International Journal of

Pharmaceutical and Clinical Research

e-ISSN: 0975 1556

p-ISSN 2820-2643

Peer Review Journal

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1. Clinical Evaluation of Aavaraiyathi churnam in the Management of Type 2 Diabetes Mellitus
Anbu N , Velpandian V
Diabetes mellitus is a heterogeneous disorder of carbohydrate, protein and fat metabolism in which sugars in the body are not oxidized to produce energy due to lack of pancreatic hormone insulin leads to disturbances of the acid base balance. There are two types. Type 1 (IDDM) patients have little or no ability to produce the hormone and are entirely dependent on insulin, whereas Type II (NIDDM) results from inadequate production of insulin which can be controlled by the oral hypoglycemic drugs. Aavaraiyathi churnam is one of the herbal based Siddha anti diabetic formulation for Type II maturity onset diabetes mellitus. So the present research work was carried out to confirm the hypoglycemic effect of Aavaraiyathi churnam clinically on patients with DM (Type II). Open clinical trial was conducted in 50 diabetic patients for the period of six months. Blood glucose level (both fasting and post prandial) were estimated before the enrollment of the study during the trial period and after the completion of the study. At the end of the study period all these parameters were statistically analyzed. The clinical studies revealed that Aavaraiyathi churnam (AC) was well tolerated in high dose and moderate diabetic cases (180 – 300 mg / dl). The blood sugar level is controlled within 4 – 16 week, depending upon its initial blood sugar level. No side effects were noted during the study period which confirms the traditional use Aavaraiyathi churnam for the treatment of diabetes mellitus

2. Pharmacognostic Account of Roots of Valeriana wallichii DC
Sonawane Akshay J, Takate Shrikant, Sherkar Mahesh R, Dhokane Sitaram T
Valeriana wallichii DC of family Valerianaceae is reported in traditional system of medicine an indigenous medicinal plant used in the treatment of constipation, insomnia, epilepsy, neurosis, anxiety and as a diuretic, hepatoprotective ,analgesic and cytotoxic. To explore the pharmacognostic account this plant was selected.The herb is an erect perennial, growing to four feet with pinnate, divided leaves and cluster of small white or pink flowers. It has massive root system and short rhizomes. The root are hairy, spindly mass and are collected in the autumn from two year old plants. The root of Valeriana wallichii contains alkaloids tannins flavonoids saponin glycosides in the methanolic extract and it was used for Pharmacognostical, Phytochemical evaluation.

3. Effect of Different Binders and Super Disintegrants on Formulation of Glimepiride Immediate Release Tablets by Wet Granulation Method
Hari Har Prasad.M, Duraivel.S
The present study aims at developing a Glimepiride immediate release tablet formulation for the effective treatment of Type-2 Diabetes mellitus (or) Non-Insulin-Dependent Diabetes Mellitus (or) adult-onset diabetes. Glimepiride is a sulfonylurea antidiabetic drug. Glimepiride acts as an insulin secretagogue. To provide the patients with the most convenient mode of administration, there was a need to develop immediate release dosage form, particularly one that disintegrates rapidly and disperses and helps in enhancing the Bioavailability of the drug. Glimepiride immediate release tablets were formulated by using wet granulation method and povidone k 30, starch as binders, croscarmellose sodium, Sodium Starch Glycolate, Crospovidone as disintegrants, Lactose monohydrate as Diluent and Magnesium stearate as Lubricant. The tablets were evaluated for Pre compression and Post compression Parameters after conducting Preformulation Studies. All the parameters were within the pharmacopoeial limits and the drug disintegration time was less and the Invitro dissolution studies showed that the drug release was fast in Formulation(F2) containing Sodium Starch Glycolate as Super disintegrant and Povidone k 30 as Binder when compared to all other Formulations.

