Effect of Excipients on the Stability and Aerosol Performance of Nebulized Aviscumine
| Autor: | Klaus Witthohn, Fadi Eskandar, Hartwig Steckel |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Pulmonary and Respiratory Medicine
Tris Octanols Surface Properties Biological Availability Excipient Hydroxyethyl starch Sensitivity and Specificity Dosage form Excipients chemistry.chemical_compound Drug Stability Administration Inhalation medicine Humans Pharmacology (medical) Plant Proteins Toxins Biological Aerosols Tricine Chromatography Equipment Safety Nebulizers and Vaporizers Equipment Design Buffer solution Models Theoretical Metered-dose inhaler Ribosome Inactivating Proteins Type 2 Nebulizer chemistry Plant Preparations medicine.drug |
| Zdroj: | Journal of Aerosol Medicine. 16:417-432 |
| ISSN: | 1557-9026 0894-2684 |
| DOI: | 10.1089/089426803772455677 |
| Popis: | Pulmonary delivery is an attractive alternative route to deliver protein drugs that are currently delivered by injection. Inhalation therapy via nebulizers is a well accepted way for pulmonary application of proteins considering the formulation difficulties of MDIs or DPIs. This research presents the effect of variable excipients on the stability and aerosol performance of freeze-dried aviscumine after reconstitution and nebulization. Aviscumine formulations containing 100 mmol/L Tris buffer, 0.1% (w/v) Polysorbate 80, 0.01% (w/v) Na(2)-EDTA and 8% (w/v) Hydroxyethyl starch have been lyophilized and reconstituted with a buffered isotonic solution pH 8. The aviscumine activity was determined by a binding assay directly after reconstitution and after nebulization with a PariBoy air-jet nebulizer, a Multisonic and a Systam ultrasonic nebulizer. The stabilization of aviscumine by the addition of variable buffer salts to the reconstitution medium, such as 50, 100, and 200 mmol/L Tris buffer, 20 and 100 mmol/L phosphate buffer, and 20 and 100 mmol/L Tricine buffer, was studied. About 50% of aviscumine activity was lost after 20 min nebulization time without any additives. Nevertheless, higher buffer concentrations confer greater stability. About 70% of the aviscumine activity could be retained by the addition 0.03% octanoyl-N-methylglucamide and 100 mmol/L Tricine to the reconstitution medium. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|