Claims
- 1. A method for the preparation of a solid pharmaceutical composition that is substantially free of any residual organic solvent comprising:
- a) solubilizing an active drug in an organic solvent;
- b) mixing the drug solution with at least one inert carrier material;
- c) removing said solvent from said drug carrier blend and adding water in the range from about 0.1% to approximately 5.0% based on the total weight of the composition to said blend when said solvent is reduced to less then half of its original amount, and;
- d) removing the remaining residual solvent to yield a dry powdered active which can be then tabletted or encapsulated.
- 2. The method of claim 1 wherein the amount of water to be added to said mixture ranges from about 1.5% to approximately 2.5% based on the total weight of the composition.
- 3. The method of claim 2 wherein said water is added to said drug-carrier blend when said organic solvent is reduced from about 50 to about 90% of its original amount.
- 4. The method of claim 3 wherein said water is added to said drug-carrier blend when said organic solvent is reduced from about 70% to approximately 90% of its original amount.
- 5. The method of claim 4 wherein said water is added to said drug-carrier blend when said remaining organic solvent is approximately 80% of its original amount.
- 6. The method of claim 5 wherein said organic solvent is selected from the group consisting of alcohols.
- 7. The method of claim 6 wherein said alcohol is selected from the group consisting of ethanol, methanol, and mixtures thereof.
- 8. The method of claim 7 wherein said drug is selected form the group consisting of hormone drugs and mixtures thereof.
- 9. The method of claim 8 wherein said hormone drugs are selected from the group consisting of steroids, oral contraceptives, estrogenic and progestational hormones and mixtures thereof.
- 10. The method of claim 9 wherein said oral contraceptives are selected from the group consisting of norethindrone acetate, and ethinyl estradiol and mixtures thereof.
- 11. The method of claim 9 wherein said alcohol is removed through the process of evaporation.
- 12. The method of claim 11 wherein said evaporation is carried out through the application of heat, reduced pressure or both.
- 13. The method of claim 12 wherein said carrier material is selected from the group consisting of lactose, microcrystalline cellulose, corn starch, dicalcium phosphate, tricalcium phosphate, carboxymethyl cellulose sodium, hydroxypropyl methyl cellulose, hydroxypropyl cellulose magnesium carbonate, sodium carbonate, calcium carbonate, sugar, sorbitol, gelatinized starch and mixtures thereof.
- 14. The method of claim 13 wherein said carrier material comprises a blend of from about 65-70% lactose, 15-25% microcrystalline cellulose and about 8-12% corn starch on a weight percent of the entire carrier composition.
- 15. A novel method for the preparation of a solid pharmaceutical composition comprising a water-insoluble drug in an inert carrier matrix comprising solubilizing the drug in alcohol, dispersing the solution throughout the inert carrier ingredients, evaporating the alcohol with heat and reduced pressure until it is substantially removed and adding water in the range from about 0.1% to approximately 5.0% based on the total weight of the composition when the alcohol is reduced to approximately 80% of its original amount followed by further heating until dry.
Parent Case Info
This is a continuation of application Ser. No. 08/021,428 filed on Feb. 23, 1993, now abandoned.
US Referenced Citations (10)
Foreign Referenced Citations (1)
Number |
Date |
Country |
287488 |
Mar 1988 |
EPX |
Continuations (1)
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Number |
Date |
Country |
Parent |
21428 |
Feb 1993 |
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