Category Archives: AMM 2012, Volume 58, Number 6

Screening the Dissolution Performance of the Modified Release Tablets Containing Insoluble Active Substance in Different Dissolution Media

Kelemen Éva Katalin1, Obreja Mona1, Gyéresi Árpád2

1 SC Gedeon Richter Romania SA, Tîrgu Mureș, Romania
2 Department of Pharmaceutical Chemistry, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Objective: The aim of the present work was to examine a test and a marketed product containing indapamide in different dissolution media: hydrochloric acid, acetate buffer solution, phosphate buffer solution, fasted state simulated intestinal fluid and fed state simulated intestinal fluid.
Methods: Dissolution testing was performed in compliance with USP, using USP apparatus 2. In order to quantify the dissolution of indapamide from modified release tablets, a high liquid chromatographic method was developed.
Results: The dissolution profiles registered in different dissolution media were represented graphically and we calculated the difference factor f1 and the similarity factor f2 between the test and the marketed product’s dissolution profiles obtained in different dissolution media. It can be observed that the dissolution behavior of the test and the marketed product is very similar in hydrochloric acid, phosphate buffer solution, in fasted state simulated intestinal fluid and fed state simulated intestinal fluid, but it is not similar in acetate buffer solution.
Conclusions: In case of poorly soluble active substances, such us indapamide, it is very difficult to develop a dissolution method in order to predict the in vivo behavior. It is necessary to investigate the dissolution profiles not only in the routine dissolution medium, and in three different pH solutions, but in biorelevant media, too.

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Personalized Cement Spacer Manufacturing Using Computer Assisted Design for the Treatment of Osteoarticular Infections

Incze Bartha S, Bod P, Nagy Ö, Incze Bartha Zsuzsánna

Clinic of Orthopedics and Traumatology, University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Background: Infection is the most feared complication in every aspect of bone surgery. Antibiotic impregnated cement spacers and cement beads are widely used since 1972 for treating prosthetic infection. The delivery of a high concentration of antibiotics in a localized area is thought to be safer than systemic administration of intravenous antibiotics in such doses.
Materials and methods: Our clinic has more than 10 years of experience in using preformed and manufactured spacers, mostly hand made. A new method developed by us puts the designing in the preoperative planning phase. Antibiotics are chosen based on the antibiogramm the cement is chemically “configured”. 3D design based on the previous implant or on the bony structure is done; negative molds are manufactured with CNC mill the manufacturing kit is sterilized with ethylene oxide. Intraoperatively the spacer is molded and implanted.
Results and Conclusions: We consider that our method meets almost all the conditions proposed by us. Problems were found with the inconsistent mechanical behavior. More studies are required regarding the mechanical properties of the bone cement in function of antibiotic concentrations and preparation methods.

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The SYNTAX Score and Distal Embolization during Primary Percutaneous Coronary Intervention

Hadadi L1, Somkereki Cristina2, Baki-Jákó LB1, Ispas Mihaela1, Ţilea I1,2, Dobreanu D1

1 Center of Cardiovascular Diseases, County Emergency Clinical Hospital, Tîrgu Mureş, Romania
2 University of Medicine and Pharmacy, Tîrgu Mureș, Romania

Introduction: Multivessel disease, as well as complex coronary anatomy – characterized by high values of the SYNTAX score – has a major impact on reperfusion and patients’ prognostic after an acute myocardial infarction with ST segment elevation (STEMI). Distal embolization, one of the main procedural complications of primary percutaneous coronary intervention (pPCI) could explain this association. However, the relationship between the SYNTAX score and distal embolization has not been studied till now.
Material and methods: A prospective clinical study was performed including all of the cases admitted with STEMI between january 1, 2011 and December 31, 2011. The SYNTAX scores were calculated and distal embolization was appreciated using the recordings of emergency coronary angiographies and pPCI procedures. Statistical analysis was performed, if the SYNTAX score values were higher or not in the cases with distal embolization.
Results: One hundred and thirty-seven patients were enrolled in the study. Distal embolization was present in 45 cases (32.8%); the calculated SYNTAX score values (range: 3 to 42) were significantly higher in these patients (p=0.0035).
Conclusion: Complex coronary anatomy, defined by higher SYNTAX score values, seems to be a contributing factor to distal embolization, determining a negative influence on myocardial reperfusion and subsequently on the prognosis of STEMI.

