Topical stabilized prostaglandin E compound dosage forms

• US 6,841,574 B2
• Filed: 01/03/2003
• Issued: 01/11/2005
• Est. Priority Date: 01/03/2003
• Status: Expired due to Term

• Current Assignee: Nexmed Holdings
• Original Assignee: Nexmed Holdings
• Inventors: Mo, Y. Joseph, Frank, Daniel W.
• Primary Examiner(s): Hartley, Michael G.
• Assistant Examiner(s): Lamm, Marina
• Application Number:
  US10/336,481
• Publication Number:
  US 20040131664A1
• Time in Patent Office: 739 Days
• Field of Search: 424/400, 424/401, 424/433, 424/434, 424/444, 424/443, 424/449, 424/484, 424/486, 424/488, 514/573, 514/947, 514/953
• US Class Current: 514/573
• CPC Class Codes: A61K 31/557 Eicosanoids, e.g. leukotrienes or prostaglandins
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 15/08 for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Compounds of prostaglandin E group (PGE compounds) are stabilized as non-aqueous compositions that include the compound together with a bulking agent that can be a non-aqueous liquid or a solid in a sheet, film or powder form. The composition can optionally include a skin penetration enhancer. A non-aqueous, solid dosage form comprises a PGE compound substantially uniformly distributed in a carrier sheet or film.

Claims

1. A packaged prostaglandin E dosage form which comprises a sealed actives compartment containing about 0.025 to 10 parts by weight of prostaglandin E₁, about 0.025 to 10 parts by weight dodecyl 2-(N,N-dimethylamino)-propionate or a salt thereof, and about 1 to 50 parts by weight lactose;

and a sealed inerts compartment containing about 0.05 to 2.5 parts by weight hydroxypropyl methylcellulose, about 0.001 to 5 parts by weight silicone antifoam agent, about 0.5 to 25 parts by weight hydroxypropyl-β

-cyclodextrin, about 5 to 75 parts by weight ethanol, and about 5 to 75 parts by weight water.

2. A packaged prostaglandin E dosage form which comprises a sealed actives compartment containing about 0.2 parts by weight of prostaglandin E₁, about 2.5 parts by weight dodecyl 2-(N,N-dimethylamino)-propionate or a salt thereof, and about 5 parts by weight anhydrous ethanol;

and a sealed inerts compartment containing about 2.5 parts by weight guar gum, 3 parts by weight ethyl laurate, and 100 parts by weight water buffered to a pH of about 5.5.