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Last Updated: October 16, 2019

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Claims for Patent: 8,962,010

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Summary for Patent: 8,962,010
Title:Intravaginal drug delivery devices for the delivery of macromolecules and water-soluble drugs
Abstract: An intravaginal drug delivery device comprises a device body comprising a hydrophobic carrier material having at least one channel defining at least one opening to the exterior of said device body, said at least one channel being adapted to receive at least one drug-containing insert; at least one drug-containing insert positioned in said at least one channel, said drug-containing insert capable of releasing a pharmaceutically effective amount of at least one drug suitable for intravaginal administration and containing about 1% to about 70% of at least one water-soluble release enhancer, both the drug and the water-soluble release enhancer dispersed in an insert carrier material; wherein said hydrophobic carrier material and said insert carrier material may be the same or different; and wherein said at least one drug-containing insert is exposed on said exterior of said device body when said intravaginal drug delivery device is in use.
Inventor(s): Woolfson; David Aaron (Belfast, IE), Malcolm; Karl (Belfast, IE)
Assignee: Warner Chilcott Company, LLC (Rockaway, NJ)
Application Number:12/147,310
Patent Claims:1. An intravaginal drug delivery device comprising: (a) a device body comprising a hydrophobic carrier material having at least one channel defining at least one opening to an exterior of said device body, said at least one channel being adapted to receive at least one drug-containing insert; and (b) at least one drug-containing insert positioned in said at least one channel, said drug-containing insert being capable of releasing a pharmaceutically effective amount of at least one drug suitable for intravaginal administration and containing at least one water-soluble release enhancer in an amount ranging from about 20% to about 70% by weight of said at least one drug-containing insert, said at least one drug and said at least one water-soluble release enhancer being dispersed in an insert carrier material; wherein said hydrophobic carrier material and said insert carrier material may be the same or different; wherein said at least one drug-containing insert is exposed on said exterior of said device body when said intravaginal drug delivery device is in use; wherein said at least one drug-containing insert is arranged to maintain surface contact between said insert and said channel in use and to be removable from said device body; wherein said at least one drug-containing insert defines a right circular cylinder, extends substantially perpendicular to the main plane of the device body, and has a cross-sectional diameter of from about 0.5 mm to about 8 mm; and wherein the device body is a partial or complete toroid shape.

2. The intravaginal drug delivery device of claim 1, wherein said at least one drug is a macromolecular drug.

3. The intravaginal drug delivery device of claim 1, wherein said at least one drug is a water-soluble drug.

4. The intravaginal drug delivery device of claim 1, wherein said at least one drug is selected from proteins, RNA- or DNA-based molecules, vaccines, and combinations thereof.

5. The intravaginal drug delivery device of claim 4, wherein said proteins are selected from antibodies, antigens, adrenocorticotropic hormone, angiotensin, beta-endorphin, blood factors, bombesin, calcitonin, calcitonin gene relating polypeptide, cholecystokinin-8, colony stimulating factors, desmopressin, endothelin, enkephalin, erythropoietins, gastrins, glucagon, human atrial natriuretic polypeptide, interferons, insulin, growth factors, growth hormones, interleukins, luteinizing hormone release hormone, monoclonal antibodies, melanocyte stimulating hormone, muramyl-dipeptide, neurotensin, oxytocin, parathyroid hormone, peptide T, secretin, somatomedins, somatostatin, thyroid stimulating hormone, thyrotropin releasing hormone, thyrotropin stimulating hormone, vasoactive intestinal polypeptide, vasopressin, and their analogues or derivatives.

6. The intravaginal drug delivery device of claim 4, wherein said RNA- or DNA-based molecules are selected from oligonucleotides, aptamers, ribozymes, DNAzymes and small interfering RNAs, for either vaccination against sexually transmitted infections or microbicidal activity against sexually transmitted microorganisms.

7. The intravaginal drug delivery device of claim 4, wherein said vaccines are selected from whole viral particles, recombinant proteins, subunit proteins, DNA vaccines, plasmids, bacterial vaccines, polysaccharides and other vaccine vectors.

8. The intravaginal drug delivery device of claim 1, wherein said at least one drug is employed in an amount ranging from about 0.001% to about 50% by weight of the insert.

9. The intravaginal drug delivery device of claim 1, comprising first and second channels and first and second drug-containing inserts positioned in said first and second channels, respectively, wherein said first and second drug-containing inserts comprise drugs that may be the same or different.

10. The intravaginal drug delivery device of claim 1, comprising first, second and third channels, and first, second and third drug-containing inserts positioned, in use, in said first, second and third channels, respectively, wherein said first, second and third drug-containing inserts comprise drugs that may be the same or different.

11. The intravaginal drug delivery device of claim 1, wherein said hydrophobic carrier material is a polymeric material selected from a polydimethylsiloxane, a copolymer of dimethylsiloxane and methylvinylsiloxane, a polyurethane, and a poly(ethylene-co-vinyl acetate).

