The objective of this study was to assess the levels of contamination by toxic metals (Pb, Al, Ni, Cd and As) that may be present in 25 infant pharmaceutical herbal products and 15 traditional herbs in Jordan. Both products and medicinal herbs are currently prescribed by paediatricians. They are available as over-the-counter medicines and are sold the in herbal market, ensuring easy accessibility for parents. Inductively coupled plasma-optical emission spectroscopy (ICP-OES), with limit of detections (LODs) of 0.10, 1.00, 0.20, 0.15 and 2.00 mg.kg for Pb, Al, Ni, Cd and As respectively, was employed to measure the levels of toxic metals in the samples. Pb, Al and Ni were detected in 88, 76 and 4% of the analysed samples of pharmaceutical herbal products and in 93, 87 and 13% of the analysed samples of traditional herbs, respectively. Neither Cd or As were detected in all analysed samples. The data obtained were subsequently compared by referral to the acceptable limits of toxic heavy metals according to World Health Organisation (WHO) standards. Largely, the results showed acceptable toxic metal levels in the finished pharmaceutical products and the traditional medicinal herbs for infants. One exception to this was Persian Thyme (Satureja thymbra) with Pb content of 41.18 mg.kg. Also, the daily intake of detected metals through pharmaceutical herbal products was found to be lower than the daily tolerable intake limit set by the regulatory bodies, except of 8% of products that exceeded the tolerable daily intake of Pb set by US FDA, as compared to traditional medicinal herbs, where the tolerable daily intake for Pb, Al and Ni were exceeded in 40, 60 and 8% of the analysed herbs, respectively. The results obtained revealed that the excessive use of medicinal plants as alternative medicine should be used with caution keeping in mind the safety factor in infants.
Paracetamol (acetaminophen) is one of the most commonly used antipyretic and analgesic drugs worldwide. It is the drug of choice for patients with bronchial asthma, hemophilia, salicylate hypersensitivity, peptic ulcer, and pregnant or breastfeeding women who cannot be treated with nonsteroidal anti-inflammatory drugs. It is marketed and manufactured by many pharmaceutical companies, which necessitates the requirement of quality control investigation. A post-market evaluation was conducted on five commercial paracetamol products (500 mg) available in Jordan, which involved quality control testing in terms of dissolution, disintegration, weight variation, and glass transition temperature (Tg) determination using dynamic mechanical thermal analysis (DMTA). Dissolution and disintegration of the five products were compared under two different conditions, compendial United States Pharmacopeial Convention (USP) and non-compendial. Compendial experiments were conducted under pH 5.8, and non-compendial testing was carried out under pH 1.2. Results revealed variations in the dissolution patterns at the different pH conditions for the same formulation. Generally, faster dissolution was observed when testing the dissolution in compendial USP conditions; pH 5.8 compared to pH 1.2. Disintegration was also affected by pH in the tested formulations. Tg detected via DMTA of the tested formulation was ranged from 18.82 ± 0.77 °C to 23.13 ± 2.46 °C. No correlation was found between Tg variation and drug dissolution. In general, all products met the compendial requirements despite their differences in the early stages of dissolution profiles. Our work highlights the importance of post-market quality control testing of generic equivalents of immediate release dosage forms, which is essential for improving upon existing formulations. It also introduces DMTA as an informative tool for detecting thermal transitions of active pharmaceutical ingredients (APIs) in solid oral dosage forms.
Electronic nicotine delivery systems (ENDs) are gaining popularity in Jordan as alternatives to tobacco cigarettes with an estimation of 10% of tobacco smokers switching to ENDs. Since nicotine is toxic and highly addictive substance, it is important to develop and validate an easy and rapid analytical method to accurately measure nicotine level in e-liquids. A simple high performance liquid chromatography–photodiode array detection (HPLC–PDA) method was developed and validated for rapid determination of the actual nicotine content in 11 of the most popular e-liquids brands available in the Jordanian market and compared to the nicotine levels appeared in the labeled packaging. The new method of analysis showed an excellent linearity with correlation factor equal to 0.9994 with analytical range between 100 and 1,000 µg/mL, and Limit of detection (LOD) and Limit of quantification (LOQ) of 32.6 µg/mL and 98.9 µg/mL, respectively. The results showed that the actual measured nicotine concentrations ranged from 0 to 25.81 mg/mL with percent deviation ranged from 63.1% less than to 3.24% more than the labeled concentration on packaging. And more than 10% deviation difference in actual nicotine concentrations versus labeled were found in 9 of the 11 e-liquid products (82%). In conclusion, nicotine labelling among e-liquids products have not accurately reflect the actual content which may have potential negative impact on users.
The objective of this study was to investigate the effect of physiological conditions on the dissolution rate of acetylsalicylic acid (ASA) from two commercial brands compared against compendial tests. All parameters of the analysis were chosen according to ICH (Q2(R1)) guidelines and were validated statistically. The maximum wavelength (λ max ) and absorptivity (ε) for ASA were determined in different solvents at different pH values (6.8 and 4.9) by a validated UV-Vis spectrophotometric method. When ethanol (EtOH) was used as co-solvent, ε was found to be 3.15, and when 0.1 N NaOH was used, ε was 18.50. Dissolution tests were conducted according to pharmacopeia specifications; however, the lack of a direct specification in determining ε in the pharmacopeia has permitted enormous probabilities of employing different solvents. Herein, when NaOH was used to dissolve ASA, ε was calculated to be 18.50, and upon conducting compendial dissolution tests for enteric-coated tablets, only 20% of ASA was released after 4 h. When analyzing the same data using ε of 3.15 (calculated from dissolving ASA in EtOH), the amount of released ASA was found to be 95% after 2 h. Furthermore, the effect of a fed and fasted state pH was not significant on the dissolution rate, and both brands met the compendial requirements.
A new series of imidazole-5-carboxamide derivatives were prepared and tested for their anti-hyperlipidemic activity in Triton-WR-1339-induced hyperlipidemic Wistar rats. The purpose of this research was to improve benzophenone carboxamides water solubility maintaining at the same time the antihyperlipidemic activity. Compounds 4, 6, 10, and 11 were synthesized through a coupling reaction between imidazoles-5-carbonyl chloride and amino benzophenones. The tested animals (n 48) were divided into six groups: the first group (hyperlipidemic control group; HCG) received an intraperitoneal injection (i.p.) of (300 mg/kg) Triton WR-1339. The second group received i.p. injection of Triton WR-1339 followed by an intra-gastric administration of bezafibrate (100 mg/kg) (bezafibrate; BF). The third, fourth, fifth, and sixth groups received i.p. injection of Triton WR-1339 followed by an intra-gastric administration of (30 mg/kg) of compounds 4, 6, 10, and 11, respectively. At a dose of 30 mg/kg body weight compounds 4, 6, 10, and 11 significantly (p<0.0001) decreased the plasma level of triglyceride (TG), low-density lipoprotein (LDL) and total cholesterol (TC) levels after 18 h of treatment. Additionally, compounds 4, 6, 11 and bezafibrate (100 mg/kg) significantly (p<0.0001) increased the plasma level of high-density lipoprotein (HDL) levels, which is known for its preventive role against atherogenesis. These results demonstrate the possibility of pharmacokinetic properties improvement maintaining the biological and pharmacological profile of these compounds.
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