Abstract: The present invention includes a compositions and methods comprising: one or more thyroid hormones in or on a micro-multi-particulate having a mean particle size of 150 uM or smaller and a Span (D90?D10)/(D50) of less than 2.0, wherein the total thyroid hormone(s) are less than 10% weight-to-weight (w/w) of the micro-multi-particulate; and a polymer release coating on the micro-multi-particulate that is greater than a 5:1 ratio w/w, on a dry weight basis, to a dry weight of the thyroid hormone(s), wherein a total tablet weight exceeds a micro-multi-particulate weight by a ratio of 5:1 or greater.

Abstract: The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

Abstract: The present invention includes a compositions and methods comprising: one or more thyroid hormones in or on a micro-multi-particulate having a mean particle size of 150 uM or smaller and a Span (D90?D10)/(D50) of less than 2.0, wherein the total thyroid hormone(s) are less than 10% weight-to-weight (w/w) of the micro-multi-particulate; and a polymer release coating on the micro-multi-particulate that is greater than a 5:1 ratio w/w, on a dry weight basis, to a dry weight of the thyroid hormone(s), wherein a total tablet weight exceeds a micro-multi-particulate weight by a ratio of 5:1 or greater.

Abstract: The present invention generally relates to treating attention-deficit disorders (e.g., ADHD) by providing an effective amount of an ADHD-effective agent to a patient in need thereof (e.g., a child).

Abstract: The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

Abstract: The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

Abstract: The present invention generally relates to treating attention-deficit disorders (e.g., ADHD) by providing an effective amount of an ADHD-effective agent to a patient in need thereof (e.g., a child).

Abstract: The present invention includes a pharmaceutical composition, and methods of making and using, a pharmaceutical composition comprising one or more thyroid hormone(s) or analogs thereof, wherein a first portion of thyroid hormone(s) is formulated for immediate release and a second portion of thyroid hormone(s) is formulated of modified release, e.g., by forming a drug-resin particle with an ion exchange resin.

Abstract: The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

Abstract: The present invention includes a pharmaceutical composition and method of making and using comprising one or more thyroid hormones or analogs thereof, wherein a first portion of thyroid hormone is formulated for modified release and a second portion of the one or more thyroid hormones is formulated for modified release, wherein the combination of the first and second portion are provided in an amount effective to treat hypothyroidism.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.

Abstract: The present invention includes a pharmaceutical composition, and methods of making and using, a pharmaceutical composition comprising one or more thyroid hormone(s) or analogs thereof, wherein a first portion of thyroid hormone(s) is formulated for immediate release and a second portion of thyroid hormone(s) is formulated of modified release, e.g., by forming a drug-resin particle with an ion exchange resin.

Abstract: The present invention includes compositions and methods for reduce the taste of the drug in the drug resin complex. The composition may include one or more drug-resin complexes and a highly compressible, free-flowing pharmaceutical excipient. The resin is present in an amount effective to reduce the taste of the drug in the drug resin complex relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient causes release of the drug-resin complex in the mouth.

Abstract: The present invention includes compositions and methods for the controlled release of active agents in a shelf-stable liquid formulation by blending one or more controlled release microbeads comprising one or more active agents, preparing a dense, thixotropic solution having a density that is at, or about, the density of the one or more microbeads comprising a thixotropic agent, water and one or more preservatives under conditions that reduce bubble formation and mixing the microbeads and the thixotropic solutions in a mixer that lacks scraping paddles.

Abstract: The invention relates to a pharmaceutical composition comprising amphetamines complexed with ion-exchanged resin particles to form drug-resin particles. The composition provides for prolonged therapy.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.

Abstract: Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating.

Abstract: Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating. Preferably, the second plurality of drug-resin particles are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating.

Abstract: The invention relates to the formulation and quality control of liquid drug suspensions. In particular, the invention relates to methods of formulating liquid suspensions comprising drug-containing resin particles. The invention also relates to methods of confirming the acceptability of drug-containing resin particles for use in formulating liquid drug suspensions. The invention further relates to methods of formulating liquid suspensions in which drug-containing resin particles, the liquid suspension, or both are modified to achieve a desired in vitro dissolution profile. The invention also relates to a novel dissolution method and methods of predicting in vivo bioequivalence based on in vitro dissolution methods.

Abstract: The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.