US5035891A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Controlled release subcutaneous implant
Assignee: Syntex USA LLC
•
Filing: 1989-08-24
•
Granted: 1991-07-30
•
Expires: 2009-08-24
Abstract
Abstract A sustained release, reservoir-type subcutaneous implant device for the sustained administration to a subject of a biologically active compound comprises: an effective amount of a biologically active compound; an amount of a solid hydrophilic polymer sufficient to cause swelling of the device by osmotic pressure after implantation; an effective amount of a solubilizing agent; and a sufficient amount of a non-porous rate-controlling membrane which completely encapsulates said biologically active compound, wherein said rate-controlling membrane is permeable to said biologically active compound, but is impermeable to said solubilizing agent. This device is particularly advantageous for the administration of growth promoting compounds to livestock.
Inventors
- 👤 Richard A. Runkel
- 👤 Jung-Chung Lee
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 09:46
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0087; A61K9/0092; A61K31/00; A61K31/56; A61K31/565; A61K9/0002; A61K9/0004; A61K9/0012; A61K9/0019; A61K9/0024; A61K9/14; A61K9/16; A61K9/1605; A61K9/1617; A61K9/1629; A61K9/1641
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
183 words
A reservoir device for the sustained administration of a steroid hormone useful for promoting weight gain in livestock, suitable for subcutaneous implantation, which device comprises: a) a pellet or plurality of pellets, wherein each pellet comprises 1) a steroid hormone in a livestock weight gain-promoting amount, 2) a solid hydrophilic polymer in an amount sufficient to cause swelling of said device by osmotic pressure, and 3) a solubilizing agent in an amount sufficient to maintain an effective concentration of said steroid hormone in solution within said device, wherein said solubilizing agent is an ionic surfactant having an aliphatic chain of 8 to 22 carbon atoms; and b) a sufficient amount of a non-porous, rate-controlling membrane which completely encapsulates said pellet or said plurality of pellets, wherein: 1) said membrane is prepared from a material that is selected from the group consisting of an aliphatic polyurethane, an aromatic polyurethane, a silicone rubber, a polyethylene-vinyl acetate copolymer, and a polystyrene-butadiene copolymer; and 2) said membrane is permeable to water and to said steroid hormone, but is impermeable to said solubilizing agent and said hydrophilic polymer.
Claim 2
Dependent Claim
183 words
A reservoir device for the sustained administration of a steroid hormone useful for promoting weight gain in livestock, suitable for subcutaneous implantation, which device comprises: a) a pellet or plurality of pellets, wherein each pellet comprises 1) a steroid hormone in a livestock weight gain-promoting amount, 2) a solid hydrophilic polymer in an amount sufficient to cause swelling of said device by osmotic pressure, and 3) a solubilizing agent in an amount sufficient to maintain an effective concentration of said steroid hormone in solution within said device, wherein said solubilizing agent is an ionic surfactant having an aliphatic chain of 8 to 22 carbon atoms; and b) a sufficient amount of a non-porous, rate-controlling membrane which completely encapsulates said pellet or said plurality of pellets, wherein: 1) said membrane is prepared from a material that is selected from the group consisting of an aliphatic polyurethane, an aromatic polyurethane, a silicone rubber, a polyethylene-vinyl acetate copolymer, and a polystyrene-butadiene copolymer; and 2) said membrane is permeable to water and to said steroid hormone, but is impermeable to said solubilizing agent and said hydrophilic polymer.
Claim 3
Dependent Claim
24 words
The device of claim 1 wherein said steroid hormone comprises an estrogen derivative in combination with a progestogen, an androgen, or a combination thereof.
Claim 4
Dependent Claim
15 words
The device of claim 2 wherein said estrogen derivative is estradiol or an ester thereof.
Claim 5
Dependent Claim
14 words
The device of claim 3 wherein said steroid hormone comprises estradiol benzoate and progesterone.
Claim 6
Dependent Claim
17 words
The device of claim 3 wherein said steroid hormone comprises estradiol benzoate and testosterone or testosterone propionate.
Claim 7
Dependent Claim
17 words
The device of claim 3 wherein said steroid hormone comprises estradiol benzoate and trenbolone or trenbolone acetate.
Claim 8
Dependent Claim
16 words
The device of claim 3 wherein said steroid hormone comprises estradiol benzoate, progesterone, and trenbolone acetate.
