SOLID DOSAGE FORM
There is provided a solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form includes at least one biologically active material, and at least one matrix forming agent, wherein the dosage form substantially dissolves in the oral cavity. A method of producing the same and a kit including the same are also provided.
1 . A solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form comprises:
a) at least one biologically active material, and
b) at least one matrix forming agent,
wherein the dosage form substantially dissolves in the oral cavity and wherein the biologically active material is chosen from the list comprising: at least one cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor, an active material that binds to one or more adrenergic receptors, and an N-methyl-D-aspartate receptor antagonist.
2 . The solid dosage form of claim 1 wherein the solid dosage form is a fast dissolving solid dosage form.
3 . The solid dosage form of claim 1 wherein the N-methyl-D-aspartate receptor antagonist is chosen from the list comprising: dextromethorphan, dextrorphan or ketamine.
4 . The solid dosage form of claim 1 wherein the active material that binds to one or more adrenergic receptors is adrenaline (epinephrine), or an adrenaline salt.
5 . The solid dosage form of claim 1 the cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor is sildenafil or a pharmaceutically acceptable salt thereof.
6 . A method to produce a solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form substantially dissolves in the oral cavity, comprising the steps of:
a) combining at least one matrix forming agent with a biologically active material to form a homogeneous mixture; and
b) freeze drying the mixture to prepare the solid dosage form of the present invention
wherein the biologically active material is chosen from the list comprising: at least one cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor, an active material that binds to one or more adrenergic receptors, and an N-methyl-D-aspartate receptor antagonist.
7 . The method of claim 6 wherein the solid dosage form is a fast dissolving solid dosage form.
8 . The method of claim 6 wherein the N-methyl-D-aspartate receptor antagonist is chosen from the list comprising: dextromethorphan, dextrorphan or ketamine.
9 . The method of claim 6 wherein the active material that binds to one or more adrenergic receptors is adrenaline, or an adrenaline salt.
10 . The method of claim 6 wherein the cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor is sildenafil or a pharmaceutically acceptable salt thereof.
11 . A kit comprising:
a) a solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form substantially dissolves in the oral cavity, wherein the dosage form comprises:
(i) at least one biologically active material, and
(ii) at least one matrix forming agent; and
b) instructions for use
wherein the biologically active material is chosen from the list comprising: at least one cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor, an active material that binds to one or more adrenergic receptors, and an N-methyl-D-aspartate receptor antagonist.
12 . The kit of claim 11 wherein the solid dosage form is a fast dissolving solid dosage form.
13 . The kit of claim 11 wherein the N-methyl-D-aspartate receptor antagonist is chosen from the list comprising: dextromethorphan, dextrorphan or ketamine.
14 . The kit of claim 11 wherein the active material that binds to one or more adrenergic receptors is adrenaline, or an adrenaline salt.
15 . The kit of claim 11 wherein the cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor is sildenafil or a pharmaceutically acceptable salt thereof.
16 . A solid dosage form wafer adapted for the release of a biologically active material in the oral cavity wherein the dosage form comprises:
a) at least one biologically active material, and
b) at least one matrix forming agent,
wherein the wafer substantially dissolves in the oral cavity and wherein the biologically active material is chosen from the list comprising: at least one cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor, an active material that binds to one or more adrenergic receptors, and an N-methyl-D-aspartate receptor antagonist.
17 . The wafer of claim 16 wherein the solid dosage form is a fast dissolving solid dosage form.
18 . The wafer of claim 16 wherein the N-methyl-D-aspartate receptor antagonist is chosen from the list comprising: dextromethorphan, dextrorphan or ketamine.
19 . The wafer of claim 16 wherein the active material that binds to one or more adrenergic receptors is adrenaline, or an adrenaline salt.
20 . The wafer of claim 16 wherein the cyclic guanosine monophosphate (cGMP) phosphodiesterase type 5 (PDE5) inhibitor is sildenafil or a pharmaceutically acceptable salt thereof.
21 . A pharmaceutical composition comprising: the solid dosage form of claim 1 .
22 . A pharmaceutical composition comprising: the solid dosage form of claim 16 .
23 . The solid dosage form of claim 1 , wherein the dosage form is adapted to not leave a residue of said dosage form in the oral cavity that is detectable by the patient.
24 . The solid dosage form of claim 1 , wherein the dosage form substantially dissolves once placed in the oral cavity in a time period selected from the group consisting of: less than 2 minutes; less than 1 minute; less than 50 seconds; less than 40 seconds; less than 30 seconds; less than 20 seconds; less than 15 seconds; less than 10 seconds; less than 7.5 seconds; less than 5 seconds; less than 4 seconds; less than 3 seconds; and less than 2 seconds after administration of the dosage form.
25 . The solid dosage form of claim 1 , wherein the dosage form completely dissolves once placed in the oral cavity in a time period selected from the group consisting of: less than 2 minutes; less than 1 minute; less than 50 seconds; less than 40 seconds; less than 30 seconds; less than 20 seconds; less than 15 seconds; less than 10 seconds; less than 7.5 seconds; less than 5 seconds; less than 4 seconds; less than 3 seconds; and less than 2 seconds after administration of the dosage form.
26 . The solid dosage form of claim 1 , wherein the dosage form provides an effective plasma concentration of the biologically active material within a period of no more than two hours, 30 minutes, 20 minutes, or 15 minutes.
27 . The solid dosage of claim 26 , wherein the period is within 10 minutes.