|Title:||Preparation of pharmaceutical and other matrix systems by solid-state dissolution|
|Abstract:||A method is disclosed for preparing pharmaceutical and other matrix systems that comprises solidifying a matrix composition dissolved or dispersed in a first solvent and subsequently contacting the solidified matrix with a second solvent that is substantially miscible with the first solvent at a temperature lower than the solidification point of the first solvent, the matrix components being substantially insoluble in the second solvent, whereby the first solvent is substantially removed resulting in a usable matrix.|
|Inventor(s):||Gole; Dilip J. (Ann Arbor, MI), Levinson; R. Saul (Saline, MI), Carbone; James (Belleville, MI), Davies; J. Desmond (Grosse Pointe Farms, MI)|
|Filing Date:||Nov 06, 1990|
|Claims:||1. A method for preparing a porous unit dosage form comprising the steps of: |
(a) dispersing or dissolving a matrix forming agent in a first solvent;
(b) solidifying a unit volume of the dispersion or solution;
(c) contacting the solidified unit volume with a second solvent, the first solvent in the solidified unit volume being substantially miscible with the second solvent, the solidification point of the first solvent being higher than the solidification point of the second solvent, the second solvent being at a temperature at or higher than the solidification point of the second solvent and at a temperature at or lower than the solidification point of the first solvent, the matrix forming agent being substantially insoluble in the second solvent, the contacting being sufficient to substantially remove the first solvent from the solidified unit volume thereby yielding a unit dosage form that is substantially free of the first solvent; and
(d) recovering the unit dosage form, the matrix forming agent being present in the dispersion or solution in an amount sufficient to form a matrix upon the substantial removal of the first solvent.
2. The method according to claim 1, wherein the first solvent is water and the second solvent is a water miscible alcohol.
3. The method according to claim 1, wherein the matrix forming agent is selected from the group consisting of gelatins, dextrins, soy proteins, wheat proteins, psyllium seed proteins, gums, alginates, polysaccharides, carboxymethylcellulose, carrageenans, dextrans, pectins, polyvinylpyrrolidone, gelatin-acacia complexes, mannitol, dextrose, lactose, galactose, cyclodextrin, konjac flour, cellulose, sodium starch glycolate, polydextrose, hydroxyethylcellulose, amino acids having 2 to 12 carbon atoms, corn syrup solids, chitosan, rice flour, wheat gluten, soy fiber proteins, potato proteins, papain, horse radish peroxidase and mixtures thereof.
4. The method according to claim 3, wherein at least one of the matrix forming agents is selected from the group consisting of gelatin, pectin, mannitol and glycine.
5. The method according to claim 2, wherein the alcohol is at a temperature from about 0 to -100.degree. C.
6. The method according to claim 1, wherein the matrix forming agent is present in a concentration of about 0.1% to 15% by weight of the dispersion or solution.
7. The method according to claim 1, comprising the additional step of:
(c) evaporating residual second solvent from the unit dosage form.
8. The method according to claim 1, wherein the dispersion or solution also contains an active agent to be delivered, the active agent being substantially insoluble in the second solvent.
9. The method according to claim 1, comprising the additional step of:
(e) contacting the unit dosage form with an active agent to be delivered such that the active agent is dispersed through the matrix.
10. The method according to claim 8 wherein the active agent is a bioactive agent.
11. The method according to claim 9 wherein the active agent is an effective unit dosage amount of a bioactive agent.
12. The method according to claim 1, wherein the matrix forming agent comprises gelatin, mannitol and glycine.
13. The method according to claim 1 wherein the delivery matrix additionally comprises an active agent.
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