12. The intravaginal drug delivery device of claim 1, wherein said at least one water-soluble release enhancer is selected from the group consisting of sugars or their water-soluble salts; sugar alcohols; salts; glycols; water-soluble or water-swellable polysaccharides; organic acids; amino acids; proteins; nonionic surface active agents; bile salts; organic solvents; polyethylene glycols; fatty acid esters; hydrophilic polymers, and combinations thereof.

13. The intravaginal drug delivery device of claim 1, wherein said at least one drug-containing insert contains from about 15% to about 60% of said at least one water-soluble release enhancer by weight of said at least one drug-containing insert.

14. The intravaginal drug delivery device of claim 13, wherein said at least one drug-containing insert contains from about 15% to about 55% of said at least one water-soluble release enhancer by weight of said at least one drug-containing insert.

15. The intravaginal drug delivery device of claim 1, wherein the insert carrier material is a polymeric material selected from a polydimethylsiloxane, a copolymer of dimethylsiloxane and methylvinylsiloxane, a polyurethane, and a poly(ethylene-co-vinyl acetate).

16. The intravaginal drug delivery device of claim 1, wherein said hydrophobic carrier material, said insert carrier material, or both said hydrophobic and said insert carrier materials, comprise a silicone elastomer.

17. The intravaginal drug delivery device of claim 1, wherein said at least one drug-containing insert has a length of from about 2 mm to about 30 mm.

18. The intravaginal drug delivery device of claim 1, wherein the cross-sectional diameter of said at least one drug-containing insert exceeds the cross-sectional diameter of said channel by an average of about 1 mm in all directions.

19. The intravaginal drug delivery device of claim 1, wherein said at least one drug-containing insert further comprises at least one pharmaceutically acceptable non-water-soluble release enhancer in an amount ranging from about 1% to about 25% by weight of the insert.

20. The intravaginal drug delivery device of claim 1, wherein the device body further comprises at least one drug, particulate filler material, diffusion inhibitor, chemical penetration enhancer, water-soluble release enhancer or combination thereof.

21. The intravaginal drug delivery device of claim 20, wherein the at least one drug in the device body is selected from the group consisting of contraceptives, pain and migraine agents, drugs for hormone replacement therapy, anxiety and depression agents, drugs for the treatment of premenstrual syndrome, drugs for the treatment of genito-urinary disorders, drugs for cervical ripening/induction of labor, antibacterials, antifungals, antimalarial agents, antiprotozoal agents, antiviral and antiretroviral agents, drugs for the treatment of endometriosis, anti-emetic drugs and osteoporosis drugs.

22. The intravaginal drug delivery device of claim 21, wherein the at least one drug is present in the device body in an amount ranging from about 0.005% to about 65% by weight of the device body.

23. The intravaginal drug delivery device of claim 20, wherein the water-soluble release enhancer in the device body is selected from the group consisting of sugars or their water-soluble salts; sugar alcohols; salts; glycols; water-soluble or water-swellable polysaccharides; organic acids; amino acids; proteins; nonionic surface active agents; bile salts; organic solvents; polyethylene glycols; fatty acid esters; and hydrophilic polymers, and combinations thereof.

24. The intravaginal drug delivery device of claim 20, wherein said device body contains less than about 10% of said water-soluble release enhancer by weight of said device body.

25. The intravaginal drug delivery device of claim 1, wherein the device body further comprises a sheath, provided that said at least one drug-containing insert is exposed on said exterior of said device body.

26. A method of preparing the intravaginal drug delivery device of claim 1 comprising the steps of: (a) molding said hydrophobic carrier material in the form of said device body defining at least one channel; and (b) inserting said at least one drug-containing insert into said at least one hollow internal channel such that said drug-containing insert is exposed on said exterior of said device body.

27. The method of claim 26 further comprising the step of curing the device body.

28. A method of intravaginally administering a drug to a female comprising the step of inserting the intravaginal drug delivery device of claim 1 into the vagina.

29. A method of preparing the intravaginal drug delivery device of claim 1 comprising the steps of: (a) molding said hydrophobic carrier material in the form of said device body defining at least one channel; (b) curing said insert material to form said at least one drug-containing insert; and (c) inserting said at least one drug-containing insert into said at least one hollow internal channel such that said drug-containing insert is exposed on said exterior of said device body.

Details for Patent 8,962,010

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Warner Chilcott Company, LLC (Rockaway, NJ) 2027-06-26 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Warner Chilcott Company, LLC (Rockaway, NJ) 2027-06-26 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Warner Chilcott Company, LLC (Rockaway, NJ) 2027-06-26 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Start Trial Warner Chilcott Company, LLC (Rockaway, NJ) 2027-06-26 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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