Print ISSN: 0253-0759

Online ISSN: 2413-4414

Volume 31, Issue 1

Volume 31, Issue 1, Winter and Spring 2013, Page 1-46

Comparative bioavailability study of three brand products of diclofenac sodium 50mg oral tablets in healthy volunteers

Montadher H. Dawod; Nazar S. Hadad; Abdullah M. Jawad

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 1-8
DOI: 10.33762/mjbu.2013.81810

Background: Poor quality medicines could be substandard, degraded or counterfeit medicines. One of the measures used to detect poor quality drugs is comparison with a reference product taking pharmacokinetic end points in consideration.
Objectives: To compare the bioavailability of three brand products of diclofenac sodium 50mg oral tablets in healthy volunteers. One of these brands is locally manufactured. The other two are from known foreign drug manufacturers.
Methods: A randomized, three-way, cross-over bioavailability study was performed on 10 apparently healthy male volunteers. Each received successively, a single oral tablet of 50 mg diclofenac sodium from the three sources with a washout interval of one week. Blood samples were taken until six hours after drug administration and analyzed using HPLC system (Agilant, model 1200-USA, with an Agilent 1200 variable wavelength detector and a Zorbax Eclipse XBD-C18 column). Quantitation was achieved by measurement of the peak height ratios of the drug to ibuprofen as internal standard. The amount of diclofenac sodium in each of the three drug products was also measured in vitro.
Results: Maximum plasma concentration (Cmax) was significantly different among the three tablets with the main difference was between the locally manufactured tablet and the two other tablets (0.72 µg/ml for the locally manufactured product compared with 1.55 and 1.24 µg/ml for the reference products). Time to reach maximum concentration (Tmax) showed no significant difference between the three brands of diclofenac sodium tablets. The area under the curve differs significantly between the three products. The area under plasma concentration-time curve (AUC) of the locally manufactured product represented 64.7% and 74% of the AUC of the two reference brands. The plasma elimination half life (t½) differs among the three different types of products but these differences ran short of statistical significance (P<0.058). In vitro assay of the amount of diclofenac sodium in each tablet showed no significant differences between the three types of tablets.
Conclusion: The locally manufactured enteric coated diclofenac tablet is not interchangeable with the two reference foreign brand products, although they contain approximately the same amount of diclofenac sodium. It is speculated that differences in bioavailability and in peak drug levels might be attributed to pharmaceutical factors such as the rate of disintegration and dissolution which can be affected by the types of additives and the coating materials in each tablet.

Extent and determinants of unintended pregnancy in Basrah

Narjis A.H. Ajeel; Wefak Hasan Abdul Rahem

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 9-14
DOI: 10.33762/mjbu.2013.81811

Background: The problem of unintended pregnancy exists in all societies, regardless of degree of development. Unintended pregnancy is associated with adverse health outcomes for both mother and child and it is a risk factor for poor health of both of them.
Objective: To assess the extent of the problem of unintended pregnancy in Basrah, and to identify the main socio-demographic and reproductive factors associated with its occurrence.
Methodology: The study was a cross sectional study involving 260 women who gave birth within the 6 months preceding the time of the study. The studied women were selected from 10 primary health care centers. Data were collected by direct interviewing of the women using a special questionnaire form constructed for the purpose of the study. The questionnaire included questions that covered socio-demographic and reproductive aspects of the participants, as well as details about their last pregnancy.
Results: Sixty seven (25.8%) of the participants reported that their last pregnancy ending in a live birth was unintended at the time of conception. This included 33(12.7%) unwanted preg¬nancies and 34(13.1%) mistimed pregnancies. The study showed that old, illiterate and unemployed women were more likely to have an unintended pregnancy than young, educated and employed women. The prevalence of unintended pregnancy increased with the increase in the number of previous pregnancies. The study also showed that women who planned their last pregnancy, were more likely to attend the antenatal care clinic than those who did not.
Conclusion: Unintended pregnancy is not a rare event in Basrah despite the fact that unintended pregnancies ended in abortion were not included in the present study.

