Adverse drug reaction is a leading cause of hospitalization in many Sri Lankan hospitals. We conducted survey on adverse reactions in all patients admitted to the tertiary care hospital in Galle Sri Lanka. A prospective observational study was conducted for actively screened ADR for causation, causality and severity using validated scales. ADR reporting cards was used from the national pharmacovigilance centre in Sri Lanka. 95 patients were analyzed for severity of ADR referring the Hartwig’s Severity Assessment Scale. Casualty assessment was done using WHO scale. We found that 51% of patients had moderate ADR, severe, 36%, mild (9%) and 4.5% in fatal. Majority ADR were (27%) antibiotic related and 73% due to other drugs. Penicillins induced majority of ADR but mild. NSAIDs had caused many fatal and severe ADR. Causality assessment shows 44% of ADRs were possibly drug-related and 30% of them were probably drug related. The mean age of patients was 45 years. Skin and the nervous system and gastrointestinal system were commonly affected (31.5%, 26% and 16% respectively) and the highest number of ADR was related to the other drugs but not to antibiotics. Our study shows that most ADR detected were possibly drug related and hence they are preventable and they had contributed big financial burden to the Sri Lankan government health budget. We suggest seeking contribution form clinical pharmacists and there is an urgent need of recruiting them to government health care sector handing over this duty for reduction of government health budget.
A simple, efficient, and reproducible RP-HPLC method for the simultaneous determination of Promethazine hydrochloride (PMZ) and Paracetamol (PCM) in pharmaceutical dosage form has been developed and validated. The separation was carried out on Hyperchrom ODS-BP (4.6 mm X 250 mm, 5 µm) column using Methanol: Water with 1% TEA in the ratio of 30:70 v/v as eluent. The flow rate was 1 ml/min and effluent was detected at 250 nm. The retention time of Promethazine hydrochloride and Paracetamol were 3.10 and 1.72 min. respectively. The linear dynamic range was 2-10 µg/ml for Promethazine hydrochloride and 50-250 µg/ml Paracetamol, respectively. Percentage recoveries for Promethazine hydrochloride and Paracetamol were 99.00-100.33% and 99.56-101.28% respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines, which indicates the validity of the method. The developed method is also found to be precise and robust for the simultaneous determination of Promethazine hydrochloride and Paracetamol in liquid dosage forms.
The aim of the present work is to develop a simple accurate, precise and cost effective UV- spectrophotometric method for the estimation of Cefadroxil, a first generation cephalosporin an anti-biotic drug in bulk and pharmaceutical dosage form. The solvent used in the combination of water and methanol in the ratio of 75:25 and the lmax of the absorption maxima of the drug was found to be 224nm. The method obeys Beers law in the concentration range of 10-50µg/ml respectively. The developed method was subjected to stress degradation under different conditions as per ICH guidelines.
S. Sethuraman*, K. Radhakrishnan, V. Venkateswarlu, M. Sravani, G. Ramathulasi, S. Bhanuteja.
The aim of this study was to assess the anti-inflammatory effect of Tragia plukenetii R. Smith leaf extracts against carrageenan induced paw edema in wistar albino rats. The preclinical evaluation of standardized benzene, chloroform, and methanolic extracts of the leaves of Tragia plukenetii R. smith was carried outfor anti-inflammatory effect against carrageenan induced paw edema in wistar albino rats. The methanolic leaf extract of Tragia plukenetii R. Smith has shown significant anti-inflammatory effect when compared with all the other groups using carrageenan induced paw edema method. The results conclusively demonstrate the efficacy of Tragia plukenetii R. Smith methanolic leaf extracts for anti inflammatory activity.
The purpose of the present study was to prepare and characterize twice-daily sustained-release matrix tablets of timolol maleate (TM) using different concentrations of hydrophilic, hydrophobic, and plastic polymers. The effect of nature of the diluents and method of preparation were also studied. Formulations were evaluated for the release of TM over a period of 12 hours using United States Pharmacopoeia (USP) type-II dissolution apparatus. Along with physical properties, the dynamics of water uptake and erosion degree of tablets were also studied. The in-vitro drug release study revealed that the most successful formulation of the study F28 (drug to polymer ratio 1:2) which includes both HPMC K100M and EC (1:1), extended the drug release up to 12 hours, exhibited satisfactory drug release in the initial hours, and the total release pattern was close to the theoretical release profile with similarity factor (f2) above 50. The drug release from optimized formulation (F28) followed first-order kinetics via non-Fickian anomalous) diffusion. FTIR studies revealed that there was no interaction between the drug and excipients. Microcrystalline cellulose (water insoluble) was found to be better diluent in the formulation of sustained release tablets of water insoluble drug like TM. Compared to direct compression, wet granulation was found to be method of choice for the preparation of these matrix tablets. In conclusion, the results indicated that the prepared sustained-release tablets of TM could perform therapeutically better than conventional tablets with improved efficacy and better patient compliance.
