Gastrointestinal drug delivery system comprising a hydrogel reservoir containing a plurality of tiny pills

• US 4,642,233 A
• Filed: 01/16/1984
• Issued: 02/10/1987
• Est. Priority Date: 03/22/1982
• 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:
  US06/571,009
• Time in Patent Office: 1,121 Days
• Field of Search: 424/81, 424/16, 424/19-22
• US Class Current: 424/470
• 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. An orally administrable device for the controlled delivery of a beneficial gastrointestional administrable drug to the fluid environment of the gastrointestinal tract over a prolonged period of time, the device comprising:

(a) a reservoir shaped and sized for oral admittance into the gastrointestinal tract comprising a pharmaceutically acceptable non-toxic polysaccharide hydrogel that absorbs, imbibes fluid from the gastrointestinal tract and retains fluid within its polysaccharide structure, expands, swells and exhibits a 2 to 50 fold volume increase, said polysaccharide hydrogel a member selected from the group consisting of a noncross-linked polysaccharide hydrogel and a covalent cross-linked polysaccharide hydrogel said hydrogel additionally selected from the group consisting of a naturally occurring polysaccharide hydrogel and a synthetic polysaccharide hydrogel;

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

(1) a core of a beneficial gastrointestinal administrable drug; and

,

(2) a wall comprising in a least a part a drug release rate controlling cellulosic polymer having 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 into the gastrointestinal tract over time.

2. A gastrointestinal delivery system for the controlled delivery of a beneficial drug to the fluidic environment of the gastrointestinal tract, the gastrointestinal delivery system comprising:

(a) means for embedding a plurality of depots comprising a beneficial gastrointestinal drug, said means a reservoir matrix comprising a non-toxic polysaccharide hydrogel that absorbs and imbibes fluid from the gastrointestinal environment and retains fluid within its polysaccharide structure, expands and exhibits a volume increase for retaining the delivery system in the gastrointestinal environment overtime, said polysaccharide hydrogel a member selected from the group consisting of naturally occurring and synthetic pharmaceutically acceptable polysaccharide hydrogels, which polysaccharide hydrogels are additionally a member selected from the group consisting of noncross-linked, covalent cross-linked and ionic cross-linked polysaccharide hydrogels;

(b) means for forming the plurality of depots in the reservoir matrix, said means a wall comprising a release rate controlling ethyl cellulose that releases the beneficial gastrointestinal administrable drug over time, which wall surrounds;

(c) a beneficial gastrointestinal drug in the depot; and

,

(d) wherein, when the delivery system is in the gastrointestinal environment, the delivery system delivers the beneficial drug to the gastrointestinal environment over time.

3. A gastrointestinal delivery system for the controlled delivery of a beneficial gastrointestinal administrable drug to the gastrointestinal environment over time, the delivery system comprising:

(1) means for housing a plurality of depots comprising a beneficial gastrointestinal administrable drug, said means a body shaped and adapted for oral admittance into the gastrointestinal environment, the body comprising a non-toxic carboxymethyl-cellulose that imbibes fluid from the gastrointestinal environment and retains fluid within its carboxymethylcellulose structure, (2) means for forming the plurality of depots in the delivery system, said means comprising a wall comprising a release rate controlling ethyl cellulose composition that releases the beneficial gastrointestinal administrable drug over time, which (3) wall surrounds the beneficial gastrointestinal administrable drug in the depot; and

(4) wherein when the delivery system is in the gastrointestinal environment, the delivery system delivers the beneficial drug at a controlled rate to the gastrointestinal environment over time.