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Depressive-Delusional Spectrum: the Impact of Delusional Paranoid Ideas on Social Functioning

Giurgi-Oncu Cătălina1, Lăzărescu M1, Ienciu Monica1, Giurgi-Oncu Felicia2, Bredicean Cristina1, Bărănescu Ramona1, Popovici Zs1

1 “Eduard Pamfil” Psychiatry Clinic, “Victor Babeș” University of Medicine and Pharmacy, Timișoara, Romania
2 County Emergency Clinical Hospital, Timișoara, Romania

Introduction: The doctrine of spectrum allows a more common ethiopathogeny for multiple nosological entities, that can be diagnosed separately and which, by their way or intensity of expression, are different. Currently, in psychiatric research, the focus is on the schizophrenic and affective spectra, on their overlap and the clinical practice has noticed the existence of a delusional-depressive spectrum.
Material and methods: Two groups of subjects were examined: group A, comprising of 16 subjects with a diagnosis of F33.3 (ICD 10) and group B, with 27 delusional depressive subjects with a diagnosis of F22 (ICD 10). In these subjects we evaluated the socio-demographic parameters, paranoid elements (Paranoid Thoughts Scale) and social functioning (SFS). The analyzed assumptions were that paranoid ideation shows a higher intensity in subjects with delusional disorder and that social functioning is lower in subjects with psychotic depression.
Results: The socio-demographic parameters show values similar to those of literature; paranoid ideation is present in both groups, but holds no influence on social functioning. There were statistically significant differences between the two groups regarding social functioning, in that it is higher in subjects with delusional disorder compared with those with delusional depression.
Conclusions: Social functioning is higher in delusional disorder subjects compared with those who suffer from psychotic depression; in both groups, all areas of social functioning are affected and the presence of sensitive and paranoid elements does not determine a lower social functioning.

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Hyoid Bone and Breathing Pattern – Cephalometric Study

Draşovean Anca1, Bică Cristina1, Draşovean C2

1 Department of Pedodontics-Orthodontics, Faculty of Dentistry, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2 Department of Prosthetic Dentistry and Oral Rehabilitation, Faculty of Dentistry, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

Introduction: Although during a normal breathing the hyoid bone is hardly moving, it is capable to change its position and probably, most importantly, the orientation according to the physiological requirements demanded by pharyngeal obstruction and mouth breathing.
Aim of the study: Determination of the position of the hyoid bone in mouth breathers in comparison with nasal breathers.
Material and method: Seventy children with ages of 8–9 years, with dental-maxillary anomalies took part in the study. After the ORL examination the initial lot has been divided in two groups: mouth and nasal breathers. On the patients’ cephalometries, by angular and lineal measurements we have determined the parameters which define the position of the hyoid bone in anterior-posterior and vertical sense.
Results: Although the distance between the hyoid bone and the mandibular basal plane is longer in case of mouth breathers than in nasal breathers (GoGn.H°: 25.12° in comparison with 24.06° and H-hy´: 12.37 mm in comparison with 11.65 mm), the results of the statistic tests did not indicate significant differences between the average values of the studied parameters for the two groups.
Conclusions: The measurements indicating the position of the hyoid bone in anterior-posterior sense (C3-H, H-RGn) are not influenced by the breathing pattern, the obtained values being approximately equal in the two studied groups; in case of our patients, on vertical position the hyoid bone having an inferior position in mouth breathers than in nasal breathers.

