Abstract: This invention is related to the use of polyurethane-based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs.

Abstract: A formulation of octreotide or pharmaceutically acceptable salts thereof, which provides controlled release of a therapeutically effective amount of octreotide for a period of at least about two months. Methods of treating acromegaly, decreasing growth hormone, decreasing IGF-1, and treating conditions associated with carcinoid tumors and VIPomas by administering a controlled release formulation of octreotide are provided herein.

Abstract: Methods and devices are described for delivering octreotide to a patient, comprising implanting a controlled release composition for delivering octreotide, wherein the composition does not require hydration prior to implantation, and wherein the composition optionally comprises a release agent.

Abstract: Medical implant devices are prepared from a polymeric material and a release agent, where the device is a molded, reservoir implant, and the release agent has a molecular weight (MW) of at least 1000. The release agent may be a non-ionic surfactant such as Brij 35, polyoxyetheylene(20)sorbitan trioleate, Tween 20, Tween 80, vitamin E TPGS, and a mixture of any two or more thereof. Hydrated implants may have a surface area of about 500 mm2 or greater.

Abstract: A formulation of octreotide or pharmaceutically acceptable salts thereof, which provides controlled release of a therapeutically effective amount of octreotide for a period of at least about two months. Methods of treating acromegaly, decreasing growth hormone, decreasing IGF-1, and treating conditions associated with carcinoid tumors and VIPomas by administering a controlled release formulation of octreotide are provided herein.

Abstract: A formulation of octreotide or pharmaceutically acceptable salts thereof, which provides controlled release of a therapeutically effective amount of octreotide for a period of at least about two months. Methods of treating acromegaly, decreasing growth hormone, decreasing IGF-1, and treating conditions associated with carcinoid tumors and VIPomas by administering a controlled release formulation of octreotide are provided herein.

Abstract: The present invention is directed to the controlled delivery of gonadotropin-releasing hormone (GnRH) agonists, preferably from a polymeric material that is implanted in the body. More specifically, the present invention relates to compositions comprised of a GnRH agonist, preferably histrelin, in a polymeric material that results in a desired and controlled delivery of a therapeutically effective amount of GnRH agonist over an extended period of time in order to treat central precocious puberty (CPP).

Abstract: This invention is related to the use of polyurethane based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs. The drug delivery device for releasing one or more drugs at controlled rates for an extended period of time to produce local or systemic pharmacological effects comprises: 1. a reservoir, said reservoir comprising; 2. at least one active ingredient; and, optionally, 3. at least one pharmaceutically acceptable carrier; a polyurethane based polymer completely surrounding the reservoir.

Abstract: A method of producing a homogenous porous hydrogel useful for drug delivery is described. The pores of the hydrogel are created by diffusion enhancers to facilitate sustained delivery of macromolecules. Also described are various articles produced from these hydrogels.

Abstract: Hydrophilic composite polymer articles are provided which comprise at least one hydrophilic polymer in a powder form and one or more liquid components of which at least one is hydrophilic and which can be polymerized with said hydrophilic polymer. This composition is produced from a homogeneously mixed paste which can be molded or cast into a desired shape which will subsequently set. The resulting article has a shape-retaining, non-tacky flexible consistency which allows the shape to be further modified, if necessary.Such object can be then cured by any of the conventional curing methods to retain its shape permanently. The final properties of the composite can be tailored to suit the final application by using fillers or modifiers. In the medical field, such articles can be utilized as a sustained release devices as they can be loaded with the desired therapeutic drugs. These articles can be made non-toxic and biocompatible and used as prosthetic devices.

Abstract: A method of preparing a hydrophilic plastic cartridge by centrifugally cang polymerizable hydrophilic material in a rotating polymerization tube whose longitudinal axis is maintained parallel to the ground. The speed of rotation causes radial outward displacement of the polymerizable material which upon assuming a predetermined shape within the rotating tube is then polymerized to the predetermined solid configuration. The resulting plastic cartridge is characterized by smooth, unscored internal and external cylindrical surfaces. The cartridges are used as a rate-limiting membrane in drug delivery devices. Sterilized kits containing a disposable needle/syringe or trocar-like instrument and the drug delivery device are used for subcutaneous implantation of the device in an animal body.

Abstract: A method is provided for the preparation of homogeneous copolymers having a redetermined equilibrium water content (EWC) value formed by the addition polymerization of a mixture of ethylenically unsaturated monomer A and ethylenically unsaturated monomer B, for example, 2-hydroxyethyl methacrylate and hydroxypropyl methacrylate. The method requires determining the EWC values of the hydrogel homopolymer of hydrophilic monomer A (homopolymer A) and the hydrogel homopolymer of hydrophilic monomer B (homopolymer B); determining the relationship of the EWC values of the homogeneous copolymers AB versus the chemical composition of said copolymers AB; selecting the targeted EWC value and determining the chemical composition of copolymer AB having the targeted EWC value; forming a polymerizable mixture of monomer A and monomer B in amounts sufficient to yield copolymer AB having the targeted EWC value; and effect the polymerization reaction to yield copolymer AB characterized by the targeted EWC value.

