Sustained antiepileptic therapy

• US 5,980,943 A
• Filed: 10/21/1997
• Issued: 11/09/1999
• Est. Priority Date: 05/28/1993
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Yien, Richard L.-C., Wong, Patrick S.-L., Pollock, Brenda J., Ayer, Atul Devatt
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US08/955,159
• Time in Patent Office: 749 Days
• Field of Search: 424/473, 424/494-497, 424/461-62, 424/486, 424/488, 424/457, 424/468, 424/470
• US Class Current: 424/470
• CPC Class Codes: A61K 31/16 Amides, e.g. hydroxamic acids
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/22 of acyclic acids, e.g. pravastatin
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Abstract

This invention pertains to a dosage form for the management of epilepsies wherein the dosage form comprises administering valproic acid or a valproic acid derivative at a continuous rate over an extended time.

Claims

1. A dosage form for delivering a drug to an environment of use, wherein the dosage form comprises:

(a) a semipermeable wall in contact with a therapeutic composition comprising;

poly(alkylene oxide) polymer coated granules comprising 10 nanograms to 750 milligrams of an antiepileptic drug selected from the group consisting of valproic acid, valproic and salts, sodium valproate, potassium valproate, calcium valproate, valpromide, valproic ester, divalproex sodium, oligomer salt of valproic acid, prodrug of valproic acid, and pharmaceutically acceptable derivations of valproic acid, and wherein the;

(b) antiepileptic drug is delivered from a member selected from the group consisting of a sustained-release dosage form and a controlled-release dosage form, which dosage form comprises means for housing and releasing the antiepileptic drug in a therapeutically responsive dose over an extended period of time.

2. The dosage form for delivering the drug to an environment of use, according to claim 9, wherein the the poly(alkylene oxide) polymer is replaced by a carboxymethylcellulose polymer.

3. A dosage form for delivering a drug to an environment of use, wherein the dosage form comprises:

(a) a semipermeable wall in contact with a therapeutic composition comprising;

poly(alkylene oxide) coated granules comprising 10 nanograms to 750 milligrams of a member selected from the group consisting of one to three moles of valproic acid and one to six moles of a salt of valproic acid;

an oligomer of valproic acid salt and valproic acid containing four moieties of the salt and the acid;

three moles of valproic acid and calcium valproate;

valproic acid and sodium valproate;

valproic acid and divalproex sodium; and

calcium valproate and valpromide, and wherein the;

(b) Antiepileptic drug is delivered from a member selected from the group consisting of a sustained-release dosage form and a controlled-release dosage form, which dosage form comprises;

(c) means for housing and releasing the antiepileptic drug in a therapeutically responsive dose over an extended period of time.

4. The dosage form for delivering the drug to an environment of use according to claim 3, wherein the poly(alkylene oxide) polymer is replaced by a carboxymethylcellulose polymer.