Patent Publication Number: US-2021187858-A1

Title: Method and system for manufacturing of pharmaceutical formulas in form of orally disintegrating films (odf)

Description:
CLAIM OF PRIORITY 
     This application is a continuation application-in-part (CIP) under 35 U.S.C. § 120 of application Ser. No. 16/719,901, entitled “Heat And Oxidation Resistant Δ9 Tetrahydrocannobinol (THC) And Cannabinol (CBN) Compound And Method Of Manufacturing the Same”, filed on Dec. 18, 2019, application patent Ser. No. 16/719,901. The patent application identified above is incorporated here by reference in its entirety to provide continuity of disclosure. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to an orally disintegrating film (ODF). More specifically, the present invention relates to a self-correcting method and system for manufacturing ODF formulas. 
     BACKGROUND ART 
     Recent research has found that when a drug is admitted sub-lingually (under the tongue), it will absorb into the blood stream more efficiently than the traditional swallowing. This is because the stomach acids destroy a decent amount of the admitted drugs. Thus, there are different methods of manufacturing orally disintegrating films, or orally dissolving films (both abbreviated to ODF) for drugs and foods in the markets. However, these conventional methods and systems involves complex machinery, expensive, and are low in efficiency. 
     Referring now to  FIG. 1  which illustrates a prior art casting production system and method  100  of  cannabis  drugs. Casting production system and method  100  involves a casting step  101 , a drying step  102 , a vision inspection step  103 , a sealing step  104 , a defect punching step  105 , a printing/slitting step  106 , a cutting step  107 , and a packaging step  108 . As seen, the prior-art casting production system and method  100  involves  8  different steps. 
     At step  101 , a 12-nozzles casting machine is used to cast or paste the heat and oxidation resistant Tetrahydrocannabinol (THC) and Cannabidiol Composition (hereinafter referred to as “cannabinoid formula e”) in the form of an ODF on a substrate. 
     At step  102 , the cannabinoid formula ODF is undergoes drying. 
     At step  103 , each cannabinoid formula ODF is inspected for defects and/or air bubbles. Air bubbles are formed during the process of casting (pasting) at the nozzles. 
     At step  104 , the cannabinoid formula ODF is sealed off to prevent further air bubbles from forming. 
     At step  105 , the defective cannabinoid formula ODF is punched marked where the defects are found. 
     At step  106 , the cannabinoid formula ODF is printing/splitting to include the name, ingredients, and usage of the cannabinoid formula ODF. 
     At step  107 , the ODF  cannabis  is cut, and defective ones are eliminated. 
     Finally, at step  108 , the cannabinoid formula ODF is packaged and shipped. 
     Prior art casting production system and method  100  involves  12  nozzle casting, tedious visual inspection of each ODF package, and punching to mark where the defects occur. At step  107 , the defective ODF are discarded without fixing them. Thus, prior art casting production system and method  100  has efficiency below 80% and involves expensive systems and labor to manufacture ODF products. 
     Furthermore, prior art casting production system and method  100  cannot produce different geometrical shapes for each cannabinoid formula ODF because casting production can only produce rectangular shaped ODFs. 
     Furthermore, prior art casting production system and method  100  cannot control the thickness and dimension of each cannabinoid formula ODF. Higher dosages of cannabinoid formula ODF will require more  cannabis  mixture raw material in each ODF, which may cause the casting machine to smear while casting the ODFs and increases the likelihood of defects such as air bubbles being present on the ODF units. 
     Finally, prior art casting production system and method  100  cannot produce cannabinoid formula ODF and track the location of each cannabinoid formula ODF. The defects in the cannabinoid formula ODF have to be punch marked as a form of tracking defective ODF units. 
     Therefore what is needed is method and system that involves a fewer steps and more cost-effective than the prior art casting production to manufacture ODF products. 
     What is needed is a method and system for manufacturing ODF products that can correct defects without discarding them, thus improving efficiency. 
