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If you are developing a lyophilized presentation, we have the ability to screen formulations with a wide variety of cryoprotectants and bulking agents, and accelerate the overall timeline of your lyophilization cycle development program. Functional uses of excipients include improving solubility and stability, safety and efficacy, as bulking agents in lyophilized formulations, tonicity agents, and aiding in controlled or prolonged drug delivery. Parenteral formulations are sterile, pyrogen-free; free of particulate matter and by-pass the body's natural defense mechanisms. Many lyophilized formulations contain a polymeric bulking agent or lyoprotector, to assist with the manufacturing process and to improve product stability and performance. Both the chemical nature of a polymer and its molecular weight might influence different stages of manufacturing process, as well as the product shelf‐life. Lyophilization of pharmaceutical solutions to produce a stable and elegant product has been a practice employed to manufacture many marketed injectable formulations, since a very long time. The pharmaceutical compositions also comprise a bulking agent. However, the compositions may comprise multiple bulking agents. Bulking agents are used to increase the total mass of the lyophilized powder cake, to reduce residual moisture levels in the cake, and provide additional structure to the freeze-dried product. The formulation of injections is same as that of formulation of parenteral products hence refer formulation of parenteral products. Formulation of sterile powders or lyophilized products: drugs which are not stable in solution form are prepared as dry sterile solids which are dissolved in water for injection just before administration. • sponsor wishes to develop a lyophilized dosage form containing their large peptide, which upon reconstitution and dilution would be suitable for sc administration. • the sponsor requests a 5 or 10 mg/ml peptide concentration in the bulk drug product solution to be filled as 5 ml volumes into 10 ml vials then lyophilized yielding 25. Crystalline bulking agents produce an elegant cake structure with good mechanical properties. However, these materials often are ineffective in stabilizing products such as emulsions, proteins, and liposome’s but may be suitable for small-chemical drugs and some peptides e. Mannitol, sucrose or one of the other disaccharides. Generally lyophilized products have short expiration dates. Stability data should be reviewed and the justification of the expiration date should be based on batches with the higher moisture content. In addition, peg 8000 was evaluated as a bulking agent because it also can function as a cosolvent in solution and forms an acceptable cake after lyophilization. Addition of peg 400 to peg 8000 caused negligible changes in the thermogram of this bulking agent. Surprisingly, the combination of peg 8000 and peg 400 forms a solid lyophilized cake. Disclosed herein is a homogeneous, lyophilized particulate product of a substance containing at least one biologically active component and a process for its preparation which involves forming a solution or colloidal suspension of the substance, spraying the solution or colloidal suspension into a moving bath of fluorocarbon refrigerant and lyophilizing the resultant frozen droplets
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Labrada mass gainer price 5 kg, labrada mass gainer 5kg flipkart
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