4. Antipyretic Activity of Some Nigerian Medicinal Plants in Rats.
Ukwuani A. N., Abubakar M. G., Warra S. H., Agaie B. M.
Preparations of Grewia crenata, Striga hermontheca and Gongronema latifolium have been used in traditional medicine for treatment of pain for many years and their efficacies are widely acclaimed among the Hausa communities of northern Nigeria. The aim of the study was to assess the activity of hydromethanolic extract of these plants in baker’s yeastinduced pyrexia in rats. The effect of the extracts on pyrexia was appreciable and significant at 1 to 3 hours at the highest dose of 400 mg/kg (Grewia crenata>Striga hermontheca>Gongronema latifolium). However, paracetamol (10 mg kg-1 ) used as the reference drug caused a greater reduction in the rectal temperature of the rats at the onset (i.e. first two hours after administration) which was significant when compare to both control and extract treated groups. In summary, these findings support the use of these extracts in traditional medicine for treatment of pain.

5. Validated Simultaneous Estimation and Development of Levofloxacin and Ornidazole by RP-HPLC Method
Shafrose Syed, Haritha Pavani
A simple, economic, selective, precise, and accurate Reverse phase High Performance Liquid Chromatography method for analysis of Levofloxacin and Ornidazole, was developed and validated according to ICH guidelines. The quantification of drug was carried out using Hypersil BDS C18 150mm × 4.6mm × 5µm column or its equivalent in isocratic mode, with mobile phase compressing of Buffer: Acetonitrile (75:25) the flow rate was 1.0ml/min and the detection was carried at 315 nm. The retention time and percentage assay for Levofloxacin and Ornidazole was found to be 3.0 and 4.8min, 103.4% and 104.16% respectively. Proposed method was validated for precision, accuracy, linearity range, specificity and robustness.

6. Analytical Method Development and Validation for the Assay of Ebastine in Ebastine Mouth Dissolving tablets
Nelofer.S.M, Janardhan M
An accurate, simple, sensitive and selective reverse phase liquid chromatographic method has been developed for the determination of Ebastine in its pharmaceutical preparations. The proposed method depends on the reverse phase chromatography which was conducted using Octadecylsilane (C18) (250 × 4.6 mm id) column at 40º C temperature with UV-detection at 255 nm. A mobile phase containing a mixture of phosphoric acid buffer adjusted to pH 6.0 and Acetonitrile in the ratio of 400:600, has been used for the determination of Ebastine at a flow rate of 1.0 ml/min. It is also desirable to have less run time; Henceforth the analysis of assay sample will become fast and reliable. The method was validated to meet requirements of global regulatory filling.

7. Effect of Super Disintegrants on Formulation of Ondansetron HCL Immediate Release Tablets by Direct Compression method
Anirudh Srivatsa.P, Harish.G, Pragath kumar.B, Debjit Bhowmik, Duraivel.S
The objective of the present investigation was to formulate Oro-dispersible tablets of Ondansetron hydrochloride, due to its application in emesis conditions where fast on set of action is required. Tablets which were prepared by direct compression using sodium starch glycolate and crosprovidone as a combination of these two agents a better disintegration was observed. The tablets were evaluated for weight variation, mechanical strength, and In-vitro disintegration time, wetting time, drug release, hardness, friability and dissolution studies. Finally all the formulation parameters were within the pharmacopoeial limits and the drug disintegration time was less and the drug release was fast. Formulation F3 was found to effective hence the disintegration time was found to be 24sec which is rapid compared to that of the marketed formulation. It was concluded that super disintegration addition technique is a useful method for preparing Oro dispersible tablets by direct compression.

8. Development and Validation of Stability-Indicating RP-HPLC Method for Estimation of Atovaquone
Viplava.K, Haritha Pavani.V
A rapid RP-HPLC method developed for determination of Atovaquone in API. Atovaquone was found to be degraded under different set of conditions as followed according to ICH guidelines and the degradants so formed along with Atovaquone are separated by using Thermo Hypersil BDS C18, 250mm×4.6mm×5µm column using Buffer: Acetonitrile (20:80) as mobile phase, with a flow rate of 1.5ml/min with a detection wavelength of 283nm with a injection volume of 20µl. The method was validated for specificity, linearity, accuracy, robustness, and precision. The obtained results were indicating that the method is selective in analysis of Atovaquone in the presence of degradation products formed under various stress conditions.