Claim 9
Dependent Claim
17 words
The device of claim 3 wherein said steroid hormone comprises estradiol benzoate, testosterone propionate, and trenbolone acetate.
Claim 10
Dependent Claim
29 words
The device of claim 1 wherein said solubilizing agent is selected from the group consisting of cetyl pyridinium chloride, cetyl trimethylammonium bromide, cetyl trimethylammonium tosylate, and sodium lauryl sulfate.
Claim 11
Dependent Claim
13 words
The device of claim 9 wherein said solubilizing agent is sodium lauryl sulfate.
Claim 12
Dependent Claim
19 words
The device of claim 10 wherein the sodium lauryl sulfate is present at a concentration between 0.001% and 10%.
Claim 13
Dependent Claim
16 words
The device of claim 11 wherein the sodium lauryl sulfate concentration is about 0.01% to 2.5%.
Claim 14
Dependent Claim
39 words
The device of claim 1 wherein said hydrophilic polymer is selected from the group consisting of polyvinylpyrrolidone, starch, gelatin, methyl cellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, and polyethylene glycol having a molecular weight between about 2000 and 20,000.
Claim 15
Dependent Claim
20 words
The device of claim 13 wherein said hydrophilic polymer is a polyethylene glycol having a molecular weight of about 8000.
Claim 16
Dependent Claim
19 words
The device of claim 14 wherein said polyethylene glycol is present at a concentration of about 0.01% to 40%.
Claim 17
Dependent Claim
12 words
The device of claim 1 wherein said membrane is an aliphatic polyurethane.
Claim 18
Dependent Claim
29 words
The device of claim 16 wherein said aliphatic polyurethane is synthesized from methylene bis(cyclohexyl) diisocyanate, poly(tetramethylene ether glycol), and a 1,4-butanediol chain extender and has the following structure: ##STR2##
Claim 19
Dependent Claim
18 words
The device of claim 17 wherein said membrane is between about 0.05 and about 1 mm in thickness.
Claim 20
Dependent Claim
21 words
The device of claim 18 wherein said membrane has a surface area between about 1 and about 10 cm 2 .
Claim 21
Dependent Claim
105 words
The device of claim 1 wherein said pellet or plurality of pellets comprises: about 20-1,000 mg of progesterone, testosterone propionate, trenbolone, or trenbolone acetate; about 2-100 mg of estradiol benzoate; about 4-400 mg of a polyethylene glycol having a molecular weight of about 8000; and about 0.2-10 mg of sodium lauryl sulfate; and wherein said membrane has a surface area between about 1 and 10 cm 2 , a thickness between about 0.05 and about 1 mm, and is prepared from an aliphatic polyurethane which is synthesized from methylene bis(cyclohexyl) diisocyanate, poly(tetramethylene ether glycol), and a 1,4-butanediol chain extender and has the following structure: ##STR3##
Claim 22
Dependent Claim
46 words
The device of claim 20 wherein said pellet or plurality of pellets comprises: about 200 mg of progesterone; about 20 mg of estradiol benzoate; about 44 mg of a polyethylene glycol having a molecular weight of about 8000; and about 5.2 mg of sodium lauryl sulfate.
Claim 23
Dependent Claim
47 words
The device of claim 20 wherein said pellet or plurality of pellets comprises: about 200 mg of testosterone propionate; about 20 mg of estradiol benzoate; about 44 mg of a polyethylene glycol having a molecular weight of about 8000; and about 5.2 mg of sodium lauryl sulfate.
Claim 24
Dependent Claim
47 words
The device of claim 20 wherein said pellet or plurality of pellets comprises: about 200 mg of trenbolone acetate; about 20 mg of estradiol benzoate; about 44 mg of a polyethylene glycol having a molecular weight of about 8000; and about 5.2 mg of sodium lauryl sulfate.
Claim 25
Dependent Claim
54 words
The device of claim 20 wherein said pellet or plurality of pellets comprises: about 200 mg of trenbolone or trenbolone acetate; about 200 mg of progesterone; about 20 mg of estradiol benzoate; about 64 mg of a polyethylene glycol having a molecular weight of about 8000; and about 5.2 mg of sodium lauryl sulfate.
Claim 26
Dependent Claim
55 words
The device of claim 20 wherein said pellet or plurality of pellets comprises: about 200 mg of trenbolone or trenbolone acetate; about 200 mg of testosterone propionate; about 20 mg of estradiol benzoate; about 64 mg of a polyethylene glycol having a molecular weight of about 8000; and about 5.2 mg of sodium lauryl sulfate.
