The invention provides gastric residence systems with specifically tailored architectures and methods for making such systems. The components of the gastric residence systems can be manufactured by three-dimensional printing or by co-extrusion. The ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the systems.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61F 5/00 - Orthopaedic methods or devices for non-surgical treatment of bones or jointsNursing devices
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A gastric residence system comprises one or more retention members comprising: at least one drug eluting component; and at least one laser linker component laser welded to the at least one drug eluting component.
A gastric residence system comprises one or more retention members comprising: at least one drug eluting component; and at least one laser linker component laser welded to the at least one drug eluting component.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
4.
GASTRIC RESIDENCE SYSTEMS FOR ADMINISTRATION OF RISPERIDONE
Gastric residence systems for administration of risperidone are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
The invention provides gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, with release rate-modulating films and methods for making and using such systems. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) present in the gastric residence system. The films also permit higher drug loading in the gastric residence systems and components of gastric residence systems while maintaining good control over release of agents. Some embodiments of the films can provide resistance against burst release of agent upon exposure to alcohol.
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
6.
GEOMETRIC CONFIGURATIONS FOR GASTRIC RESIDENCE SYSTEMS
The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/46 - Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
C08G 18/12 - Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step using two or more compounds having active hydrogen in the first polymerisation step
C08G 18/42 - Polycondensates having carboxylic or carbonic ester groups in the main chain
C08G 18/73 - Polyisocyanates or polyisothiocyanates acyclic
Provided are gastric residence systems comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50 wt % polycaprolactone, and 0.5-3 wt % poloxamer, and a rate-modulating release film coating the at least one co-extruded drug eluting component. The gastric residence systems comprising at least one drug-eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release methadone for at least 48 hours, such that the at least one drug eluting component with the rate-modulating release film is configured to release at least 10% of the methadone or the salt thereof after the first 24 hours of residence within the stomach.
A61K 31/137 - Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
8.
GASTRIC RESIDENCE SYSTEMS COMPRISING BUPRENORPHINE AND NALOXONE
Provided are gastric residence systems comprising at least one co-extruded drug-eluting component comprising a carrier polymer, buprenorphine or a salt thereof, and naloxone or a salt thereof, and a rate-modulating release film coating the at least one co-extruded drug-eluting component. The gastric residence systems comprising at least one co-extruded drug-eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release buprenorphine for at least 48 hours, such that the at least one co-extruded drug eluting component with the rate-modulating release film is configured to release at least 10% of the buprenorphine or the salt thereof after the first 24 hours of residence within the stomach and at least 10% of the naloxone or the salt thereof after the first 24 hours of residence within the stomach.
Compactable gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods and systems for encapsulating such gastric residence systems. The methods and systems for encapsulating the gastric residence systems can be automated from receiving a bulk of gastric residence systems, orienting, placing, compacting, securing, and encapsulating the gastric residence systems.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
10.
RISPERIDONE DOSAGE REGIMENS WITH GASTRIC RESIDENCE SYSTEMS
Dosage regimens for gastric residence systems comprising risperidone or a salt thereof are disclosed. The dosage regimens include regimens where immediate release risperidone or a salt thereof is administered during a first period, immediate release risperidone or a salt thereof and gastric residence systems comprising risperidone or a salt thereof are administered during a second period, and gastric residence systems comprising risperidone or a salt thereof are administered over a third period. The dosage regimens also include regimens where immediate release risperidone or a salt thereof and gastric residence systems comprising risperidone or a salt thereof are administered during a co-administration period, and gastric residence systems comprising risperidone or a salt thereof are administered over a subsequent period.
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 9/00 - Medicinal preparations characterised by special physical form
Provided are metal cores for gastric residence system and gastric residence systems comprising metal cores. A metal core according to some embodiments includes a plurality of arm mounts, each arm mount configured to receive an elongate arm of a gastric residence system, wherein the core is configured to bend into a compacted form such that each arm mount of the plurality of arm mounts approach each other and, when a plurality of elongate arms are attached to the metal core, the distal ends of the plurality of elongate arms approach each other, and wherein the metal of the metal core provides elasticity and shape memory to cause the metal core to unfold into an uncompacted form and, when a plurality of elongate arms are attached to the metal core, allow retention of the gastric residence system.
