Embodiments provide methods and apparatus for manufacturing a microtablet from a precursor material such as a pharmaceutical powder. Various embodiments provide a method which includes compressing the powder to form a compressed mass of a selected density and repeatedly compacting the compressed mass to increase the density of the compressed mass and form a microtablet. Related methods and apparatus are provided.

An isolator system, having an isolator (10), which has an interior space (22) for processing a substance, the interior space being delimited by a base-side mounting surface (14) for the arrangement of a substance-processing unit (20) and by an isolator cabin (12) with at least one access opening (24), the access opening being assigned at least one closure device for optionally opening up or blocking the access opening. The isolator cabin can be placed or is placed onto the base-side mounting surface, and wherein the isolator system has at least one quick-change interface (34) for exchanging the isolator cabin (12) for an additional cabin with a different protection level and/or for exchanging the closure device for an additional closure device with a different protection level.

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.

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.

Disclosed herein are new injection molding-coating devices for the continuous manufacturing of coated pharmaceutical tablets comprising one or more active pharmaceutical ingredients and one or more excipients. Also disclosed herein are methods for the continuous manufacture of coated pharmaceutical tablets using these new devices for the purpose application in the pharmaceutical and drug manufacturing industries.

Disclosed herein are new injection molding-coating devices for the continuous manufacturing of coated pharmaceutical tablets comprising one or more active pharmaceutical ingredients and one or more excipients. Also disclosed herein are methods for the continuous manufacture of coated pharmaceutical tablets using these new devices for the purpose application in the pharmaceutical and drug manufacturing industries.

The first object of the invention is a method of tableting a tablet mass comprising components crystallizing in a tetrahedral and/or regular system and/or subjected to micronization or nanonization, carried out in the following steps: moving the punches, filling the die cavities and/or die cavity with a tablet mass, lowering the punches and/or punch and compressing a tablet mass, pushing the tablets and/or tablet out of the die cavity, pushing the tablets and/or tablet out of the die, characterized in that the pressure in the tablet press chamber is lowered in the range from −0.005 MPa to −0.15 MPa, wherein the lowering of the pressure in the tablet press chamber reduces the pressure in the tablet press die cavity. The second object of the invention is a device for tableting a tablet mass. Another object of the invention is a kit comprising a tablet mass tableting device, as defined in the second aspect of the invention, and a vacuum pump.

The first object of the invention is a method of tableting a tablet mass comprising components crystallizing in a tetrahedral and/or regular system and/or subjected to micronization or nanonization, carried out in the following steps: moving the punches, filling the die cavities and/or die cavity with a tablet mass, lowering the punches and/or punch and compressing a tablet mass, pushing the tablets and/or tablet out of the die cavity, pushing the tablets and/or tablet out of the die, characterized in that the pressure in the tablet press chamber is lowered in the range from −0.005 MPa to −0.15 MPa, wherein the lowering of the pressure in the tablet press chamber reduces the pressure in the tablet press die cavity. The second object of the invention is a device for tableting a tablet mass. Another object of the invention is a kit comprising a tablet mass tableting device, as defined in the second aspect of the invention, and a vacuum pump.

Systems, methods, and materials are described for making solid unit dosage forms for administration of therapeutic and biotherapeutic agents, particularly dosage forms for various enteral, nasal, pulmonary, vaginal, topical, and other suitable non-injection delivery routes. Contact freezing methods may be used in conjunction with lyophilization or vacuum drying to process a liquid formulation and produce solid unit dosage forms having a high degree of structural stability while preserving the therapeutic activity of the included agents.

Systems, methods, and materials are described for making solid unit dosage forms for administration of therapeutic and biotherapeutic agents, particularly dosage forms for various enteral, nasal, pulmonary, vaginal, topical, and other suitable non-injection delivery routes. Contact freezing methods may be used in conjunction with lyophilization or vacuum drying to process a liquid formulation and produce solid unit dosage forms having a high degree of structural stability while preserving the therapeutic activity of the included agents.