Abstract: The present invention discloses a method and a device or tooth pod for regeneration of teeth. In some exemplary embodiments, a method of implanting a tooth pod comprises of providing a tooth pod, implanting the tooth pod into an insertion point, and sealing the insertion point. The tooth pod comprises a composition of vitamin E oil and penicillin. In some exemplary embodiments, the tooth pod comprises of a permeable membrane defined by an outer layer and an inner layer, and a cavity defined by the space enclosed within the inner layer. In some exemplary embodiments, the device is a spherical pod. The tooth pod is implanted into the gum line at approximately ½ the depth of a tooth, which provides space to growth of tooth upwards and downwards. The blood fills the hollow space of the tooth pod and forms nerve roots. Thereafter, a new adult tooth is formed.

Abstract: Provided are methods for delaying or preventing onset of progressive memory decline by administering a muscarinic M2 receptor blocking compound to patients identified as at risk of developing a condition characterized by progressive memory decline, prior to onset of the condition.

Abstract: A therapeutic delivery device that provides a controlled release of high doses of a therapeutic agent in a local area, sustains the high dose controlled release with a percutaneous port for refilling the device, and is versatile for use with multiple types of therapeutic agents and/or implant systems. A rate determining/controlled release membrane is used to decrease the molecular mobility of the therapeutic compounds thereby controlling the therapeutic release profile. The therapeutic delivery device includes a body defining an internal reservoir for receiving a therapeutic agent and including a first membrane for providing a controlled release of the therapeutic agent to the surgical site, a port in fluid communication with the reservoir, a sleeve configured to encapsulate the body, and a rigid housing configured to support the body and a portion of the sleeve, the rigid housing configured to release the body and the sleeve after the body and the sleeve are anchored position relative to the surgical site.

Abstract: The present invention relates to a vaginal sustained-release drug delivery system for luteal support and a method for preparation and use thereof. The vaginal sustained-release drug delivery system for luteal support is a progesterone depot-type vaginal ring having a bilayer structure of a core layer and a film layer enclosing the core layer, wherein the core layer is composed of a solid scaffold carrier of medical EVA containing a drug uniformly dispersed therein, and the film layer is composed of a medical EVA material containing no drug. The vaginal sustained-release drug delivery system for luteal support according to the present invention can be used for assisted reproduction and for treatment of functional uterine bleeding, premenstrual syndrome and the like due to luteal phase defect with a significantly improved therapeutic effect.

Abstract: Provided herein are drug implants comprising a therapeutically active agent for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and a therapeutically active agent disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may comprise bicalutamide, e.g., for use in the treatment of prostate cancer.

Abstract: Geometrically complex intravaginal rings, systems and methods of making the same are provided herein. Disclosed herein are geometrically complex intravaginal rings with tunable and enhanced drug release, which in some embodiments can be fabricated by 3D printing technologies. The disclosed IVRs include a ring structure comprising a plurality of unit cells or macroscopic and/or microscopic architecture, which can be tuned to control the loading capacity of an active compound within the IVR, the diffusion of an active compound from the IVR, the surface area of the IVR, and/or the mechanical properties of the IVR. The disclosed geometrically complex IVRs can provide superior control over drug loading and drug release compared to conventional IVRs fabricated by injection molding or hot-melt extrusion.

Abstract: Provided herein are drug implants comprising a therapeutically active agent for the treatment of disease in a subject. In some cases, the drug implant may comprise a polymer matrix and a therapeutically active agent disposed therein. Additionally provided are methods for manufacturing the drug implants and methods of treating diseases with the implants. In some cases, the drug implant may comprise bicalutamide, e.g., for use in the treatment of prostate cancer.

Abstract: The present invention relates to methods, compositions and kits for controlling, managing or manipulating the non-human mammalian female reproductive cycle. The methods include oestrus induction and/or synchronisation, induction of ovulation and/or superovulation and optionally further includes a method of providing an immunopermissive uterine environment prior to insemination or implantation of embryos.

