Flow-Induced Delivery from a Drug Mass

• US 20110071493A1
• Filed: 07/19/2010
• Published: 03/24/2011
• Est. Priority Date: 06/09/2006
• Status: Active Grant

• Current Assignee: Otonomy, Inc.
• Original Assignee: NeuroSystec Corporation
• Inventors: Pananen, Jacob E., Nagy, Anna Imola, Schloss, John V., Lobl, Thomas J.
• Granted Patent: US 8,298,176 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

Drug solutions (or other combinations of vehicle with entrained drug) are prepared by removing drug from one or more masses of a solid form of the drug. The solid form of the drug may be sparingly soluble or insoluble in water. Examples of devices for holding solid drug and facilitating delivery of such drug to targeted regions are also described.

Claims

1. A method, comprising:

implanting a reservoir into a human or other animal, the reservoir containing a mass of a solid form of a drug that is sparingly water-soluble;

passing vehicle from a source past the solid drug mass so as to entrain drug from the mass; and

delivering the passed vehicle and entrained drug to a target tissue in the human or other animal.

2. The method of claim 1, further comprising determining a desired therapeutically-effective concentration of the drug, and wherein the solid form of the drug is a basic form and the vehicle includes an acid at a concentration that is substantially the same as the desired therapeutically-effective concentration.

3. The method of claim 2, wherein the acid is at least one of hydrochloric acid, phosphoric acid, monosodium phosphate, citric acid, a sodium salt of citric acid and lactic acid.

4. The method of claim 3, wherein the drug is gacyclidine.

5. The method of claim 1, wherein the vehicle is at least one of Ringer'"'"'s solution, lactated Ringer'"'"'s solution, artificial perilymph and physiological saline.

6. The method of claim 1, further comprising determining a desired therapeutically-effective concentration of the drug, and wherein the solid form of the drug is an acidic form and the vehicle includes a base at a concentration that is substantially the same as the desired therapeutically-effective concentration.

7. The method of claim 6, wherein the base is at least one of sodium bicarbonate, sodium hydroxide and choline hydroxide.

8. The method of claim 1, wherein the vehicle includes a component having an amphipathic molecule.

9. The method of claim 8, wherein the component is one or more of polysorbate 80, an acyl glycerol, a poly-oxyethylene ester of 12-hydroxysteric acid, beta-cyclodextrin, a bile acid such as taurocholic acid, tauroursodeoxycholic acid, cholic acid or ursodeoxycholic acid, a naturally occurring anionic surfactant such as galactocerebroside sulfate, a naturally occurring neutral surfactant such as lactosylceramide or a naturally occurring zwitterionic surfactant such as sphingomyelin, phosphatidyl choline or palmitoyl carnitine.

10. The method of claim 1, wherein the vehicle comprises a suspension of at least one of the following:

small particles (100 nm to 0.1 mm in size), or

nanoparticles (10 nm to 100 nm in size) having an affinity for the drug.

11. The method of claim 10 wherein the small particles or nanoparticles comprise one or more of polylactic acid, polyglycolic acid, a co-polymer of lactic acid and glycolic acid, polypropylene, polyethylene, polystyrene and a magnetic material.

12. The method of claim 1, wherein the vehicle comprises a physiological fluid.

13. The method of claim 12, wherein the vehicle comprises at least one of cochlear perilymph, cerebrospinal fluid and interstitial fluid.