SOLID DOSAGE FORM PRODUCTION
The present invention provides methods of preparing solid dosage form, particularly pharmaceutical dosage forms, using extrusion and 3D-printing, as well as the solid dosage form itself, the compositions used to make said items, uses of the solid dosage forms, and containers used in their preparation.
1 .- 42 . (canceled)
43 . A method of preparing a pharmaceutical, nutraceutical, or food supplement solid dosage form, the method comprising:
i) providing an extrudable composition, initially provided as a solid extrudable composition, comprising: an extrudable carrier and at least one active ingredient;
ii) prior to any extruding, transforming the extrudable composition into the form of an extrudable fluid, via heating, so that the extrudable composition can thereafter be directly extruded in a fluid state; and
iii) extruding the extrudable fluid, via 3D printing, into a tablet;
wherein the solid extrudable composition is initially provided either as granules, as a plurality of extrudable tablets or plurality of minitablets, or as a compressed monolith, on the proviso that the solid extrudable composition is not in the form of a filament; and
the extruding step is performed by a 3D-printer comprising a container for containing the extrudable composition prior to any extruding, and a nozzle for dispensing the extrudable composition during the extruding step; wherein the container is heated at a temperature to maintain the extrudable composition in a fluid state.
44 . The method of claim 43 , wherein the solid extrudable composition is initially provided either as a plurality of extrudable tablets or plurality of minitablets, or as a compressed monolith.
45 . The method of claim 43 , wherein the container is a heatable storage container.
46 . The method of claim 43 , wherein the container is adapted to fit into the 3D-printer, so the extrudable fluid within the container can be conveyed through the nozzle.
47 . The method of claim 43 , wherein providing the extrudable composition comprises providing an extrudable composition package comprising the extrudable composition and the container, wherein the container contains the extrudable composition; wherein said package is inserted into the 3D-printer.
48 . The method of claim 43 , wherein the container has a valve-operated outlet.
49 . The method of claim 43 , wherein the extrudable fluid is pumped from the container under pressure.
50 . The method of claim 43 , wherein the extrudable fluid is printed from a syringe, wherein the extrudable fluid is caused to flow from the syringe when pressure is applied to the syringe.
51 . The method of claim 43 , wherein extrudable fluid is dispensed from the container by a piston or plunger.
52 . The method as claimed in claim 43 , wherein the solid extrudable composition is provided within a heatable or heated syringe, and is mobilised (or converted into an extrudable fluid) by heating prior to extrusion into the extruded item.
53 . The method of claim 43 , wherein the solid extrudable composition is provided as a plurality of minitablets, wherein each minitablet has a longest dimension of between 0.5 mm and 10 mm.
54 . The method of claim 43 , wherein the solid extrudable composition is provided as a plurality of minitablets, wherein each minitablet weighs between 10 and 100 mg.
55 . The method of claim 43 , wherein the solid extrudable composition is provided as a monolithic extrudable compressed form.
56 . The method of claim 43 , wherein the solid extrudable composition is provided as a monolith of compressed powder or compressed granules.
57 . The method of claim 43 , wherein extrusion is performed at a temperature between 4° and 120° C.
58 . The method of claim 43 , wherein extrusion is performed at a temperature between 6° and 100° C.
59 . The method of claim 43 , wherein the extrudable carrier is a polymer having a melting point or glass transition temperature less than the active ingredient.
60 . The method of claim 43 , wherein the extrudable composition is initially provided as an extrudable composition comprising a permanent plasticizer selected from one or more of triethylcitrate (TEC), glycerol, castor oil, oleic acid, tryacetin, polyalkylene glycols, polyethylene glycol, polypropylene glycol, a sugar alcohol with the general formula of HOCH 2 (CHOH) n CH 2 OH wherein n is between 2 and 12, ethylene glycol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, and maltotritol.
61 . The method of claim 43 , wherein one or more tablets produced in step iii) are returned as inputs to step i) of the method.
62 . A pharmaceutical, nutraceutical, or food supplement solid dosage form obtainable by, obtained by, or directly obtained by the method of claim 43 .