Claim 27
Dependent Claim
38 words
The device of claim 1 which further comprises an antibiotic present in an amount sufficient to prevent infection associated with implantation of said device, wherein said antibiotic is selected from the group consisting of oxytetracycline, oxytetracycline.HCL and gentimycin.
Claim 28
Dependent Claim
17 words
The device of claim 26 wherein said antibiotic is present on the outer surface of said membrane.
Claim 29
Independent Claim
181 words
A method for promoting weight gain and increasing feed efficiency in livestock, which method comprises: subcutaneously administering a reservoir device which device comprises: a) a pellet or plurality of pellets, wherein each pellet comprises: 1) a steroid hormone in a livestock weight gain-promoting amount, 2) a solid hydrophilic polymer in an amount sufficient to cause swelling of said device by osmotic pressure, and 3) a solubilizing agent in an amount sufficient to maintain an effective concentration of said steroid hormone in solution within said device, wherein said solubilizing agent is an ionic surfactant having an aliphatic chain of 8 to 22 carbon atoms; and b) a sufficient amount of a non-porous, rate-controlling membrane which completely encapsulates said pellet or said plurality of pellets, wherein: 1) said membrane is prepared from a material that is selected from the group consisting of an aliphatic polyurethane, an aromatic polyurethane, a silicone rubber, a polyethylene-vinyl acetate copolymer, and a polystyrene-butadiene copolymer; and 2) said membrane is permeable to water and to said steroid hormone, but is impermeable to said solubilizing agent and said hydrophilic polymer.
Claim 30
Independent Claim
181 words
A method for promoting weight gain and increasing feed efficiency in livestock, which method comprises: subcutaneously administering a reservoir device which device comprises: a) a pellet or plurality of pellets, wherein each pellet comprises: 1) a steroid hormone in a livestock weight gain-promoting amount, 2) a solid hydrophilic polymer in an amount sufficient to cause swelling of said device by osmotic pressure, and 3) a solubilizing agent in an amount sufficient to maintain an effective concentration of said steroid hormone in solution within said device, wherein said solubilizing agent is an ionic surfactant having an aliphatic chain of 8 to 22 carbon atoms; and b) a sufficient amount of a non-porous, rate-controlling membrane which completely encapsulates said pellet or said plurality of pellets, wherein: 1) said membrane is prepared from a material that is selected from the group consisting of an aliphatic polyurethane, an aromatic polyurethane, a silicone rubber, a polyethylene-vinyl acetate copolymer, and a polystyrene-butadiene copolymer; and 2) said membrane is permeable to water and to said steroid hormone, but is impermeable to said solubilizing agent and said hydrophilic polymer.
Claim 31
Dependent Claim
102 words
The method of claim 28 wherein said pellet or plurality of pellets comprises: 20-1,000 mg of progesterone, testosterone, testosterone propionate, trenbolone, or trenbolone acetate; 2-100 mg of estradiol benzoate; 4-400 mg of a polyethylene glycol having a molecular weight of about 8000; and 0.2-10 mg of sodium lauryl sulfate; and wherein said membrane has a surface area between about 1 and 10 cm 2 , a thickness between about 0.05 and about 1 mm, and is prepared from an aliphatic polyurethane which is synthesized from methylene bis(cyclohexyl) diisocyanate, poly(tetramethylene ether glycol), and a 1,4-butanediol chain extender and has the following structure: ##STR4##
References Cited (Backward Citations)
US3948254A
Cited
US3939265A
Cited
US3992518A
Cited
US4180560A
Cited
US4207890A
Cited
GB2010676A
Cited
US4210644A
Cited
US4220153A
Cited
US4331651A
Cited
US4404183A
Cited
US4333919A
Cited
US4315925A
Cited
US4326525A
Cited
US4524060A
Cited
US4432964A
Cited
GB2136688A
Cited
GB2154138A
Cited
US4927633A
Cited
US4666702A
Cited
GB2167662A
Cited
US4786501A
Cited
US4765980A
Cited
US4816568A
Cited
JPH0944310A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-07-29 | 1995-01-28 | 1995-07-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-07-29 | 1999-01-28 | 1999-07-30 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-07-29 | 2003-01-28 | 2003-07-30 | $7700.00 | Window Closed / Lapsed |