Claims
- 1. A method for manufacturing pergolide mesylate comprising:
forming a powder mixture having lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch, glycolate; dissolving pergolide mesylate in water and alcohol to form a pergolide mesylate solution; forming a wet granulation by adding the pergolide mesylate solution to the powder mixture; drying the wet granulation to form dry granulate; milling the dry granulate to form milled granulate; mixing magnesium stearate with milled granulate to form a blend.
- 2. The method of claim 1, wherein pergolide mesylate is dissolved in water and alcohol having a ration of 1 to 3.
- 3. The method of claim 2, wherein said drying step is carried out in a fluid bed drier.
- 4. The method of claim 3, wherein the fluid bed dryer uses an airflow of 200 to 500 m3/h/kg.
- 5. The method of claim 1, further comprising the step of compressing said blend into tablets.
- 6. A pergolide mesylate in therapeutically effective amount and in unit dry dosage form which degrades to pergolide sulfoxide less than 4.8% after three month of storage at 40° C. and 75% relative humidity.
- 7. The pergolide mesylate of claim 6, wherein the amount of total degradation to pergolide sulfoxide does not exceed 1.3%.
- 8. The pergolide mesylate of claim 6, wherein said pergolide mesylate does not contain stabilizers.
- 9. A pergolide mesylate composition initially containing 0.3% pergolide sulfoxide and containing 1.3% pergolide sulfoxide after 3 months storage at 40° C. and 75% relative humidity.
- 10. The pergolide mesylate composition of claim 8, wherein said composition does not contain stabilizer.
- 11. A pergolide mesylate composition as produced according to claim 1.
- 12. A method for manufacturing stable pergolide mesylate comprising:
forming a powder mixture having lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, color ferric oxide and magnesium stearate; compressing the powder mixture into at least one slug tablet; milling the rotary tablets; and mixing the milled rotary tablets with magnesium stearate to produce stable pergolide mesylate.
- 13. The method of claim 12, wherein the step of compressing the powder mixture is accomplished by a rotary tableting machine.
- 14. The method of step 12, further comprising compressing the stable pergolide mesylate into tablets.
- 15. The method of claim 12, wherein the stable pergolide mesylate initially contains less than 0.5% pergolide sulfoxide.
Parent Case Info
[0001] The instant application claims priority to the U.S. Provisional Application No. 60/223,774, filed Aug. 8, 2000 by the same inventors.
Provisional Applications (1)
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Number |
Date |
Country |
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60223774 |
Aug 2000 |
US |