Abstract: The present disclosure is in the field of gastric resident systems. A device for extended retention in a stomach is provided. The device includes: first, second, and third arms, the second and third arms being pivotally connected to respective ends of the first arm. The device is configured to transform between a compressed configuration and an expanded configuration. The device further includes a biasing member configured to bias the device into the expanded configuration whereby the second and third arms are configured to mechanically engage each other to retain the system in the expanded configuration.

Abstract: The present disclosure is in the field of gastric resident systems. A device for extended retention in a stomach is provided. The device includes: first, second, and third arms, the second and third arms being pivotally connected to respective ends of the first arm. The device is configured to transform between a compressed configuration and an expanded configuration. The device further includes a biasing member configured to bias the device into the expanded configuration whereby the second and third arms are configured to mechanically engage each other to retain the system in the expanded configuration.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: The present disclosure provides a device for self-preparation of a gastroretentive dosage form being capable of transitioning between a collapsed configuration and an expanded configuration, the device comprising an assembly unit including: a compartment configured for accommodating the gastroretentive dosage form in the expanded configuration; and a mechanical system configured for, upon operation of an actuation mechanism: (a) transitioning said gastroretentive dosage form into the collapsed configuration; and (b) locking said collapsed gastroretentive dosage form into the collapsed configuration; wherein the device is configured for being portable.

Abstract: Provided are devices that are configured for gastric retention for a period of at least six hours (or at least three hours if the subject is in the fasted state) while maintaining their structural integrity and releasing or holding an active or diagnostic agent into or in gastric fluid of a human subject over that period, as well as methods of delivering an agent over an extended period by orally administering such devices to a subject, uses of an enteric polymer in the formation of devices that deliver an agent over an extended period of time, and methods of making such devices.

Abstract: The present disclosure provides a device for self-preparation of a gastroretentive dosage form being capable of transitioning between a collapsed configuration and an expanded configuration, the device comprising an assembly unit including: a compartment configured for accommodating the gastroretentive dosage form in the expanded configuration; and a mechanical system configured for, upon operation of an actuation mechanism: (a) transitioning said gastroretentive dosage form into the collapsed configuration; and (b) locking said collapsed gastroretentive dosage form into the collapsed configuration; wherein the device is configured for being portable.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: A pharmaceutical formulation of compounds with low aqueous solubility and method of manufacture thereof. The formulation may include a pharmacologically active compound having low aqueous solubility and starch in the amount of greater than about 25 weight percent. A manufacturing method may include blending the active compound and starch, compressing the blend into a solid, comminuting the solid into granules, wetting the granules, drying the granules, and tabletting the dried granules to make a solid pharmaceutical formulation.

Abstract: A pharmaceutical formulation of compounds with low aqueous solubility and method of manufacture thereof. The formulation may include a pharmacologically active compound having low aqueous solubility and starch in the amount of greater than about 25 weight percent. A manufacturing method may include blending the active compound and starch, compressing the blend into a solid, comminuting the solid into granules, wetting the granules, drying the granules, and tabletting the dried granules to make a solid pharmaceutical formulation.

Abstract: A pharmaceutical formulation of compounds with low aqueous solubility and method of manufacture thereof. The formulation may include a pharmacologically active compound having low aqueous solubility and starch in the amount of greater than about 25 weight percent. A manufacturing method may include blending the active compound and starch, compressing the blend into a solid, comminuting the solid into granules, wetting the granules, drying the granules, and tabletting the dried granules to make a solid pharmaceutical formulation.

Abstract: A pharmaceutical formulation of compounds with low aqueous solubility and method of manufacture thereof. The formulation may include a pharmacologically active compound having low aqueous solubility and starch in the amount of greater than about 25 weight percent. A manufacturing method may include blending the active compound and starch, compressing the blend into a solid, comminuting the solid into granules, wetting the granules, drying the granules, and tabletting the dried granules to make a solid pharmaceutical formulation.

Abstract: The present invention provides a stabilized composition comprising a non-crystalline gabapentin enacarbil and at least one crystallization-inhibiting compound. In particular, the present invention provides a stabilized composition of gabapentin enacarbil, wherein the gabapentin enacarbil is maintained in a non-crystalline form by the composition, for example, as an amorphous form. The invention also provides, among other things, methods of making the stabilized composition, or use of the stabilized composition for making a medicament.

Abstract: The invention encompasses solid composites of the calcium receptor-active compounds, processes for preparing the solid composites, immediate and controlled-release pharmaceutical formulations comprising the solid composites, and methods of treatment therewith.

Abstract: This invention relates to oral pharmaceutical compositions suitable for making pharmaceutical formulations for oral administration that provide for the rapid dissolution of the phosphodiesterase 5 inhibitor tadalafil. In particular, the pharmaceutical compositions comprise solid composites of tadalafil exhibiting high solubility and rate of dissolution. The invention further relates to methods of preparing these pharmaceutical formulations and the use of such pharmaceutical formulations for treating diseases associated with PDE5 inhibitors.

Abstract: The present invention provides pharmaceutical formulations of dipyridamole and acetylsalicylic acid, methods of making thereof, and methods of using thereof.

Abstract: Provided are compositions of imatinib, methods for their preparation, and methods for treatment using the same.

Abstract: The present invention provides a process of preparing a high-load formulation of deferasirox with a sufficiently high dissolution rate and good bioavailability, which reduces the effect of the active material's physical characteristics on the chemical and physical properties of the final product.

Abstract: Pharmaceutical dosage forms comprising tadalafil are described. Preferred dosage forms are bioequivalent to Cialis® notwithstanding a large particle size.

Abstract: Provided are methods and compositions for controlling the bioavailability of poorly soluble drugs, including, for example, efravirenz.