Method of manufacturing multiple dosage forms with personalised composition and device for carrying out this method

A computer-implemented method for preparing multiple dosage forms with personalised composition, comprising the following steps:

• (i) a control unit (A) generates an input protocol of a personalised composition of a multiple dosage form, said input protocol containing information about the type and amount of individual sub-units to be dosed, about the type of cartridges to be used for dosing, and about the size, type, number and arrangement of capsules to be used for the particular personalised dosage form;
• (ii) a cartridge of the required type according to the input protocol, labelled with a specific machine-readable code, is placed in the automatic transport system (E), wherein the specific machine-readable code of the cartridge is recorded in the input protocol;
• (iii) at least two different types of sub-units are placed into at least two dosing stations (DI, D2), the sub-unit having sizes in the range of from 0.1 to 4 mm, and containing a different active ingredient and/or different amounts of the same active ingredient and/or having coatings with different functions and/or different thicknesses and/or possibly containing different pharmaceutical excipients according to the input protocol;
• wherein the different sub-unit types correspond to the sub-unit types generated in the input protocol;
• (iv) an automatic transport system (E) transports the cartridge to the means for placing capsules in the cartridge, wherein a pre-defined number of the given type of capsules is placed in the cartridge according to the input protocol;
• (v) the automatic transport system (E) transports the cartridge to the first dosing station (DI), which reads the specific code of the cartridge and, according to the input protocol, doses a predefined number of the first sub-units into the capsule bodies placed in the cartridge;
• (vi) the automatic transport system (E) transports the cartridge with capsules to the next dosing station (D2), which reads the specific code of the cartridge and, according to the input protocol, doses a pre-defined number of the next sub-units into the capsule bodies placed in the cartridge;
• wherein this step is repeated according to the input protocol until the capsules are filled with all of the pre-defined types of sub-units according to the input protocol;
• (vii) the capsules are closed with caps;
• (viii) the quality control of capsules and discarding of the non-compliant ones using means for removing of non-compliant capsules;
• and
• (ix) step of packaging and labelling with a batch number;
• wherein the information from each process step ii) to viii) is stored in a process record in the control unit (A);
• and wherein the quality control of capsules in step viii) is performed by comparing information from the input protocol and from the process record of said cartridge in the control unit (A);
• wherein if the information relating to a particular position on the cartridge contained in the input protocol and in the process record differs, the capsule at that particular position is removed.