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US4016251A Expired / Lapsed US ⏱️ 0.0 years remaining

Vaginal drug dispensing device

Assignee: Alza Corp
•
Filing: 1975-05-30
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Granted: 1977-04-05
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Expires: 1995-05-30
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Abstract

Abstract Drug-delivery device for releasing a drug at a continuous and controlled rate for a prolonged period of time is comprised of a shaped body of polymeric material containing a pharmaceutically acceptable drug and permeable to passage of the drug by diffusion. The polymeric material is an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per 10 minutes.

Inventors

  • 👤 Takeru Higuchi
  • 👤 Anwar Hussain

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 17:02
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7084; A61F; A61F6/00; A61F6/06; A61F6/14; A61F6/142; A61F9/00; A61F9/0008; A61F9/0017; A61K9/0002; A61K9/0004; A61K9/0012; A61K9/0034; A61K9/0036; A61K9/0039; A61M; A61M31/00; A61M31/002

Claims Analysis

Total Claims: 27
Claim 1
Independent Claim 66 words
A vaginal insert comprising a reservoir for containing a drug, a drug in the reservoir, a polymeric barrier through which the drug passes by diffusion as it is released from the reservoir, the improvement wherein said barrier is an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.
Claim 2
Dependent Claim 66 words
A vaginal insert comprising a reservoir for containing a drug, a drug in the reservoir, a polymeric barrier through which the drug passes by diffusion as it is released from the reservoir, the improvement wherein said barrier is an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.
Claim 3
Dependent Claim 86 words
A vaginal dispensing device shaped and size adapted for insertion and placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a vaginal acceptable drug capable of diffusing through the material at a controlled and continuous rate over a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.
Claim 4
Dependent Claim 86 words
A vaginal dispensing device shaped and size adapted for insertion and placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a vaginal acceptable drug capable of diffusing through the material at a controlled and continuous rate over a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per ten minutes.
Claim 5
Dependent Claim 42 words
A vaginal dispensing device according to claim 2 wherein the ethylene-vinyl acetate copolymer has a vinyl acetate content of 4 to 50%, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 and a density of 0.920 to 0.980.
Claim 6
Dependent Claim 15 words
A vaginal dispensing device according to claim 2 wherein the drug is an anti-infective drug.
Claim 7
Dependent Claim 17 words
A vaginal dispensing device according to claim 2 wherein the device is ring-shaped with drug housed therein.
Claim 8
Dependent Claim 24 words
A vaginal dispensing device according to claim 2 wherein the drug is a member selected from the group consisting of progestational and estrogenic steroids.
Claim 9
Dependent Claim 21 words
A vaginal dispensing device according to claim 6 wherein the device contains from 250 nanograms to 5 grams of the drug.
Claim 10
Dependent Claim 85 words
A vaginal dispensing device comprising a polymeric membrane surrounding a reservoir containing a drug and formed of a drug release rate controlling material, the improvement wherein the material is comprised of a biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes, and wherein said drug is dispensed from the device at a controlled and continuous rate over a prolonged period of time by passing through the copolymer.
Claim 11
Dependent Claim 85 words
A vaginal dispensing device comprising a polymeric membrane surrounding a reservoir containing a drug and formed of a drug release rate controlling material, the improvement wherein the material is comprised of a biologically compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes, and wherein said drug is dispensed from the device at a controlled and continuous rate over a prolonged period of time by passing through the copolymer.
Claim 12
Dependent Claim 23 words
A vaginal dispensing device according to claim 8 wherein the device is a container and said drug is contained in the interior thereof.
Claim 13
Dependent Claim 20 words
A vaginal dispensing device according to claim 8 wherein the reservoir is comprised of a solid matrix with drug therein.
Claim 14
Dependent Claim 40 words
A vaginal dispensing device according to claim 8 wherein the copolymer has a vinyl acetate content of 4 to 50%, a frequency of acetoxy groups on the polyethylene backbone of 1/150 to 1/8 and a density of 0.920 to 0.980.
Claim 15
Dependent Claim 25 words
A vaginal dispensing device according to claim 8 wherein the drug is a member selected from the group consisting of progestational, estrogenic and anti-infective drugs.
Claim 16
Dependent Claim 21 words
A vaginal dispensing device according to claim 12 wherein the device contains from 250 nanograms to 5 grams of the drug.
Claim 17
Dependent Claim 14 words
A vaginal dispensing device according to claim 12 wherein the progestational drug is progesterone.
Claim 18
Dependent Claim 27 words
A vaginal dispensing device according to claim 12 wherein the progestational drug is a member selected from the group consisting of 19-nor-progesterone, norethinione, medroxyprogesterone, norethynodrel and 17α-hydroxy-progesterone.
Claim 19
Dependent Claim 31 words
A vaginal dispensing device according to claim 12 wherein the anti-infective drug is a member selected from the group consisting of penicillin, tetracycline, chloramphenicol, sulfacetamide, sulfamethazine, sulfadiazine, sulfamerazine, sulfamethizole and sulfisoxazole.
Claim 20
Dependent Claim 30 words
A vaginal dispensing device according to claim 8 wherein the drug is a member selected from the group of anti-inflammatories consisting of hydrocortisone, cortisone, dexamethasone, fluocinolone, triamincolone, medrysone, and prednisolone.
Claim 21
Dependent Claim 26 words
A vaginal dispensing device according to claim 12 wherein the estrogenic drug is a member selected from the group consisting of estrone, 17β-estradiol and ethinyl estradiol.
Claim 22
Dependent Claim 20 words
A vaginal dispensing device according to claim 8 wherein the reservoir is comprised of a liquid matrix with drug therein.
Claim 23
Dependent Claim 20 words
A vaginal dispensing device according to claim 8 wherein the device is ring-shaped with drug housed in the reservoir thereof.
Claim 24
Independent Claim 150 words
A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material at a controlled and continuous rate of a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of 0.1 to 1000 grams per ten minutes and permeable to the steroid with the steroid dissolving in an passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.
Claim 25
Independent Claim 150 words
A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a non-toxic, flexible, polymeric release rate controlling material containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material at a controlled and continuous rate of a prolonged period of time, the improvement wherein said polymeric material is comprised of an ethylene-vinyl acetate copolymer having a vinyl acetate content of 4 to 80% by weight and a melt index of 0.1 to 1000 grams per ten minutes and permeable to the steroid with the steroid dissolving in an passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.
Claim 26
Independent Claim 147 words
A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a polymeric membrane surrounding a reservoir containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material in a controlled rate and continuously over a prolonged period of time, the improvement wherein the material is comprised of a vaginal compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes and to the steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.
Claim 27
Independent Claim 147 words
A method for controlling fertility which method is comprised of placing in the vagina of a warm blooded animal a vaginal dispensing device shaped and size adapted for insertion and comfortable placement in the vagina and formed of a polymeric membrane surrounding a reservoir containing a dosage unit amount of a vaginally acceptable antifertility steroid selected from the group consisting of progestational and estrogenic steroids capable of diffusing through the material in a controlled rate and continuously over a prolonged period of time, the improvement wherein the material is comprised of a vaginal compatible ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% and a melt index of 0.1 to 1000 grams per ten minutes and to the steroid with the steroid dissolving in and passing through the ethylene-vinyl acetate copolymer in a fertility controlling effective amount for controlling fertility in the animal.

References Cited (Backward Citations)

US3545439A Cited
US3854480A Cited
US3710795A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1980-04-04 1980-10-04 1981-04-05 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1984-04-04 1984-10-04 1985-04-05 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1988-04-04 1988-10-04 1989-04-05 $7700.00 Window Closed / Lapsed

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