     What is needed is a method and system for manufacturing ODF products that can control the numbers, the dimension, and the geographical shapes of the ODF products. 
     What is needed is a method and system for manufacturing ODF products that can use advanced printing technology such as 4D printing. 
     SUMMARY OF THE INVENTION 
     Accordingly, an object of the present invention is to provide a system of manufacturing a formula in the form of ODF which comprises the means for preparing the formula; a printer for generating the formula in the form of a matrix ODF, wherein the matrix ODF further comprises a plurality of ODF units each containing such formula and having xyz-coordinates (pursuant to the Cartesian coordinate system); and a scanner for detecting defects in the plurality of ODF units. 
     Another object of the present invention is to provide a method manufacturing a formula in form of ODF that includes: preparing the formula; coordinated matrix forming the formula in form of a plurality of ODF units, each having a geometrical shape and xyz-coordinates; scanning for defects in the plurality of ODF units; and reforming the plurality of ODF units that are defected at the exact xyz-coordinates of defects. 
     Another object of the present invention is to provide a simple and defect-free or close to defect-free method and system for manufacturing cannabinoid formula ODFs. 
     Another object of the present invention is to provide a self-correcting method and system of manufacturing ODF formulas. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention. 
         FIG. 1  is a flow chart illustrating a prior-art casting production of ODF; 
         FIG. 2  is a flow chart of a coordinated matrix manufacturing of a pharmaceutical formula in ODF form in accordance with an exemplary embodiment of the present invention; 
         FIG. 3  is a flow chart of a self-correcting process of the coordinated matrix manufacturing of a pharmaceutical formula in ODF form in accordance with an exemplary embodiment of the present invention; and 
         FIG. 4A - FIG. 4B  illustrate different geometrical shapes of ODF in the coordinated matrix manufacturing in accordance with an exemplary embodiment of the present invention. 
     
    
    
     The figures depict various embodiments of the technology for the purposes of illustration only. A person of ordinary skill in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the technology described herein. 
     DETAILED DESCRIPTION OF THE INVENTION 
     Reference will now be made in details to the preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the preferred embodiments, it will be understood that they are not intended to limit the invention to these embodiments. On the contrary, the invention is intended to cover alternatives, modifications and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims. Furthermore, in the following detailed description of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be obvious to one of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in details so as not to unnecessarily obscure aspects of the present invention. 
     Exemplary embodiments and aspects of the present invention are now described with reference to  FIG. 2  to  FIG. 4 . The present disclosure discloses the following features of the present invention: (1) a method and manufacturing system for producing ODFs of any formula which can detect and correct defects without discarding any of them, (2) a method and manufacturing system for producing ODF of any formulas that involves fewer steps than the conventional casting production method, (3) a method and manufacturing system for producing ODF of any formulas that can conveniently control the geometrical shapes, number, and dimension of each ODF product, and (4) a method and manufacturing system for producing ODFs of any formula that uses high-technology printing methods such as 4D printing and self-configuring materials. 
     Now referring to  FIG. 2 ,  FIG. 2  is a flow chart illustrating a method  200  for manufacturing ODF products in accordance with an exemplary embodiment of the present invention. In a generalized structure of the present invention, food identification method  200  includes 4 major components: a preparation of a product formula step  201 , coordinated matrix forming step  202  of the product formula in ODF format, a defect correction step  203 , and a packaging step  204 . 
     At preparation step  201  includes mixing the formula product conducive to the ODF format. In various aspects of the present invention, the formula product is a sub-lingual heat resistant and antioxidant cannabinoid mixture which comprises tetrahydrocannabinol (THC) having a first predetermined percentage (%) by weight, a cannabidiol (CBD) having a second predetermined percentage (%) by weight nixed with saturated fatty acids such as stearic adds. More particularly, the mixture includes cannabinoids compounds  203  (C 41 H 65 O 2 ) and  213  (C 61 H 106 O 2 ) and coating cellulose that is oil insoluble and water soluble excipient polymer such as hydroxyl propyl methyl cellulose (HPMC), cellulose derivative gelatin, and/or pullulan described in a patent application entitled, “Heat and Oxidation Resistance Tetrahydrocannabinol and Cannabidiol (CBD) Compound and Method of Manufacturing the Same”. The patent applications identified above is incorporated herewith by reference in its entirety to provide continuity of disclosure. 
