93360-07-7Relevant academic research and scientific papers
Identification, synthesis, characterization and quality control strategy of new process-related impurities in fosphenytoin sodium
Singaram, Sathiyanarayanan,Subramanian, Venkatesan Chidambaram,Kabilan, Senthamaraikannan,Raju, Dandu Bhaskara Suresh
, p. 1881 - 1885 (2020/09/02)
Fosphenytoin sodium is a water dissolvable phenytoin prodrug that is directed intravenously to convey phenytoin, conceivably more securely than intravenous phenytoin. It is most ordinarily utilized in the intense treatment of convulsive status epileptics. The examination of the procedure-related contaminants will not help exclusively to advance the process parameters yet additionally to create sensible analytical methods and set the quality standard for a quality control system in pharmaceutical manufacturing. During the production of fosphenytoin sodium, all the process-related impurities are controlled in every stage and three degradation impurities are managed in the final API as per USP monograph. Besides, five unknown and one known contaminants were detected by HPLC method. All these impurities were identified, synthesized, isolated and characterized by IR, 1D-NMR (1H, 13C, DEPT) and HRMS spectral techniques. The mechanism of the formed impurities is examined for the first time. Quality control procedures to manage these impurities were developed to acquire the mass medication of ICH grade quality.
MANUFACTURING METHOD OF SODIUM FOSPHENYTOIN HYDRATE AND SYNTHETIC INTERMEDIATE THEREOF
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Paragraph 0030, (2018/05/24)
PROBLEM TO BE SOLVED: To provide a manufacturing method of sodium fosphenytoin hydrate capable of shortening time for all manufacturing processes and reducing manufacturing cost and a synthetic intermediate thereof. SOLUTION: There is provided a method for manufacturing 3-hydroxymethyl-5,5-diphenyl-2,4-imidazolidinedione, including a process for heating 5,5-diphenyl-2,4-imidazolidinedione (phenytoin), formaldehyde and alcohol and using no alkaline material. SELECTED DRAWING: None COPYRIGHT: (C)2018,JPOandINPIT
Process for the synthesis of diesters of phosphoric acid 2,5-dioxo-4,4-diphenyl-imidazolidin-1-ylmethyl ester
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, (2008/06/13)
PCT No. PCT/US97/05307 Sec. 371 Date Oct. 15, 1998 Sec. 102(e) Date Oct. 15, 1998 PCT Filed Apr. 1, 1997 PCT Pub. No. WO97/41132 PCT Pub. Date Nov. 6, 1997An improved process for the preparation of a diester of phosphoric acid 2,5-dioxo-4, 4-diphenyl-imidazolidin-1-ylmethyl ester is described where an alkali metal phosphate is treated with a 3-(chloromethyl)- or 3-(bromomethyl)-5,5-diphenyl-2,4-imidazolidinedione to afford the desired product, as well as valuable intermediates used in the process.
Phenytoin prodrugs III: Water-soluble prodrugs for oral and/or parenteral use
Varia,Schuller,Sloan,Stella
, p. 1068 - 1073 (2007/10/02)
Various bioreversible derivatives of phenytoin, a poorly water soluble and erratically absorbed drug after both oral and parenteral dosing, were synthesized. Initial evaluation of these expected prodrugs, i.e., their aqueous solubility, cleavage in the presence of various animal tissues, and anticonvulsant activity in mice, confirmed that a number of the derivatives did indeed behave as prodrugs. The more promising prodrugs were the disodium phosphate ester and various amino groups containing acyl esters of 3-(hydroxymethyl)-5,5-diphenylhydantoin.