Abstract: Delivery devices of a degradable or nondegradable biocompatible matrix with one or more encapsulated active pharmaceutical ingredients or one or more particle-bound active pharmaceutical ingredients dispersed in the matrix are provided. Also provided are methods for delivering an active pharmaceutical ingredient to a subject with these delivery devices. Modified vaginal rings are also provided as well as surface coatings for delivery devices which minimize bio-interaction of the coated delivery devices.

Abstract: Cerclage pessary containing progesterone homogeneously distributed in the pessary body providing a prolonged, sustained and continuous release for a period of at least 6 months, wherein the pessary consists of dimethylsiloxane elastomer with RTV (Room Temperature Vulcanization) mechanism, the progesterone amount is from 20% to 30% w/w, relative to pessary weight and the ratios of the polymers forming the matrix is from 6:1 to 14 1. The cerclage pessary is useful for the prevention of preterm birth. Progesterone diffuses through the polymer continuously, without altering the shape and integrity of the pessary, since the elastomer forming the polymeric matrix used herein is not biodegradable. This guarantees that the form of pessary remains intact until the end of treatment.

Abstract: The invention relates to a sustained-release vaginal ring which includes meloxicam and an agent for modulating the release of the active principle, such as polyvinylpyrrolidone K-30, which releases the active principle over at least 90 days and which can be used as a continuous-use contraceptive in women. The vaginal ring preferably includes 5 wt % to 30 wt % of meloxicam, relation to total weight of the formulation.

Abstract: Described are drug delivery systems incorporating electrospun fibers that comprise and deliver physicochemically diverse drug compounds. Such fibers provide significant advantages in drug agent release, such as adaptability for solid dosage delivery to mucosal tissues. This is in addition to allowing for controlled drug release. Systems and methods for large-scale electrospinning productivity are described, including novel microarchitectures allowing for variable pharmacokinetics in drug release.

Abstract: It relates to a device comprising (a) a core comprising polyurethane; (b) a sheath comprising ethylene vinyl acetate copolymer, said sheath substantially or completely surrounding said core; and (c) one or more active pharmaceutical ingredients dissolved or dispersed in said core and/or said sheath; and to a process for its preparation.

Abstract: A method of embryo transfer (“ET”) that improves fertility rates by eliminating transferred air during the procedure is provided. Also provided is a method for hormonally enhancing the uterine wall of a patient either prior to or during the time of ET. Quantitative administration of transfer solutions is accomplished with a modified apparatus that provides for implantation of an embryo into the uterus of a patient. The apparatus comprises an outer sheath and an inner lumen arranged to be slidably disposed within the outer sheath. The inner lumen includes at least one visual marker situated on the exterior surface adjacent its distal end thereof.

Abstract: Biostable, multipurpose, microbicidal intravaginal devices in the form of rings, ringed-meshes, sponges, or diaphragms for use by women and condoms for use by male partners are provided, wherein each of the devices contains a drug effective in treating a particular vaginal infection, while further exhibiting at least one additional function selected from the group dealing with non-hormonal contraception, management of sexually transmitted diseases, viral infections, and retroviral infections as well as the treatment of cervical cancer.

Abstract: A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Abstract: A water-swellable linear polymer is made by reacting together a polyethylene oxide of number average molecular weight less than 4,000, an aliphatic diol, and a difunctional diisocyanate. Controlled release composition comprises the polymer together with an active agent. The polymer is able to take up pharmaceutically active agents of molecular weight 200 to 20,000.

Abstract: An intrauterine device and more specifically an intracervical device (ICD) for the local release of drugs in the loco-regional treatment of tumours of the uterine cervix comprises an elongated stem (2) to be positioned in the cervical canal (15), this stem consisting of an inner hollow core (3) and a coating (4) containing a gradual-release drug, the stem being attached to: a first element (5) for blocking the stem (2) inside the uterine cavity (12), and located at the cranial or upper end; a second blocking element (7, 71) positioned inside the vagina (11), against the ectocervix (16), located at the caudal or lower end of the stem (2).

