The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Injectable depot compositions comprising a biocompatible polymer which is a polymer or copolymer based on lactic acid and/or lactic acid plus glycolic acid having a monomer ratio of lactic to glycolic acid in the range from 48:52 to 100:0, a water-miscible solvent having a dipole moment of about 3.7-4.5 D and a dielectric constant of between 30 and 50, and a drug, were found suitable for forming in-situ biodegradable implants which can evoke therapeutic drug plasma levels from the first day and for at least 14 days.

Provided are formulations and methods for treating one or more genitourinary conditions. The formulations may include a therapeutic agent that includes a calcium channel blocker, a rho kinase inhibitor, or a combination thereof. The methods may include locally administering a therapeutic agent into a ureter. Systems for delivering a therapeutic agent also are provided.

The present invention relates to an abuse-proofed, oral dosage form with controlled opioid-release for once daily administration, characterised in that it comprises at least one opioid with potential for abuse (A), at least one synthetic or natural polymer (C), optionally delayed-release matrix auxiliary substances, physiologically acceptable auxiliary substances (B), optionally a wax (D) and optionally at least one delayed-release coating, component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

A delivery system for local drug delivery to a target site of internal body tissue is provided. The delivery system comprises a source electrode adapted to be positioned proximate to a target site of internal body tissue. A counter electrode is in electrical communication with the source electrode, and is configured to cooperate with the source electrode to form a localized electric field proximate to the target site. A reservoir is configured to be disposed such that the reservoir is capable of interacting with the localized electric field. The reservoir is configured to carry a cargo capable of being delivered to the target site when exposed to the localized electric field. Associated methods are also provided.

A composite anti-restenosis drug for use with a coronary drug-eluting stent, and a controlled release system for the drug. The composite drug comprises arsenic trioxide and rapamycin, which may be used in combination to prevent in-stent restenosis and reduce the incidence of intravascular thrombosis. The controlled release system for the composite drug may control the release of the composite drug so as to achieve the therapeutic effect of controlling restenosis and preventing the formation of thromboses.

There is provided a solid pharmaceutical composition for delivering by oral administration a pharmaceutically active binding polypeptide to a region of the intestinal tract comprising a compressed core, wherein the compressed core comprises a pharmaceutically active binding polypeptide and wherein the compressed core is coated with a pH sensitive enteric coating.

A system for delivering energy to an isolated part of a mammalian body includes an electrically powered patch and a self-supporting adhesive film. The patch has a major surface and comprises a matrix of at least one flexible, biocompatible material which is capable of conforming to the isolated body part. The self-supporting adhesive film has a first non-tacky surface arranged and configured for releasable attachment to the patch and a second tacky surface, opposite the first surface, for adhesive attachment to the isolated body part. The releasable attachment between the self-supporting adhesive film and the electrically powered patch has a lower strength than the adhesive attachment between the film and the isolated body part. Thus, during use the electrically powered patch is removable from the self-supporting adhesive film while leaving the self-supporting adhesive film adhered to the isolated body part.

Pediatric and modified release dosage forms of vitamin D compounds, and methods of making and using the same, are disclosed.

Multilayer thin emulsion films are disclosed. Also disclosed are methods for preparing the multilayer thin emulsion films. According to the methods, an amphiphilic block polymer is used as a surfactant to form a polymer thin film at the oil/water interface, ionic lecithin is used as an auxiliary surfactant to prepare physically stable ionic oil-in-water nanoemulsions, and a layer-by-layer assembly technique is used to alternately laminate polymer thin films and nanoemulsion layers. The multilayer thin emulsion films enable slow release of active substances in specific temperature ranges and are structurally biocompatible while possessing improved capture efficiency and physically stable membrane structures. Spinodal decomposition of the multilayer thin emulsion films is induced by heating, allowing release of oils and active substances loaded into the nanoemulsions. Therefore, the multilayer thin emulsion films are expected to be useful as smart drug release materials in a variety of applications, including cosmetics, pharmaceuticals, and biotherapy.