Biomedical subjects

P Raggi

Publications and source records attributed to P Raggi.

39 records · Page 3Linked to original sources

PubMed1994

Symptoms of patients with silent ischemia as detected by thallium stress testing.

This study was undertaken to determine whether patients with silent ischemia (SI) (a positive thallium stress test without chest pain) have nonchest-pain symptoms that might serve as "anginal equivalents." Two hundred ninety-four individuals on completing a stress test were requested to score ten symptoms on a questionnaire (0 absent; 3 severe). Forty-three with a positive test had pains (chest, back, arm, and/or jaw) (no SI), whereas 93 with a positive test did not (SI). Patients with SI and patients without SI did not differ as to age, gender, or clinical features (including presence of diabetes or a history of myocardial infarction), but patients with SI were less likely to report a history of effort-related chest pains. Patients with SI exercised longer and had a higher peak heart rate. Patients were comparable with respect to myocardial ischemia (ST segment depression, double product, thallium lung uptake, and positive thallium scintigrams) and severity of coronary disease. Patients with SI complained less of weakness (p < 0.02) and tended to have lower overall symptom scores (4.2 +/- 0.3 vs 5.4 +/- 0.6), but breathlessness was comparable for both groups. On multivariate analysis, no nonanginal symptom was associated with SI. Only absence of a history of chest pain with activity and longer exercise time were related to SI. Patients with SI have similar clinical features as those with angina but tend to be less symptomatic with myocardial ischemia even for symptoms other than chest pain.

Exercise Test↗

PubMed1991

Evaluation of factors influencing ampoule secondary particulate contamination. A strategy for its reduction in small volume parenterals.

In this paper, we evaluated the influence of some glass ampoules characteristics that are critical as far as secondary particle contamination (visible and sub-visible) of small volume parenterals. Following characteristics were considered: snap-opening system (colour-break scoring and o.p.c.); break-point strength (high and low); dimensional characteristics (three types D1, D2, D3). According to the proper statistical design, 18 different batches of 2 ml ampoules filled with water for injection were manufactured; then sub-visible and visible particulate contamination generated on snap-opening the ampoules were examined. Sub visible particle counting was performed by the light-blockage method and visible particles counting by the membrane-filtration method. With regard to sub-visible particles, statistical analysis showed significant interactions of break-point strength with both ampoule dimensional characteristics and the type of snap-opening system. Break-point strength seems to have the greatest influence on the level of particulate contamination. Differences in ampoule snap-opening systems and dimensional characteristics exert a significant effect on the level of particle contamination only at high break-point strength. With regard to visible particles generated on snapping the ampoules, data are consistent with the findings of sub-visible particulate contamination. Ampoules manufactured according to DIN dimensional characteristics and with an o.p.c. snap-opening system provide the lowest particle burden.

Drug Contamination↗

PubMedDate not supplied

Evaluation of the influence of open and closed-ampoule technologies on particulate matter in small-volume parenterals.

SVP in glass ampoules are manufactured using two main different technological production processes: the open-ampoule process (O) and the closed-ampoule process (C). In principle, the open-ampoule production technology should lead to better controlled production process. To test this hypothesis and quantify the possible qualitative differences in the manufactured ampoules, a suitable experimental design was set up. The two ampoule production processes have been compared on the basis of the visible particulate burden. Two batches of ampoules filled with water for injections were produced for each type of process, following conventional industrial procedures. Two samples of 20,000 units were taken from each batch and inspected with different automatic inspection systems: two Brevetti CEA machines (S1, S2--light scattering) and two EISAI machines (S3, S4--light absorbtion). The comparison between the processes was based on the rejection percentage. On both inspection machines the open-ampoule production samples present rejection percentages (ranging from 0.154% to 1.248% rejection percentages) which, on average, are lower than those detected in closed-ampoule production (ranging from 1.434% to 3.86% rejection percentages). The difference between the two processes is even more marked if we also consider the data obtained using inspection machines S3 and S4. The substantial differences in performance of the four inspection machines stress the need to provide for adequate validation procedures.

Drug Contamination↗