93360-08-8Relevant 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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, (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
Organic amine salt of fosphenytoin stability and its preparation and use
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, (2017/01/19)
The invention relates to a stable organic amine salt of fosphenytoin and the preparation method and use thereof, the related organic amine salt of fosphenytoin having a structure of the general formula as shown in general formula (I), and the use comprisi
Novel synthesis of fosphenytoin: Anti-convulsant prodrug
Elati, Chandrashekar R.,Gangula, Srinivas,Naredla, Anitha,Ashok,Bhattacharya, Apurba,Bandichhor, Rakeshwarar
, p. 2950 - 2957 (2008/12/22)
A simple, new synthesis of fosphenytoin sodium 1, a prodrug, via imidate ester and employing mild reaction conditions is described. Copyright Taylor & Francis Group, LLC.
Method for Producing Sodium Fosphenytoin
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, (2008/06/13)
Sodium fosphenytoin, 5,5-diphenyl-3-[(phosphonooxy)methyl]imidazolidine-2,4-dione disodium salt, a known anticonvulsive, antiepileptic and antiarrhythmic, can be prepared by reacting 3-hydroxymethyl-5,5-diphenylimidazoline-2,4-dione with a phosphorous aci
PROCESS FOR PREPARING FOSPHENYTOIN
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Page/Page column 13, (2010/11/28)
Processes for preparing fosphenytoin.
Process for the preparation of sodium fosphenytoin
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Page/Page column 3, (2008/06/13)
Phosphoric acid diester 2,5-dioxo-4,4-diphenylimidazolidin-1-ylmethyl esters, both of whose ester groups can be selectively cleaved, are obtained by converting 3-(hydroxymethyl)-5,5-diphenylimidazolidine-2,4-dione to an alkylsulfonate or arylsulfonate and reacting this with a phosphoric acid diester whose ester groups can be selectively cleaved from the reaction product. The two ester groups can be selectively cleaved from the phosphoric acid diesters obtained and the resulting product can be converted to 5,5-diphenyl-3-[(phosphonooxy)methyl]imidazolidine-2,4-dione disodium salt. The latter is an anticonvulsive, antiepileptic and antiarrhythmic known under the abbreviated name of sodium fosphenytoin.
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.
