Abstract: This disclosure provides a novel freeze-dried amlodipine composition which when admixed with an aqueous diluent almost instantly forms an oral solution at the time of use. The disclosed freeze-dried amlodipine composition is stable at room temperature for at least 12-24 months and does not require refrigeration during its shipping, storage, use, and during its shelflife. In addition, the disclosed freeze-dried amlodipine composition does not contain any alcohol and/or benzoates that are harmful to vulnerable patient populations such as younger children (e.g., children less than six years of age, including infants and neonates). Moreover, the oral solution reconstituted from the disclosed freeze-dried amlodipine composition does not have a potential dose uniformity risk caused by drug sedimentation of an amlodipine suspension.
Abstract: This disclosure provides a novel freeze-dried amlodipine composition which when admixed with an aqueous diluent almost instantly forms an oral solution at the time of use. The disclosed freeze-dried amlodipine composition is stable at room temperature for at least 12-24 months and does not require refrigeration during its shipping, storage, use, and during its shelf-life. In addition, the disclosed freeze-dried amlodipine composition does not contain any alcohol and/or benzoates that are harmful to vulnerable patient populations such as younger children (e.g., children less than six years of age, including infants and neonates). Moreover, the oral solution reconstituted from the disclosed freeze-dried amlodipine composition does not have a potential dose uniformity risk caused by drug sedimentation of an amlodipine suspension.
Abstract: This disclosure provides a method of coating ion exchange resin or ion exchange resin-drug solid particles. The coated micronized or non-micronized ion exchange resin or ion exchange resin-drug solid complex particles as prepared by the disclosed methods are suitable for being used directly or as a component for bringing added features for a pharmaceutical product.
Abstract: This disclosure provides a method of administrating to a subject a two-portion solution system in a specific ingesting order to yield a water-insoluble cross-linked hydrogel mass in the stomach. The volume of the formed water-insoluble cross-linked hydrogel mass is at least 50% v/v of the total volume of the two-portion solution system. The method is useful for preventing and treating overweight and obesity.
Abstract: This disclosure provides a pharmaceutical unit dose system. The unit dose system includes a unit-of-use self-dispersing dry composition for oral suspension. Also provided is a method for preparing a single unit dose of a dry pharmaceutical composition for oral administration. The unit dose system is advantageous in the convenience of use, dosing accuracy, long term storage, suspension uniformity over conventional multidose powder composition for oral suspension.
Abstract: This disclosure provides a method of administrating to a subject a two-portion solution system in a specific ingesting order to yield a water-insoluble cross-linked hydrogel mass in the stomach. The volume of the formed water-insoluble cross-linked hydrogel mass is at least 50% v/v of the total volume of the two-portion solution system. The method is useful for preventing and treating overweight and obesity.
Abstract: This disclosure provides a pharmaceutical composition for oral administration, which comprises micronized ion-exchange resin particles having particle sizes less than 50 pm and at least one therapeutic agent releasably bound to the micronized resin particles through ionic interaction to form resin-therapeutic agent complexes. The resin-therapeutic agent complexes have particle sizes less than 50 pm, and the pharmaceutical composition is formulated as a dosage form providing uniform dispersion of the resin-therapeutic agent complexes with a substantially masked taste of the therapeutic agent, and a reduced gritty mouthfeel for geriatric patients and pediatric patients.