Layered sustained-release microbeads and methods of making the same

Abstract

A layered microbead suitable for incorporating into a non-prescription consumable product is disclosed. The layered microbead may include a core and at least one active ingredient layer encapsulating the core. The active ingredient in the core can be different from the active ingredient in the encapsulating layer. The active ingredient in the core can be selected to counteract or enhance the effect of the active ingredient in the encapsulating layer. The layered microbead can further incorporate microspheres of active ingredient surrounded by polymer material. Method of manufacturing microspheres and microbeads are also described.

1 . A layered microbead comprising:
 a microbead core comprising:
 a first binding agent; and 
 a plurality of first microspheres dispersed throughout the first binding agent, 
   each first microsphere comprising:
 a first active ingredient core; and 
 a first polymer material encapsulating the active ingredient core; and 
   at least one active ingredient layer encapsulating the microbead core, the at least
 one active ingredient layer comprising: 
 a second active ingredient; and 
 a second binding agent, wherein the first active ingredient, the second active ingredient, or both is cannabidiol (CBD). 
   
     
     
         2 . The layered microbead recited in  claim 1 , wherein the at least one active ingredient layer further comprises a plurality of second microspheres dispersed throughout the active ingredient layer. 
     
     
         3 . The layered microbead recited in  claim 2 , wherein each second microsphere comprises:
 a second active ingredient core; and   a second polymer material encapsulating the second active ingredient core   
     
     
         4 . The layered microbead recited in  claim 1 , wherein the at least one active ingredient is free of the microspheres. 
     
     
         5 . The layered microbead recited in  claim 1 , wherein the microbead has a diameter in the range of from 25 to 5000 microns and the plurality of first microspheres have a diameter in a range of from 0.5 to 100 microns. 
     
     
         6 . The layered microbead recited in  claim 1 , wherein the first polymer is selected from the group including methyl cellulose, ethyl cellulose, microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate, cellulose, prolamine protein (Zein), hypromellose, hydroxypropyl methylcellulose, carboxymethylcellulose, hydroxyethyl cellulose, povidone, hypromellose, lipids/waxes, trigylcerides, phospholipids, carnuba wax, cottonseed oil, palm oil, soybean oil, and stearines. 
     
     
         7 . A method of manufacturing a layered microbead comprising:
 mixing at least one active ingredient with at least one polymer to form an active ingredient mass;   micronizing the active ingredient mass to form microspheres;   forming a microbead core incorporating the microspheres, wherein the at least one active ingredient is cannabidiol (CBD).   
     
     
         8 . The method of  claim 7 , further comprising solidifying the active ingredient mass prior to micronizing the active ingredient mass. 
     
     
         9 . The method of  claim 7 , further comprising:
 forming an active ingredient layer incorporating the microspheres, wherein the active ingredient layer encapsulates the microbead core.   
     
     
         10 . The method of  claim 7 , wherein the at least one polymer is selected from the group including methyl cellulose, ethyl cellulose, microcrystalline cellulose, croscarmellose sodium, dicalcium phosphate, cellulose, prolamine protein (Zein), hypromellose, hydroxypropyl methylcellulose, carboxymethylcellulose, hydroxyethyl cellulose, povidone, hypromellose, lipids/waxes, trigylcerides, phospholipids, carnuba wax, cottonseed oil, palm oil, soybean oil, and stearines. 
     
     
         11 . The method of  claim 7 , wherein the at least one active ingredient in the microspheres is encapsulated by the at least one polymer. 
     
     
         12 . A non-prescription consumable product comprising:
 a layered microbead incorporated into the consumable product, the layered microbead comprising:   a microbead core comprising:
 a first active ingredient; and 
 a first binding agent, wherein the first active ingredient is dispersed throughout the first binding agent, 
   at least one active ingredient layer encapsulating the core, the at least one
 active ingredient layer comprising: 
 a second active ingredient different from the first active ingredient; and 
 a second binding agent, wherein the second active ingredient is dispersed throughout the second binding agent, wherein the first active ingredient, the second active ingredient, or both is cannabidiol (CBD). 
   
     
     
         13 . The non-prescription consumable product recited in  claim 12 , further comprising:
 a sealing layer encapsulating the microbead core and the at least one active ingredient layer, wherein the sealing layer does not substantially break down prior to being consumed.   
     
     
         14 . The non-prescription consumable product recited in  claim 12 , wherein the layered microbead comprises a first active ingredient layer encapsulating the core and a second active ingredient layer encapsulating the first active ingredient layer, wherein the first active ingredient layer comprises the second active ingredient and the second active ingredient layer comprises a third active ingredient. 
     
     
         15 . The non-prescription consumable product recited in  claim 14 , wherein the third active ingredient is CBD. 
     
     
         16 . The non-prescription consumable product recited in  claim 14 , wherein the second active ingredient is the same active ingredient as the third active ingredient. 
     
     
         17 . The non-prescription consumable product recited in  claim 14 , wherein the second active ingredient layer further comprises a third binding agent, and wherein the amount of second binding agent in the first active ingredient layer is different from the amount of third binding agent in the second active ingredient layer. 
     
     
         18 . The non-prescription consumable product recited in  claim 14 , wherein the microbead further comprises a sealing layer disposed between the first active ingredient layer and the second active ingredient layer. 
     
     
         19 . The non-prescription consumable product of  claim 12 , wherein the first active ingredient counteracts or reduces the effect of the second active ingredient. 
     
     
         20 . The non-prescription consumable product of  claim 12 , wherein the first active ingredient enhances or complements the effect of the second active ingredient.