In vitro study of the fragility and deformability of the sickle cell: the effects of NSAIDs and primaquine

Kamla A. Hussein; Nabeel A.J.Ali

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 15-20
DOI: 10.33762/mjbu.2013.81812

Background: The sickle red blood cell differs physiologically from the normal red cell, especially in fragility and viscocity. The effects whether useful or deleterious of various drugs such as antibiotics or analgesics on the sickle red blood cell are not well investigated, especially the drugs with oxidative potential.
Objectives: The present study was carried out to examine the difference in osmotic fragility and deformability between normal and sickle red blood cells before and after, in vitro incubation with oxidative drugs.
Materials and Methods: Blood samples were obtained from sickle cell disease patients (n=39) and normal volunteers (n=19). Sickle hemoglobin was detected by electrophoresis; osmotic fragility was measured by using hypotonic sodium chloride solutions at decreasing concentrations and erythrocyte filterability by filtration method. Different concentrations of aspirin, indomethacin and primaquine were prepared in absolute ethanol and incubated with red cells to measure their effects on fragility and deformability.
Results: Osmotic fragility curve was shifted to the left by the sickle red blood cells, the initial haemolysis occurred at concentration of 0.5% for normal and 4.5% for sickle cell. The concentration of hypotonic saline that cause 50% lyses for the normal and sickle red cell were 0.41% and 0.33% respectively. The erythrocyte filtration time was 83.1± 11.4 seconds for normal and 106.4±23.9 seconds for sickle cell. Aspirin, indomethacin and primaquine produced no effect on osmotic fragility of both normal and sickle cells. Only primaquine at concentration of 2µg/ml caused statistically significant prolongation in filtration time.
Conclusion: The sickle red blood cell resists in vitro haemolysis by hypotonic saline and has longer filtration time than the normal cell; primaquine has deleterious effect on the sickle cell in vitro. This drug should be given with caution to patients with sickle cell disease. Further studies to explore the in vivo effects are recommended.

A study of renal artery stenosis among hypertensive patients in Basrah (Iraq)

Hayder Salih Abbood

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 21-27
DOI: 10.33762/mjbu.2013.81814

Background: Renal artery stenosis (RAS) is the most common potentially curable cause of secondary hypertension. It accounts for less than one percent of mild hypertension and 10 to 45 percent of severe or malignant hypertension. Atherosclerotic type is the most common form.
Objective: To study the prevalence of renal artery stenosis among hypertensive patients with the aid of clinical criteria suggestive of the diagnosis.
Patients and Methods: A cross-sectional study of patients with hypertension attended a private clinic, outpatient's clinic, emergency department, nephrology ward and coronary care unit in Basrah teaching hospital from the period of January 2010 to January 2012.
Results: The study involved 27 patients with hypertension diagnosed as renal artery stenosis. Atherosclerotic RAS accounted for 77.8% of cases, while fibromuscular dysplastic RAS accounted for 22.2% of cases. The ARAS was more common in female (57.1%) and accounted for 100% of cases more than 60-year old. The FMD type was more common in female (66.7%) and accounted for 100% of cases younger than 30-year old. The most common clinical criteria suggestive for the diagnosis was unexplained renal azotemia (25.9%). Nephrotic range proteinuria was reported in 11.1% while non-nephrotic proteinuria in 51.9%. LVH was reported in 40.7%. The Doppler ultrasound was normal in 96.3. The MRA shows left proximal stenosis in 22.2%, right proximal stenosis in 33.3%, left distal stenosis in 3.7%, right distal stenosis in 18.5% and bilateral stenosis in 22.2%. Hypokalemia was reported in 70.4%. The serum cholesterol was normal in 77.8%.
Conclusion: Renal artery stenosis is more common in whites and rare in blacks. The atherosclerotic type is more common and it is more common in the older age group. The fibromusculr type is more common in the younger age group. Right renal artery stenosis is more common than the left.

