-dried pharmaceuticals. Thermal analysis of heat-melt sugar and sugar alcohol solids as well as their frozen aqueous solutions showed high crystallization propensity of meso-erythritol and D-mannitol. WebBulking agent, opacifier, anti-caking agent, extrusion aid and stabilizer for foams and emulsions. High purity cellulose powders for partition chromatography. Packaging 250 g in poly bottle 1 kg in poly bottle Features and Benefits Amorphous regions are hydrolyzed leaving crystalline microfibrils. Forms thixotropic gels, good thermal stability. diamond of stars c++ coding ninjas
Crystallizing Amino Acids as Bulking Agents in Freeze …
WebJun 10, 2024 · Crystalline bulking agent in lyophilized biopharmaceutical formulations provides an elegant lyophilized cake structure and allows aggressive primary drying … WebJun 13, 2013 · This critical process temperature is the collapse temperature for amorphous substance, or eutectic melt for the crystalline substance1,9,10.During freezing, ice crystals start separating out until the solution becomes maximally concentrated. On further cooling, phase separation of the solute and ice takes place. WebOct 23, 2024 · Other uses are as a bulking agent in tablet sugar-coating processes and as an extender and opacifier in tablet film-coatings. ... It occurs as a white, crystalline powder with a saline taste. Sodium chloride is used widely in parenteral products to produce isotonic solutions. In oral products, it functions as a diluent (capsules and direct ... diamond of power