Stable pergolide mesylate and process for making same
AssigneeTeva Pharmaceuticals Industries, Ltd.
InventorsRuth Tenengauzer, Minutza Leibovici
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Abstract
A formulation and a method for manufacturing pergolide mesylate is disclosed whereby substantially stable pergolide mesylate can be manufactured without having to introduce stabilizing additives.
Claims15
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.
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.
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.
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.
The method of step 12, further comprising compressing the stable pergolide mesylate into tablets.
Dependencies are inferred from the claim text.