http://localhost:8080/xmlui/handle/123456789/7322 2026-04-30T16:29:32Z 2026-04-30T16:29:32Z MYAKAM, DIVYABEN http://localhost:8080/xmlui/handle/123456789/8188 2020-11-30T08:42:26Z 2016-04-01T00:00:00Z

Analytical method development and validationfor simultaneous estimation of rosuvastatin calcium, clopidogrel bisulphate and aspirin in pharmaceutical dosage form MYAKAM, DIVYABEN A First order derivative spectroscopic method and RP-HPLC method were developed and validated for simultaneous estimation of Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin in Pharmaceutical Dosage form. First order derivative method based on the measurement of absorbance at three wavelengths 362.49nm, 224.05nm and 288.45nm i.e. Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin respectively. The calibration curve was linear in a concentration range of 2-14μg/ml for Rosuvastatin Calcium, 7.5-52.5μg/ml for Clopidogrel Bisulphate and 7.5-52.5μg/ml for Aspirin. The RP-HPLC method has shown adequate separation of Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin in Pharmaceutical Dosage form. The separation was achieved on a Luna C18 (250mmX4.6 mm i.d., 5μm particle size) with an Isocratic system of Acetonitrile: Buffer (0.05M Potassium Dihydrogen Phosphate and pH 3 was adjusted with Ortho phosphoric Acid) in the ratio of 60:40v/v, flow rate was at 1.0 ml/min, and wavelength of detection used was 238nm. The retention time for Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin was obtained as 2.030±0.027min, 3.681±0.0259 and 6.293±0.028 respectively. The linearity of the proposed method was investigated in the range of 10-60μg/ml, 37.5-225μg/ml and 37.5-225μg/ml for Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin respectively. Correlation coefficient was 0.998, 0.998 and 0.999for Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin respectively. The developed method was validated as per ICH guideline, for its linearity, accuracy, precision, and robustness the results were found to be satisfactory. Thus, the method is specific, rapid and simple for estimation of Rosuvastatin Calcium, Clopidogrel Bisulphate and Aspirin. For Full Thesis Kindly contact to respective Library

2016-04-01T00:00:00Z PATEL, DISHA http://localhost:8080/xmlui/handle/123456789/8187 2020-11-30T08:34:50Z 2018-05-01T00:00:00Z

Local delivery of ornidazole-loaded chitosan nanoparticles containing ethyl cellulose film for the enhanced treatment of periodontitis PATEL, DISHA Problem Statement: Periodontal (gum) diseases are a “chronic inflammatory disease and infection” that destroy the tissue that support the teeth and finally, tooth loss. It involves the absorption of Alveolar bone, periodontal ligaments and formation of Pocket or space between tooth and gum is called as “Periodontitis”. The major cause is growth of microorganism in the pockets and release enzyme, toxins and stimulation of body’s immune response. Periodontitis is a very common and, is widely regarded as the second most common disease worldwide. In the United states has a prevalence of 30-50% of the population, but about 10% have severe form. This severe form is known as periodontitis. • Purpose: The objective of this study was to resolve the problems in different dosage form which are given in systemic root. Topical site-specific delivery of ornidazole was reduced the side effects occurs by the systemic drug delivery like hypersensitivity, gastrointestinal intolerance and bacterial resistance because of ornidazole have a longer half-life 12 to 14 hrs. Nanoparticles loaded film having a potential to deliver small amount of drug with prolonged period of time. • Methods: The Chitosan containing ornidazole nanoparticles was prepared by Ionic gelation mechanism using 1% Acetic acid. The nanoparticles were evaluated for Particle size, Zeta potential, Drug content, antimicrobial study and In-vitro drug release study. After preparation of nanoparticles they have loaded in film. Nanoparticle loaded film was formulated by solvent casting method using ethyl cellulose as a polymer, Dichloromethane as a solvent and Dibutyl phthalate as a plasticizer. The film was evaluated for thickness uniformity, folding endurance, weight uniformity, surface pH, swelling index, Surface morphology study with scanning electron microscopy, In-vitro drug release study, antibacterial study, FT-IR study of film and comparison study with marketed formulation. • Results: The optimized batch of nanoparticles was selected using Design of Experiment (DOE) Software7. F1 to F9 batch was prepared and evaluate all batches such as particle size, Drug content and In-vitro drug release study. After prepared F1-F9 batches, Design of experiment software 7 was applied and select the optimized batch. F2 have optimized batch, they have maximum drug release 82% and minimum inhibitory concentration. Optimized nanoparticles were loaded in ethyl cellulose film and they evaluate such parameters. In-vitro antibacterial of formulated nanoparticle containing ethyl cellulose film of ornidazole have similar activity as compare to standard drug sample. In compare to marketed formulation (Chlorhexidine mouth- wash) fabricated film have better antibacterial activity. The surface morphological study by scanning electron microscopy show that the molecules are uniformly distributed with nanoparticle in the formulation. • Conclusion: Chitosan nanoparticles loaded ethyl cellulose film combination is the better carrier among the others for the preparation of ornidazole periodontal film for prolonged the drug action up to 7days. For Full Thesis Kindly contact to respective Library

