DESIGN AND CHARACTERIZATION OF CANDESARTAN CILEXETIL ORAL NANOEMULSION CONTAINING GARLIC OIL

Objective: This study was designed to prepare and characterize oil in water (o/w) nanoemulsion of candesartan cilexetil for oral administration. Preparation of candesartan cilexetil as nanoemulsion could increase its water solubility and thus could enhance its bioavailability. Methods: Aqueous titration method was used to construct the pseudo-ternary phase diagrams of nanoemulsion (NE) consisting of oil, various weight ratios of surfactant and co-surfactant (S mix), and deionized water. Different characterization techniques were conducted on the prepared nanoemulsions to obtain the optimized formula. Results: Characterizations of formula NE-4 (consists of 0.16% of candesartan cilexetil, 10% of garlic oil, 35 % of S mix (3:1) and 54.84% of deionized water) revealed the following characteristics: droplet size range (95-139 nm), polydispersity index (0.14), zeta potential value (-41.06 mV) and pH value (6.71), which are suitable for oral administration. Candesartan cilexetil in vitro release from this formula was significantly high (P<0.05) and scanning probe microscopy (SPM) study confirmed that the optimized formula (NE-4) was in nano-scale. Conclusion: Nanoemulsion formula 4 (NE-4) of candesartan cilexetil is the optimized formula and it could be a promising formula for improving the water solubility of candesartan cilaxetil

QUALITY CONTROL TESTING OF CONVENTIONAL CLOPIDOGREL BISULFATE TABLETS MARKETED IN IRAQ

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

A COMPARATIVE STUDY OF QUALITY CONTROL TESTING OF MEFENAMIC ACID TABLETS IN IRAQ

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

QUALITY EVALUATION OF BRANDS OF PROPRANOLOL HCL TABLETS AVAILABLE ON IRAQI MARKET

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

A A COMPARATIVE STUDY OF QUALITY CONTROL TESTING ON CANDESARTAN CILEXETIL CONVENTIONAL TABLETS IN IRAQ

Objective: The present study was performed to compare the quality of conventional tablets loaded with candesartan cilexetil. The selected candesartan cilexetil tablets were commercialized in the Iraq market and produced by different companies.  Methods: Different batches of candesartan cilexetil oral tablets (the concentration of candesartan was 8 mg) were subjected to quality control tests. Tests included weight variation, friability, hardness, drug content, disintegration time and in vitro release study. The protocols of these tests were performed according to USP pharmacopeia. Results: The results, in this study, revealed that all the used batches of candesartan cilexetil oral tablets complied with the specification of USP pharmacopeia for weight uniformity, friability value (% loss) was<1. Hardness results of the tablets were 4.9-6.6 Kg/cm2, which was within the required limits (i.e. 4-8 Kg/cm2). Disintegration time was<15 min in both Simulated Gastric Fluid (SGF) and Simulated Intestinal Fluid (SIF). The percentage of drug content in all marketed tablets was found between 96.2 % and 99.8 %, reflecting compliance with the pharmacopeia limits (i.e. 85-115 %). An in vitro release study indicated that the release of all marketed tablets exceeds 80 % within 15 min. Conclusion: All the studied tablets, loaded with candesartan cilexetil, were produced within the standard criteria of tablet production. The quality control analysis of the selected tablets, in this study, revealed satisfactory pharmaceutical properties (including safety and effectiveness) that comply within the limits of USP pharmacopeia