Sustained Release Suspension Preparation For Dextromethorphan
A stabilized pharmaceutical composition comprises a drug-resin complex wherein the resin has been treated with an alkaline material prior to the formation of the drug-resin complex. The drug-resin complex may further be impregnated with an alkalizing agent, L-methionine, an antioxidant agent, or a combination thereof, or be coated with a diffusion barrier. A method of preparation of the pharmaceutical composition is provided.
1 . A stabilized pharmaceutical composition comprising a drug-resin complex and L-methionine,
wherein the resin is treated with an inorganic alkaline material prior to forming the drug-resin complex.
2 . The composition of claim 1 , wherein the inorganic alkaline material is an alkali metal, an alkaline earth or post transition metal in form of oxide, hydroxide, carbonate or bicarbonate.
3 . The composition of claim 2 , wherein the inorganic alkaline material is sodium hydroxide.
4 . The composition of claim 1 , wherein the resin is a cationic exchange resin.
5 . The composition of claim 4 , wherein the resin is divinylbenzene sulfonic acid cationic resin.
6 . The composition of claim 1 , wherein the drug is prone to degradation.
7 . The composition of claim 6 , wherein the drug selected from a group consisting of dextromethorphan, codeine, morphine, hydrcodone, pseudoephedrine, phenylpropanolamine, and the salts thereof.
8 . The composition of claim 7 , wherein the drug is dextromethorphan.
9 . The composition of claim 1 further comprising an antioxidant agent.
10 . The composition of claim 9 , wherein the antioxidant agent is butylated hydroxyanisole or butylated hydroxytoluene.
11 . The composition of claim 10 , wherein the antioxidant agent is butylated hydroxytoluene.
12 . The composition of claim 9 , further comprising phosphoric acid.
13 . The composition of claim 12 , wherein the composition does not include propylene glycol.
14 . A stabilized pharmaceutical composition comprising a drug-resin complex,
wherein the resin is treated with an inorganic alkaline material prior to forming the drug-resin complex, and
wherein the drug-resin complex is coated with a diffusion barrier coat.
15 . The composition of claim 14 , wherein the diffusion barrier coat allows for sustained release of the drug.
16 . The composition of claim 14 , wherein the diffusion barrier coat allows for delayed release of the drug.
17 . The composition of claim 14 , wherein the inorganic alkaline material is an alkali metal, an alkaline earth or post transition metal in form of oxide, hydroxide, carbonate or bicarbonate.
18 . The composition of claim 14 , wherein the inorganic alkaline material is sodium hydroxide.
19 . A stabilized pharmaceutical composition comprising a drug-resin complex,
wherein the resin is treated with an inorganic alkaline material prior to forming the drug-resin complex, and
wherein the drug-resin complex is impregnated with an alkalizing agent.
20 . The composition of claim 19 , wherein the inorganic alkaline material is an alkali metal, an alkaline earth or post transition metal in form of oxide, hydroxide, carbonate or bicarbonate.
21 . The composition of claim 20 , wherein the inorganic alkaline material is sodium hydroxide.
22 . The composition of claim 19 , wherein the alkalizing agent is selected from a group consisting of pseudoephedrine, phenylpropanolamine, MgO, Mg(OH) 2 , CaCO 3 , Ca(OH) 2 , and MgCO 3 .
23 . The composition of claim 22 , wherein the alkalizing agent is MgO.
24 . The composition of claim 19 , wherein the drug-resin complex is further impregnated with a solvating agent.
25 . The composition of claim 24 , wherein the solvating agent is selected from a group consisting of polyethylene glycol, propylene glycol, and glycerol.
26 . A method for preparing a pharmaceutical composition comprising:
a) contacting a resin with an inorganic alkaline material in an aqueous medium to obtain a treated resin;
b) combining a drug and the treated resin in a liquid to form a drug-resin complex;
c) formulating the alkalized drug-resin complex to form a pharmaceutical composition.
27 . The method of claim 26 , wherein the inorganic alkaline material is an alkali metal, an alkaline earth or post transition metal in form of oxide, hydroxide, carbonate or bicarbonate.
28 . The method of claim 26 , wherein the inorganic alkaline material is sodium hydroxide.
29 . The method of claim 26 , further comprising the step of impregnating the drug-resin complex with magnesium oxide after step b) of forming the drug-resin complex and prior to step c) of the formulation.
30 . The method of claim 26 , further comprising the step of impregnating the drug-resin complex with L-methionine after step b) of forming the drug-resin complex and prior to step c) of the formulation.
31 . The method of claim 26 , further comprising the step of impregnating the drug-resin complex with L-methionine and butylated hydroxytoluene after step b) of forming the drug-resin complex and prior to step c) of the formulation.
32 . The method of claim 31 , wherein the formulating step comprising the adding of phosphoric acid.
33 . The method of claim 26 , further comprising the step of coating the drug-resin complex with a diffusion barrier coat after step b) of forming the drug-resin complex and prior to step c) of the formulation.