9. Trace Elements as Risk Indicator for Coronary Artery Disease among Cigarette Smokers
Antony Thangadurai T., Savariraj Sagayam C., Victor Rajamanickam G., Saranathan E
Cigarette smoking has been accepted as a risk factor for coronary artery disease. The present study investigate the influence of cigarette smoking on Copper (Cu), Zinc (Zn), Chromium (Cr), Nickel (Ni) and cholesterol (TC) and triglycerides (TG). Thirty three healthy men (21 Smokers and 12 non-smokers) from Thanjavur Transport Corporation, Thanjavur, volunteered to participate in this study. A questionnaire was used to assess smoking habits, blood pressure and anthropometric measurements. The random blood samples were collected. Two statistical methods were used. The Pearson correlation co-efficient indicates the strong positive relationship of Cu with smokers, Ni and Zn. Likewise Zn reciprocates its positive relation with smokers and Ni. TG is significantly correlated with smokers and Cu. As per PCA analysis, Factor 1 shows strong influence due to smoking, Zn, Cu, and TG. The factors in 2 and 3 one finds the role of Cr and Ni, and TC and TG respectively. These findings suggest that cigarette smoking may cause an imbalance among trace elements which may initiate the deterioration process associated with cardiovascular disease; thereby it becomes a risk factor to coronary artery disease.

10. Design and Characterization of Ranitidine Hydrochloride Floating Tablets by Wet Granulation Method
K.NagaRaju, Duraivel.S, Pragath Kumar.B
Currently there are a number of technologies available that have been used to provide sustained release dosage forms and some of these involve the use of a wide range of polymers. This present research describes an investigation of the effects of formulation and processing parameters on a floating matrix controlled drug delivery system consisting Methods: The tablets were prepared by Wet granulation process using Ranitidine hydrochloride, HPMC K-4M ,Carbopol ,sodium carboxy methyl cellulose ,Guar Gum ,Xanthan gum ,sodium bicarbonate ,citric acid ,Stearic acid ,Hydrochloric acid ,Talc ,Mag.Stearate. The physicochemical properties like thickness, hardness, Weight variations, Friability, Drug content, Floating log time, Swelling Index etc were determined. The In-Vitro drug release rate of floating tablets was determined using United States Pharmacopeia Dissolution Testing Apparatus 2 (paddle method). The dissolution test was performed using 900 ml of 0.1N HCL, at 37 ± 0.5°C and 50 rpm. A sample (5 mL) of the solution was withdrawn at 1,2,3,4, up to 12hrs from and the samples were replaced with fresh dissolution medium. The samples were filtered. Through a 0.45μ membrane filters and diluted to a suitable concentration with 0.1N HCL. Absorbance of these solutions was measured using a UV- spectrophotometer and the stability studies were conducted for a period of three months Conclusion: It was established that formulation R11 (360 minutes) has better in vitro release profiles in comparison to the commercial product. The result obtained is encouraging, because a longer gastric residence time is an important condition for higher bioavailability of the drugs included in the floating dosage forms. Hence Ranitidine HCL floating tablets could be promising one as they, minimizes the dose, and reduces the side effects.

11 Preparation and In Vitro Evaluation of Lamivudine Floating Sodium Alginate Beads
R.B.Desi Reddy, Malleswari.K, Prasad.G, D.Prasanna
The objective of the study was to develop a oral controlled release drug delivery system of lamivudine using non effervescent approach with hydrocolloid gel forming agent HPMC (hydroxylpropyl methylcellulose) and sodium alginate. Alginate beads of lamivudine were prepared by ionotropic gelation method. The prepared alginate beads were subjected to evaluation for particle size, incorporation efficiency and in vitro drug release characteristics. Alginate beads were discrete spherical and free flowing with smooth surfaces and completely covered with polymer coat. The alginate beads produced were smooth and small in size with an average diameter of about 506.19±7.2µm to 537.31±8.6µm. The prepared floating alginate beads were exhibited prolonged drug release (~12 hrs) and remained buoyant for greater than 12hrs.The release kinetics showed that the release of drug from the beads followed zero order kinetics. Drug release was controlled by diffusion from the alginate beads that was slow and spreads over an extended period of time depending upon the drug polymer ratio.


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