     At step  202 , the formula composition is coordinated matrix formed in an array of ODF units. Each ODF unit has a matrix address such as column and row address. Each droplet that constitutes the ODF unit has xyz-coordinates. For ex ample, each droplet is similar to a pixel of a picture that has xyz-coordinates. If an ODF unit is dimensioned as 100×200, then there are 20,000 droplets that constitutes the ODF unit, each droplet having its own xyz-coordinates. In various embodiments of the present invention, step  202  is implemented using a 2D dot printer, a 3D printer, and a 4D printer. 
     At step  203 , detected defects are corrected by reforming those ODF units that are defected at the matrix addresses and at the xyz-coordinates of the defected droplets. Step  203  is implemented by a controller operative to keep tracks of the dimension, geometrical shapes, matrix addresses, and droplet xyz-coordinates of each ODF unit. This controller controls the coordinated matrix forming device such as 2D, 3D, and 4D printers. 
     At step  204 , after all ODF units are scanned and defects are cured, ODF units are cut and packaged. 
     Now referring to  FIG. 3 , a flow chart of a self-correcting process  300  of the coordinated matrix manufacturing of a pharmaceutical formula in ODF form in accordance with an exemplary embodiment of the present invention is presented. It is noted that self-correcting process  300  is applicable to  cannabis  medicine, supplementary foods, and other pharmaceutical formulas for both human and animals. 
     At step  301 , the self-correcting process  300  begins. In various implementations of step  301 , a mixture such as sub-lingual  cannabis  product which includes the formula product is a sub-lingual heat resistant and antioxidant cannabinoid mixture which comprises tetrahydrocannabinol (THC) having a first predetermined percentage (%) by weight, a cannabidiol (CBD) having a second predetermined percentage (%) by weight mixed with saturated fatty acids such as olive oils. In other implementations, printable polymer is mixed with the heat resistant and antioxidant cannabinoid mixture is prepared so that ODF can be produced using printer devices. In other implementations, form-configuring materials are mixed with the heat resistant and antioxidant cannabinoid mixture for 4D printer so that the ODF he heat resistant and antioxidant cannabinoid mixture is conformed to the shape of the tongue and dissolve quickly when stimulated by saliva. 
     At step  302 , the geometrical shape and number of ODF units are entered. In the present invention, the shape and number of OBF units can be determined. For example, instead of a rectangular ODF unit, the implementation of step  302  can produce 3D pill shape, oval shape, cylindrical shape, animal shapes, leaf shapes, or any shapes that the manufacturer prefers. For example, children prefers animal shape OBD units. In addition, the thickness, and dimension, and the array size of ODF units can be precisely controlled. Please refer to  FIG. 4  for illustrative implementations of step  302 . 
     At step  303 , the matrix having column and row addresses as well as xyz-coordinates of each droplet of each ODF unit are recorded. Step  303  is implemented by a controller. Any high-speed microprocessors from AMD or Intel available in the market can be used to implement step  303 . 
     Next, at step  304 , the ODF units in form of coordinated matrix are printed. In some implementations of step  304 , a printer including 2D, 3D, or 4D printer is used. 2D printer can be a dot matrix printer. 3D printer adds thickness to the 2D printer. 4D printer enables ODF units to dissolve and change shape upon contact with saliva. As a non-limiting example of steps  303  and  304 , if 100 ODF units of the heat resistant and antioxidant cannabinoid mixture are to be manufactured. A 10×10 matrix of ODF units is entered. The geometrical shape of each ODF unit can be selected. If a rectangular shape is chosen, the width, the length, the thickness, and the resolution of each ODF are also entered. As alluded above, a 1×0.5×0.005 cm ODF unit having a droplet resolution of 100×200 are entered. That is, each ODF unit is constituted by 20,000 droplets of CBD material, each having xyz-coordinates. 
