Preparation for formulations for electrotransport drug delivery

• US 5,853,383 A
• Filed: 05/03/1995
• Issued: 12/29/1998
• Est. Priority Date: 05/03/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Murdock, Thomas Owen
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/433,173
• Time in Patent Office: 1,336 Days
• Field of Search: 604/20, 210/660, 210/681
• US Class Current: 604/20
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61P 25/06 Antimigraine agents

Abstract

A method is provided for preparing drug formulations suitable for electrotransport drug delivery. The drug to be delivered, present in salt form, is contacted with an ion exchange material prior to incorporation into the reservoir (26) of an electrotransport delivery system (10). In this way, the drug salt is partially or completely neutralized. This technique is useful for adjusting the pH of the drug formulation without incorporating extraneous materials, e.g., competing ions or the like, into the reservoir (26).

Claims

1. A process for making a pH adjusted composition in an electrotransport delivery system comprising the steps of:

providing an aqueous drug solution including drug ions and counter ions;

adjusting the pH of the drug solution by contacting an ion exchanger and the drug in solution;

exchanging hydronium or hydroxyl ions for the counter ions;

removing the ion exchanger from the aqueous solution; and

,

adding the aqueous solution to at least one reservoir of the electrotransport delivery system.

2. The process of claim 1 wherein the drug ions are divalent, polyvalent or a combination thereof, and the ionized drug is partially neutralized producing a partially neutralized drug that is at least about 80% by mole monovalent.

3. The process of claim 1 wherein the ion exchanger is removed by filtering.

4. The process of claim 1 wherein drug in the aqueous drug solution is in the form of a free acid or base, a salt, or a combination thereof.

5. The process of claim 1 wherein the drug ions are monovalent or polyvalent ions derived from a cationic drug.

6. The process of claim 1 wherein the aqueous solution is pH adjusted to about 6.0 to 9.0.

7. The process of claim 1 wherein the aqueous solution is pH adjusted to about 7.5 to 8.5.

8. The process of claim 1 wherein the drug ions are monovalent or polyvalent ions derived from an anionic drug.

9. The process of claim 1 wherein the aqueous solution is DH adjusted to about 3.0 to 6.0.

10. The process of claim 1 wherein the aqueous solution is pH adjusted to about 3.5 to 5.0.