Pharmaceutical development of a parenteral lyophilized formulation of the novel indoloquinone antitumor agent EO9
| Autor: | Auke Bult, Jantien J. Kettenes-van den Bosch, Herre Talsma, Jantine D. Jonkman-de Vries, Roland E. C. Henrar, Jos H. Beijnen |
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| Rok vydání: | 1994 |
| Předmět: |
Quality Control
Cancer Research Indoles Stereochemistry Drug Storage Aziridines Antineoplastic Agents Toxicology Vial Dosage form Freeze-drying chemistry.chemical_compound Differential scanning calorimetry Drug Stability Medicine Technology Pharmaceutical Pharmacology (medical) Dosing Solubility Lactose Indolequinones Chromatography High Pressure Liquid Pharmacology Antitumor activity Chromatography Calorimetry Differential Scanning business.industry Quinones Freeze Drying Oncology chemistry Spectrophotometry Ultraviolet business |
| Zdroj: | Cancer chemotherapy and pharmacology. 34(5) |
| ISSN: | 0344-5704 |
| Popis: | The aim of this study was to design a stable parenteral dosing form of the investigational cytotoxic drug, encoded EO9. EO9 exhibits poor aqueous solubility and stability characteristics. Freeze-drying was selected as the manufacturing process. Differential scanning calorimetry studies were conducted to determine the freeze-drying cycle parameters. A stable lyophilized formulation of EO9 was developed. The prototype, containing 8.0 mg EO9 and 200 mg lactose/vial, was found to be the optimal formulation in terms of solubility, length of the freeze-drying cycle, stability, and dosing requirements for phase I clinical trials. Quality control of the freeze-dried formulation showed that the manufacturing process does not change the integrity of EO9. Shelf-life studies demonstrated that the formulation remains stable for at least 1 year when stored at +4 degrees C in a dark environment. |
| Databáze: | OpenAIRE |
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