Comparative study of efficacy and safety of omega 3 fatty acids and fenofibrate with background atorvastatin therapy in patients of atherogenic dyslipidaemia

Background: Trials of atorvastatin combined either with fenofibrate or with omega-3 fatty acids (O3FA) have shown promising results in atherogenic dyslipidemia but there are very few studies where both these TGs lowering agents have been compared with each other. This study was conducted to compare efficacy and safety of these two agents on lipid profile of patients of atherogenic dyslipidaemia on background statin therapy and also to monitor effects of these interventions on serum uric acid (SUA) levels.Methods: About 90 patients of dyslipidemia were randomised to 3 groups and received O3FA (2000 mg), fenofibrate (80 mg) or dietary restrictions, each with atorvastatin (20 mg) in background for a period of 90 days. Total cholesterol (TC), HDL-C,TGs, LDL-C, SGOT and SGPT levels were done at baseline, 6 weeks and 12 weeks. Other parameters (SUA and BMI) were done at baseline and 12 weeks.Results: Both group 1 (O3FA) and group 2 (fenofibrate) showed highly significant fall in TG levels (p <0.001) in comparison to group 3 (dietary restrictions) whereas comparative TG reduction between groups 1 and group 2 was not significant. Group 2 also showed significant fall in LDL-C levels (p <0.01) in comparison to group 3. LDL-C reduction, TG reduction and SUA reduction was more in group 2 compared to group 1 followed by group 3. No significant difference was observed in the incidence of adverse effects in three study groups.Conclusions: Combination of fenofibrate and atorvastatin was more effective than that of omega-3 fatty acid and atorvastatin, in lowering serum TG and LDL-C levels. There was a significant reduction in SUA levels in all three groups, but combination of fenofibrate and atorvastatin again showed better outcomes. With respect to the safety, all the 3 groups were comparable. O3FA, however, may be a good alternative to fibrates in patients not tolerating latter.

Formulation and Optimization of Chronotherapeutic Drug Delivery from Carvedilol Sulphate Compression Coated Tablets by using Design of Experiment Approach.

The aim of this present work was to develop and optimize compression coated tablet of carvedilol sulphate for chronotherapeutic application by response surface methodology based on 32 factorial designs. Compression coated tablet containing carvedilol phosphate in the core was formulated with an outer coat by eudragit L 100 and ethyl cellulose. The percentage weight ratio of ethyl cellulose to eudragit L 100 and coating level were selected as critical process parameters (CPPs), whereas critical quality attributes (CQAs) were lag time and cumulative percentage drug release at 8 hr in current study. For optimization, the effects of critical process parameters upon the critical quality attributes were modelled using the polynomial equations involving critical process parameters and their interactions for various critical quality attributes. A numerical optimization technique was adopted to achieve optimized formulation which was also used as the check point.The observed responses were closed well with the predicted values. The formulation exhibited pulsed release profile after a programmed lag time and thus suitable for chronotherapeutic delivery. The study demonstrated a successful optimized formulation followed by evaluation of compression coated tablet of carvedilol sulphate for chronotherapeutic drug delivery.

Statistical Optimization of Olanzapine Ternary Solid Dispersions with Pvp K 30 and Peg 20,000 by Response Surface Methodology.

The aim of present study was to improve dissolution rate of olanzapine by means of solid dispersion using combination of hydrophilic polymer (PEG & PVP) by using response surface design. Solid dispersion containing olanzapine were prepared using PEG 20000 & PVP K 30 by melted fusion method. Response surface method was used for the optimization olanzapine solid dispersions. Amount of PEG 20000 and Amount of PVP K 30 were selected as the critical process parameters (Independent variable) whereas amount dissolved in 10 minute (Q 10) and amount dissolved in 45 minute (Q 45) were selected as critical quality attributes (dependent variables). Optimized solid dispersion batch was characterized using infrared spectroscopy, differential scanning calorimetry (DSC) and X-ray diffractometry (XRD).Dissolution studies indicated a significant improvement in dissolution of olanzapine when dispersed in PEG 20000 and PVP k 30. XRD and DSC study indicated amorphous form of prepared solid dispersions. On the basis of numerical optimization technique, PEG 20000(X1) and amount of PVP K 30(X2) were 11.20 % and 14.53 % in optimized solid dispersion. The observed responses were closed well with the predicted values. The response surface method is found to be robust and accurate for optimization of solid dispersion for increase in solubility and dissolution rate of olanzapine, coherent with the needs of poorly water soluble drugs.

Ochronosis or Alkaptonuric Arthropathy.

A rare case ofOchronotic arthropathy diagnosed on roentgen examination and confirmed by clinical history and urine examination is reported in this communication. To our knowledge this is the first ever case of this entity being reported from this region.