2018-05-01T00:00:00Z BHATIYA, VISHALKUMAR http://localhost:8080/xmlui/handle/123456789/8186 2020-11-30T08:29:06Z 2014-06-01T00:00:00Z

Preparation and evaluation of venlafaxine hydrochloride transdermal patch using natural polymers BHATIYA, VISHALKUMAR The aim of the present investigation was to prepare and evaluate Venlafaxine hydrochloride transdermal patch using natural polymers to provide sustained release of the drug and to overcome the drawbacks associated with the conventional dosage forms such as frequency of dosing, poor bioavailability, GIT irritation, GIT degradation, first pass metabolism, nausea, vomiting, metallic taste, poor patient compliance. Transdermal patch containing Venlafaxine hydrochloride was prepared by solvent casting technique. FTIR study was carried out to assess any interaction between the drug and the polymers. The formulated Venlafaxine HCL transdermal patches were evaluated for different parameters like thickness, weight variation, drug content, percentage moisture loss, percentage moisture uptake, folding endurance, surface pH and tensile strength. Ex-vivo diffusion was determined by Franz diffusion cell. The transdermal patch was tested for their potential to cause skin irritation in rats. The optimized formulation batch F9 was having excellent tensile strength, folding endurance and maximum drug release, also it followed Korsmeyer-peppas kinetic model. The stability study was performed in accelerated conditions (40±2 ºC and 75±5 %RH) and in room storage conditions (30±2 ºC and 65±5 %RH) for optimized batch. At room temperature there was no problem of stability and transdermal patch remained stable for one month during the course of stability study. From all the obtained results it may be concluded that the optimized formulation batch F9 is most suitable for transdermal drug delivery of Venlafaxine HCL. For Full Thesis Kindly contact to respective Library

2014-06-01T00:00:00Z TAI, PARVEZ http://localhost:8080/xmlui/handle/123456789/7323 2020-11-07T06:47:05Z 2014-09-01T00:00:00Z

Bioequivalence study of fenofibric acid 135mg delayed release capsule under fasting condition TAI, PARVEZ Objective: The objective of present study was to assess the bioequivalence of two Test Products (A)/(B): Fenofíbric Acid 135 mg delayed release capsules with Reference Product (C): Trilipix® 135 mg delayed release capsules (containing choline fenofibrate equivalent to 135 mg of fenofibric acid) of Abbott Laboratories North Chicago, IL 60064, U.S.A. in healthy human volunteers after administration of single capsule of either test A or B or reference C formulation under fasting condition, in each period. Methods: This single-dose, randomized, 2-period, 3- Treatment, 2- Sequence, 2- Group, crossover study compared the pharmacokinetic properties within healthy human volunteers under fasting condition. Volunteers were assigned to receive, in randomized order, a single oral dose of test formulation (A) or a reference formulation(C) to Group I and a single oral dose of test formulation (B) or a reference formulation(C) to Group II. Each study period was separated by a 10-days washout period. Blood samples were collected at pre-specified times over a period of 96 hours after administration. An LC-MS/MS method was used for the estimation of plasma Fenofibric acid concentrations. A non-compartmental method was employed to determine the pharmacokinetic properties (Cmax, Tmax, AUC0–t, AUC0–∞, and Thalf) to test for bioequivalence. The predetermined regulatory range of 90% CI for bioequivalence was 80% to 125%. Safety was assessed using physical examination, including vital sign measurement, and direct questioning. Results and discussion: The study was conducted in 48 volunteers divided in two groups 24 in each from both male and female (18-45 yrs; BMI (According to LIC chart)). For test formulation versus the reference formulation, the least squares mean test A/reference C ratios of Ln(Cmax) and Ln(AUC(0–t)) were 103.89% and 96.32% for Group I and the least squares mean test B/reference C ratios of Ln(Cmax) and Ln(AUC(0–t)) were 87.64% and 88.38% for Group II. CI for Ln(Cmax) and Ln(AUC(0–t)) were 98.50-113.84 and 90.43- 106.91 for Group I and CI for Ln(Cmax) and Ln(AUC(0–t)) were 83.67-99.73 and 84.45- 95.26 for Group II. No Serious adverse events were found or reported by volunteers throughout the study. In this study, both the test formulations was found bioequivalent to the reference formulation as per predetermined regulatory criteria. Conclusion: These observations confirm that the both the test formulations of Fenofibric acid 135mg Delayed release capsule are bioequivalent with the Trilipix® and it is found to be safe. For Full Thesis Kindly contact to respective Library

2014-09-01T00:00:00Z