Abstract: Disclosed are a controlled-release dosage form with an absorption window in the upper gastrointestinal tract and a preparation method therefor, wherein the controlled-release dosage form comprises a controlled-release platform and a retention platform. The controlled-release platform is a pharmaceutical composition comprising a tablet core and a coating membrane; and the retention platform holds the controlled-release platform in the oral cavity. The operation steps of the controlled-release dosage form are as follows: placing the controlled-release platform in the retention platform, and fixing the retention platform on matching teeth in the oral cavity; taking out the controlled-release dosage form after 4-24 hours and replacing same with a new controlled-release platform; and re-fixing the retention platform on the matching teeth in the oral cavity to achieve the sustained and stable release of drugs.

Abstract: Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, an amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and a hydrophilic polymer of polyoxyethylene-polyoxypropylene glycol block copolymer. The mass percentage of the active pharmaceutical ingredient in the pharmaceutical composition is 5 wt % to 60 wt %; the mass percentage of the amphiphilic polymer in the pharmaceutical composition is 3 wt % to 40 wt %; and the mass percentage of the hydrophilic polymer in the pharmaceutical composition is 10 wt % to 90 wt %. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

Abstract: A solid particle, a preparation method therefor, and a pharmaceutical composition. The solid particle comprises a porous solid particle and a non-aqueous liquid formula. The non-aqueous liquid formula comprises 0.10-4.00 wt % of a hydrophobic active pharmaceutical agent, 28.00-99.90 wt % of a hydrophobic solubilizing solution, 0-70.00 wt % of a non-ionic surfactant, and 0-1.00 wt % of an antioxidant. The hydrophobic solubilizing solution comprises a medium-chain monoglyceride and diglyceride, and/or a propylene glycol fatty acid monoester.

Abstract: Disclosed are a pharmaceutical composition, an osmotic pump controlled-release drug delivery system comprising the pharmaceutical composition and a preparation method therefor. The pharmaceutical composition comprises a tablet core and a coating film. The tablet core comprises a drug-pulling layer, and the coating film comprises 50-90 wt % of cellulose acetate and 10-50 wt % of Copovidone. The Copovidone can be obtained by means of the polymerization of vinyl pyrrolidone and vinyl acetate in a molar ratio of 40:60-80:20.

Abstract: Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and a amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23 to 1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

Abstract: A drug accommodating device of a solid oral formulation and an oral administration and delivery apparatus comprising same. The drug accommodating device comprises a filtering component and a supporting component; the filtering component and the supporting component cooperate with each other to form a space used for bearing drug particles or multiple pills; the filtering component has one or more pore channels allowing a liquid to pass; the pore channels are distributed in the filtering component in an up-down intricate intersection mode; alternatively, a water-soluble polymer material layer is provided on the filtering component.

Abstract: Disclosed is an oral drug delivery device, comprising a tubular member, a drug holding part, a device cap and a turbulence-creating means. The tubular member has openings at both ends and an inner cavity; the opening at one end is a first opening and the opening at the other end is a second opening; the inner cavity communicates the first opening and the second opening. The turbulence-creating means comprises a step structure or a fold structure, and is disposed in the inner cavity and positioned between the second opening and the drug holding part. By using the oral drug delivery device of the present invention, turbulence can be generated during a normal sipping process, thereby providing ample mixing of drug-containing granules or multi-particulates with drinkable liquids. Moreover, the device is telescopic, which reduces the size and is convenient to carry.

Abstract: Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and an polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23 to 1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.

Abstract: Disclosed are a controlled-release dosage form with an absorption window in the upper gastrointestinal tract and a preparation method therefor, wherein the controlled-release dosage form comprises a controlled-release platform and a retention platform. The controlled-release platform is a pharmaceutical composition comprising a tablet core and a coating membrane; and the retention platform holds the controlled-release platform in the oral cavity. The operation steps of the controlled-release dosage form are as follows: placing the controlled-release platform in the retention platform, and fixing the retention platform on matching teeth in the oral cavity; taking out the controlled-release dosage form after 4-24 hours and replacing same with a new controlled-release platform; and re-fixing the retention platform on the matching teeth in the oral cavity to achieve the sustained and stable release of drugs.