A61K 47/30 - Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
A61J 3/00 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/52 - Sustained or differential release type
Gastric residence systems for administration of risperidone are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
Gastric residence systems and methods of delivering a drug to an individual using a gastric residence system are described herein. The gastric residence system may include a time-dependent and/or enteric, or dual time-dependent and enteric polymeric linker. In some embodiments, the time-dependent polymeric linker includes PLGA, and optionally PLA or a carrier polymer. The enteric polymeric linker includes an enteric polymeric, and optionally a carrier polymer such as PCL or TPU. The time-dependent polymeric linker may degrade in the stomach of the individual according to a degradation (or flexural modulus loss) profile described herein, and the enteric polymeric linker may degrade in the intestine of the individual another degradation profile described herein (or flexural modulus loss).
A61K 47/59 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
A61K 47/69 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61F 2/04 - Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
A61L 31/06 - Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61P 1/04 - Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
15.
GASTRIC RESIDENCE SYSTEMS HAVING A FILAMENT FOR IMPROVED GASTRIC RESIDENCE
Provided are gastric residence systems comprising: a core; a plurality of arms connected to the core at a proximal end through a plurality of linker components, one linker component of the plurality of linker components corresponding to each arm of the plurality of arms, and the plurality of arms extending radially from the proximal end, and a filament circumferentially connecting each arm of the plurality of arms.
Gastric residence systems for administration of agents, such as drugs, are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; flexible arms for a gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Provided are gastric residence dosage forms comprising flexible arms that can help prevent premature passage of the gastric residence system through the pylorus of a patient. In particular, described herein are gastric residence systems comprising one or more arms extending radially, the one or more arms comprising a first segment comprising a first polymer composition and a second segment comprising a second polymer composition, wherein the first segment has a stiffness of greater than a stiffness of the second segment, as measured using a 3-point bending test per ASTM D790. The second segments of the arms of the gastric residence systems help prevent premature passage of the gastric residence system through the pylorus of a patient.
Provided herein are gastric residence systems, or components of gastric residence system such as arms (elongate members) or segments of gastric residence systems, with release rate-modulating films. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) from the gastric residence systems. The release rate-modulating films disclosed herein resist changes to their release properties during heat-assisted assembly of the gastric residence systems.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Provided are gastric residence systems comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50 wt% polycaprolactone, and 0.5-3 wt% poloxamer, and a rate-modulating release film coating the at least one co-extruded drug eluting component. The gastric residence systems comprising at least one drug-eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release methadone for at least 48 hours, such that the at least one drug eluting component with the rate-modulating release film is configured to release at least 10 % of the methadone or the salt thereof after the first 24 hours of residence within the stomach.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A61K 31/485 - Morphinan derivatives, e.g. morphine, codeine
Provided are gastric residence systems comprising at least one co-extruded drug-eluting component comprising a carrier polymer, buprenorphine or a salt thereof, and naloxone or a salt thereof, and a rate-modulating release fdm coating the at least one co-extruded drug¬ eluting component. The gastric residence systems comprising at least one co-extruded drug¬ eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release buprenorphine for at least 48 hours, such that the at least one co¬ extruded drug eluting component with the rate-modulating release film is configured to release at least 10 % of the buprenorphine or the salt thereof after the first 24 hours of residence within the stomach and at least 10 % of the naloxone or the salt thereof after the first 24 hours of residence within the stomach.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A61K 31/485 - Morphinan derivatives, e.g. morphine, codeine
