مازن ثامر عبد الحسن البوجاسم

Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia. Keywords: Oral tablets, Clopidogrel bisulfate, Biopharmaceutics classification system (BCS) solubility

Objective: The purpose of this study is to evaluate the quality control of marketed tablets containing propranolol hydrochloride available on the Iraqi market and manufactured by different companies. Methods: Different batches of propranolol hydrochloride 40 mg tablets were assessed using quality control tests. Weight variation, diameter, thickness, friability, disintegration time and dissolution study were carried out in this study. Results: Based on the data obtained in this study, all brands of PPL available on the Iraqi market showed weight variation within the acceptable limit of USP. Marketed products of Becardin and Propranolol lie within the acceptable limit of hardness and Inderal was observed to be slightly higher than the normal upper range of USP. Diameter and thickness for all brands were almost the same, except the diameter of Becardin was slightly higher and friability was zero for all brands. All brands demonstrated a time of disintegration of fewer than 30 min. The tested marketed propranolol products; Inderal, Procard, Becardin and Propranolol showed cumulative drug release of 90.08%, 94.46%, 92.4% and 79.51%, respectively at the end of the first 20 min. This variation in the release profile of marketed tablets of Propranolol HCl might be attributed to the excipients present in the marketed tablets where some of these excipients may behave as a disintegrant and enhance dissolution rate while others may act as dissolution retardants. Conclusion: All marketed tablets of Propranolol HCl employed in this study were produced within the standard criteria of tablet manufacturing. Evaluation of quality control of these selected tablets showed acceptable pharmaceutical properties that lie within the limits of USP. Keywords: Quality control, Propranolol HCl, Oral tablets

Purpose Coronary artery disease (CAD) is a major cause of death worldwide. There is relatively little data available on the genetic susceptibility to CAD in the Iraqi population. We have therefore investigated the association between angiotensin II type 1 receptor gene polymorphism A1166C and the presence of CAD in a sample of the Iraqi population. Methods This case–control study enrolled 150 CAD patients, with CAD confirmed by coronary angiography, and 200 controls. The AT1R polymorphism A1166C was analyzed by the allele-specific polymerase chain reaction (AS-PCR) technique. Serum analyses, such as lipid concentrations, were measured and analyzed. Results The C allele and CC genotype frequencies were significantly higher in patients with CAD compared to the controls. Logistic regression analysis showed that the codominant, dominant, and recessive models were associated with risk of CAD of (OR = 1.32, 95% CI: 1.2–1.4, P = 0.000; OR = 1.25, 95% CI: 1.1–1.3, P = 0.000, OR = 1.27, 95% CI: 1.1–1.3, P = 0.000, OR = 1.18, 95% CI: 1.0–1.4), respectively. In the patient group, the presence of the mutant C allele was significantly associated with higher levels of CAD risk factors such as total cholesterol (TC) and low-density lipoprotein (LDL). Conclusion The study indicated that the A1166C polymorphism may be associated with the presence of CAD in the Iraqi population. The AT1R polymorphism may therefore be a useful marker of susceptibility to CAD.

Objective: This research was performed to assess the quality of different marketed tablets having mefenamic acid (500 mg). The selected tablets are produced by numerous companies and presented in the Iraqi pharmaceutical marketplace. Methods: Different batches of mefenamic acid conventional tablets were exposed for several tests of quality control. These evaluation tests include hardness, weight variation, friability, disintegration time, drug content, and drug dissolution profile. The properties of these quality tests were made conferring to the specification of USP-pharmacopeia. Results: The data of this study indicate that each tablet of mefenamic acid batches conformed to the requirement of USP pharmacopeia, the hardness was (6.87-8.06 Kg/cm2), and the drug content results were (90.666-99.214%) within USP limitation. The data of disintegration time and weight uniformity were agreeable with pharmacopeia and the in vitro release assay showed that the release of each mefenamic acid marketed tablet was highest than (80 %) in 45 min, which reproducing compliance with the USP pharmacopeia's limitation. Conclusion: From this study, it was proved that all of the marketed brands of mefenamic acid tablets meet the standard character in the USP pharmacopeia for in vitro quality control tests. Keywords: Mefenamic acid, Quality test, Oral dosage form

The current study was designed to investigate the changes of oxidative stress (OS) in primary infertility of females. To achieve the intended aim, 84 infertile women of ages 28.66 ± 6.29 years (mean ± SD) and 30 healthy fertile women of ages 30.3± 6.45 years (mean±SD) were enrolled. The levels of malondialdehyde (MDA), catalase (CAT) and glutathione-S-transferase (GST) were determined by spectrophotometric methods. Serum follicule stimulating hormone (FSH) and luteinizing hormone (LH) levels were measured by an enzyme linked fluorescent assay (ELFA). The results indicated a significant (p<0.001) increase of MDA concentration and significant (p<0.001) decreases of CAT and GST activities in the infertile women when compared with those of the control group. The linear regression analysis demonstrated significant (r = 0.27,p<0.05) positive correlation for MDA levels and significant negative correlations for CAT (r = - 0.24, p<0.05) and GST levels (r = - 0.26,p<0.05) with the age of infertile women. Changes of oxidative stress was observed to be dependent on the body mass index (BMI) and the duration of infertility of the enrolled women. The changes of MDA, CAT and GST levels seem to be independent on etiology of infertility and the menstruation pattern. The2linear regression analysis revealed significant (r = 0.28, p<0.05) positive correlation for MDA levels with the FSH concentration and significant(r = - 0.29, p<0.05) negative correlation with the LH concentration.CAT exhibited significant (r = 0.30, p<0.05) positive correlation with the FSH concentration, while GST activity demonstrated significant(r = 0.24, p<0.05) positive correlation with the LH concentration. These results suggest that oxidative stress is involved in the path ophysiology of primary infertility in females, in particular through the directing of gonadotrophin changes in these patients