Stabilization of Octastation, a Somatostatin Analogue. Preparation of Freeze-Dried Products for Parenteral Injection

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概要

• 論文の詳細を見る

• Octastatin (RC-160,vapreotide INN) is a somatostatin analogue being developed for use in oncological, enterologic and neuroendocrine applications. The pharmaceutical form is a freeze-dried preparation for parenteral injection use. Three dosage forms containing 0.5,1.5 and 15 mg of vapreotide base have been investigated. Various freeze-drying conditions, stabilizing agents, membranes for sterile filtration and heating procedures have been examined. The formulation with glutamic acid-sodium glutamate buffer as a stabilizing agent, the type of membrane for filtration and the freeze-drying procedure have been found appropriate for subsequent industrial production. No evident degradation was observed either after manufacturing, or after a three-week accelerated stability study at 50℃ and 70% relative humidity.

• 公益社団法人日本薬学会の論文
• 1995-05-15

著者

• POURRAT Aimee

  Laboratoire de Pharmacie Galenique et Pharmacotechnie Industrielle

• POURRAT HENRI

  Laboratoire de Pharmacie Galenique et Pharmacotechnie

• Pourrat A

  Laboratoire De Pharmacie Galenique Et Pharmacotechnie Industrielle

• Pourrat H

  Laboratoire De Pharmacognosie Et Biotechnologie

• BARTHOMEUF Chantal

  Laboratoire de Pharmacognosie et Biotechnologie

• COTTIER Pierre-Edouard

  Debiopharm S.A.

• IBRAHIM Houssam

  Debiopharm S.A.

• Barthomeuf C

  Laboratoire De Pharmacognosie Et Biotechnologie

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• Stabilization of Octastation, a Somatostatin Analogue. Preparation of Freeze-Dried Products for Parenteral Injection
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