Provided are gastric residence systems comprising at least one co-extruded drug-eluting component comprising a carrier polymer, buprenorphine or a salt thereof, and naloxone or a salt thereof, and a rate-modulating release fdm coating the at least one co-extruded drug¬ eluting component. The gastric residence systems comprising at least one co-extruded drug¬ eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release buprenorphine for at least 48 hours, such that the at least one co¬ extruded drug eluting component with the rate-modulating release film is configured to release at least 10 % of the buprenorphine or the salt thereof after the first 24 hours of residence within the stomach and at least 10 % of the naloxone or the salt thereof after the first 24 hours of residence within the stomach.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A61K 31/485 - Morphinan derivatives, e.g. morphine, codeine
Provided are gastric residence systems comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50 wt% polycaprolactone, and 0.5-3 wt% poloxamer, and a rate-modulating release film coating the at least one co-extruded drug eluting component. The gastric residence systems comprising at least one drug-eluting component are configured to be maintained within a stomach of a human body for at least 48 hours and to release methadone for at least 48 hours, such that the at least one drug eluting component with the rate-modulating release film is configured to release at least 10 % of the methadone or the salt thereof after the first 24 hours of residence within the stomach.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A61K 31/485 - Morphinan derivatives, e.g. morphine, codeine
Gastric residence systems for administration of risperidone are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
Gastric residence systems for administration of risperidone are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Drug delivery platform technology, namely, orally
administered gastric resident drug delivery forms for the
controlled release of a wide variety of therapeutic agents.
Provided are enrobed gastric residence dosage forms comprising: a gastric residence system in a folded configuration; and a coating enrobing the gastric residence system in the folded configuration, wherein the enrobed gastric residence dosage form is configured to release the gastric residence system in the folded configuration in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating comprises water, a plasticizer, a gelling agent, and/or a polymer.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical products, preparations, and substances. Research and development services in the field of dosage
forms for extended release pharmaceuticals.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Drug delivery agents in the form of orally administered gastric resident tablets and capsules for the controlled release of the active ingredients of a wide variety of pharmaceuticals.
29.
CAPSULES AND CAPSULE COATINGS FOR GASTRIC RESIDENCE DOSAGE FORMS
Provided are gastric residence dosage forms comprising: a gastric residence system in a folded configuration; a capsule encapsulating the gastric residence system in a folded configuration; and a coating on the capsule, wherein the gastric residence dosage form is configured to release the gastric residence system in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating on the capsule includes a polymer, an anti-tacking agent, and/or a hydration aid.
Provided are stomach simulating devices and methods for simulating a stomach. Stomach simulating devices can comprise a bag-shaped conduit, a mechanical constrictor, and a valve. The conduit can have a body portion, a first diameter at an inlet portion, and a second diameter at an outlet portion, wherein the first diameter at the inlet portion is greater than the second diameter at the outlet portion, the body portion is located between the inlet portion and the outlet portion, and at least a portion of the conduit is curved in a direction from the inlet portion the outlet portion. The mechanical constrictor can he configured to constrict at least a portion of the body portion of the conduit. The valve can be configured to at least partially close a portion of the conduit closer to the outlet portion than the inlet portion of the conduit.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceutical preparations for human use for the treatment of allergies, autoimmune diseases, blood disorders, bone diseases, cardiovascular diseases, cerebrovascular diseases, diabetes, digestive diseases, gastrointestinal diseases, genetic disorders, hepatological diseases and disorders, hematological diseases and disorders, hormonal disorders, kidney diseases, liver diseases and disorders, migraines, headaches, pain, musculoskeletal disorders, ophthalmic diseases, oncological diseases and disorders, pulmonary diseases and disorders, respiratory diseases, renal disease and disorders, skin and nail diseases, and vascular diseases; Antivirals; Pharmaceutical preparations for use in tissue and organ transplantation; Pharmaceutical preparations for the treatment of dermatological