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Alcohol Consumption and the Risk of Developing Colorectal Cancer and Colorectal Polyps

Crosnoi Daniela1, Bățagă Simona2, Macarie Melania2, Chindriș V3

1 County Emergency Clinical Hospital, Tîrgu Mureș, Romania
2 First Clinic of Gastroenterology, Faculty of Medicine, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
3 Nova Vita Hospital, Tîrgu Mureș, Romania

Purpose: Among other risk factors in the developing of colorectal polyps and colorectal cancer, alcohol consumption represents a real risk factor. We have studied the association between alcohol consumption and the risk of developing colorectal cancer and colorectal polyps.
Materials and methods: We conducted a retrospective study reviewing the medical records of all consecutive patients hospitalized with mucosal modifications at the colon level, investigated by colonoscopy in the 1st Clinic of Gastroenterology of Tîrgu Mureș between 2008 and 2011.
Results: We analyzed 324 patients with colorectal cancer and colorectal polyps, compared with 352 control patients investigated in our medical institution. We had 87 patients with colorectal cancer, out of which 1 patient was an ex-drinker, 31 were occasional drinkers and 17 regular drinkers. We found a strong positive association between alcohol consumption and the risk of colorectal cancer: ex drinkers – statistically insignificant; occasional drinkers – OR = 4.04, CI: 2.31–7.06; regular drinkers – OR = 5.45, CI: 2.65–11.18. Concerning the 237 patients with colorectal polyps we obtained similar results: 5 ex-drinkers – statistically insignificant; 76 occasional drinkers – OR = 3.46, CI: 2.28–5.23; 47 regular drinkers – OR = 5.25, CI: 3.05–9.13.
Conclusions: Our results suggest that alcohol consumption elevates the risk of colorectal polyps and colorectal cancer.

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New Method to Predict Postoperative Complications: Protein Electrophoresis by Geometrical Electrofocusing

Cozma D1, Dobre A1, Stoian M2, Iacob Oana3, Coroş MF1, Crăciun C1

1 County Emergency Clinical Hospital, Tîrgu Mureș, Romania
2 Gastroenterology Clinic 1, Faculty of Medicine, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
3 Nova Vita Hospital, Tîrgu Mureș, Romania

Purpose: To evaluate drainage liquid protein electrophoresis as a predictive marker for postoperative complications.
Assumption: Postoperative drainage liquid has variable protein concentrations which decrease progressively in the absence of local complications, therefore the postoperative rising of protein fractions could be a signal for a future complication.
Material and method: Drainage liquid samples collected at 24 h, 72 h and 5 days after surgery from patients operated in the 1st Surgery Clinic of the County Emergency Clinical Hospital of Tîrgu Mureș, were analyzed regarding the protein concentration and compared against a sample of human serum provided by the I.C. Cantacuzino institute, București. Quantitative variations in protein concentrations were assessed by 280 nm spectrophotometry and qualitative variations were evaluated by colorimetric comparison of the protein fractions obtained at electrophoresis by geometrical electrofocusing. Results were computer analyzed and graphically transposed.
Results: Electrophoresis identified, in all cases, protein fractions similar with those from the reference serum. All protein fractions tended to decrease in samples obtained from operated patients with normal, uncomplicated postoperative evolution. In case of a complicated evolution (local peritonitis after splenopancreatectomy) protein levels were constantly elevated in all three samples (at 24 h, 72 h and 5 days).
Conclusions: Geometrical electrofocusing of serum protein proved to be qualitatively efficient, low cost and very sensible, detecting protein concentrations over 10 mg/dl; normal serum protein concentration is over 7000 mg/dl. This method could be a predictive factor for a local postoperative complication and also a trigger for protein replacements in cases with large amount of drainage liquid losses.

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The Association of Month of Birth with Allergic Sensitization in Pediatric Patients with Asthma in Mureș County, Romania

Căpîlna Brîndușa¹, Baghiu Maria Despina¹, Căpîlna R

1 Pediatric Clinic, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
2 County Emergency Clinical Hospital, Tîrgu Mureș, Romania

Objective: To demonstrate a link between the allergy disease and birth date, starting from the hypothesis that the season of birth may affect the future development of allergy.
Methods: Our prospective study included eighty-six asthmatic children, with ages between 1 and 18 years, who were admitted to the Clinic of Pediatrics I from Tîrgu Mureș, Romania, between October 2008 and June 2010. We analyzed the age, month of birth, sensitization to a given antigen (Dermatophagoides pteronyssinus, Dermatophagoides farinae, milk proteins, egg, mold, dog epithelium, cat epithelium, soya, carrot, potatoes, peanuts, tomato). Specific IgE serum levels to allergens were measured. RAST equal or higher than class 1 was considered as positive. This data was combined with the presence of different types of allergens during the year. The study was extended to the intrauterine period, when the fetus is also faced with different type of antigens, and maternal antibody.
Results: We observed the appearance of three “waves”, in February, April, September and early October the incidence of allergic sensitization was higher than in other months.
Conclusions: Our results support the hypothesis that the first few months of life represent a sensitive period, during which protection from exposure to pollen allergens may be associated with decreased sensitization to pollens.

