Multi-Unit Drug Delivery Devices and Methods
Implantable drug delivery devices include a housing defining a reservoir, a first unit within the reservoir, and a second unit within the reservoir. The first unit contains a drug and the second unit contains a functional agent that facilitates release of the drug. Intravesical drug delivery devices include a housing portion containing a drug formulation and a housing portion containing an excipient, and are configured to release the drug according to a first release profile and the excipient according to a second release profile. Methods include inserting any of these devices into a patient and releasing drug from the device.
1 . A drug formulation comprising:
a plurality of first tablets which comprise:
at least 75% by weight gemcitabine HCl;
urea; and
at least one pharmaceutical excipient.
2 . The drug formulation of claim 1 , wherein the at least one pharmaceutical excipient of the plurality of first tablets comprises polyvinylpyrrolidone, polyethylene glycol, or a combination thereof.
3 . The drug formulation of claim 2 , wherein the at least one pharmaceutical excipient of the plurality of first tablets comprises polyvinylpyrrolidone, and wherein the plurality of first tablets comprises 4.2% by weight polyvinylpyrrolidone.
4 . The drug formulation of claim 2 , wherein the at least one pharmaceutical excipient of the plurality of first tablets comprises polyethylene glycol 8000, and wherein the plurality of first tablets comprises 2.5% by weight polyethylene glycol 8000.
5 . The drug formulation of claim 1 , wherein the plurality of first tablets comprises from 75% by weight to 85% by weight gemcitabine HCL.
6 . The drug formulation of claim 1 , wherein the plurality of first tablets comprises about 80% by weight gemcitabine HCL.
7 . The drug formulation of claim 6 , wherein the plurality of first tablets comprises 13% by weight urea.
8 . The drug formulation of claim 7 , further comprising a plurality of second tablets, which comprise at least 85% by weight urea.
9 . The drug formulation of claim 8 , wherein the plurality of second tablets comprises 90% by weight urea.
10 . The drug formulation of claim 9 , wherein the plurality of first tablets and the plurality of second tablets are mini-tablets.
11 . A drug formulation consisting of:
one or more first tablets comprising:
at least 80% by weight gemcitabine HCl;
urea;
polyvinylpyrrolidone; and
polyethylene glycol; and
one or more second tablets comprising:
at least 90% by weight urea; and
the balance being one or more excipients.
12 . The drug formulation of claim 11 , wherein the urea is about 13% by weight of the one or more first tablets.
13 . The drug formulation of claim 11 , wherein the polyethylene glycol comprises PEG 8000.
14 . The drug formulation of claim 11 , which is wherein the one or more first tablets and the one or more second tablets each are in the form of a plurality of mini-tablets.
15 . The drug formulation of claim 11 , wherein the gemcitabine HCL is from 80% by weight to 85% by weight of the one or more first tablets.
16 . The drug formulation of claim 11 , wherein the one or more first tablets are 80% by weight gemcitabine HCL.
17 . The drug formulation of claim 11 , wherein the one or more first tablets are 4.2% by weight polyvinylpyrrolidone.
18 . The drug formulation of claim 11 , wherein the one or more first tablets are 2.5% by weight polyethylene glycol.
19 . The drug formulation of claim 11 , wherein the one or more second tablets are 90% by weight urea.
20 . A drug formulation comprising:
a first plurality of mini-tablets comprising:
at least 75% by weight gemcitabine HCl;
urea;
polyvinylpyrrolidone; and
polyethylene glycol; and
a second plurality of mini-tablets comprising:
at least 90% by weight urea; and
the balance being one or more excipients.
21 . The drug formulation of claim 20 , wherein the gemcitabine HCl is from 75% by weight to 85% by weight of the first plurality of mini-tablets.
22 . The drug formulation of claim 20 , wherein the urea is 13% by weight of the first plurality of mini-tablets.
23 . The drug formulation of claim 20 , wherein the polyethylene glycol comprises PEG 8000.
24 . The drug formulation of claim 20 , wherein the first plurality of mini-tablets are 80% by weight gemcitabine HCL.
25 . The drug formulation of claim 20 , wherein the first plurality of mini-tablets are 4.2% by weight polyvinylpyrrolidone.
26 . The drug formulation of claim 20 , wherein the first plurality of mini-tablets are 2.5% by weight polyethylene glycol.
27 . The drug formulation of claim 20 , wherein the second plurality of mini-tablets are 90% by weight urea.