The present invention is drawn to novel topiramate compositions as well as methods for effecting weight loss, e.g., in the treatment of obesity and related conditions, including conditions associated with and/or caused by obesity per se. The present invention features an escalating dosing regimen adapted for the administration of topiramate and optionally a sympathomimetic agent such as phentermine or bupropion, in the treatment of obesity and related conditions.

Disclosed are compositions and formulations of non-porcine lipase and methods of treatment and manufacture thereof.

A drug delivery device includes an enteric capsule enclosing an internal volume and a plurality of drug containing particles positioned within the internal volume. Each of the plurality of drug containing particles includes a matrix body and an active pharmaceutical ingredient (API) distributed within the matrix body. The plurality of drug containing particles are configured to penetrate tissue, such as intestinal mucosa.

The present invention relates to a polymer composite for ultrasound-based cancer immunotherapy, which comprises an peroxalate derivatives, and a preparation method thereof. The polymer composite according to the present invention is a structure in which the peroxalate derivatives are encapsulated in an amphipathic polymer compound in which a biocompatible polymer and a sonosensitizer are combined. The peroxalate derivatives produce free electrons and carbon dioxide (CO.sub.2) by reaction with a high concentration of hydrogen peroxide (H.sub.2O.sub.2) in cancer tissue, the generated electrons raise the energy level of the sonosensitizer in the polymer composite to increase the amount of reactive oxygen species (ROS) production, thereby exhibiting an effect of increasing the death rate of cancer cells. In addition, by ultrasound treatment, immunogenic cell death (ICD) is induced due to the cavitation effect of the produced CO.sub.2, so molecules capable of activating immune cells in cancer cells are released without damage to induce an immune response to cancer. Therefore, the polymer composite according to the present invention is expected to be effectively used as an ultrasound-based cancer immunotherapeutic agent.

The instant invention provides a process for reducing the drying time of softgel capsules by incorporating drying accelerators based on organic sulfonic acids and salts thereof into the formulations used to make the capsules.

A process for preparing a powder for reconstitution as a suspension includes the following steps: First, complexing Valaciclovir with an ion exchange resin and forming Drug-Resin complex (DRC) particles. The complexing includes Dry blending of Drug:Ion Exchange Resin in a ratio 1:0.8 to form a blend; Kneading the blend with water in a ratio of Drug:Ion Exchange Resin:Water 1:0.8:0.5 to form a wet mass; Drying of the wet mass at 40° C.
Next, milling of the Drug-Resin complex particles until particle size gets less than 250 μm, and then dry mixing of the Drug-Resin complex particles with excipients to form an internal phase. The excipients of the internal phase comprise a suspending agent and a pH agent, and the suspending agent forms a film around each DRC particle and the film decreases interparticle attraction. Next, mixing the internal phase with excipients of an external phase to form the powder, and then sifting the powder to eliminate any clumps.

Pharmaceutical compositions and stable nano-suspensions comprising mifepristone and at least one pharmaceutically acceptable excipient, which exhibit enhanced bioavailability compared to the currently marketed or commercially available formulations. Manufacturing process and methods of use are also provided. The pharmaceutical compositions are used for prevention, treatment or prophylaxis of disorders in human patients in need thereof. Oral pharmaceutical compositions of mifepristone, methods for their administration, processes for thei r production, and use of these compositions are described for the treatment of diseases for which mifepristone is indicated.

The invention is directed to a biodegradable, phase separated, thermoplastic multi-block copolymer, to a process for preparing a biodegradable, phase separated, thermoplastic multi-block copolymer, to the use of a biodegradable, semi-crystalline, phase separated, thermoplastic multi-block copolymer, and to a composition for the delivery of at least one biologically active compound to a host.

The biodegradable, phase separated, thermoplastic multi-block copolymer of the invention comprises at least one amorphous hydrolysable pre-polymer (A) segment and at least one semi-crystalline hydrolysable pre-polymer (B) segment, wherein said multi-block copolymer under physiological conditions has a T.sub.g of 37° C. or less and a T.sub.m of 50-110° C.; the segments are linked by a multifunctional chain extender; the segments are randomly distributed over the polymer chain; and the pre-polymer (B) segment comprises a X-Y-X tri-block, wherein Y is a polymerisation initiator, and X is a poly(p-dioxanone) segment with a block length expressed in p-dioxanone monomer units of 7 or more.

The disclosure is directed to methods of treating schizophrenia or bipolar disorder by subcutaneously administering a sustained-release dosage form of olanzapine, or a pharmaceutically acceptable salt thereof. Methods of subcutaneously administering olanzapine, or a pharmaceutically acceptable salt thereof, are also described.

The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.