diseases and disorders namely dermatitis, skin and bacterial skin infections and fungal skin infections; Pharmaceutical preparations for the treatment of diseases, disorders and infections of the endocrine system, namely growth and thyroid disorders; Pharmaceutical preparations for the treatment of diseases, disorders and infections of the central nervous system namely brain, movement, ocular motility and spinal cord diseases; Pharmaceutical preparations for the treatment of neurological diseases, namely, myasthenia gravis, Alzheimer's, Huntington's Disease, cerebral palsy; Pharmaceutical preparations for the treatment of psychiatric diseases and disorders namely mood disorders, anxiety disorders, cognitive disorders, schizophrenia, and psychoses; Pharmaceutical preparations for the treatment of genitourinary and pelvic diseases, disorders and infections, namely infertility, sexually transmitted diseases, incontinence and sexual dysfunction; Pharmaceutical preparations for the treatment and prevention of HIV infection; Neurological and psychological pharmaceutical preparations for the treatment of drug addictions; Pharmaceutical preparations for the treatment and prevention of HIV infection; Contraceptive preparations; Pharmaceutical preparations for the treatment of malaria; Drug delivery agents in the form of capsules that provide controlled release of the active ingredients for a wide variety of pharmaceuticals.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Pharmaceutical preparations for human use for the treatment of allergies, autoimmune diseases, blood disorders, bone diseases, cardiovascular diseases, cerebrovascular diseases, diabetes, digestive diseases, gastrointestinal diseases, genetic disorders, hepatological diseases and disorders, hematological diseases and disorders, hormonal disorders, kidney diseases, liver diseases and disorders, migraines, headaches, pain, musculoskeletal disorders, ophthalmic diseases, oncological diseases and disorders, pulmonary diseases and disorders, respiratory diseases, renal disease and disorders, skin and nail diseases, and vascular diseases; Antivirals; Pharmaceutical preparations for use in tissue and organ transplantation; Pharmaceutical preparations for the treatment of dermatological diseases and disorders namely dermatitis, skin and bacterial skin infections and fungal skin infections; Pharmaceutical preparations for the treatment of diseases, disorders and infections of the endocrine system, namely growth and thyroid disorders; Pharmaceutical preparations for the treatment of diseases, disorders and infections of the central nervous system namely brain, movement, ocular motility and spinal cord diseases; Pharmaceutical preparations for the treatment of neurological diseases, namely, myasthenia gravis, Alzheimer's, Huntington's Disease, cerebral palsy; Pharmaceutical preparations for the treatment of psychiatric diseases and disorders namely mood disorders, anxiety disorders, cognitive disorders, schizophrenia, and psychoses; Pharmaceutical preparations for the treatment of genitourinary and pelvic diseases, disorders and infections, namely infertility, sexually transmitted diseases, incontinence and sexual dysfunction; Pharmaceutical preparations for the treatment and prevention of HIV infection; Neurological and psychological pharmaceutical preparations for the treatment of drug addictions; Pharmaceutical preparations for the treatment and prevention of HIV infection; Contraceptive preparations; Pharmaceutical preparations for the treatment of malaria; Drug delivery agents in the form of capsules that provide controlled release of the active ingredients for a wide variety of pharmaceuticals. (1) Medical and pharmacological research and development services in the field of drug delivery agents for regulating dosage forms for extended release pharmaceuticals; Pharmaceutical research and development services, namely, research and development in the field of drug delivery agents for the extended release of the active ingredients for a wide variety of pharmaceuticals.
Gastric residence systems and methods of delivering a drug to an individual using a gastric residence system are described herein. The gastric residence system may include a time-dependent and/or enteric, or dual time-dependent and enteric polymeric linker. In some embodiments, the time-dependent polymeric linker includes PLGA, and optionally PLA or a carrier polymer. The enteric polymeric linker includes an enteric polymeric, and optionally a carrier polymer such as PCL or TPU. The time-dependent polymeric linker may degrade in the stomach of the individual according to a degradation (or flexural modulus loss) profile described herein, and the enteric polymeric linker may degrade in the intestine of the individual another degradation profile described herein (or flexural modulus loss).
A61F 2/04 - Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61L 31/06 - Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61P 1/00 - Drugs for disorders of the alimentary tract or the digestive system
38.
