Drug counterfeiting and production of substandard drug is a global problem. Substandard or counterfeit drugs are threat for the effective treatment of diseases and highly worsen the quality of life of patients. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health.

BackgroundPresent study describe the in vitro model of plasma oxidation of patients with different lipid profile, that can be correlated to their invivo plasma oxidizability in order to find the arterial diseases prone patient groups.MethodThe method applied here to measure the invitro plasma oxidizability, accounts a convenient way that can be well suited in any clinical laboratory settings. Un-fractionated plasma was exposed to CuSO4 (5.0 mmol/L), a pro-oxidant, and low frequency ultrasonic wave to induce oxidation, and finally oxidizability was calculated by TBARS and Conjugated Diene methods.ResultIn our study, plasma LDL greater than 150 mg/dL possess 1.75 times more risk to undergo oxidation (CI, 0.7774 to 3.94; p = 0.071) than the low LDL plasma, percent of oxidation increased from 38.3% to 67.1% for the LDL level upto 150 mg/dL and high. Lag phase, which is considered as the plasma antioxidative protection, was also influenced by the higher LDL concentration. The mean lag time was 65.27 ± 20.02 (p = 0.02 compared to healthy), where as for 94.71 ± 35.11 min for the normolipidemic subject. The plasma oxidizability was also changed drastically for total cholesterol level, oxidative susceptibility shown 35% and 55.02% for 200 mg/dL and high respectively, however it didn’t appear as risk factor. Patient samples were also stratified according to their age, gender, and blood glucose level. Older persons (≥40 years) were 1.096 times (95% CL, 0.5607 to 2.141, p = 0.396) than younger (≤39 years age), males are 1.071 (95% CI, 0.5072- 2.264) times than the females, and diabetic patients are 1.091 (CI, 0.6153 to 1.934, p = 0.391) times in more risk than the non-diabetic counterpart.ConclusionThis method addressing its easy applicability in biomedical research. And by this we were able to show that patients with high LDL (≥150 mg/dL) are in alarming condition besides diabetic and elderly (≥40 years age) males are considered to be susceptible and more prone to develop vascular diseases.

This research work was carried out to determine whether the film coating is effective to prevent the photolytic degradation of Metoprolol tartrate which is known to have photosensitivity. For this purpose, two randomly selected brands of two different pharmaceutical companies were chosen i.e. Brand A and Brand B. These two brands were exposed to different lighting conditions (normal light, direct sunlight as well as two incandescent lights i.e. 25 watt bulb, 40 watt bulb). Potency tests were performed using UV spectroscopy which showed gradual decline in potency of the tablets under aforesaid lighting conditions and the potency degradations were found 11.48%, 12.92%, 22.62%, 16.87% for Brand A and 14.74%, 14.24%, 10.88%, 18.10% for Brand B under 25 watt bulb, 40 watt bulb, direct sunlight and normal room light respectively. So this study reveals that the both brands containing metoprolol tartrate showed significant light sensitivity even though they are coated and protective opaque packaging is highly recommended for their protection.

Objective: Despite its sensitivity to light, atenolol has been manufactured as a film-coated tablet with normal blister packaging by several pharmaceutical companies in Bangladesh. The aim of this study was to investigate the extent of light-induced potency degradation of a randomly selected film coated brand of atenolol.Methods: Atenolol tablets were exposed to different lighting conditions such as normal room light, direct sunlight and different incandescent lights (25W and 40W). Subsequently, UV spectroscopy technique was employed to determine the relative reduction of light absorbance compared to their respective controls. Thereafter, photolytic degradation was calculated by means of the potency reduction of tablets.Results: In all lighting conditions, atenolol tablets underwent exposure dependent gradual decrease in potency. Except for normal room light condition, a significant decrease in potency was found even after 4 to 6 h of exposure to all lighting conditions. After 6 h, potency reduction was found at 40-47%, 26-38% and 34-36% in the samples exposed to direct sunlight, 25 W bulb, and 40 W bulb respectively. Although the shelf life of the film coated tables was 2 y, surprisingly, statistically significant reduction in potency was observed within only 30 d in room light condition.Conclusion: In order to protect from light, blister packaging is not sufficient for film coated atenolol tablets. Photo-stability of all brands of atenolol must be ensured either by protective packaging materials or by optimizing the formulations.