     At step  305 , the ODF units are scanned for defects. Defects include, but not limited to, air bubbles, non-uniform thickness, smears, etc. In various implementation of step  305 , optical scanners can be used. 
     At step  306 , if no defects are found, process  100  moves to step  308 . 
     At step  307 , if defects are found, the exact matrix addresses and xyz-coordinates of defects are recorded. Step  307  reprints any defective ODF units at their matrix addresses and xyz-coordinates where defects are located. Step  307  helps achieving high efficiency because defective ODF units are reprinted without being discarded. Steps  305 - 307  are repeated until all defects are fixed. 
     Finally, at step  308 , when no defects are found, the ODF units are cut and packaged. 
     Finally referring to  FIG. 4A  and  FIG. 4B  illustrating different geometrical shapes of ODF in the coordinated matrix manufacturing in accordance with an exemplary embodiment of the present invention are presented. 
     Referring to  FIG. 4A , an N×M matrix  400 A of ODF units in form of 3D rectangular shape is illustrated. Matrix  400 A has N rows and M columns, where M and N are non-zero positive integers. Each ODF unit has a matrix address of row and column. Matrix  400 A contains: in the first row, a ODF unit  401 - 1 ,  402 - 1 , . . . , and  40 M- 1 ; in the second row, a ODF unit  401 - 2 ,  402 - 2 , . . . , and  40 M- 2 ; and in the Nth row (bottom row), a ODF unit  401 -N,  402 -N, . . . , and  40 M-N. In the first row, ODF unit  401 - 1  is constituted by droplets  4011   p  each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  402 - 1  has droplets  4021   p  each having xyz coordinates (xi, yi, zi), ODF unit  40 M- 1  has droplets  40 M 1   p  each having xyz coordinates (xi, yi, zi). In the second row, ODF unit  401 - 2  is constituted by droplets  4012   p  each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  402 - 2  has droplets  4022   p  each having xyz coordinates (xi, yi, zi), ODF unit  40 M- 2  has droplets  40 M 2   p  each having xyz coordinates (xi, yi, zi). In the last row, ODF unit  401 -N is constituted by droplets  401 Np each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  402 -N has droplets  402 Np each having xyz coordinates (xi, yi, zi), ODF unit  40 M-N has droplets  40 MNp each having xyz coordinates (xi, yi, zi). That way, any defective ODF units at any particular matrix location can be reprinted and corrected. It is noted that each unit in matrix  400 A described above includes cannabinoid medication  300  as described in a patent application entitled, “Heat And Oxidation Resistant Δ9 Tetrahydrocannobinol (THC) And Cannabinol (CBN) Compound And Method Of Manufacturing the Same”, filed on Dec. 18, 2019. The patent application identified above is incorporated herewith by reference in its entirety to provide continuity of disclosure. Briefly, cannabinoid formula  300  includes a cannabinoid compound  302  coated by an edible-water-dissolvable polymer  301  (“coating layer  301 ”). In many embodiments of the present invention, cannabinoid compound  302  is either compound  203  (C 41 H 65 O 2 ), compound  213  (C 61 H 106 O 2 ). In other embodiments, cannabinoid compound  302  also includes terpenes, CBN reacted with saturated fatty acids as described above in method  100 . Coating layer  301  includes hydroxyl propyl methyl cellulose (HPMC), polyglycerol polyricinoleate (PGPR), cellulose derivative gelatin, and/or pullulan. Coating layer  301  is a water dissolvable and bioavailable protective layer that prevent deteriorating agent from degrading cannabinoid compound  302 .
         Indifferent embodiments, each unit  411 - 1  . . .  41 M-N, also includes peppermint oil and other flavonoids.       

