Compositions and methods for mucosal delivery
First Claim
1. A dosage unit, comprising:
- an effective dose of sildenafil citrate;
the sildenafil citrate being formed in a solid dispersion with a water soluble inert filler, the solid dispersion being mixed with film forming reagents including a hydropolymer so as to form a film, the film being capable of dissolving on a mucosal surface so as to release the sildenafil citrate;
wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70°
C. for a 2% polymer solution, a dry film thickness of not more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface.
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Accused Products
Abstract
Mucosal surface-coat-forming film dosage units containing a water-soluble hydrocolloid, an effective dose of an active agent and a mucosal adhesion enhancer; wherein the active agent is encapsulated within a polymer which is chemically or physically distinct from the hydocolloid; wherein the mucosal adhesion enhancer is a starch graft copolymer; wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70° C. for a 2% polymer solution, a dry film thickness of less than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear probagation resistance of 0.001 to 1 N, and a dissolution time in the range of 1 to 600 seconds upon application to an oral mucosal surface.
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Citations
51 Claims
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1. A dosage unit, comprising:
- an effective dose of sildenafil citrate;
the sildenafil citrate being formed in a solid dispersion with a water soluble inert filler, the solid dispersion being mixed with film forming reagents including a hydropolymer so as to form a film, the film being capable of dissolving on a mucosal surface so as to release the sildenafil citrate;
wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70°
C. for a 2% polymer solution, a dry film thickness of not more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface.
- an effective dose of sildenafil citrate;
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2. A dosage unit comprising a mucosal surface-coat-forming film, wherein the mucosal surface-coat-forming film comprises a water-soluble hydrocolloid, an effective dose of an active agent and a mucosal adhesion enhancer;
- wherein the active agent is encapsulated within a polymer which is chemically or physically distinct from the hydocolloid;
wherein the mucosal adhesion enhancer is a starch graft copolymer;
wherein the film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70°
C. for a 2% polymer solution, a dry film thickness of no more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
- wherein the active agent is encapsulated within a polymer which is chemically or physically distinct from the hydocolloid;
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26. A dosage unit comprising a mucosal surface-coat-forming film, wherein the mucosal surface-coat-forming film comprises a water soluble hydrocolloid and an effective dose of an active agent, wherein the active agent comprises sildenafil citrate;
- wherein the mucosal surface-coat-forming film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70°
C. for a 2% polymer solution, a dry film thickness of not more than 20 mil, a water content of 0.5 to 10%, a tensile strength greater than 1500 psi, a modulus in the range of 35,000 to 300,000 psi, a % elongation of less than 20%, a tear propagation resistance of 0.001 to 1 N, and a dissolution time of not more than 600 seconds upon application to an oral mucosal surface. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
- wherein the mucosal surface-coat-forming film exhibits a dry tack value of less than 3.5 g, a wet tack of greater than 35 g, a gelation temperature that is greater than 70°
Specification