Non High Density Lipoproteins (Non-HDL-C) and the degree of glycemic control of type 2 diabetes mellitus

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 28-33
DOI: 10.33762/mjbu.2013.81816

Objective: To evaluate the level of non high density lipoprotein among dyslipedemic type 2 diabetic patients and its correlation to the degree of glycemic control according to HbA1c.
Patients and methods: The study was conducted prospectively on 113 patients with type 2 diabetes mellitus. 62 (54.9%) patients were females and 51(45.1%) patients were males. Their ages ranged from 34 to 67 with a mean age 50.37±8.76 years. All consulted endocrine and diabetic center in Al-Mawani General Hospital in Basrah Southern Iraq during the period from April 2010 to February 2012. Fasting blood was taken for each patient and send for sugar, lipid profile and HbA1c. Height, weight were taken to calculate body mass index (BMI). Non-HDL-C were calculated by subtracting HDL-C from total cholesterol.
Result: The level of non-HDL-C was significantly elevated in patients with poorly controlled type 2 DM (P-value <0.01) in spite of absent of increments of their HDL-C levels that shows a mean value of (43.19±12.68) in patients with poorly controlled as compaired to fairly controlled diabetes (40.25±14.18).
Conclusions: Non-high density lipoprotein level can be calculated easily from total cholesterol and high density lipoproteins, it provides an index of atherogenic lipid other than low density lipoprotein and its level below 130 mgdl directly correlated with the glycemic control as measured by HbA1c.

The Pattern of Psychoactive Drugs Abuse Among Selected Group in Basrah

Raad S. Luty; Aqeel I. Saleh; Nabeel A.J. Ali

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 34-42
DOI: 10.33762/mjbu.2013.90700

Background: Abuse of psychoactive drugs is common worldwide. The WHO has plans to halt the problems. To be effective, such plans need information on the pattern of abuse, which is scanty in Iraq.
Objectives: To study the pattern of drug abuse in Basrah by types of drugs and characteristics of abusers, to elucidate the risk factors and its relation to psychiatric illnesses and to evaluate immunoassay test for drug detection in urine.
Method: This is an observational study on patients attending psychiatric clinic in Basrah journal Hospital and hospital workers. Interview, questionnaire form, and urine samples for screening for drugs of abuse using immunoassay multi-drug panel test.
Results: Two hundreds and six subjects (59 patients, 96 health workers, and 51 volunteers for validation studies) were included. Forty-four percent of patients were manual workers, 20% were unemployed, and eighty-eight percent of them were smokers. Half of the patients have pure drug abuse, while the others have co-occurring psychiatric disorders. Personality disorder was the most commonly associated disease. Abuse of more than one drug reported by 66% of patients. Benzodiazepines abuse was reported by 78% of patients followed by opioids in 56% and centrally acting anticholinergics in 48% of patients. Fourteen percent of patients denied abuse. Sixty four percent of patients had moderate to substantial abuse severity score. Of the 96 health workers 12(12.5%) subjects were found positive mainly for benzodiazepines followed by tramadol.
Conclusions: The problem of drug abuse affects young age group and psychiatric patients and involved mainly pharmaceuticals and lead sometimes to psychiatric consultation.

Juvenile gigantomastia, two cases treated by reduction mammoplasty with nipple-areola complex graft

Zuhair F. Fathallah; Jabir R. Hameed

The Medical Journal of Basrah University, Volume 31, Issue 1, Pages 43-46
DOI: 10.33762/mjbu.2013.90703

Gigantomastia or “Gravidic macromastia” is a rare benign disorder of the breast, in which the breasts undergo a massive hypertrophy and increase in size. It may occur during marked hormonal changes as in puberty or pregnancy or after prolonged intake of certain medicine. The condition is manifested as a massive diffuse enlargement of the breast. It is usually associated with psychological effect on the patient and her family and physical disability due to excessive breast growth. This rare condition is of undetermined aetiology, which may be due to excess hormonal secretion, or hypersensitivity of the target organ to normal hormonal level. Histologically it is a glandular hyperplasia with an increase in connective tissue. This paper reports two case of gigantomastia due to hormonal changes during puberty. Ulceration and haemorrhage of the breasts complicated the picture and is the main cause of coming to surgery. Surgical procedure was subtotal mastectomy and free implantation of the nipple areola complex.