SOLID DRUG TABLETS FOR IMPLANTABLE DRUG DELIVERY DEVICES
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 anesthetic 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.
1 . A solid drug unit comprising:
a drug in the form of a mini-tablet which is greater than 70% by weight the drug, with the balance being at least one excipient,
wherein the mini-tablet is cylindrical with flat end faces, the length of the tablet exceeding its diameter so that the mini-tablet has an aspect ratio of greater than 1:1, and
wherein the mini-tablet has 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.
2 . The solid drug unit of claim 1 , wherein the mini-tablet has a diameter from 1.5 mm to 3.1 mm and a length from 2.0 mm to 4.5 mm.
3 . The solid drug unit of claim 1 , wherein the drug is between 70 wt % and 99 wt % of the mini-tablet.
4 . The solid drug unit of claim 1 , wherein the drug is an anesthetic agent, an antimicrobial agent, or a chemotherapeutic agent.
5 . The solid drug unit of claim 4 , wherein the excipient comprises a binder and a lubricant.
6 . The solid drug unit of claim 1 , wherein the drug comprises lidocaine.
7 . The solid drug unit of claim 1 , wherein the mini-tablet is between 85 wt % and 95 wt % lidocaine.
8 . The solid drug unit of claim 1 , wherein the friability of the mini-tablet is less than 2%.
9 . The solid drug unit of claim 1 , wherein the mini-tablet is sterilized.
10 . The solid drug unit of claim 1 , wherein the aspect ratio is from about 3:2 to about 5:2.
11 . A solid drug unit for insertion into an intravesical device, comprising:
a drug in the form of a mini-tablet which is greater than 70% by weight the drug, with the balance being at least one excipient,
wherein the mini-tablet is cylindrical with end faces that are not convex, the length of the tablet exceeding its diameter so that the mini-tablet has an aspect ratio of greater than 1:1, and
wherein the mini-tablet has 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.
12 . The solid drug unit of claim 11 , wherein the mini-tablet has a diameter from 1.5 mm to 3.1 mm and a length from 2.0 mm to 4.5 mm.
13 . The solid drug unit of claim 11 , wherein the drug is between 70 wt % and 99 wt % of the mini-tablet.
14 . The solid drug unit of claim 11 , wherein the drug is an anesthetic agent, an antimicrobial agent, or a chemotherapeutic agent.
15 . The solid drug unit of claim 14 , wherein the excipient comprises a binder and a lubricant.
16 . The solid drug unit of claim 11 , wherein the drug comprises lidocaine.
17 . The solid drug unit of claim 11 , wherein the mini-tablet is between 85 wt % and 95 wt % lidocaine.
18 . The solid drug unit of claim 11 , wherein the friability of the mini-tablet is less than 2%.
19 . The solid drug unit of claim 11 , wherein the mini-tablet is sterilized.
20 . The solid drug unit of claim 11 , wherein the aspect ratio is from about 3:2 to about 5:2.