Semi-moist oral delivery system

Abstract

The subject invention is a carrier or product formed of a matrix having starch, sugar, fat, polyhydric alcohol and water in suitable ratios such that there exists a water activity of 0.6-0.75. The water activity of the product matrix may be adjusted up or down so that the availability of water in the finished product is not detrimental to the included active ingredient, be it pharmaceutical, nutraceutical, or a vitamin mineral complex.

1. A composition  An extrudate for the oral administration of an additive selected from the group consisting of pharmaceutical, nutritional supplements, vitamins and minerals, and mixtures thereof pharmaceuticals and nutraceuticals to mammals in a discrete dosage form , said discrete dosage form  extrudate comprising:
 said additive, 
 ansaid extrudate comprising a matrix having about 10 to about 50% wt starch,about  4 . 5  to about  22 . 5 %  wt pregelatinized starch, polyhydric alcohol ingredients selected from the group    
 a sweetener  consisting essentially  of glycerol, propylene glycol,  1 , 3 - butanediol  sucrose, corn syrup and sorbitol, and mixtures thereof, said sucrose being in an amount of at least 10% 5 % by weight, and  
 at least about 5% wt water,  
 said composition  extrudate having an A w  of about 0.60 to about 0.75, and a soft and chewy texture, and said A w  and the amount of said polyhydric alcohol ingredients being adjusted to permit an appropriate amount of free water in the presence of the additive  maintain stability and texture of the extrudate with the additive.  
 
     
     
       2. The carrier  extrudate composition of  claim 1  wherein the water content is about 10%. 
     
     
       3. The carrier  extrudate composition of  claim 1  wherein the  a polyhydric alcohol content is about 40%. 
     
     
       4. The carrier of  claim 1  wherein the starch content is about 32%. 
     
     
       5. The carrier  extrudate composition of  claim 1  wherein said carrier  composition has a pregelatinized starch content of about 15%. 
     
     
       6. The carrier  extrudate composition of  claim 1  wherein the A w  is 0.65 and the additive is aspirin. 
     
     
       7. The carrier  extrudate composition of  claim 1  wherein the polyhydric alcohol  one of the ingredients is sorbitol. 
     
     
       8. The carrier  extrudate composition of  claim 1  wherein the sugar content is about 15%. 
     
     
       9. A method of making a carrier and additive mixture for use in an oral administration of a therapeutically effective amount of the additive in a discrete dosage form, comprising the steps of:
 a) forming a matrix and additive admixture by mixing, in a one-step procedure additive,    about 10 to about 50% wt starch,    0 to about 40% wt fat or oil,    a sweetener consisting of sucrose, corn syrup and sorbitol, said sucrose being in an amount of at least 10%,    and water,    and mixing;    
       adjusting the relative amounts of polyhydric alcohol and water to control the A w  of said admixture to adjust the level of moisture in the carrier to be a level not inimical to the additive and extruding said admixture to form an extrudate. 
     
     
       10. The method of  claim 9  including adjusting the water content to about 10%. 
     
     
       11. The method of  claim 9  including adjusting the polyhydric alcohol content to about 40%. 
     
     
       12. The method of  claim 9  including adjusting the starch content to about 32%. 
     
     
       13. The method of  claim 9  including adjusting the sugar content to about 15%. 
     
     
       14. The method of  claim 9  further including adding pregelatinized starch to about 15% of the total carrier. 
     
     
       15. The method of  claim 9  including the step of mixing in a pharmaceutical. 
     
     
       16. The method of  claim 9  including the step of mixing in a nutraceutical. 
     
     
       17. The method of  claim 9  including the step of mixing in a vitamin and mineral mix. 
     
     
       18. The method of  claim 9  including the step of adding sorbitol. 
     
     
       19. The method of  claim 9  including the step of controlling the A w  to be at about 0.60 to about 0.75. 
     
     
       20. The method of  claim 9  including the step of adding aspirin as the active ingredient and controlling the A w  of said carrier to about 0.65. 
     
     
       21. The carrier of  claim 2 , wherein the additive constitutes from about 0.1% to about 5.0% of the resulting mixture. 
     
     
       22. The method of  claim 9 , further including adding about 0.1% to about 5.0% additive. 
     
     
       23. A composition for the oral administration of a pharmaceutical additive to mammals in a discrete dosage form, said discrete dosage form comprising:
 an extrudate having a matrix, and comprising: 
 10-50% starch,  
 0-40% fat or oil,  
 a sweetener consisting essentially of sucrose, corn syrup and sorbitol, said sucrose being in an amount of least 10%,  
 at least about 5% water,  
   
       said composition having an A w  of about 0.60 to about 0.75, and a soft and chewy texture, and said A w  being adjusted to permit an appropriate amount of free water in the presence of the additive.