Abstract: An acoustically sealed earmold for a hearing aid insertable into the ear of individuals with impaired hearing can be prepared in situ employing the hydrophilic composite polymer materials described herein. Such composite materials include at least one hydrophilic polymer in a powder form and one or more liquid components of which at least one is hydrophilic and which can be polymerized with said hydrophilic polymer. The resulting earmold has a shape-retaining, non-tacky flexible consistency which allows it to be shaped further and also to be modified to accommodate a receiver adapter or external receiver. The earmold can then be cured by any of the conventional curing methods to retain its shape permanently. This method enables an audiologist to fit the earmold and evaluate the hearing aid in a single office visit.

Abstract: There is prepared a hydrophilic water swellable water insoluble copolymer of (1) at least 35% of a hydroxy (C.sub.2 -C.sub.4 -alkyl)-2-alkenoate, (2) 30 to 60% of a 2-alkenamide or an N,N-di (C.sub.1 -C.sub.6 -alkyl)2-alkenamide, (3) 5 to 20% of R --OR.sub.1).sub.x Z where R is C.sub.1 -C.sub.6 alkyl, R.sub.1 is C.sub.2 -C.sub.4 alkylene, x is an integer of 1 to 4 and Z is 2-alkenoyloxy and (4) 0.3 to 5% of a polyethylenically unsaturated crosslinking agent having a relatively long aliphatic chain, the copolymer being capable of holding 80 to 80 weight % of water. The polymers are particularly useful in preparing hydrophilic contact lenses of high burst strength and extended wear properties.

Abstract: Hydrogels are prepared by subjecting to poymerization conditions an aqueous admixture comprising a major amount of an organic monomer which is characterized by a polymerizable ethylenic group ##STR1## as illustrated by N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, dimethylaminoethyl methacrylate or methoxytriethylene glycol methacrylate, and a minor amount of solubilized collagen. The reactants employed are at least partially soluble in the aqueous reaction medium. The hydrogels thus prepared are novel shaped articles having utility in the medical and cosmetic fields. Contact lenses of such hydrogels exhibit high water content, high oxygen permeability and good mechanical strength characteristics.

Abstract: Biologically stabilized compositions are prepared by subjecting to polymerization conditions an aqueous admixture comprising from 50 to about 70 weight percent solubilized collagen and from about 30 to less than 50 weight percent of an organic compound which is characterized by a polymerizable ethylenic group (>C.dbd.C<) as illustrated by N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, dimethylaminoethyl methacrylate or methoxytriethylene glycol methacrylate. The reactants employed are at least partially soluble in the aqueous reaction medium. The hydrogels thus prepared can be in the form of novel shaped articles having utility in the medical and cosmetic fields. Such hydrogels exhibit good biological stability, high water content, high oxygen permeability and sufficient mechanical strength characteristics to be useful as contact lenses.

Abstract: There is a prepared a hydrophilic water swellable, water insoluble copolymer of (1) at least 35% of a hydroxy (C.sub.2 -C.sub.4 -alkyl)-2-alkenoate, (2) 30 to 60% of a 2-alkenamide or an N, N-di (C.sub.1 -C.sub.6 -alkyl)2-alkenamide, (3) 5 to 20% of R --OR.sub.1 --.sub.x Z where R is C.sub.1 -C.sub.6 alkyl, R.sub.1 is C.sub.2 -C.sub.4 alkylene, x is an integer of 1 to 4 and Z is 2-alkenoyloxy and (4) 0.3 to 5% of a polyethylenically unsaturated crosslinking agent having a relatively long aliphatic chain, the copolymer being capable of holding 50 to 80 weight % of water. The polymers are particularly useful in preparing hydrophilic contact lenses of high burst strength and extended wear properties.

Abstract: Hydrogels are prepared by subjecting to poymerization conditions an aqueous admixture comprising a major amount of an organic monomer which is characterized by a polymerizable ethylenic group ##STR1## as illustrated by N,N-dimethylacrylamide, 2-hydroxyethyl methacrylate, dimethylaminoethyl methacrylate or methoxytriethylene glycol methacrylate, and a minor amount of solubilized collagen. The reactants employed are at least partially soluble in the aqueous reaction medium. The hydrogels thus prepared are novel shaped articles having utility in the medical and cosmetic fields. Contact lenses of such hydrogels exhibit high water content, high oxygen permeability and good mechanical strength characteristics.