GB2628595A — A biphasic liquid pharmaceutical composition of an anticonvulsant drug and the process of preparing the same

USPTO Abstract

Oral Biphasic liquid pharmaceutical composition of anticonvulsant drug comprising: 0.3-4.0 % anticonvulsant; preservative (preferably methyl paraben or propyl paraben); 0.1-3.5 % suspending agent (preferably carbomer); 2.5-7.5 % dispersing agent (preferably glycerol); pH adjusting agent (preferably sodium hydroxide); and vehicle (preferably purified water). The anticonvulsant drug may be carbamazepine, oxcarbazepine, lamotrigine, phenytoin, valproic acid, zonisamide, gabapentin, levetiracetam, preganalin, clonazepam, lacosamide, rufinamide, vigabatrin, phenobarbital, valnoctamide, perampanel, or pyridoxine. The composition may additionally comprise: a sweetener, e.g. sodium saccharin; a flavouring agent, e.g. strawberry flavour; an anti-foaming agent, e.g. simethicone. The pH of the composition is preferably 3.0-8.0. The composition may be manufactured by dissolving preservatives in heated purified water, before adding, in order, simethicone emulsion 39 % and carbomer, anticonvulsant drug, carbomer, and sodium saccharine. The pH is measured and sodium hydroxide used to adjust to 6.7-7.0. Strawberry flavour is added, final volume of water is added, and the final dispersion is placed in an amber coloured bottle. The composition may be used to treat alcohol and/or benzodiazepine withdrawal symptoms, panic and anxiety disorders, dementia, schizophrenia, epilepsy, bipolar disorder, partial seizures, primary and secondary tonic-clonic seizures, seizures associated with Lennoz-Gastau syndrome, and personality disorders.