Apparatus and Method for the Production of Solid Dosage Forms

Abstract

An apparatus for the production of solid dosage forms is presented, wherein the apparatus comprises a material processing chamber which is operable for manufacturing a product according to a pre-set product formation process path. The apparatus has at least one sensor for continuously monitoring formation of the product in the material processing chamber during the product formation process non-invasively in real time by sensing at least one product functional attribute value and a means for comparing each sensed product functional attribute value with a desirable product functional attribute value for that point on the product formation process path. A controller controls operation of the material processing chamber in response to the sensed product functional attribute value for maintaining the product on the product formation process path.

1 - 15 . (canceled) 
     
     
         16 . A method for manufacturing a solid dosage form product comprising:
 operating a material processing chamber for manufacturing the product according to a pre-set product formation process path;   continuously monitoring formation of the product in the material processing chamber during the product formation process non-invasively in real time by sensing at least one product functional attribute value by two on-line sensors mounted at a side wall of the material processing chamber which do not come into contact with any process material within the processing chamber;   generating real-time on-screen images pertaining to particle size and shape of material being processed within the material processing chamber, and measuring moisture content of product within the material processing chamber;   comparing each sensed product functional attribute value with a desirable product functional attribute value for that point on the product formation process path; and   controlling operation of the material processing chamber in response to the sensed product functional attribute value for maintaining the product on the product formation process path.   
     
     
         17 . The method as claimed in  claim 16 , wherein the method comprises the steps:
 (a) running a schedule experiments for process development using a user interface;   (b) scheduling a DoE using a user interface;   (c) measuring the functional attributes of the process material using the at least one sensor;   (d) analyzing the sensor data of (c) using the PAT analyzer suite to result in PAT data;   (e) transmitting the PAT data to the data control unit;   (f) transforming the PAT data of (e) into a processor readable format using the data control unit;   (g) transmitting the processor readable format of (f) to the processor;   (h) utilizing the processor readable format of (g) to make logic decisions using the processor;   (i) selecting a command to be made to the material processing chamber;   (j) transmitting the command of (i) to the data control unit;   (k) transforming the command of (i) into a material processing chamber readable command format using the data control unit;   (l) transmitting the material processing chamber readable command format of (k) to the material processing chamber.   
     
     
         18 . The method as claimed in  claim 17 , wherein the method comprises the steps of:
 (m) effecting a change in the system variables of the material processing chamber in response to the material processing chamber readable format of ( 1 ); and   (n) effecting a change in the functional attributes of the process material in the material processing chamber.   
     
     
         19 . The method as claimed in  claim 17 , wherein the method comprises the steps of:
 (I) transforming PAT data of (d) into a data historian readable PAT format using the data control unit;   (II) analyzing the data historian readable PAT format of (I) using the data analytics unit of the data historian;   (III) producing a predictive model of end-product attributes as a result of the schedule of experiments for process development and system variables of the material processing chamber;   (IV) transmitting the predictive model of (III) to the data control unit; and   (V) transforming the predictive model (IV) to a processor readable model format.   
     
     
         20 . (canceled) 
     
     
         21 . Apparatus for the production of solid dosage forms, comprising:
 a material processing chamber which is operable for manufacturing a product according to a pre-set product formation process path;   at least two sensors for continuously monitoring formation of the product in the material processing chamber during the product formation process non-invasively in real time by sensing at least one product functional attribute value;   two on-line sensors being provided, namely a first sensor and a second sensor, wherein the first sensor senses a first desirable product functional attribute value and the second sensor senses a second desirable product functional attribute value, the second desirable product functional attribute value being different to the first,   each sensor being mounted on a side wall of the material processing chamber, such that, in use, each sensor does not come into contact with any process material within the material processing chamber;   the sensors including a direct imaging particle analyzer operable to generate real-time on screen images pertaining to particle size and shape of material being processed within the material processing chamber, and a multipoint near-infrared spectrometer which enables moisture measurement of product within the material processing chamber;   means for comparing each sensed product functional attribute value with a desirable product functional attribute value for that point on the product formation process path; and   a processor for controlling operation of the material processing chamber in response to the sensed product functional attribute value for maintaining the product on the product formation process path.   
     
     
         22 . Apparatus as claimed in  claim 21 , including:
 means to measure system variables of the material processing chamber;   a PAT analyzer suite;   a data control unit, wherein the data control unit is in communication with the PAT analyzer suite;   a processor, wherein the processor is in communication with the data control unit;   a data historian;   a user interface, wherein the user interface is independently in communication with the processor, the data control unit and the data historian; and   a data analytics unit, wherein the data analytics unit is capable of processing real-time data on the functional attributes of the material being processed to provide a predictive model of the resulting end-product attributes;   wherein the apparatus is configured to enable in-line adaptation of the system variables of the material processing chamber in response to the predictive model of the end-product functional attributes modelled from the process material functional attributes measured by the at least one sensor, such that adaptation of material processing chamber system variables results in optimal process material functional attributes.   
     
     
         23 . Apparatus as claimed in  claim 22 , wherein the data analytics unit is operable to use aggregated data on the functional attributes of the process material to form the predictive model. 
     
     
         24 . Apparatus as claimed in  claim 22 , wherein the data on the functional attributes of the process material relates to physiochemical properties of the process material. 
     
     
         25 . Apparatus as claimed in  claim 22 , wherein the functional attributes of the process material are selected from one or more of particle size, particle distribution, granulate size, granulate distribution, moisture content, moisture distribution pattern, shape, bead thickness and dissolution rate. 
     
     
         26 . Apparatus as claimed in  claim 22 , wherein the end-product attributes are selected from one or more of dissolution rate, solubility, stability, form definition, solid-state properties, hardness, friability, assay content uniformity, disintegration, compressibility, degradation, flowability, compactability and ionization.