PubMed · 5907963
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H Melich. 1966. [Antigest].. https://pubmed.ncbi.nlm.nih.gov/5907963/
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A new atomizer that operates with ultrasonic energy is described. This apparatus is intended to obtain microparticulate drug delivery systems through spray-congealing or spray-drying technologies. In this work, some experimental results are reported on model systems submitted to spray-congealing. The formulations under examination contained theophylline and fenbufen as model drugs and stearic acid, carnauba wax, Cutina HR(R) and Compritol 888 ATO(R) as low melting excipients. Non-aggregate and spherical-shaped microparticles were obtained with all the materials tested; moreover, they had smooth surface and good flowability. The particle sizes depend on the amount of drug present and in each case the maximum size value of the distribution frequency was found to be 375 mu. In vitro release of the drug depends on its solubility and on the excipient lipophilicity. The results suggest that the ultrasound-assisted atomizer could be proposed as a possible alternative to traditional atomizers used for spray-congealing in the pharmaceutical field.
BACKGROUND: Neoral, a microemulsion formulation of cyclosporine, was approved for use in the United States in 1995. Many studies comparing Neoral and Sandimmune have been conducted, and although most state that Neoral is the superior cyclosporine formulation, results have failed to conclusively demonstrate this claim. The aim of this meta-analysis was to compare the safety and efficacy of Neoral and Sandimmune. METHODS: Publications comparing the use of Neoral and Sandimmune were reviewed for demographic variables, adverse events, rejection incidence, graft losses, and serum creatinine. Neoral and Sandimmune were compared in all patients and in the following subgroups: (1) age (adult or pediatric), (2) transplant type (kidney, liver, or heart), (3) indication (de novo or stable), and (4) study design (randomized prospective trials versus nonrandomized, blinded versus open-labeled studies). RESULTS: The rate of graft loss was similar when comparing Neoral and Sandimmune in all analyses. The incidence of rejection was lower in Neoral-treated de novo renal, liver, and cardiac transplants (P<0.05). There were significantly more adverse events in Sandimmune-treated de novo liver transplants than Neoral-treated de novo liver transplants (P<0.00001). When considering only randomized prospective trials, the incidence of rejection was lower in Neoral-treated de novo and stable patients (P<0.05). However, there were more adverse events in Neoral-treated stable patients (P<0.00001). When considering only blinded studies, there were more adverse events in Neoral-treated patients (P<0.05), whereas in open-labeled studies there was no difference in adverse events comparing Neoral and Sandimmune (P=NS). CONCLUSIONS: Considering all published trials, the data seem to indicate that Neoral therapy is preferred because of a lower rejection incidence, with a trend toward less adverse events. However, when limiting the analysis to only randomized prospective trials, and specifically assessing blinded studies, the data become less clear. Neoral use was associated with more adverse events in blinded studies, and Sandimmune use was associated with more adverse events in open-labeled studies. Careful individual consideration must be given in choosing the best possible cyclosporine formulation.
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