Stabilization of Octastatin, a somatostatin analogue: comparative accelerated stability studies of two formulations for freeze-dried products.
Octastatin (vapreotide INN) is a somatostatin analogue being developed in gastro-enterologic, neuroendocrine and oncologic applications. The pharmaceutical form is a freeze-dried preparation for parental injection use. This study was intended to evaluate the stability of the freeze-dried products and to determine the optimally stable formulation. Two types of stabilizing agents (lactose and glutamic acid/sodium glutamate buffer) and three dosage forms (0.5, 1.5, 15 mg of vapreotide base) were investigated. The peptide content and chemical stability of cakes stored at 50 degrees C and 70% relative humidity were determined by HPLC and the regression analysis parameters calculated. Results indicate that the formulation with glutamate buffer is appropriate for long term storage.
Barthomeuf
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Laboratoire de Pharmacognosie et de Biotechnologie, Faculté de Pharmacie, Clermont-Ferrand, France.
Pourrat
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Pourrat
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Ibrahim
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Cottier
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PE
D000970:Antineoplastic Agents / Q000737:chemistry*; D002021:Buffers; D004355:Drug Stability; D005612:Freeze Drying; D018698:Glutamic Acid / Q000008:administration & dosage; D007785:Lactose / Q000008:administration & dosage; D013004:Somatostatin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry
D000970:Antineoplastic Agents; D002021:Buffers; C051458:vapreotide; D018698:Glutamic Acid; D013004:Somatostatin; D007785:Lactose