GASTRIC RESIDENCE SYSTEMS FOR ADMINISTRATION OF ACTIVE AGENTS
Gastric residence systems for administration of agents, such as drugs, are disclosed. Features which enhance gastric retention during the desired residence time and which allow for more precise control over residence time are disclosed, including circumferential filaments connecting the arms of a stellate gastric residence system; flexible arms for a gastric residence system; improved time-dependent and enteric disintegrating matrices (linkers); and release rate-modulating polymer coatings which are resistant to change in release rate properties during heat-assisted assembly or thermal cycling. Combinations of these features are also disclosed.
A61K 31/495 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
A61K 31/505 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61L 27/54 - Biologically active materials, e.g. therapeutic substances
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
39.
GASTRIC RESIDENCE SYSTEMS HAVING A FILAMENT FOR IMPROVED GASTRIC RESIDENCE
Provided are gastric residence systems comprising: a core; a plurality of arms connected to the core at a proximal end through a plurality of linker components, one linker component of the plurality of linker components corresponding to each arm of the plurality of arms, and the plurality of arms extending radially from the proximal end, and a filament circumferentially connecting each arm of the plurality of arms.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceuticals for the treatment of neurological and
metabolic related diseases and disorders; pharmaceutical
preparations and substances for the treatment of cognitive
disorders; pharmaceuticals for the treatment of viral,
endocrine, musculoskeletal, cardiovascular, cardiopulmonary,
genitourinary, sexual dysfunction, oncological,
hepatological, ophthalmic, respiratory, neurological,
gastrointestinal, hormonal, dermatological, psychiatric,
drug addiction, substance abuse and immune system related
diseases and disorders; pharmaceuticals for the treatment of
mosquito-borne illnesses; antibiotics; pharmaceutical
preparations and substances for the treatment of infectious
diseases, blood disorders, pain, inflammation, sepsis,
alopecia and obesity; pharmaceuticals for immunosuppression,
namely, solid organ transplant; contraceptive preparations;
pharmaceuticals for the prevention of opioid toxicity or
overdosage, chemical or nerve agent toxicity and radiation
poisoning or sickness. Research and development services in the field of dosage
forms for extended release pharmaceuticals.
41.
CAPSULES AND CAPSULE COATINGS FOR GASTRIC RESIDENCE DOSAGE FORMS
Provided are gastric residence dosage forms comprising: a gastric residence system in a folded configuration; a capsule encapsulating the gastric residence system in a folded configuration; and a coating on the capsule, wherein the gastric residence dosage form is configured to release the gastric residence system in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating on the capsule includes a polymer, an anti-tacking agent, and/or a hydration aid.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
A61K 47/12 - Carboxylic acidsSalts or anhydrides thereof
Provided are enrobed gastric residence dosage forms comprising: a gastric residence system in a folded configuration; and a coating enrobing the gastric residence system in the folded configuration, wherein the enrobed gastric residence dosage form is configured to release the gastric residence system in the folded configuration in a stomach of a patient, allowing the gastric residence system to assume an open configuration. The coating comprises water, a plasticizer, a gelling agent, and/or a polymer.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
A61K 47/12 - Carboxylic acidsSalts or anhydrides thereof
Compactable gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods and systems for encapsulating such gastric residence systems. Hie methods and systems for encapsulating the gastric residence systems can be automated from receiving a bulk of gastric residence systems, orienting, placing, compacting, securing, and encapsulating the gastric residence systems.
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
A61K 9/00 - Medicinal preparations characterised by special physical form
44.
Gastric residence systems with release rate-modulating films
The invention provides gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, with release rate-modulating films and methods for making and using such systems. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) present in the gastric residence system. The films also permit higher drug loading in the gastric residence systems and components of gastric residence systems while maintaining good control over release of agents. Some embodiments of the films can provide resistance against burst release of agent upon exposure to alcohol.
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceuticals for the treatment of neurological and metabolic related diseases and disorders; pharmaceutical preparations and substances for the treatment of cognitive disorders Research and development services in the field of dosage forms for extended release pharmaceuticals
46.
