For manufacturing a solid administration form comprising at least one active pharmaceutical ingredient, a flowable but setting composite material comprising the at least one active pharmaceutical ingredient is added together and set to generate the solid administration form. The flowable composite material is liquefied and delivered to a discharge unit. Small portions of liquefied composite material are intermittently discharged through an outlet into a setting unit. The flowable composite material comprises a polymer and at least one active pharmaceutical ingredient dispersed or dissolved within the polymer. The small portions are droplets and the solid administration form is generated by adding droplets that stick together before or during the setting of the liquefied composite material. An average diameter of the droplets can be less than 350 μm. There can be a void space between at least some small portions, resulting in a porous structure of the solid administration form.

Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

A process prepares a rapidly disintegrating tablet with a disintegration time of at most 15 minutes for the peroral administration of a dry extract of the leaves of Ginkgo biloba, and with a total weight of the tablet of between 150 mg and 300 mg per 100 mg of ginkgo extract contained. Rapidly disintegrating tablets containing dry extract of the leaves of Ginkgo biloba can be prepared, which, due to their smaller dimensions, are easier to take than the tablets used hitherto. In a preferred form, the tablets do not contain lactose and are therefore also well tolerated.

Treatments of cancers involve a wide range of treatment. The current invention relates to chemotherapy of tumors using taxanes, in particular docetaxel. More in particular it relates to a method for the treatment of a cancer in a patient comprising orally administering an effective dose of docetaxel, whereby side effects are controlled by preventing peak plasma levels of docetaxel that induce said side effects, whilst maintaining an effective plasma level of docetaxel to eradicate tumor cells.

The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. In certain embodiments, the programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The programmable osmotic-controlled oral compositions of the disclosure comprise a multilayer core comprising a drug for controlled release, wherein the core is coated with a semipermeable membrane comprising an orifice and, optionally, an immediate release coating, comprising a drug for immediate release, over the semipermeable membrane. The multilayered core comprises a pull layer containing the drug and a push layer. The pull layer comprises at least two layers: a placebo layer for providing a desired lag time for the drug release; and an active layer containing the drug and providing a delayed controlled release of the drug. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

Provided herein are pharmaceutical formulations comprising a monoacylglycerol lipase (MAGL) inhibitor, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient.

Herein is described the conversion of deoxynybomycin (DNM), a natural product and DNA gyrase inhibitor with minimal cytotoxicity, into a compound (Formula I) that has anticancer activity. Detailed in vitro and cell culture experiments demonstrate that these compounds inhibit Top2 and also act upon topoisomerase I. Similar approaches are applicable to other classes of gyrase inhibitors and other antibacterial targets for discovery of new anticancer drugs. ##STR00001##

A dosage form contains a polymeric matrix, containing one or more polymer(s) and a biologically active ingredient. The polymeric matrix contains 10% by weight or more of the one or more polymer(s). The one or more polymer(s) are polymerized from a monomer mixture containing the monomers (a) 70 to 95% by weight of 2-ethylhexyl methacrylate (EHMA) and ethyl methacrylate (EMA), or 2-ethylhexyl methacrylate (EHMA) and methyl methacrylate (MMA); (b) 0 to 25% by weight of a C.sub.2 to C.sub.6 hydroxy-alkylester of acrylic acid or methacrylic acid; and (c) 2.5 to 20% by weight of a C.sub.2 to C.sub.8 alkyl ester of acrylic acid or of methacrylic acid with a quaternary cationic group in the alkyl group.

An object of the invention is to provide a mucoadhesive oral preparation having high drug absorption rate and rapid drug release rate. The means for solving the problem is a mucoadhesive oral preparation having (a) a basal layer substantially consisting of a water-insoluble material, (b) a drug layer locating above the basal layer and containing a drug but not containing mucoadhesive material, and (c) an adhesive portion locating on a portion of the surface of the drug layer side of the oral formulation and containing mucoadhesive material.