Abstract: Disclosed are a pharmaceutical composition, an osmotic pump controlled-release drug delivery system comprising the pharmaceutical composition and a preparation method therefor. The pharmaceutical composition comprises a tablet core and a coating film. The tablet core comprises a drug-pulling layer, and the coating film comprises 50-90 wt % of cellulose acetate and 10-50 wt % of Copovidone. The Copovidone can be obtained by means of the polymerization of vinyl pyrrolidone and vinyl acetate in a molar ratio of 40:60-80:20.

Abstract: A solid particle, a preparation method therefor, and a pharmaceutical composition. The solid particle comprises a porous solid particle and a non-aqueous liquid formula. The non-aqueous liquid formula comprises 0.10-4.00 wt % of a hydrophobic active pharmaceutical agent, 28.00-99.90 wt % of a hydrophobic solubilizing solution, 0-70.00 wt % of a non-ionic surfactant, and 0-1.00 wt % of an antioxidant. The hydrophobic solubilizing solution comprises a medium-chain monoglyceride and diglyceride, and/or a propylene glycol fatty acid monoester.

Abstract: The present invention provides orodispersable tablets and methods of using the same. The tablets and methods are useful, for example, for reducing first pass metabolism of orally administered active agents, enhancing bioavailability of active agents, and/or reducing the time it takes for an active agent to achieve maximal effect in a subject. The tablets, when taken orally, disintegrate or dissolve rapidly such that active agent included in the tablets is absorbed in the buccal cavity. The invention further provides methods of manufacturing any of the tablets disclosed herein and containers that include any of the tablets disclosed herein.

Abstract: A sustained release dosage form includes a capsule made of a thermoplastic polymer having a softening point below 200° C. and an orifice formed or formable within the capsule, an emulsion formulation contained within the capsule, and an expandable composition within the capsule remote from the orifice. The emulsion formulation comprises a drug, an emulsifying surfactant, and an oil. The expandable composition is configured to expand and expel the emulsion formulation through the orifice.

Abstract: A thin-walled capsule of defined permeability is produced by blow-molding an aqueous-based polymer composition.

Abstract: A dosage form is disclosed comprising a semipermeable walled container that houses a capsule, which capsule comprises a drug formulation, a piston, and an osmotic composition. The dosage form delivers the drug formulation through a passageway at a controlled rate over a sustained-release period of time up to 24 hours.

Abstract: An extended release oral administered dosage form of acetaminophen and tramadol. The dosage form includes a composition of acetaminophen together with a tramadol complex formed with an anionic polymer. The tramadol complex provides sustained release of tramadol for a synchronized (coordinated) release profile of acetaminophen and tramadol.

Abstract: The present invention provides orodispersable tablets and methods of using the same. The tablets and methods are useful, for example, for reducing first pass metabolism of orally administered active agents, enhancing bioavailability of active agents, and/or reducing the time it takes for an active agent to achieve maximal effect in a subject. The tablets, when taken orally, disintegrate or dissolve rapidly such that active agent included in the tablets is absorbed in the buccal cavity. The invention further provides methods of manufacturing any of the tablets disclosed herein and containers that include any of the tablets disclosed herein.

Abstract: A dosage form is disclosed comprising a semipermeable walled container that houses a capsule, which capsule comprises a drug formulation, a piston, and an osmotic composition. The dosage form delivers the drug formulation through a passageway at a controlled rate over a sustained-release period of time up to 24 hours.

Abstract: A dosage form is disclosed comprising a semipermeable walled container that houses a capsule, which capsule comprises a drug formulation, a piston, and an osmotic composition. The dosage form delivers the drug formulation through a passageway at a controlled rate over a sustained-release period of time up to 24 hours.

Abstract: The present invention includes an expandable osmotic layer and a coating suspension for providing an expandable osmotic layer, both of which are useful for the manufacture of controlled release dosage forms. The expandable osmotic layer of the present invention may be produced using the coating suspension of the present invention. Advantageously, the coating suspension of the present invention can be used to coat expandable osmotic layers under both wet and dry process conditions without sacrificing the quality of the expandable osmotic layers produced, and therefore provides a relatively robust coating suspension that facilitates commercial production of controlled release dosage forms including a coated expandable osmotic layer.