Back to Search
Start Over
Physical stability of ethyl diatrizoate nanocrystalline suspension in steam sterilization.
- Source :
-
Pharmaceutical research [Pharm Res] 1999 Apr; Vol. 16 (4), pp. 569-74. - Publication Year :
- 1999
-
Abstract
- Purpose: To study the effects of formulation variables on the physical stability of a submicron crystal (nanocrystal) suspension under steam sterilization conditions.<br />Methods: Suspensions of ethyl diatrizoate nanocrystals were prepared by wet milling in the presence of the surfactant poloxamine 908. Particle size distribution and zeta potential were measured by photon correlation spectroscopy.<br />Results: On heating, the mean particle size of the nanocrystal suspension remained essentially unchanged up to 110 degrees C, the cloud point of the stabilizing surfactant, but increased significantly above that temperature. The increase in particle size was a result of particle aggregation rather than crystal growth. Adding a cloud point booster to the suspension significantly minimized the particle aggregation at high temperatures. The purity of poloxamine 908 and the tonicity agent and buffer salt used also affected the heat stability of the suspension, the latter agents apparently through altering the surfactant cloud point.<br />Conclusions: The aggregation of the ethyl diatrizoate nanocrystalline suspension under steam sterilization conditions was a result of phase separation of the stabilizing surfactant at its cloud point. When formulated with a cloud point booster to prevent the phase-separation, the suspension maintained its physical stability under steam sterilization without any significant change in particle size distribution.
- Subjects :
- Buffers
Crystallization
Diatrizoate chemistry
Drug Carriers chemistry
Drug Carriers isolation & purification
Drug Stability
Ethylenediamines chemistry
Ethylenediamines isolation & purification
Hot Temperature
Ionophores chemistry
Ionophores isolation & purification
Ions
Polyethylene Glycols chemistry
Polyethylene Glycols isolation & purification
Solubility
Sonication
Steam
Surface-Active Agents chemistry
Surface-Active Agents isolation & purification
Time Factors
Contrast Media chemistry
Diatrizoate analogs & derivatives
Sterilization
Subjects
Details
- Language :
- English
- ISSN :
- 0724-8741
- Volume :
- 16
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Pharmaceutical research
- Publication Type :
- Academic Journal
- Accession number :
- 10227714
- Full Text :
- https://doi.org/10.1023/a:1018883431970