     Now referring to  FIG. 4B , an N×M matrix  400 B of ODF units in form of 3D oval shape is illustrated. Matrix  400 B has N rows and M columns, where M and N are non-zero positive integers. Each ODF unit has a matrix address of row and column. Matrix  400 B contains: in the first row, a ODF unit  411 - 1 ,  402 - 1 , . . . , and  41 M- 1 ; in the second row, a ODF unit  411 - 2 ,  412 - 2 , . . . , and  41 M- 2 ; and in the Nth row (bottom row), a ODF unit  411 -N,  402 -N, . . . , and  41 M-N. In the first row, ODF unit  411 - 1  is constituted by droplets  4111   p  each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  412 - 1  has droplets  4121   p  each having xyz coordinates (xi, yi, zi), ODF unit  41 M- 1  has droplets  41 M 1   p  each having xyz coordinates (xi, yi, zi). In the second row, ODF unit  411 - 2  is constituted by droplets  4112   p  each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  412 - 2  has droplets  4122   p  each having xyz coordinates (xi, yi, zi), ODF unit  41 M- 2  has droplets  41 M 2   p  each having xyz coordinates (xi, yi, zi). In the last row, ODF unit  411 -N is constituted by droplets  411 Np each having xyz coordinates (xi, yi, zi). Similarly, ODF unit  412 -N has droplets  412 Np each having xyz coordinates (xi, yi, zi), ODF unit  41 M-N has droplets  41 MNp each having xyz coordinates (xi, yi, zi). That way, any defective ODF units at any particular matrix location can be reprinted and corrected. It is noted that each unit in matrix  400 B described above includes cannabinoid medication  300  as described in a patent application entitled, “Heat And Oxidation Resistant Δ9 Tetrahydrocannobinol (THC) And Cannabinol (CBN) Compound And Method Of Manufacturing the Same”, filed on Dec. 18, 2019. The patent application identified above is incorporated herewith by reference in its entirety to provide continuity of disclosure. Briefly, cannabinoid formula  300  includes a cannabinoid compound  302  coated by an edible-water-dissolvable polymer  301  (“coating layer  301 ”). In many embodiments of the present invention, cannabinoid compound  302  is either compound  203  (C 41 H 65 O 2 ), compound  213  (C 61 H 106 O 2 ). In other embodiments, cannabinoid compound  302  also includes terpenes, CBN reacted with saturated fatty acids as described above in method  100 . Coating layer  301  includes hydroxyl propyl methyl cellulose (HPMC), polyglycerol polyricinoleate (PGPR), cellulose derivative gelatin, and/or pullulan. Coating layer  301  is a water dissolvable and bioavailable protective layer that prevent deteriorating agent from degrading cannabinoid compound  302 . 
     From the forgoing disclosure, method  200  and method  300  of the present invention achieves the following objectives:
         a fewer steps and more cost-effective manufacturing process than the prior art casting production to manufacture ODF products.   a system and process of manufacturing ODF products that can correct defects without discarding them, thus improving efficiency.   a system and process of manufacturing ODF products that can control the numbers, the dimension, and the geographical shapes of the ODF products.   a system and process of manufacturing ODF products that can use advanced printing technology such as 4D printing.       

     The manufacturing processes such as  200  and  300  may be implemented in a non-transitory computer software programs stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks. 
     The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. 
     The disclosed flowchart and block diagrams illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, element components, and/or groups thereof. 
     The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated. 
     The flow diagrams depicted herein are just one example. There may be many variations to this diagram or the steps (or operations) described therein without departing from the spirit of the invention. For instance, the steps may be performed in a differing order or steps may be added, deleted or modified. All of these variations are considered a part of the claimed invention. 
     While the preferred embodiment to the invention had been described, it will be understood that those skilled in the art, both now and in the future, may make various improvements and enhancements which fall within the scope of the claims which follow. These claims should be construed to maintain the proper protection for the invention first described. 
     The foregoing description details certain embodiments of the invention. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the invention can be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the invention with which that terminology is associated. The scope of the invention should therefore be construed in accordance with the appended claims and any equivalents thereof.