Solid drug tablets for implantable drug delivery devices

Abstract

A drug dosage form is provided in the form of a solid tablet which is greater than 50% by weight the local anesthetic agent. The local anesthetic agent may be selected from the group consisting of an aminoamide, an aminoester, and a combination thereof. The drug tablet may be in the form of a mini-tablet which is greater than 70 wt % drug, with the balance being excipient. For example, the anesethetic agent may include lidocaine, in a salt or base form, combined with binder and lubricant excipients. Implantable drug delivery devices including the tablets are also provided, e.g., one or more of the drug tablets may be contained in a biocompatible housing. The drug tablets may be substantially cylindrical with flat end faces, and the device may have from 10 to 100 drug tablets aligned in the housing with the flat end faces of adjacent tablets abutting one another.

We claim: 
     
         1 . A drug tablet comprising:
 lidocaine in an amount from 85% to 95% by weight of the drug tablet, with the balance being excipients,   wherein the excipients comprise:
 a lubricant in an amount from 5.5 wt % to 8.5 wt % of the drug tablet; and 
 a binder in an amount from 1 wt % to 5 wt % of the drug tablet. 
   
     
     
         2 . The drug tablet of  claim 1 , wherein the binder is selected from the group consisting of polyvinylpyrrolidone, poly(ethylene glycol), poly(ethylene oxide), poloxamers, and combinations thereof. 
     
     
         3 . The drug tablet of  claim 1 , wherein the lubricant is selected from the group consisting of leucine, sodium lauryl sulfate, sucrose stearate, boric acid, sodium acetate, sodium oleate, sodium stearyl fumarate, poly(ethylene glycol), and combinations thereof. 
     
     
         4 . The drug tablet of  claim 1 , wherein the lubricant comprises PEG 8000 and the binder comprises polyvinylpyrrolidone. 
     
     
         5 . The drug tablet of  claim 1 , which comprises from 3 mg to 40 mg of lidocaine base. 
     
     
         6 . The drug tablet of  claim 1 , which comprises from 3 mg to 40 mg of a water soluble salt of lidocaine. 
     
     
         7 . The drug tablet of  claim 1 , which is in form of a mini-tablet having an aspect ratio of greater than 1:1, a diameter from 1.0 mm to 3.2 mm, and a length from 1.7 mm to 4.8 mm, such that the mini-tablet is sized and shaped for insertion through the urethra of a patient. 
     
     
         8 . The drug tablet of  claim 1 , wherein the drug tablet is sterilized. 
     
     
         9 . A method of making a solid drug tablet comprising:
 combining a drug in particulate form with at least one excipient to form a composition; and   compressing the composition to form a solid drug tablet,   wherein the drug comprises an anesthetic agent selected from the group consisting of an aminoamide, an aminoester, and a combination thereof, and the excipient comprises less than 50% of the solid drug tablet by weight.   
     
     
         10 . The method of  claim 9 , wherein the anesthetic agent comprises lidocaine. 
     
     
         11 . The method of  claim 9 , wherein the solid tablet is between 70 wt % and 99 wt % the anesthetic agent. 
     
     
         12 . The method of  claim 9 , wherein the excipient comprises a binder and a lubricant. 
     
     
         13 . The method of  claim 9 , wherein combining the drug and the excipient comprises:
 granulating the drug with the binder to form granules, and   dry blending the granules with the lubricant to form the composition.   
     
     
         14 . The method of  claim 9 , wherein the solid drug tablet is a mini-tablet having an aspect ratio of greater than 1:1, a diameter from 1.0 mm to 3.2 mm, and a length from 1.7 mm to 4.8 mm, such that the mini-tablet is sized and shaped for insertion through the urethra of a patient.