Otorhinological delivery device

• US 7,294,345 B2
• Filed: 01/14/2004
• Issued: 11/13/2007
• Est. Priority Date: 01/17/2003
• Status: Expired due to Fees

• Current Assignee: Schering Corporation (Merck & Co., Inc.)
• Original Assignee: Schering Corporation (Merck & Co., Inc.)
• Inventors: Jukarainen, Harri, Arnold, Wolfgang, Riphagen, Frederik E., Ala-Sorvari, Juha, Haapakumpu, Timo, Rankonen, Henry
• Primary Examiner(s): Zimmer; Marc S.
• Application Number:
  US10/542,420
• Publication Number:
  US 20060067982A1
• Time in Patent Office: 1,399 Days
• Field of Search: None
• US Class Current: 424/434
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/04 for throat disorders
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 27/00 Drugs for disorders of the senses
• CPC Class Codes: A61P 27/16 Otologicals
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: A61P 9/08 Vasodilators for multiple indications
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

The invention relates to an otorhinological delivery device comprising at least one pharmaceutically active agent. According to the invention the device comprises a core comprising said at least one pharmaceutically active agent wherein said core is made of an elastomer composition selected from the group consisting of poly(dimethylsiloxane), a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Siatoms of the siloxane units, a siloxane-based elastomer comprising poly(alkylene oxide) groups and mixtures thereof, and a membrane encasing said core, said membrane being made of a same or a different elastomer composition than said core, said elastomer composition being selected from the group consisting of poly(dimethylsiloxane), a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Siatoms of the siloxane units, a siloxane-based elastomer comprising poly(alkylene oxide) groups and mixtures thereof. The invention is characterized in that the pharmaceutically active agent is selected from the group comprising anti-allergic agents, anti-inflammatory agents, anti-fungicides, glucocorticoids and mixtures thereof.

Claims

1. A method for manufacturing an otorhinological delivery device, comprising

preparing a core comprising at least one pharmaceutically active agent and an elastomer composition selected from the group consisting of poly(dimethylsiloxane), a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Si-atoms of the siloxane units, a siloxane-based elastomer comprising poly(alkylene oxide) groups and mixtures thereof;

encasing said core with a membrane, said membrane being made of the same or a different elastomer composition than said core, said elastomer composition of said membrane being selected from said group, thereby forming an implantable device,

shaping said implantable device into a shape suitable for implantation into the ear or nose of a human or animal,

wherein the pharmaceutically active agent is selected from the group comprising dexamethasone, betamethasone, beclomethasone, budesonide and mixtures thereof.

2. The method of claim 1, wherein said elastomer composition comprises a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Si-atoms of the siloxane units and wherein in said siloxane-based elastomer 1 to 49.5% of the substituents attached to the Si-atoms of the siloxane units are 3,3,3-trifluoropropyl groups.

3. The method of claim 1, wherein said elastomer composition comprises a siloxane-based elastomer comprising poly(alkylene oxide) groups and wherein said poly(alkylene oxide) groups are present as alkoxy-terminated grafts or blocks linked to the polysiloxane units by silicon-carbon bonds or as a mixture of these forms.

4. The method of claim 3, wherein said poly(alkylene oxide) groups are poly(ethylene oxide) groups.

5. The method of claim 1, wherein said membrane and said core are made of the same elastomer composition.

6. The method of claim 1, wherein said membrane and said core are made of different elastomer compositions.

7. The method of claim 1, wherein said device is an otological delivery device and wherein the elastomer composition comprises poly(dimethylsiloxane) and a siloxane-based elastomer comprising poly(ethylene oxide) groups.

8. A method of treatment of an otological disorder, comprising placing in the ear of a patient in need of said treatment an otorhinological delivery device prepared according to claim 1, wherein said otological disorder is selected from the group consisting of otitis, acute infections, cochlear and vestibular disorders, vertigo, Meniere'"'"'s disease, sudden deafness, sensoneurinal hearing loss, tinnitus, motion sickness, endolymphatic hydrops, endolymphatic hypertension, perilymphatic hypertension, perilymphatic hydrops, perilymphatic fistula, intracochlear fistula and ruptures in various membrane structures within the ear.

9. A method of treatment of a nasal disorder, comprising placing in the nose of a patient in need of said treatment an otorhinological delivery device prepared according to claim 1, wherein said nasal disorder is selected from the group consisting of nasal inflammatory disorders, allergic reactions, asthma and fungal infections.