Abstract: Sustained-release vaginal ring for comprising dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S) or pharmaceutically acceptable thereof as active principle, and optionally a release-modulating agent of the active principle, wherein the amount of active principle is between 1% to 32% by weight, relative to the total weight of the formulation, and the modulator is selected from: polyvinylpyrrolidone K-30, lactose, microcrystalline cellulose and sodium lauryl sulfate. The vaginal ring of the present invention can be used to increase ovarian reserve in women, to be used as drug in assisted reproduction programs, and to relieve symptoms associated with menopause, such as symptoms of vulvar and vaginal atrophy and sexual dysfunction in postmenopausal women.

Abstract: According to one claim of the invention, a method for occluding a fallopian tube in a vertebrate subject is described, which comprises comprising transcervically delivering a solid blocking material into the fallopian tube. In various embodiments, a fluid sealing material is delivered along with the solid blocking material. Other claims of the invention pertain to articles of manufacture, delivery devices and kits for use in occluding the fallopian tubes of a vertebrate subject.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment consisting of (i) a drug-loaded thermoplastic polymer core, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said intermediate layer is loaded with (a) crystals of a first pharmaceutically active compound and with (b) a second pharmaceutically active compound in dissolved form and wherein said core is loaded with said second compound in dissolved form.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment consisting of (i) a drug-loaded thermoplastic polymer core, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said intermediate layer is loaded with (a) crystals of a first pharmaceutically active compound and with (b) a second pharmaceutically active compound in dissolved form and wherein said core is loaded with said second compound in dissolved form.

Abstract: A drug delivery system consisting of one or more compartments and comprising a progestogenic compound dissolved in a thermoplastic polyethylene vinylacetate copolymer whereby, if the delivery system consists of one compartment, the compartment comprises (i) a core of a thermoplastic polyethylene vinylacetate copolymer comprising the progestogenic compound, such progestogenic compound being dissolved in the polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C., and an estrogenic compound; and (ii) a skin of a thermoplastic polyethylene vinylacetate copolymer covering the core, said skin being permeable for both compounds; if the delivery system consists of more than one compartment, only one compartment comprises (iii) the progestogenic compound, such progestogenic compound being dissolved in a core of a thermoplastic polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C.

Abstract: The invention relates to the use of an antimycotic agent and an epithelial cell or endothelial cell adhesion inhibitor for producing a combination drug for the topical treatment of Candida mycoses selected from vulvovaginal candidiasis, oropharyngeal candidiasis (oral thrush), diaper dermatitis (diaper thrush) and intertriginous (Candida) eczema.

Abstract: The invention described is directed to an intracorporeal occluding device having elements with non-traumatic ends and devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Abstract: Methods for the treatment of CNS disorders using combinations of muscarinic activators and inhibitors, and medicaments comprising muscarinic activators and inhibitors.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment comprising (i) a drug-loaded thermoplastic polymer core layer, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said core layer is loaded with crystals of a first (pharmaceutically) active compound and said intermediate layer is loaded with crystals of the second (pharmaceutically) active compound.

Abstract: The present invention provides improved intravaginal drug delivery devices, i.e., intravaginal rings, useful for the prophylactic administration of an antimicrobial compound, e.g., Dapivirine, to a human. The intravaginal rings of the invention address previous stability issues by utilizing a platinum catalyst (e.g., in the form of a platinum-siloxane complex) for the cross-linking reaction. The vaginal rings surprisingly achieve relatively high and steady release rates in vivo with a matrix ring containing a relatively small loading dose. While the matrix rings of the present invention have in vivo the steady release rates associated with reservoir rings, they are easier and less expensive to manufacture. The present invention also provides methods of blocking DNA polymerization by an HIV reverse transcriptase enzyme, methods of preventing HIV infection in a female human, methods of treating HIV infection in a female human, and methods of preparing platinum-catalyzed intravaginal rings.