SYSTEMS FOR ENTERIC DELIVERY OF THERAPEUTIC AGENTS
Described herein are systems for the enteric delivery of therapeutic agents, and methods of administering a therapeutic agent to a patient by orally administering an enteric delivery system. The enteric deliver system includes one or more carrier members comprising a carrier polymer and a therapeutic agent, and the system is configurable in a compacted configuration and an expanded configuration, and is sized to maintain contact with the intestinal wall of the small intestine by applying an outwardly directed pressure to the intestinal wall and transport at least a portion of the therapeutic agent across the enteric mucosa of the small intestine.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 9/52 - Sustained or differential release type
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
47.
Geometric configurations for gastric residence systems
The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/46 - Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
A61M 31/00 - Devices for introducing or retaining media, e.g. remedies, in cavities of the body
C08G 18/12 - Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step using two or more compounds having active hydrogen in the first polymerisation step
C08G 18/42 - Polycondensates having carboxylic or carbonic ester groups in the main chain
C08G 18/73 - Polyisocyanates or polyisothiocyanates acyclic
48.
Materials architecture for gastric residence systems
The invention provides gastric residence systems with specifically tailored architectures and methods for making such systems. The components of the gastric residence systems can be manufactured by three-dimensional printing or by co-extrusion. The ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the systems.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61F 5/00 - Orthopaedic methods or devices for non-surgical treatment of bones or jointsNursing devices
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.
A61P 25/28 - Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
A61P 31/16 - Antivirals for RNA viruses for influenza or rhinoviruses
A61K 9/00 - Medicinal preparations characterised by special physical form
Compactable gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods and systems for encapsulating such gastric residence systems. Hie methods and systems for encapsulating the gastric residence systems can be automated from receiving a bulk of gastric residence systems, orienting, placing, compacting, securing, and encapsulating the gastric residence systems.
A61J 3/07 - Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
A61K 9/52 - Sustained or differential release type
51.
GASTRIC RESIDENCE SYSTEMS WITH RELEASE RATE-MODULATING FILMS
The invention provides gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, with release rate- modulating films and methods for making and using such systems. The release rate-modulating films provide good control over release of agents (such as therapeutic, diagnostic, or nutritional agents) present in the gastric residence system. The films also permit higher drug loading in the gastric residence systems and components of gastric residence systems while maintaining good control over release of agents. Some embodiments of the films can provide resistance against burst release of agent upon exposure to alcohol.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
52.
Gastric residence systems for sustained release of therapeutic agents and methods of use thereof
Gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.
A61K 31/495 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
A61K 31/505 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim
53.
GASTRIC RESIDENCE SYSTEMS FOR SUSTAINED DELIVERY OF ADAMANTANE-CLASS DRUGS
The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.
The invention provides gastric residence systems with specifically tailored architectures and methods for making such systems. The components of the gastric residence systems can be manufactured by three-dimensional printing or by co-extrusion. The ability to construct precise architectures for the systems provides excellent control over drug release, in vivo stability, and residence time of the systems.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceuticals for the treatment of viral, metabolic, endocrine, musculoskeletal, cardiovascular, cardiopulmonary, genitourinary, sexual dysfunction, oncological, hepatological, ophthalmic, respiratory, neurological, gastrointestinal, hormonal, dermatological, psychiatric and immune system related diseases and disorders; antibiotics; pharmaceutical preparations and substances for the treatment of infectious diseases, blood disorders, pain, inflammation, sepsis, alopecia, obesity and cognitive disorders; pharmaceuticals for immunosuppression, namely, solid organ transplant. Research and development services in the field of a platform for extended release pharmaceuticals.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceuticals for the treatment of neurological diseases and disorders; pharmaceutical preparations and substances for the treatment of cognitive disorders Research and development services in the field of dosage forms for extended release pharmaceuticals
The invention provides gastric residence systems with configurations and geometrical dimensions that allow for improved shelf life during prolonged storage, and optimal residence properties when the systems are deployed in the stomach of a patient.
Gastric residence systems comprising therapeutic agent formulationsfor sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.
