05 - Pharmaceutical, veterinary and sanitary products
40 - Treatment of materials; recycling, air and water treatment,
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical preparations; drug delivery agents; drug
delivery systems in the nature of orally administrated
capsules comprised of polymer-based layers for controlled
release of therapeutic agents. Manufacture of pharmaceuticals, drugs and drug delivery
systems in the nature of orally administrated capsules for
others. Development of drug delivery systems in the nature of orally
administrated capsules; development and research in the
field of drug agents, pharmaceuticals and drug delivery
agents.
2.
ORAL GASTRORETENTIVE FORMULATIONS AND USES THEREOF
Disclosed are gastro-retentive drug delivery devices and dosage units, for delivery of poorly water-soluble drugs, and methods of use thereof. Specific delivery devices and dosage forms are designed for delivery of cannabinoids.
The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.
The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about I 0 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.
A gastroretentive drug formulation for the sustained release of an active agent in the gastrointestinal tract comprises an internal layer or compartment comprising an active agent and one or more pharmaceutical excipients, of which at least one is a polymer and two membranes forming together an envelope around the inner membrane, each membrane comprising at least one polymeric combination of an enteric polymer which is not soluble in gastric juice, and an hydrophilic swelling polymer, and at least one plasticizer.
Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. In the broadest aspect, the method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an integrated, for example a laminated, device; folding the integrated delivery device to form a folded integrated delivery device; and at least partially enclosing the fold delivery device to a form suitable for oral delivery. The integrated device can include a first external layer of a first material; a frame of a second material mounted on the first external layer; an agent-releasing formulation housed within the frame; and a second external layer of the first material mounted on the frame.
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
Provided are methods, systems and apparatuses for producing delivery devices, for example, for oral intake of an agent. The method can include assembling one or more layers including one or more materials with an agent or an agent-releasing formulation to form an intergraded device; folding the intergrated delivery device to form a folded integrated delivery device; and at least partially enclosing the folded delivery device to a form suitable for oral delivery.
The invention provides for the use of an accordion pill comprising levodopa for the treatment of symptoms of Parkinson's disease in a subject in need thereof over a 24 hour period, to be administered to the subject in a twice daily administration regimen, with an interval of about 8 to about 10 hours between the first dose and the second dose, and with an interval of about 14 to about 16 hours between the second dose and the first dose of the following day. The twice daily administration regimen provides a stable blood plasma level of levodopa in the subject after multiple administrations and is effective in treating the symptoms of Parkinson's disease over a 24 hour period.
A biodegradable, multi-layered controlled release gastroretentive dosage form which is optionally divided into a first dosage of zaleplon for controlled release and a second dosage of zaleplon for immediate release in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates upon contact with gastric juice and the gastroretentive dosage form unfolds rapidly upon contact with gastric juice. The biodegradable, multi-layered gastroretentive dosage forms of the invention provide efficient sleep induction with good sleep maintenance and minimal next day residual effects.
Disclosed is a multi-layered gastroretentive dosage form for the controlled release of a poorly soluble drug or diagnostic in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates rapidly and the said multi-layered dosage form unfolds rapidly upon contact with the gastric juice. The mechanisms of the gastric retention are not dependent on and do not influence the materials and methods used in controlling the release of the said poorly soluble drug.
A biodegradable, multi-layered controlled release gastroretentive baclofen dosage form which is optionally divided into a first dosage of baclofen for immediate release and a second dosage of baclofen for controlled release in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates upon contact with gastric juice and the dosage form unfolds rapidly upon contact with gastric juice. The biodegradable, multi- layered gastroretentive dosage forms of the invention provide fast onset of baclofen activity with prolonged absorption and minimal undesirable side effects.
A biodegradable, multi-layered controlled release gastroretentive dosage form which is optionally divided into a first dosage of zaleplon for controlled release and a second dosage of zaleplon for immediate release in the stomach and gastrointestinal tract of a patient, folded into a capsule which disintegrates upon contact with gastric juice and the gastroretentive dosage form unfolds rapidly upon contact with gastric juice. The biodegradable, multi- layered gastroretentive dosage forms of the invention provide efficient sleep induction with good sleep maintenance and minimal next day residual effects.
A01N 43/90 - Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having two or more relevant hetero rings, condensed among themselves or with a common carbocyclic ring system
A61K 31/519 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM, LTD. (Israel)
Inventor
Friedman, Michael
Kirmayer, David
Abstract
A novel gastroretentive delivery system comprising a tablet comprising a pharmaceutical ingredient or diagnostic, which tablet comprises a gas releasing ingredient or a tandem of two gas releasing ingredients, an ingredient capable of unrestricted swelling in gastric fluid, an ingredient capable of limiting the unrestricted swelling and a hardening ingredient. The said system is based on the use of three different gastroretentive mechanisms: flotation, swelling and mechanical strength, the three mechanisms acting in a complimentary way. Processes for manufacturing same and methods of treatment are also disclosed.
Methods, systems and apparatuses are provided for producing delivery devices, preferably for oral intake of an agent. In the broadest aspect, the method comprises assembling one or more layers comprising one or more materials with an agent or an agent-releasing formulation to form an intergraded, preferably laminated device; folding said integrated delivery device to form a folded integrated delivery device; and at least partially enclosing said folded delivery device to a form suitable for oral delivery. Preferably, the integrated device comprise a first external layer of a first material; a frame of a second material mounted on the first external layer; an agent-releasing formulation housed within the frame; and a second external layer of the first material mounted on the frame.
A gastroretentive drug formulation for the sustained release of an active agent in the gastrointestinal tract comprises an internal layer or compartment comprising an active agent and one or more pharmaceutical excipients, of which at least one is a polymer and two membranes forming together an envelope around the inner membrane, each membrane comprising at least one polymeric combination of an enteric polymer which is not soluble in gastric juice, and an hydrophilic swelling polymer, and at least one plasticizer.