Anhydrous hydrogel composition

Abstract

The present disclosure relates to anhydrous hydrogels useful as mucoadhesive (oral compositions) or as topical agents and may be used to deliver an active agent such as active pharmaceutical agents (API's), coagulants, fragrances, flavors, and other actives and excipients.

1 . An active agent delivery system, comprising
 a. a solid or semi-solid gel composition, the solid or semi-solid gel composition comprising:
 i. sodium carboxymethyl cellulose (NaCMC) in an amount of from 5% (w/w) to 30% (w/w), said sodium carboxymethyl cellulose including minimal residual water, and 
 ii. anhydrous glycerine in an amount of from 70% (w/w) to 95% (w/w); 
   b. an active agent; and   c. a rate controlling membrane.   
     
     
         2 . The active agent delivery system of  claim 1 , wherein the active agent delivery system is a patch, capsule, lozenge or chew. 
     
     
         3 . The active agent delivery system of  claim 1 , wherein the amount of active agent is from 0.1% (w/w) to 30% (w/w). 
     
     
         4 . The active agent delivery system of  claim 1 , wherein the solid or semi-solid gel composition includes an interior, a reservoir is within the interior and the reservoir includes the active agent. 
     
     
         5 . The active agent delivery system of  claim 1 , wherein said active agent is cannabidiol (CBD). 
     
     
         6 . The active agent delivery system of  claim 1 , wherein said active agent is selected from cannabidiol (CBD) oil and tetrahydrocannabinol (THC) oil. 
     
     
         7 . The active agent delivery system of  claim 1 , wherein said active agent is a moisture sensitive active agent and said moisture sensitive active agent comprises pharmaceutical agents including biologicals, enzymes, proteins and fragments thereof, Adderall, alprazolam, gemifloxacin, hydromorphone and zolmitriptan. 
     
     
         8 . The active agent delivery system of  claim 1 , wherein said active agent is a pharmaceutical agent selected from analgesics, decongestants, bronchodilators, antiasthmatic agents, cardiovascular agents, diabetic agents, antihistamines, anesthetics, antifungals, anti-nauseants, antiemetics, antibacterial agents, antifungal agents, corticosteroids, neurological agents, anti-inflammatories, vaccines, biological agents, wound healing agents, anticonvulsants and vitamins. 
     
     
         9 . The active agent delivery system of  claim 1 , wherein said active agent is a wound healing agent selected from becaplermin, antimicrobial agents, silver, povidone-iodine, polyhexamethylene biguanide, dialkylcarbamoylchloride, lactoferrin, and growth factors. 
     
     
         10 . The active agent delivery system of  claim 1 , wherein said rate controlling membrane is selected from polyolefins, polyamides, polyesters, ethylene-ethacrylate copolymer, ethylene-vinyl acetate copolymer, ethylene-vinyl methylacetate copolymer, ethylene-vinyl ethylacetate copolymer, ethylene-vinyl propylacetate copolymer, polyisoprene, polyacrylonitrile, ethylene-propylene copolymer and polysiloxane-polycarbonate block copolymer. 
     
     
         11 . An active agent delivery system, comprising
 b. a substrate;   c. a solid or semi-solid gel composition on the substrate, the solid or semi-solid gel composition including:
 i. sodium carboxymethyl cellulose (NaCMC) in an amount of from 5% (w/w) to 30% (w/w), said sodium carboxymethyl cellulose including minimal residual water, 
 ii. anhydrous glycerine in an amount of from 70% (w/w) to 95% (w/w); 
 iii. an active agent; and 
 iv. a rate controlling membrane. 
   
     
     
         12 . The active agent delivery system of  claim 11 , wherein the solid or semi-solid gel composition includes an interior, a reservoir is within the interior, the reservoir includes the active agent and the rate controlling membrane is on a surface side of the composition to be applied to a body surface of a patient. 
     
     
         13 . The active agent delivery system of  claim 11 , wherein the substrate is a backing layer or a release liner that covers a surface of the composition that includes the rate controlling membrane and that upon removal of the substrate becomes an exposed surface of the composition to be applied to a body surface of a patient in active agent-transmitting relationship thereto. 
     
     
         14 . The active agent delivery system of  claim 11 , wherein the active agent delivery system is a patch. 
     
     
         15 . The active agent delivery system of  claim 11 , further including a skin contact adhesive to affix the active agent delivery system to a patient's body. 
     
     
         16 . The active agent delivery system of  claim 11 , wherein said active agent is cannabidiol (CBD). 
     
     
         17 . The active agent delivery system of  claim 11 , wherein said active agent is selected from cannabidiol (CBD) oil and tetrahydrocannabinol (THC) oil. 
     
     
         18 . The active agent delivery system of  claim 11 , wherein s said active agent is a moisture sensitive active agent and said aid moisture sensitive active agent comprises pharmaceutical agents including biologicals, enzymes, proteins and fragments thereof, Adderall, alprazolam, gemifloxacin, hydromorphone and zolmitriptan. 
     
     
         19 . The active agent delivery system of  claim 11 , wherein said active agent is a pharmaceutical agent selected from analgesics, decongestants, bronchodilators, antiasthmatic agents, cardiovascular agents, diabetic agents, antihistamines, anesthetics, antifungals, anti-nauseants, antiemetics, antibacterial agents, antifungal agents, corticosteroids, neurological agents, anti-inflammatories, vaccines, biological agents, wound healing agents, anticonvulsants and vitamins. 
     
     
         20 . The active agent delivery system of  claim 11 , wherein said active agent is a wound healing agent selected from becaplermin, antimicrobial agents, silver, povidone-iodine, polyhexamethylene biguanide, dialkylcarbamoylchloride, lactoferrin, and growth factors. 
     
     
         21 . The active agent delivery system of  claim 11 , wherein said rate controlling membrane is selected from polyolefins, polyamides, polyesters, ethylene-ethacrylate copolymer, ethylene-vinyl acetate copolymer, ethylene-vinyl methylacetate copolymer, ethylene-vinyl ethylacetate copolymer, ethylene-vinyl propylacetate copolymer, polyisoprene, polyacrylonitrile, ethylene-propylene copolymer and polysiloxane-polycarbonate block copolymer. 
     
     
         22 . A method of using an active agent delivery system, the active agent delivery system comprising
 a. a solid or semi-solid gel composition including a reservoir, the solid or semi-solid gel composition comprising:
 i. sodium carboxymethyl cellulose (NaCMC) in an amount of from 5% (w/w) to 30% (w/w), said sodium carboxymethyl cellulose including minimal residual water, and 
 ii. anhydrous glycerine in an amount of from 70% (w/w) to 95% (w/w); 
 iii. the reservoir including an active agent; and 
 iv. a rate controlling membrane on the surface side of the active agent delivery system covered by a substrate; and 
   b. the substrate including a backing layer or a release liner that covers a surface of the composition,   the method comprising:   1) removing the substrate from the active agent delivery system where upon removal, the surface of the active agent delivery system becomes an exposed surface of the active agent delivery system; and   2) applying the exposed surface of the active agent delivery system to a body surface of a patient in active agent-transmitting relationship thereto.   
     
     
         23 . The active agent delivery system of  claim 22 , wherein said rate controlling membrane is selected from polyolefins, polyamides, polyesters, ethylene-ethacrylate copolymer, ethylene-vinyl acetate copolymer, ethylene-vinyl methylacetate copolymer, ethylene-vinyl ethylacetate copolymer, ethylene-vinyl propylacetate copolymer, polyisoprene, polyacrylonitrile, ethylene-propylene copolymer and polysiloxane-polycarbonate block copolymer.