Drug delivery system with means for obtaining desirable in vivo release rate pattern

• US 4,851,232 A
• Filed: 06/08/1987
• Issued: 07/25/1989
• Est. Priority Date: 02/13/1987
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Urquhart, John, Theeuwes, Felix
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US07/059,306
• Time in Patent Office: 778 Days
• Field of Search: 424/469, 424/470, 424/458, 424/488, 424/489, 424/490, 424/494
• US Class Current: 424/469
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Abstract

A delivery device is disclosed for delivering a beneficial drug to a biological environment of use. The device comprises a hydrogel reservoir containing tiny pills. The tiny pills comprise a wall surrounding a drug core.

Claims

1. A drug delivery device for the controlled delivery of a beneficial drug to an environment of use over a prolonged period of time, the delivery device comprising:

(a) a reservoir comprising a pharmaceutically acceptable hydroxypropylmethylcellulose; and

,

(b) a plurality of tiny pills housed in the reservoir, the tiny pills comprising;

(1) a core of a beneficial drug; and

,

(2) a wall comprising in at least a part a drug release rate controlling cellulosic polymer comprising an acetyl content of 21 to 44.8% that surrounds the core of the beneficial drug and releases the drug when the device is in use in the environment of use.

2. The drug delivery device for the controlled delivery of the beneficial drug according to claim 1, wherein the environment of use is the gastrointestinal tract, the drug is a beneficial gastrointestinal administrable drug, and the hydroxypropylmethylcellulose comprises a viscosity of from 3 to 258,000, a degree of polymerization of from 48 to 2,000 and a number average molecular weight of from 9,200 to 350,000.

3. A drug delivery device for the controlled delivery of a beneficial drug to an environment of use over a prolonged period of time, the delivery device comprising:

(a) a reservoir comprising a hydroxypropylmethylcellulose; and

,

(b) a multiplicity of tiny pills housed in the reservoir, the tiny pills comprising;

(1) a dosage unit amount of a beneficial drug;

(2) a wall comprising in at least a part etyl cellulose that surrounds the beneficial drug and releases the beneficial drug when the device is in operation in the environment of use.

4. The drug delivery device for the controlled delivery of a beneficial drug according to claim 3, wherein the environment of use is the gastrointestinal tract the drug is a beneficial gastrointestinal administrable drug, the delivery device is admittted orally into the gastrointestinal tract, and the hydroxypropylmethylcellulose comprises a viscosity of from 3 to 258,000 centipoises, a degree of polymerization of from 48 to 2,000, a number average molecular weight of from 9,200 to 350,000, and exhibits a 2 to 50 fold volume increase in the fluid environment of the gastrointestinal tract.

5. A drug delivery device for the controlled delivery of a beneficial drug to an environment of use over a prolonged period of time, the delivery device comprising:

(a) a matrix shaped and sized for oral admittance into the environment of use, the matrix comprising a pharmaceutically acceptable non-toxic hydroxypropylcellulose that absorbs fluid from the gastrointestinal tract, expands and exhibits a 2 to 50 fold volume increase and comprises a hydroxypropyl content of 7 to 16%; and

,

(b) a plurality of tiny pills dispersed in the matrix, the tiny pills comprising;

(1) a dosage amount of a beneficial drug; and

,

(2) a wall that surrounds the beneficial drug, the wall comprising in at least a part of cellulosic polymer comprising an acetyl content of from 21 to 44.8%.

6. The drug delivery device for the controlled delivery of a beneficial drug according to claim 5, wherein the reservoir releases the tiny pills over time and tiny pills release the beneficial drug over time.

7. The drug delivery device for the controlled delivery of a beneficial drug according to claim 5, wherein the environment of use is the gastrointestinal tract, the tiny pills comprise from 10 mg to 50 mg of the beneficial drug, the beneficial drug is a gastrointestinal administrable drug, and the delivery device exhibits gastric retention.

8. A drug delivery device for the controlled delivery of a beneficial gastrointestinal administrable drug to the fluid environment of the gastrointestinal tract over a prolonged period of time, the delivery device comprising:

(a) a matrix adapted for oral admittance into the gastrointestinal tract, the matrix comprising a pharmaceutically acceptable nontoxic hydroxypropylcellulose that absorbs fluid from the gastrointestinal tract, retains some fluid within its matrix structure, expands from 2 to 50 fold volume increase and comprises a hydroxypropyl content of 7 to 16%; and

,

(b) a plurality of tiny pills dispersed throughout the matrix, the tiny pills comprising;

(1) a dosage amount of a beneficial drug; and

,

(2) a wall that surrounds the beneficial drug, the wall comprising at least in part ethyl cellulose that releases the beneficial drug when the delivery device is in use in the gastrointestinal tract over time.