Home About us Contact
|
Home About us Contact | ||
|
|
||
Sterile Powder (sterile + powder)
Selected AbstractsFreeze-drying of tert- butanol/water cosolvent systems: A case report on formation of a friable freeze-dried powder of tobramycin sulfateJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 4 2002Sakchai Wittaya-Areekul Abstract A case study is presented in which a tert -butanol (TBA)/water cosolvent system was found to be a useful means of producing freeze-dried tobramycin sulfate that readily forms a loose powder upon agitation in a specialized application in which a critical quality attribute is the ability to pour the sterile powder from the vial. Both formulation and processing variables are important in achieving acceptable physical properties of the cake as well as minimizing residual TBA levels. Liquid/liquid phase separation was observed above critical concentrations of both drug and TBA, resulting in a two-layered lyophilized cake with unacceptable appearance, physical properties, and residual TBA levels. However, the choice of tobramycin sulfate and TBA concentrations in the single-phase region of the phase diagram resulted in a lyophilized solid that can readily be poured from vials. Crystallization of TBA before drying is critical to achieving adequately low residual TBA levels, and this is reflected in the effect of thermal history of freezing on residual TBA levels, where rapid freezing results in incomplete crystallization of TBA and relatively high levels of residual solvent. Annealing at a temperature above T,g of the system after an initial freezing step significantly reduces the level of residual TBA. Secondary drying, even at increased temperature and for extended times, is not an effective method of reducing residual TBA levels. © 2002 Wiley-Liss, Inc. and the American Pharmaceutical Association J Pharm Sci 91: 1147,1155, 2002 [source] Liquid chromatographic/mass spectrometric assay of rabprazole in dog plasma for a pharmacokinetic studyBIOMEDICAL CHROMATOGRAPHY, Issue 11 2006Shao Feng Abstract In order to evaluate the pharmacokinetic (PK) profile of rabeprazole (RA) sterile powder for injection, a rapid, sensitive and specific assay for quantitative determination of RA in dog plasma was developed and validated. After a liquid,liquid extraction procedure, samples were analyzed by liquid chromatography,electrospray ionization mass spectrometry (LC-ESI-MS) using omepazole as the internal standard (IS). The analyte and IS was chromatographed on a ZORBAX Extend-C18 analytical column (50 × 2 mm i.d, 5 µm, Agilent Technologies, USA). The assay was linear in the range 1,2000 ng/mL. The lower limit of quantification of RA was 1 ng/mL. The recovery of RA was greater than 70%. The within- and between-batch accuracy was 102.7,107.4% and 103.5,105.7%, respectively. The plasma samples for the PK study were collected at defined time points during and after an intravenous injection (1 mg/kg) to beagle dogs and analyzed by LC-ESI-MS method. The PK parameters, such as half-life, volume of distribution, total clearance and elimination rate constant, were determined. The PK profile of RA gave insights into the application in the clinics. Copyright © 2006 John Wiley & Sons, Ltd. [source] Liquid chromatographic,mass spectrometry analysis and pharmacokinetic studies of a novel rabeprazole formulation, sterile powder for injection, in dogs and ratsBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 4 2007Feng Shao Abstract Rabeprazole is among the most potent proton pump inhibitors (PPI) identified to date and it has been demonstrated that it is effective in such diseases as gastroesophageal reflux disease (GERD), duodenal ulcer and gastric ulcer. There is currently interest in developing a new formulation: rabeprazole sterile powder for injection (RSPI). This investigation was conducted to evaluate the preclinical pharmacokinetics of RSPI in rats and at the same time a comparative study was carried out in dogs between RSPI and Pariet® tablets using liquid chromatographic,mass spectrometry analysis. The liquid chromatographic,mass spectrometry method was first conducted and validated as being specific, and having accuracy, precision, sensitivity and a satisfactory recovery. After intravenous administration of RSPI (i.v.: 2, 6 and 18 mg/kg) to rats, no significant dose-dependency was found in the CL (4.20,5.72 l/h/kg), Varead (0.94,1.32 l/kg), dose-normalized AUC (197.20,245.82 µg/l*h based on 1 mg/kg) and t1/2 (p>0.05). In the dog, a randomized, open-label, crossover experiment was carried out to show that the mean area under the plasma concentration-time curve (AUC0,,) after i.v. administration of RSPI was at least four times larger than that following oral administration of Pariet® tablet at an equivalent dose but the elimination half-life of these two formulation was similar (p>0.05). The results showed that the pharmacokinetics of RSPI was linear (r2 = 0.98) in the dose range 2,18 mg/kg and the RSPI had a much higher AUC0,, and similar t1/2 values compared with the enteric-coated tablet. Copyright © 2007 John Wiley & Sons, Ltd. [source] | ||||||||||