Delivery system comprising kinetic forces

• US 5,499,979 A
• Filed: 03/10/1994
• Issued: 03/19/1996
• Est. Priority Date: 06/25/1987
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Wong, Patrick S.-L., Eckenhoff, James B., Theeuwes, Felix
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/209,033
• Time in Patent Office: 740 Days
• Field of Search: 424/438, 424/422, 424/457, 424/468, 424/471-473, 604/131, 604/890.1, 604/891.1, 604/892.1
• US Class Current: 604/891.1
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A dispenser for use in a fluid environment which is capable of delivery of plurality of drugs in any desired delivery pattern or profile.

Claims

1. A dispenser for delivering a drug to an environment comprising a fluid, the dispenser comprising:

(a) a housing;

(b) an inlet in the housing;

(c) an outlet in the housing;

(d) a plurality of longitudinally aligned layers in the housing comprising;

(e) a drug formulation layer, which drug formulation layer erodes over time when moved by the gas pressure to a contacting fluid at the outlet of the dispenser,

(f) an inert formulation layer in contacting arrangement with the drug formulation layer, which inert formulation layer is a means for enabling the drug formulation layer to be delivered as a unit dose over time to the environment; and

,

(g) a gas generating formulation layer in the housing for generating a gas pressure for moving the drug formulation layer and the inert formulation layer out of the dispenser at a rate that is solely governed by the rate of fluid that enters the housing and the gas generated, said gas generating formulation layer positioned at the inlet in the housing for receiving fluid that enters the dispenser.

2. The dispenser for delivering the drug according to claim 1, wherein said drug in the drug formulation layer is selected from the group consisting of pharmacologically active peptides, protein anabolic hormones, growth promoting hormones related to the endocrine system, porcine growth promoting hormone, bovine growth promoting hormone, equine growth promoting hormone, ovine growth promoting hormone, human growth promoting hormone, growth promoting hormones derived by extraction and concentration from pituitary and hypothalamus glands, growth promoting hormones produced by recombinant DNA methods, polypeptides, growth hormone, somatropin, somatotropin, somatomedin-C, gonadotropin releasing hormone, follicle stimulating hormone, luteinizing hormone, LH-RH, growth hormone releasing factor, gonadotropin releasing factor, insulin, colchicine, chorionic gonadotropin, oxytocin, vasopressin, adrenocorticotrophic hormone, epidermal growth factor, prolactin, somatostatin, cosyntropin, lypressin, thyrotropin releasing hormone, thyroid stimulating hormone, secretin, pancreozymin, enkephalin, and glucagon.

3. A dispenser for delivering a drug to an environment comprising a fluid, the dispenser comprising:

(a) a housing;

(b) an inlet in the housing;

(c) an outlet in the housing;

(d) a plurality of longitudinally aligned layers in the housing, comprising;

(e) a drug formulation layer, which drug formulation layer dissolves over time when pushed by the hydropressure to a contacting fluid at the outlet of the dispenser,

(f) an inert formulation layer in contacting arrangement with the drug formulation layer, which inert formulation layer is a means for effecting the delivery of the drug formulation layer as a unit dose of drug to the environment; and

(g) a hydropressure generating layer in the housing, said hydropressure generating layer positioned at the inlet in the housing and comprising a material selected from the group consisting of an osmotically effective solute or a fluid-swellable polymer, wherein said hydropressure generating layer increases in dimension and pushes the inert formulation layer and the drug formulation layer through the outlet in the housing at a rate that is solely controlled by the rate of fluid imbibed by the hydropressure generating layer.

4. The dispenser for delivering the drug according to claim 3, wherein the drug in the drug formulation layer is selected from the group consisting of pharmacologically active peptides, protein anabolic hormones, growth promoting hormones related to the endocrine system, porcine growth promoting hormone, bovine growth promoting hormone, equine growth promoting hormone, ovine growth promoting hormone, human growth promoting hormone, growth promoting hormones derived by extraction and concentration from pituitary and hypothalamus glands, growth promoting hormones produced by recombinant DNA methods, polypeptides, growth hormone, somatropin, somatotropin, somatomedin-C, gonadotropin releasing hormone, follicle stimulating hormone, luteinizing hormone, LH-RH, growth hormone releasing factor, gonadotropin releasing factor, insulin, colchicine, chorionic gonadotropin, oxytocin, vasopressin, adrenocorticotrophic hormone, epidermal growth factor, prolactin, somatostatin, cosyntropin, lypressin, thyrotropin releasing hormone, thyroid stimulating hormone, secretin, pancreozymin, enkephalin, and glucagon, which drug is delivered at a rate of delivery greater than the rate the hydropressure pushes the drug formulation layer in the dispenser.

5. A dispenser for delivering a drug to an environment comprising a fluid, the dispenser comprising:

(a) a housing;

(b) an inlet in the housing;

(c) an outlet in the housing;

(d) a plurality of longitudinally aligned layers in the housing comprising;

(e) a drug formulation layer, which drug formulation layer performs by at least one of dissolving or eroding over time when pushed towards the outlet of the dispenser,

(f) an inert formulation layer in contacting arrangement with the drug formulation layer, which inert formulation layer is a means for effecting the delivery of the drug formulation layer as a unit dose of drug to the environment; and

,

(g) an osmotic layer positioned at the inlet in the housing, said osmotic layer comprising a semipermeable wall that surrounds a core, said core comprising a material selected from the group consisting of a solution and a suspension, said semipermeable wall comprising an orifice oriented towards the outlet in the housing for directing said core material towards the drug formulation layer for moving the drug formulation layer through the outlet in the housing at a controlled rate over time, said rate solely governed by the osmotic layer.

6. The dispenser for delivering the drug according to claim 5, wherein the drug in the drug formulation layer is selected from the group consisting of pharmacologically active peptides, protein anabolic hormones, growth promoting hormones related to the endocrine system, porcine growth promoting hormone, bovine growth promoting hormone, equine growth promoting hormone, ovine growth promoting hormone, human growth promoting hormone, growth promoting hormones derived by extraction and concentration from pituitary and hypothalamus glands, growth promoting hormones produced by recombinant DNA methods, polypeptides, growth hormone, somatropin, somatotropin, somatomedin-C, gonadotropin releasing hormone, follicle stimulating hormone, luteinizing hormone, LH-RH, growth hormone releasing factor, gonadotropin releasing factor, insulin, colchicine, chorionic gonadotropin, oxytocin, vasopressin, adrenocorticotrophic hormone, epidermal growth factor, prolactin, somatostatin, cosyntropin, lypressin, thyrotropin releasing hormone, thyroid stimulating hormone, secretin, pancreozymin, enkephalin, and glucagon.