ABSTRACT
The stability of alprostadil diluted in 0.9% sodium chloride stored in polyvinyl chloride (VIAFLEX) containers at refrigerated temperature, protected from light, is reported. Five solutions of alprostadil 11 mcg/mL were prepared in 250 mL 0.9% sodium chloride polyvinyl chloride (PL146) containers. The final concentration of alcohol was 2%. Samples were stored under refrigeration (2°C to 8°C) with protection from light. Two containers were submitted for potency testing and analyzed in duplicate with the stability-indicating high-performance liquid chromatography assay at specific time points over 14 days. Three containers were submitted for pH and visual testing at specific time points over 14 days. Stability was defined as retention of 90% to 110% of initial alprostadil concentration, with maintenance of the original clear, colorless, and visually particulate-free solution. Study results reported retention of 90% to 110% initial alprostadil concentration at all time points through day 10. One sample exceeded 110% potency at day 14. pH values did not change appreciably over the 14 days. There were no color changes or particle formation detected in the solutions over the study period. This study concluded that during refrigerated, light-protected storage in polyvinyl chloride (VIAFLEX) containers, a commercial alcohol-containing alprostadil formulation diluted to 11 mcg/mL with 0.9% sodium chloride 250 mL was stable for 10 days.
Subject(s)
Alprostadil/chemistry , Drug Packaging , Excipients/chemistry , Platelet Aggregation Inhibitors/chemistry , Polyvinyl Chloride/chemistry , Sodium Chloride/chemistry , Vasodilator Agents/chemistry , Alprostadil/pharmacology , Alprostadil/radiation effects , Chromatography, High Pressure Liquid , Cold Temperature , Drug Compounding , Drug Stability , Drug Storage , Hydrogen-Ion Concentration , Isotonic Solutions , Light , Platelet Aggregation Inhibitors/pharmacology , Platelet Aggregation Inhibitors/radiation effects , Sodium Chloride/radiation effects , Time Factors , Vasodilator Agents/pharmacology , Vasodilator Agents/radiation effectsSubject(s)
Laser Therapy , Lung Diseases/surgery , Pneumonectomy , Thoracoplasty , 6-Ketoprostaglandin F1 alpha/metabolism , 6-Ketoprostaglandin F1 alpha/radiation effects , Adolescent , Adult , Aged , Alprostadil/metabolism , Alprostadil/radiation effects , Combined Modality Therapy , Cyclic AMP/metabolism , Cyclic AMP/radiation effects , Cyclic GMP/metabolism , Cyclic GMP/radiation effects , Dinoprost/metabolism , Dinoprost/radiation effects , Dinoprostone/metabolism , Dinoprostone/radiation effects , Female , Humans , Lung Diseases/metabolism , Lung Diseases/radiotherapy , Male , Middle Aged , Preoperative Care , Prostaglandin D2/metabolism , Prostaglandin D2/radiation effects , Thromboxane B2/metabolism , Thromboxane B2/radiation effectsABSTRACT
The results of the experimental papers of the Soviet and foreign investigators concerning the role of cyclic AMP in modification of radiosensitivity of biological objects and the participation of cAMP system in the realization of radioprotective effect of various radioprotectants have been summarized. The action of radioprotectors on the cAMP level in cells and tissues of organism and their effect on the proteins activity of cAMP system has been considered. Particular attention has been given to the mechanisms of the radio-protective action of catecholamines on mammalian cells in vitro. On the grounds of the authors' own and literary data has been supposed that beta-adrenergic receptors and cAMP system, coupled with them, are obligatory for the performance of the radioprotective potency of catecholamines. The methodological problems of radiobiological experiments and adequate interpretation of results in compliance with terms of biochemistry and molecular endocrinology is discussed.