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Effect of Different Fluoridated Dentifrices on Salivary pH and Fluoride Content

Cămărăşan Alina1, Fazakas Zita2, Cerghizan Diana3, Balogh-Sămărghițan V2, Székely Melinda1

1 Department of Morphology of Teeth and Dental Arches; Technology of Dental Prosthesis and Dental Materials, Faculty of Dental Medicine, University of Medicine and Pharmacy, Tîrgu Mureş, Romania
2 Department of Biochemistry, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
3 Department of Prosthetic Dentistry and Oral Rehabilitation, Faculty of Dental Medicine, University of Medicine and Pharmacy, Tîrgu Mureş, Romania

Aims: The study was aimed to establish the influence of toothpaste fluoride (F) concentration on salivary F levels and pH in order to evaluate oral F retention.
Material and methods: Thirty-four healthy young volunteers participated in this study performed on two separate occasions in which the subjects brushed their teeth with low- and conventional fluoridated dentifrices: 1) 500 ppmF and 2) 1450 ppmF. Three samples of whole unstimulated saliva were collected from each participant in all occasions: T1 – before brushing (baseline), T2 – right after brushing and T3 – 60 min. after completing each experimental procedure. Salivary pH and F concentration were determined. The Mann-Withney test was used for statistical analysis.
Results: The mean salivary F values (mean value±SD) measured right after toothbrushing were 1.439±0.732 when low-fluoride dentifrice was used and 4.160±2.53 with 1450 ppmF toothpaste, respectively. One hour after toothbrushing salivary F decreased significantly compared to the T2 values (p<0.001), however remained significantly higher than baseline in both occasions: 1) 0.159±0.026 (T3), and 2) 0.29±0.206 (T3). No significant differences could be observed between the salivary pH values.
Conclusions: After toothbrushing with fluoridated toothpaste containing 500 ppmF and 1450 ppmF, salivary F concentration increased significantly and remained elevated above the baseline one hour after brushing. The results suggests that toothpaste with higher F concentration could have more efficacy in caries prevention. Salivary pH is not influenced by fluoride content of dentifrices.

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Chromoendoscopy and Magnification for the Evaluation of the Intragastric Extent of Atrophic Gastritis and Intestinal Metaplasia

Boeriu Alina1, Dobru Daniela1, Pascarenco Ofelia2, Mocan Simona3, Onișor Danusia2

1 Internal Medicine VII, Gastroenterology Clinic, Faculty of Medicine, University of Medicine and Pharmacy, Tîrgu Mureș, Romania
2 Gastroenterology Clinic, County Emergency Clinical Hospital, Tîrgu Mureș, Romania
3 Department of Pathology, County Emergency Clinical Hospital, Tîrgu Mureș, Romania

Introduction: The detection of intragastric extent and progression of atrophic gastritis and intestinal metaplasia are mandatory in order to quantify the risk of development of the gastric cancer. The aim of the study is to assess the clinical value of magnifying endoscopy and chromoendoscopy in the evaluation of the intragastric extent of atrophic gastritis and intestinal metaplasia.
Material and methods: We performed magnifying chromoendoscopy with methylene blue and we identified modified patterns corresponding to premalignant gastric lesions. We studied the intragastric extent of these lesions. Biopsy specimens were taken from modified areas in order to confirm the presence of atrophic gastritis and intestinal metaplasia.
Results: We identified specific pit patterns for atrophic gastritis and intestinal metaplasia. In 21 patients (30%) these lesions were confined to gastric antrum. In 7 cases (17.5%), lesions were extended in gastric corpus. These patients were selected for further endoscopic surveillance.
Conclusions: Magnifying endoscopy and chromoendoscopy allow the detection of intragastric extent of intestinal metaplasia and atrophic gastritis. This could help to a better selection of patients for surveillance endoscopy.

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