Process for preparing formulations of lipid-regulating drugs
A process for preparing a formulation of a lipid-regulating drug is disclosed, the process comprising dissolving lipid-regulating drug in a solvent free of surfactant to form a solution, premixing an excipient to form an admixture, wet granulating the solution and admixture to form a granulated admixture, drying the granulated admixture and utilizing the dried material to obtain a final dosage form.
1. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution, wherein the drug solution consists of the lipid-regulating drug and the solvent;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture, wherein the drug solution is not mixed with a second solution prior to wet granulating; and
drying the granulated admixture.
2. The process of claim 1 wherein the lipid-regulating drug is a fibrate.
3. The process of claim 2 wherein the fibrate is fenofibrate.
4. The process of claim 1 wherein the drying step includes evaporating the solvent.
5. The process of claim 4 wherein the evaporating is performed under vacuum.
6. The process of claim 1 wherein the drying step is accomplished using a fluid bed, tray dryer or rotary atomizer.
7. The process of claim 1 comprising the additional step of adding other excipients.
8. The process of claim 1 comprising the additional step of forming a final dosage form.
9. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution; wherein the drug solution consists of the lipid-regulating drug and the solvent;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture; wherein the drug solution is not mixed with a second solution prior to wet granulating;
drying the granulated admixture; and
tableting the dried granulated admixture.
10. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution; wherein the drug solution consists of the lipid-regulating drug and the solvent;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture; wherein the drug solution is not mixed with a second solution prior to wet granulating;
drying the granulated admixture; and
filling capsules with the dried granulated admixture.
11. The process of claim 1 wherein the excipient is one or more members selected from the group consisting of lactose, starch, polyvinyl pyrrolidone, magnesium stearate, and other pharmaceutically-acceptable excipients.
12. The process of claim 1 wherein the admixture is granulated in a fluidized bed.
13. The process of claim 1 wherein the admixture is granulated in a low shear or high shear mixer.
14. A method for treating of hyperlipidemia comprising the step of administering the final drug formulation prepared by the process of claim 9 .
15. A method for treating of hyperlipidemia comprising the step of administering the final drug formulation prepared by the process of claim 10 .
16. A method for treating of hyperlipidemia comprising the administration of the formulation prepared by the process of claim 3 .