Method for treating epilepsies

• US 5,906,832 A
• Filed: 05/12/1995
• Issued: 05/25/1999
• Est. Priority Date: 04/28/1994
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cruz, Evangeline, Wong, Patrick S.-L., Kuczynski, Anthony L., Jao, Frank, Sy, Eduardo C.
• Primary Examiner(s): Weddington, Kevin E.
• Application Number:
  US08/439,914
• Time in Patent Office: 1,474 Days
• Field of Search: 424/462, 424/465, 514/217, 514/219, 514/374, 514/376, 514/386, 514/408, 514/630
• US Class Current: 424/465
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/27 of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
• CPC Class Codes: A61K 31/4015 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
• CPC Class Codes: A61K 31/4166 having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
• CPC Class Codes: A61K 31/421 1,3-Oxazoles, e.g. pemoline, trimethadione
• CPC Class Codes: A61K 31/426 1,3-Thiazoles
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/515 Barbituric acids; Derivatives thereof, e.g. sodium pentobarbital
• CPC Class Codes: A61K 31/53 having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine melarsoprol A61K31/555 ; with four nitrogen atoms A61K31/495
• CPC Class Codes: A61K 31/54 having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A dosage form is disclosed for delivering an antiepileptic drug, which dosage form comprises for maintaining the integrity of the dosage form and of the antiepileptic drug.

Claims

1. A method for the continuous administration of an antiepileptic drug to the gastrointestinal tract of a human, wherein the method comprises:

(a) admitting orally into the gastrointestinal tract of the human an osmotic dosage form that maintains its integrity in the gastrointestinal tract, comprising;

a composition comprising;

0.5 wt % to 90 wt % of an antiepileptic drug selected from the group consisting of phenytoin, mephenytoin, phenobarbital, primidone, carbamazepine, ethosuximide, methsuximide, phensuximide, trimethadione, clonazipam, clorazepate, phenacemide, paramethadione, primaclone, clobazam, felbamate, flunarizine, lamotrigine, progabide, vibabatim, eterobarb, gabapentin, oxcarbazepine, ralitoline, tiagobine, sulthiame, and tioridone;

10 wt % to 75 wt % of a dispensing polymer compatible with the antiepileptic drug that aids in delivering the antiepileptic drug in a therapeutic dose from the dosage form; and

0 wt % to 10 wt % of a pharmaceutically acceptable surfactant;

with the total weight of all ingredients in the composition equal to 100 wt % which composition is surrounded by a subcoat comprising a nontoxic, nonionic polymer that prevents the antiepileptic drug from converting from a soluble to an insoluble antiepileptic drug in the gastrointestinal pH;

a wall permeable to fluid and impermeable to an antiepileptic drug that surrounds the subcoat; and

, an exit in the wall for delivering the antiepileptic drug from the dosage form; and

, (b) administering the antiepileptic drug from the dosage form to the human over an extended period of time by continuous release in a therapeutically responsive dose to provide antiepileptic therapy for the human.