Abstract: A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Abstract: A method for relieving menstrual pain and reducing menstrual blood loss in a female is provided. The method comprises administering intravaginally to the female a first therapeutically effective amount of a non-steroidal anti-inflammatory drug (NSAID) that relieves menstrual pain and a second therapeutically effective amount of an active agent that reduces menstrual blood loss, wherein the NSAID and the active agent are simultaneously administered by the same drug delivery device, wherein the active agent is any one of an antifibrinolytic agent and a hemostatic agent.

Abstract: The invention relates to the use of an antimycotic agent and an epithelial cell or endothelial cell adhesion inhibitor for producing a combination drug for the topical treatment of Candida mycoses selected from vulvovaginal candidiasis, oropharyngeal candidiasis (oral thrush), diaper dermatitis (diaper thrush) and intertriginous (Candida) eczema.

Abstract: A method and intravaginal drug delivery device for reducing size of endometrial implants in a female in need thereof are provided. The method includes administering intravaginally to the female a therapeutically effective amount of an active agent, wherein the agent is delivered on a delivery device directly to the endometrial implants, wherein said amount is able to significantly reduce the size of endometrial implants, wherein the active agent is any one of selective progesterone receptor modulator (SPRM), an anti-progestin agent, and an anti-progestational agent.

Abstract: Disclosed herein are compositions and methods for controlling fertility of a female subject. Particularly exemplified are compositions comprising sugar derivatives, such as 2-deoxyglucose, D-mannoheptulose; and/or 5-thio-D-glucose. Also disclosed herein are methods of preserving ova supply in a female subject that involves administering glucose derivatives. The composition typically includes a glucose derivative that affects Foxo3a expression.

Abstract: The present invention relates to monolithic intravaginal rings comprising progesterone, methods of making, and uses thereof. The intravaginal rings comprise progesterone, a polysiloxane elastomer, and a pharmaceutically acceptable hydrocarbon or glycerol esters of a fatty acid.

Abstract: The present invention provides improved intravaginal drug delivery devices, i.e., intravaginal rings, useful for the prophylactic administration of an antimicrobial compound, e.g., Dapivirine, to a human. The intravaginal rings of the invention address previous stability issues by utilizing a platinum catalyst (e.g., in the form of a platinum-siloxane complex) for the cross-linking reaction. The vaginal rings surprisingly achieve relatively high and steady release rates in vivo with a matrix ring containing a relatively small loading dose. While the matrix rings of the present invention have in vivo the steady release rates associated with reservoir rings, they are easier and less expensive to manufacture. The present invention also provides methods of blocking DNA polymerization by an HIV reverse transcriptase enzyme, methods of preventing HIV infection in a female human, methods of treating HIV infection in a female human, and methods of preparing platinum-catalyzed intravaginal rings.

Abstract: A drug delivery system consisting of one or more compartments and comprising a progestogenic compound dissolved in a thermoplastic polyethylene vinylacetate copolymer whereby, if the delivery system consists of one compartment, the compartment comprises (i) a core of a thermoplastic polyethylene vinylacetate copolymer comprising the progestogenic compound, such progestogenic compound being dissolved in the polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C., and an estrogenic compound; and (ii) a skin of a thermoplastic polyethylene vinylacetate copolymer covering the core, said skin being permeable for both compounds; if the delivery system consists of more than one compartment, only one compartment comprises (iii) the progestogenic compound, such progestogenic compound being dissolved in a core of a thermoplastic polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C.

Abstract: The invention relates to the use of an antimycotic agent and an epithelial cell or endothelial cell adhesion inhibitor for producing a combination drug for the topical treatment of Candida mycoses selected from vulvovaginal candidiasis, oropharyngeal candidiasis (oral thrush), diaper dermatitis (diaper thrush) and intertriginous (Candida) eczema.

