7/1/2023 0 Comments Vertis freeze dryer3 of the study paper, annealing at 166K, slightly above the Tg=163 K, increased the oxidation rate which could indicate increased instability. The glassy sample was prepared by “freezing” of liquid 2-methylpentanol-2 in liquid nitrogen followed by gamma-irradiation. 195 (1995) 305-311, the effect of annealing slightly above Tg on oxidation of free radicals in 2-methylpentanol-2 was reported. Vasenkov, et, al., “The influence of deep traps for gas molecules on oxygen transport in the glass of 2-methylpentanol-2”, Chem. The literature discloses annealing as one way to stabilize amorphous materials. Thus, there has been ongoing investigation to find ways to stabilize pharmaceutical compositions. While freeze-drying has become a standard method utilized for the stabilization of many drug substances in the solid state, many freeze-dried materials undergo chemical degradation during storage. The solution contains an accelerant excipient to enhance the rate of solvent sublimation. The method comprises the steps of freezing the solution to a temperature at or below the lower of its eutectic temperature or its glass transition temperature, and in a first drying stage, removing at least a portion of the solvent by sublimation. WO99/30688 describes a method of lyophilizing a solution. Depending on its chemical composition and conditions of freeze-drying, the dried product may be wholly or partially disordered or amorphous. Freeze-drying typically consists of three stages: 1) concentration of the product by freezing (removal of liquid water) 2) sublimation of the ice so formed and 3) removal from the product of residual unfrozen water by diffusion/desorption/evaporation. Freeze-drying may be accomplished by any method known in the art. Such changes can include chemical modifications and phase transformations which may affect various pharmaceutical properties such as stability and bioavailability of drug.įreeze-drying or lyophilization is one well-known method used to stabilize drug substances. BACKGROUND OF THE INVENTIONĪn understanding of the physical and chemical processes which can lead to unwanted changes in amorphous or other disordered state systems during prolonged storage is a fundamental concern to pharmaceutical scientists. In particular, the present invention relates to a method of increasing the stability of pharmaceutical compositions containing cefovecin sodium salt which is in an amorphous or other disordered state. The present invention relates to a method of stabilizing pharmaceutical compositions.
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