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Lyophilized solid drug

The effect of storage conditions on the crystalline nature of lyophilized ethacrynate sodium has been reported [37]. Samples of the drug substance were dried to various moisture levels and then stored at either 60°C or 30°C/75% RH. It was found that crystalline drug substance was obtained after short periods of time as long as sufficient levels of water were either present in the initial lyophilized solid or introduced by adsorption of humidity. The crystalline form of the drug was identified as a monohydrate phase. [Pg.346]

The reaction solution was diluted with 36 mL of water. The unreacted free drug and other low molecular weight materials were removed by a Centriprep-10 concentrator. Purification was repeated until HPLC analysis (Bio-Sil TSK-250) of the product indicated the absence of free drug. The final purified product was lyophilized to afford 483 mg of a yellow solid. This solid product was readily soluble in water or aqueous buffer. The amount of drug covalently bound to MVE was estimated by the absorbance at 303 nm using a molar extinction coefficient of 17.03 x 103. The MVE-y-hy-MTX contains 26% methotrexate-y-hydrazide by weight. [Pg.88]

The degradation of proteins in the solid state occur to a lesser extent and typically via different mechanisms than those that occur in solution [109,110]. Lyophilization is currently the more common technique in the manufacture of dried therapeutic proteins however, there is increasing interest in the use of spraydrying, owing to the unique physical nature of the spray-dried powder and its potential usefulness in protein drug delivery. [Pg.710]

Drug development, proteins in, 20 839 Drug discovery, yeasts in, 26 488 Drug dosage forms, 15 702-718 aerosols, IS 717 biotechnology and, IS 717-718 capsules, 15 708 granules, 15 702-705 liquid, 15 712-713 lyophilization, 15 716 ophthalmic, 15 716 parenteral, IS 713-716 prolonged action/controlled release solid, 15 708-712... [Pg.291]

Lyophilization is a process in which a solution of a drug is frozen to a solid and the solvent, usually water, removed by sublimation on exposure to a vacuum. The process has been studied intensively because it can be applied to the preservation of labile drugs or materials such as proteins which would otherwise be adversely affected by the solvent over a period of time. [Pg.193]

There are environmental (and sometimes safety) concerns with evaporative techniques of the above types whenever the solid to be dried, or the solution to be spray dried or lyophilized, contains volatile organic solvents. Of the above three drying techniques, spray drying is probably the most widely used, especially in recovering water-soluble drug substances from water solution (e.g., the aminoglycosides). [Pg.186]

Dry solids are dissolved in a suitable vehicle system just prior to injection. These products are prepared by lyophilization, for example, when the component drug is unstable in the desired aqueous vehicle... [Pg.377]

The majority of medicines today are formulated as tablets [1], Tablets are formulated rapidly and economically, and they have high patience compliance. Also, many compounds, such as aspirin, degrade rapidly in solution and are formulated in solid dosages to increase stability [2]. Drug substances that are oils, liquids, and solids may be formulated into capsules, tablets, lyophiles, creams, or microsuspensions. Administration may be through ingestion, injection, topical application, inhalation, and other routes. The reader may consult other texts for discussion of formulation options [1,3]. Formulations are selected for stability and the ability to best deliver the active agent to the affected area of the patient or consumer. [Pg.250]

Not all drug substances are prepared as crystalline solids. Amorphous solids, such as nelfmavir mesylate [8], often display increased solubility and bioavailability [7], Lyophilized powders, which are prepared by freeze-drying solutions of the drug substance, may be crystalline or amorphous before they are reconstituted by adding water [7]. Whether the form is crystalline or amorphous, the goal is to prepare medicines that offer the most benefit to the consumer. [Pg.251]

A drug solution is first frozen at atmospheric pressure, and then water is removed by a reduction of pressure in the lyophilizer chamber, coUecting the water as ice on a condenser. Samples are placed in glass vials and frozen, either before being put in the lyophilizer or on the lyophilizer shelves. The samples contain ice crystals, tmfrozen water, amorphous solids (including the therapeutic protein), and crystalline additives. Pressure is reduced, and the ice crystals sublime. This constitutes the primary drying. [Pg.351]

General ingredients include the drug, solid lipids, emulsifiers, and water. Depending on the application, other ingredients might be present (osmotic agents, matrices for lyophilization, buffers, etc.). [Pg.4]

Heiati, H., Tawashi, R. and Phillips, N.C. (1998) Drug retention and stability of solid lipid nanoparticles containing azidothymidine palmitate after autoclaving, storage and lyophilization. J. Microencapsulation 15, 173-184. [Pg.21]


See other pages where Lyophilized solid drug is mentioned: [Pg.10]    [Pg.999]    [Pg.274]    [Pg.234]    [Pg.167]    [Pg.398]    [Pg.111]    [Pg.123]    [Pg.221]    [Pg.246]    [Pg.537]    [Pg.557]    [Pg.272]    [Pg.281]    [Pg.282]    [Pg.401]    [Pg.544]    [Pg.114]    [Pg.310]    [Pg.310]    [Pg.286]    [Pg.414]    [Pg.434]    [Pg.1006]    [Pg.1108]    [Pg.1967]    [Pg.2394]    [Pg.2661]    [Pg.258]    [Pg.77]    [Pg.184]    [Pg.395]    [Pg.259]    [Pg.19]   
See also in sourсe #XX -- [ Pg.233 , Pg.235 ]




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