Abstract: It relates to a device comprising (a) a core comprising polyurethane; (b) a sheath comprising ethylene vinyl acetate copolymer, said sheath substantially or completely surrounding said core; and (c) one or more active pharmaceutical ingredients dissolved or dispersed in said core and/or said sheath; and to a process for its preparation.

Abstract: A process for making a multicomponent microbicidal contraceptive intravaginal ringed-mesh device that includes forming a polymeric, fibrous mesh and adjoining a reinforcing yarn about the periphery of the fibrous mesh. The process further involves forming a polymeric ring matrix, that includes at least one contraceptive agent on the reinforced fibrous mesh, thereby encasing the reinforcing yarn and the mesh periphery, and applying at least one bioactive agent to the ringed-mesh.

Abstract: A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Abstract: This invention describes a partially absorbable, fiber-reinforced composite in the form of a ring, or a suture-like thread, with modified terminals for use as a controlled delivery system of at least one bioactive agent, wherein said composite comprising an absorbable fiber construct capable of providing time-dependent mechanical properties of a biostable elastomeric matrix containing an absorbable microparticulate ion-exchanger to modulate the release of the bioactive agent(s) for a desired period(s) of time at a specific biological site; this can be a vaginal canal, peritoneal cavity, scrotum, prostate gland, an ear loop or subcutaneous tissue. Such drug delivery systems can be used for the local administration of at least one bioactive agent, including those used as contraceptive, antimicrobial, anti-inflammatory and/or antiviral agents as well as for cancer treatment.

Abstract: A biodegradable biodelivery device is disclosed. The biodelivery device is formed from a polymer comprising the reaction product of a polyol and a polyacid. When exposed to water, the polymer degrades through hydrolysis. Of particular advantage, the polymer can be formed so as to be elastic and flexible. In one embodiment, the polymer is formed into a vaginal insert. As the polymer degrades, the polymer releases acid to a vaginal environment for decreasing the pH of the environment.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment consisting of (i) a drug-loaded thermoplastic polymer core, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said intermediate layer is loaded with (a) crystals of a first pharmaceutically active compound and with (b) a second pharmaceutically active compound in dissolved form and wherein said core is loaded with said second compound in dissolved form.

Abstract: The present invention is directed to flexible, compressed intravaginal rings comprising a substantially homogeneous compressed mixture comprising a polymethacrylate, a plasticizer, and an active agent, and methods of making and using the same, and apparatus for making the same.

Abstract: The invention described is directed to an intracorporeal occluding device having elements with non-traumatic ends and devices, systems and methods for occluding the lumens of anatomical passageways and/or for delivering drugs or other substances to the bodies of human or animal subjects.

Abstract: Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol. The drug delivery compositions are administered directly to the vagina and do not require the use of a solid device. This method of administration reduces the systematic levels of the drugs.

Abstract: Described herein is an intravaginal drug delivery system. In an embodiment the intravaginal drug delivery system includes a progestin and estrogen compound, and releases the active ingredients in a fixed physiological ratio over a prolonged period of time to produce a contraceptive state in a female.

Abstract: The present invention is directed to flexible, compressed intravaginal rings comprising a substantially homogeneous compressed mixture comprising a polymethacrylate, a plasticizer, and an active agent, and methods of making and using the same, and apparatus for making the same.

Abstract: Methods and kits for preventing or reducing the likelihood of implantation failure and pregnancy-related disorders in a recipient of artificial insemination are provided. The methods include administering into a recipient of artificial insemination in need of such treatment an effective amount of granulocyte colony stimulating factor (G-CSF).

Abstract: The invention provides a device and a compound for the prevention and/or treatment of uterine fibroids in human patients, wherein the compound is dispensed from the device and is administered locally to the uterine tissue.