Abstract:
The invention provides a novel “separation marking” on a tablet as a means for assisting in the identification of a region on the tablet that is desired to be able to be broken from time to time. Said breaking allows production of smaller dosage forms known herein as tablettes. In a preferred embodiment, the separation mark will be a printed mark that is made on the tablet surface.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     Not Applicable  
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OF DEVELOPMENT  
       [0002]     Not Applicable  
       INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISK  
       [0003]     Not Applicable  
       REFERENCE TO A MICROFICHE APPENDIX  
       [0004]     Not Applicable  
       BACKGROUND OF THE INVENTION  
       [0005]     (1) Field of the Invention  
         [0006]     This invention is concerned with the manufacture of pharmaceutical tablets adapted to be intentionally broken.  
         [0007]     (2) Description of the Related Art  
         [0008]     Pharmaceutical tablets (“tablets” herein) have long been produced with an indentation known as a score, which both locates and tends to physically assist in breaking said tablets into smaller units, called tablettes herein, that are intended to serve as dosage forms. Many tablets are not produced or may not be able to be produced with a score. It would be helpful if unscored tablets were marked in a manner that allowed identification of a suitable region of division when desired.  
       SUMMARY OF THE INVENTION  
       [0009]     The invention provides a novel “separation marking” on a tablet that comprises a means for assisting in the identification of a region on the tablet that is desired to be able to be broken from time to time. Said breaking allows production of smaller dosage forms known herein as tablettes. In a preferred embodiment, the separation mark will be a printed mark that is made on the tablet surface with an edible ink that will provide a guide to breaking a tablet. In many preferred embodiments, said separation mark will allow location of a bisection of the tablet. The invention also provides a method of identifying a suitable breaking region of a pharmaceutical tablet by placing a separation mark on a tablet at, in or on a region where it is desired that breaking of the tablet is to be accomplished.  
         [0010]     Accordingly, it is an object of the invention to provide an improved method of manufacturing tablets which are adapted for optional breaking so that more accurate breaking of both scored and unscored tablets may be obtained by breaking a tablet.  
         [0011]     It is also an object of this invention to provide a separation mark on a relatively inactive part of the tablet.  
         [0012]     These and other objects of the invention will become apparent from the appended specification. 
     
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       [0013]      FIG. 1  is a partially exploded perspective view of a dosage form where two active segments contain an active ingredient and another segment having a printed separation mark is interposed between the two active segments;  
         [0014]      FIG. 2  is a top view of a tablet having a separation mark in the mid-point of the tablet;  
         [0015]      FIG. 3  is front view of a tablet having a separation mark at the mid-point of the tablet and a score placed on one end;  
         [0016]      FIG. 4  is a top view of a tablet according to the invention which has two separation marks;  
         [0017]      FIG. 5  is a top view of a tablet having a single separation mark;  
         [0018]      FIG. 6  is a top view of tablet according to the invention having crossed separation marks which divide the top of the tablet into four sections;  
         [0019]      FIG. 7  is a top view of a tablet according to the invention which has a printed symbol as a separation mark. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]     Separation markings according to the invention include, without limitation:  
         [0021]     Indicia applied by contact, spraying or printing in the form of a solid or dotted line at a desired breaking region on the tablet;  
         [0022]     Indicia applied by printing a logo or series of logos, or such indications in appropriate language the word “Break,” a symbol suggestive of breaking such as a representation of a scissors, a knife, tablet breaking device, or the like.  
         [0023]     Other forms of separation marks may include, without limitation, application of one or more gelatin strips (bands, etc.) or strips applied by a biocompatible adhesive such as an Eudragit, shellac, or Hydroxypropyl methylcellulose.  
         [0024]     The term “separation mark” or “separation marking” includes without limitation a continuous marking that is preferably linear, a discontinuous marking such as a dashed or dotted line, a raised addition to a tablet such a band of gelatin that may be applied in liquid or semi-liquid form, removable or non-removable tape, and the like. All embodiments may be provided in duplicate, triplicate, etc. For example, two or more printed lines may be utilized to delineate a region(s) between them suitable for optional tablet breaking.  
         [0025]     A separation mark of the invention may be applied to the same surface of a tablet that contains a score. For example, a bisecting score could be present on a capsule-shaped tablet. Printed marks locating breaking regions that would, if broken precisely, create a quarter tablet could be added as well. Also, a separation mark could be on a different surface of the tablet than a score. For example, a three layer tablet could be formed in which the bottom punch contain an embossing that creates a score on the bottom of the tablet. Subsequently, a middle layer could be provided with a separation mark that would direct optional tablet breaking through said middle layer, separating the top and bottom layers from each other.  
         [0026]     The separation marks may be applied at any suitable location on a tablet.  
         [0027]     Generally, the indicia may be applied using edible inks and conventional printing techniques that are utilized to mark tablets with code numbers, logs and the like.  
         [0028]     In preferred cases, tablets of the invention are provided to a patient, consumer, nurse, aide, etc. with a means of verification that a separation marking is indeed intended to delineate a guide to tablet breaking. Such means may be via printed product information on paper that accompanies the tablet upon sale, or may be via a convenient oral, electronic, recorded, etc. manner. Such instruction may not be necessary, however, as a printed mark that is on the center of a tablet will be apparent to a person of adequate sight to be a bisecting mark, and such a person who may have been intending to break said tablet into two equal parts would likely make use of said bisecting separation mark without specific instruction of its significance. Additionally, in cases in which a separation mark comprises the word “Break” or the words “Break Here,” or comprises a scissors, said separation mark will tend to speak for itself.  
         [0029]     Layered tablets may be produced that involve a middle layer that is formed from a granulation that optionally lacks an active pharmaceutical ingredient. Such a layer cannot be scored during tablet production. Providing a tablet a separation mark may be useful to guide optional tablet breaking through said layer.  
         [0030]     As best shown in  FIG. 1 , a tablet having segments  2  and  6  and one pharmacologically inactive segment  4  is shown with space  10  that depicts the alignment of segment  8  and segment  6  which in use are joined to one another. Printed line  14  is located in segment  4  as a region where the breaking force is to be directed. The elongated segment  4  is long enough to be easily broken by hand.  FIG. 2  shows a tablet having printed separation marks  16  and  18  and a score  20 .  FIG. 3  is a front view of a tablet having a printed separation mark  22  and a score  24 . This tablet may be first broken at printed mark  22  and may thereafter be broken at score  24 .  FIG. 4  is a top view of a tablet having printed separation mark  26  and printed separation mark  28  spaced slightly apart to mark a breaking region between the two separation marks.  FIG. 5  is a top view of a round tablet having a single printed separation mark  30  which marks the approximate mid-point of the tablet.  FIG. 6  is a top view of a round tablet having printed separation mark  32  and printed separation mark  34  which are arranged in such a manner that the top surface is divided into four substantially equal parts.  FIG. 7  is a top view of a tablet where a printed symbol which is a stylized letter “S” is used as a printed separation mark to identify the approximate mid-point of the tablet as a breaking region. This type of a separation mark may comprise a logo which is applied alone of as a plurality of marks that form a linear pattern.  
         [0031]     The invention also includes the method of administration of a pharmaceutical to a patient, mammal, or other animal in need of said pharmaceutical where a region on a pharmaceutical tablet is provided with a separation mark or marks and the tablet is broken through, by, or between said mark or marks to form one or more parts of said tablet which are designated herein as “tablettes”. The method of administration is completed by having the patient ingest the tablette formed from breaking the tablet.