Does the cigarette smoking influence the perinatal outcome?

Cigarette smoking, active or passive, is related to adverse perinatal outcome, and affects breastfeeding. It increases risks of spontaneous abortions, preterm delivery, low birthweight, malformations, placenta previa, abruption. The aim of our study was to evaluate whether cigarette smoking has influence to perinatal outcome. Material : newborns and their mothers admitted to Gynecology&Obstetric Clinic, Skopje, Macedonia. Methods : epidemiological, clinical, statistical. Our results showed high influence of the cigarette smoking to some indicators of perinatal outcome (prematurity, low birthweight, Apgar scores). These finding derive conclusion that cigarette smoking is the most frequent and completely preventable risk factor for the adverse neonatal outcome. Key words: newborn, cigarette smoke, outcome, prematurit

Design of Experiments (DoE)-based approach for improvement of dry mixing processes in the production of low-dose Alprazolam tablets using Raman spectroscopy for content uniformity monitoring

A low-dose tablet formulation, containing a potent Benzodiazepine derivative Alprazolam was developed, considering the achievement of appropriate content uniformity of the active substance in powder blends and tablets as a major challenge. Two different types of lactose monohydrate (Tablettose 80 and Granulac 200) and two different types of dry mixing processes (high-shear mixing and "in bulk" mixing) were employed. To evaluate the influence of the variables (mixing speed, mixing time, filling level of the high-shear and cube mixer, lactose monohydrate type) and their interactions upon the response (content uniformity of Alprazolam in the powder blends), a Factorial 2 4 design (with 4 factors at 2 levels in 1 block) was generated for each type of mixer. For high-shear dry mixing the Response Surface, D-optimal Factorial 2 4 design (with 2 replications and 31 experiments) was used, while for the "in bulk" dry mixing the Response Surface, Central Composite Factorial 2 4 design (with 34 experiments) was used. The process parameters for the high-shear mixer were varied within the following ranges: filling level of 70-100%, impeller mixing speed of 50-300 rpm and mixing time of 2-10 minutes. For the cube mixer the following process parameter ranges were employed: filling level of 30-60%, mixing speed of 20-390 rpm and mixing time of 2-10 minutes. Raman spectroscopy in conjunction with a validated Partial Least Square (PLS) regression model was used as a Process Analytical Technology (PAT) tool for Alprazolam content determination and content uniformity monitoring. The DoE model was further employed to optimize the powder blending process in regard to the achievement of appropriate Alprazolam content uniformity using high-shear mixing and Tabletosse 80 as filler. The desirability function revealed that the following process parameters: a mixing time of 2 minutes, a mixing speed of 300 rpm and a 70% filling level of the mixer would produce powder blends with the lowest variability in Alprazolam content. The three independent lab batches of low-dose Alprazolam tablets, produced with high-shear mixing using these process parameters, conformed to the requirements of the European Pharmacopoeia for content (assay) of Alprazolam and uniformity of the dosage units

Tobacco influence on the neonatal outcome

Background: Cigarette smoking, active or passive, is related to adverse perinatal outcomes, increased risk of spontaneous abortions, preterm delivery, low birth weight, malformations, placenta previa, and abruption. It is also known to have adverse effects on the fetus and newborn, as well as affecting breastfeeding. The literature data gave the initial idea to identify some possibly smoking-influenced conditions on perinatal/ neonatal outcome indicators. Patients and Methods: Newborns and their mothers admitted to Gynecology& Obstetric Clinic, Skopje, Macedonia were selected to participate in the study. The patients were divided into 3 groups: the first group consisted of newborns unexposed to tobacco smoke, the second group were newborns born to mothers who smoked more than 20 cigarettes per day, who did not try to quit smoking during the pregnancy, and the third group were newborns born to the mothers who don’t smoke, but were in close contact with other smokers (intensively exposed to the tobacco smoke).Methods used: epidemiological, clinical examinations, biochemical analysis and statistical analysis of the results. Our results clearly demonstrated that maternal smoking had a significant effect (p<0.01) on indictors for perinatal/neonatal outcomes such as: prematurity combined with low birth weight (3,3% vs 12% for the first and second group respectively, and 3,3% vs 9,7% for the first and third group respectively), Apgar scores <6 in the 5-th minute (5,3% vs 13,7% for the first and second group respectively, and 5,3% vs 12,7% for the first and third group respectively), elevated NRBC (2,3% vs 14,7% for the first and second group respectively, and 2,3% vs 12,7% for the first and third group respectively), and for pregnancy outcomes, anemia and premature rupture of the amniotic sac membranes. The following indicators were also significantly affected (p<0.05) by maternal smoking: respiratory distress, cord blood gases, prematurity rate, and for the pregnancy outcome placental abruption and anemia of pregnancy. There was also a statistically significant difference between the results in the unexposed group and both exposed groups. Although smoking and tobacco cannot be considered unique factors influencing the worse perinatal/neonatal outcomes, our study suggests that cigarette smoking is the most frequent, and completely preventable risk factor for adverse neonatal outcomes. Key words: newborn, cigarette smoke, outcome, prematurit

Evaluation of Measles Outbreak During 2010/2011 in Skopje, Macedonia

Background Due to low rates of vaccination coverage, in mostly rural in Skopje and as a result of military conflict in 2001, lead to spillover of the measles from neighboring countries, where outbreak of measles was already declared. Methods and materials: Measles reporting is mandatory in Macedonia. Cases analyzed had to meet the national case definition. Case-series investigation were conducted, surveys of rates of vaccination coverage. Results From 07.09.2010 to 22.07.2011, we have registered 596 cases of measles. Of these 596, twenty five case after getting a negative result from laboratory testing were discarded, so the number of cases of measles in the area of Skopje was 572 (Mb = 97.0/100.000). The first case was during a 13 months of age unvaccinated child. Out of 572 cases of measles 235 (41.0%) were hospitalized, mostly with severe clinical symptoms. According to the patients vaccination status the conclusion was that: 517 (90.4%) persons were vaccinated, of which 59 not subject to the vaccination, 19 (3.3%) persons no data, 36 (6.3%) persons were vaccinated, of which a portion of MMR are 30 and 6 with two doses. During the outbreak, laboratory confirmed 84 cases out of 103 taken materials, were positive. Conclusions The high rate of vaccine coverage in most municipalities in Skopje, unvaccinated children with a first dose and absence of the second dose in the first grade in elementary school, mostly in rural areas affected by the military conflict in 2001, were the cause of measles in epidemic form

Air pollution and the birth weight - are they correlated?

Air pollution has harmful effects to fetuses. Pregnant women have to be protected from a dirty air environment and smoking. The birthweight is a determinant of neonatal well being, and recently published studies potentiated air pollution as a potential factor for low birthweight, and that was investigated in our study. The results showed more Small-for-gestational age babies in the central city district (highly polluted) compared to the eastern rural area, and because we excluded majority of the associated risk factors for this condition, maternal exposure to air pollution during the pregnancy may contribute to lesser weight gain in the fetus. Key words: newborn, air pollution, birth weight, pregnanc