Lyophilized Powders

Clinical Use. Vancomycin and teicoplanin as fomiulated dmgs are lyophilized powders to be reconstituted with sterile water for injection. Vancomycin hydrochloride [1404-93-9] is presented in vials of 500 mg that give 100—200 mL solution of pH 2.5—4.2. It is administered by slow (60 min) infusion at a dose of 500 mg every 6 h or 1 g every 12 h/d. The teicoplanin contains the five factors (87%) plus 13% of the pseudoaglycone T-A3-1. It is presented in vials containing 200 mg of lyophili ed power that after dissolution with 3 mL of solvent gives a solution at pH 7.5. The dose regimen is 200—800 mg/d by iv bolus adrninistration. 

Technetium-99m oxidronate is a bone imaging agent used to demonstrate areas of altered osteogenesis. It is rapidly cleared from the blood and taken up in areas of bone that are undergoing osteogenesis. The kit is a vial containing a lyophilized powder where sodium oxidronate is the active... 

IgE monoclonal antibody Lyophilized powder for reconstitution with sterile Dosed every 2 or 4 weeks based on patient weight and ... 

In addition to the additives used in a formulation to help stabilize the protein to freezing, the residual moisture content of the lyophilized powder needs to be considered. Not only is moisture capable of affecting the physicochemical stability of the protein itself, equally important is the ability of moisture to affect the Tg of the formulation. Water acts as a plasticizer and depresses the Tg of amorphous solids [124,137,138]. During primary drying, as water is gradually removed from the product, the Tg increases accordingly. The duration and temperature of the secondary drying step of the lyophilization process determines how much moisture remains bound to the powder. Usually lower residual moisture in the finished biopharmaceutical product leads to enhanced stability. Typically, moisture content in lyophilized formulations should not exceed 2% [139]. The optimal moisture level for maximum stability of a particular product must be demonstrated on a case-by-case basis. 

Viral vaccines are cultivated on inanimate media. Some examples include hepatitis b vaccine, influenza virus vaccine, measles virus vaccine, rabies vaccine, rubella vaccine, and yellow fever vaccine. The viral vaccines are available as lyophilized powder for reconstitution, or suspension for injections,... 

Solid state 15N NMR has also been used103 to study lyophilized powders of 15N-enriched histidine and imidazole, prepared from aqueous solutions with pH ranging... 

Enbrel Enbrel is used for the treatment of rheumatoid arthritis. It is supplied as a sterile, preservative-free, lyophilized powder. The powder is reconstituted with 1 mL sterile bacteriostatic water-for-injection (containing 0.9% benzyl alcohol) prior to parenteral injection. 

The finished form is a sterile, lyophilized powder formulated with tri-methamine, mannitol, and sucrose as excipients. 

Aprotinin is a polypeptide consisting of a chain of 58 amino acid residues, which inhibits stoichiometrically the activity of several proteolytic enzymes such as chymotrypsin, kallikrein, plasmin, and trypsin. Aprotinin is obtained from bovine tissues and purified by a suitable process. It is stored as a bulk solution or lyophilized powder. The amount of two related substances des-Ala-des-Gly-aprotinin and des-Ala-aprotinin is determined by CZE with a 100% analysis. The relative migration times are 0.98 for des-Ala-des-Gly-aprotinin and 0.99 for des-Ala-aprotinin, and the specified limits are 8.0 and 7.5%, respectively. 

The lyophilized cake must then be milled. The particle size of milled lyophilized powders generally has a broader distribution than spray-dried powder, which is formed one particle at a time in a continuous process. Despite the longer processing time necessary to create a dry powder through lyophilization (and the consequent... 

The antimykotie amphotericine is eneapsulated in liposomes and marketed as Am-Bisome" against severe systemic mycosis. The liposomal encapsulation reduces the toxicity of amphotericine while increasing the half-life of the drug and plasma level peaks [31], For stability reasons, the parenteral formulation is a lyophilized powder whieh has to be reeonstituted by adding the solvent just before administration. 

Performing a systematic comparison of lipase-catalyzed kinetic resolutions of several seeondaiy aleohols in continuous flow mode (Figure 7) and shake flask batch mode using immobilized and non-mobilized lipases was reported by Csajagi and eo-workers [25]. The results indieated that immobilized as well as lyophilized powder forms of liphases can be effeetively used in eontinuous flow mode kinetie resolutions of raeemic alcohols in non-aqueous solvent systems. The produetivity of the lipases was higher in continuous flow reactors than in batch mode systems, whereas the enantiomer selectivities were similar. 

Lyophilized powder for aerosol reconstitution 6 g ribavirin/100 ml vial. Contains 20 mg/mL when reconstituted with 300 ml sterile water Rx)... 

The presence of small amounts of water was found to be essential even for hydrophobic ionic liquids (284). When a-chymotrypsin (in the form of salt-free lyophilized powder) was applied for the transesterification of Ai-acetyl-L-phenyl-alanine ethyl ester with 1-propanol in the dry ionic liquids [BMIM]PFg and [OMIMJPFg, little enzymatic activity was observed. The maximum activity was observed when 0.5 vol% water was added to the ionic liquids. Supercritical CO2 was also sufficient to activate the enzyme in dry ionic liquids. The addition of water to the supercritical C02-ionic liquid system further enhanced the enzymatic activity. 

Table 6.6 lists the phenolic acid content of 25 potato powders prepared by lyophilization of commercial potatoes with unknown history. For the dry lyophilized powders, the data show that chlorogenic acid levels (in mg/lOOg wt) ranged from 3.28 for Kenebec potatoes to 637 for... 

ACTH is available as lyophilized powder which on reconstitution gives 40 lU/ml solution and is used mainly for the diagnosis of pituitary adrenal axis disorders. 

Dosage form Neumega is available for injection in single-use vials containing 5 mg of oprelvekin as a sterile lyophilized powder. It is reconstituted by the addition of sterile water for injection. 

Dosage form NovoSeven is supplied as a sterile lyophilized powder of coagulation... 

Dosage form Angiomax is available as a sterile lyophilized powder for injection after reconstitution with sterile water for injection. Each single-use vial contains bivalirudin 250 mg. 

Dosage form Protropin is supplied as a sterile, lyophilized powder for reconstitution with bacteriostatic water for injection. Each vial contains somatrem 5 mg or 10 mg. 

Dosage form Simulect is a sterile lyophilized powder, packaged in glass vials. Each vial contains basiliximab 20 mg, to be reconstituted in sterile water for injection. 

Dosage form Mylotarg is a sterile, preservative-free lyophilized powder containing 5 mg of drug conjugate in a 20ml vial. The contents of the vial are reconstituted with sterile water for injection. 

Dosage form Synagis is supplied in single-use vials as lyophilized powder to deliver either 50 or 100 mg when reconstituted with sterile water for injection. 

Lyophilized 1 mg vial (Glucagon), lyophilized powder 2 ml vial (Glucagen)... 

To demonstrate the control of aseptic operations maintained by well-trained personnel, defined procedures, and appropriately designed equipment and facilities. Media filling in conjunction with comprehensive environmental monitoring will be conducted three times to demonstrate that the aseptic processing of lyophilized powder is functioning as intended. 

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