Kadi Sarva Vishwavidyalaya University

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Bodh Gaya, India
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Modi D.K.,Kadi Sarva Vishwavidyalaya University | Patel C.N.,Hemchandracharya North Gujarat University
International Journal of PharmTech Research | Year: 2010

A new sensitive, simple, rapid and precise two spectrophotometric method has been developed for simultaneous estimation of perindopril and indapamide in pharmaceutical dosage form. This method was based on UVspectrophotometric determination of two drugs, using absorbance correction method. It involves measurement of absorbances at two wavelengths 210.4nm (λmax of perindopril) and 285.8nm (λmax of indapamide) in methanol for the simultaneous quantitative determination of perindopril and indapamide in the binary mixture without previous separation. The linearity was observed in the concentration range of 24 - 56 μ g mL -1 for perindopril and 7.5 - 17.5 μ g mL -1 for indapamide. The accuracy and precision of the method was determined and validated statically. The method showed good reproducibility and recovery with % RSD less than 2. Method was found to be rapid, specific, precise and accurate, can be successfully applied for the routine analysis of perindopril and indapamide in bulk, and combined dosage form without any interference by the excipients. The method was validated according to ICH guidelines.


Patel G.M.,Kadi Sarva Vishwavidyalaya University | Shelat P.K.,Kadi Sarva Vishwavidyalaya University | Lalwani A.N.,Kadi Sarva Vishwavidyalaya University
European Journal of Pharmaceutical Sciences | Year: 2016

Aim of present work was to apply quality by design (QbD) principles for the development of proliposome of poorly soluble lopinavir (LPV). The patient-centric quality target product profile (QTPP) was defined and critical quality attributes (CQAs) earmarked. Risk assessment studies were carried out to identify the probable risks affecting the CQAs of the product. On the basis of preliminary study, lipid:drug ratio and amount of carrier were selected as critical material attributes (CMAs) and were optimized by face centered central composite design. Liposome vesicle size, drug entrapment efficiency and % drug release after 60. min were selected as CQAs and mathematical relationship between CQAs and CMAs was derived using multiple linear regression analysis. Optimum composition of CMAs, identified using numerical optimization and desirability function, demonstrated excellent entrapment efficiency (> 90%), drug release characteristics (> 95% in 60. min) and had vesicle size of 659.7. ±. 23.1. nm. Solid state characterization studies (Differential Scanning Calorimetry, scanning electron microscopy and X-ray diffraction) were performed for optimized proliposome, suggested transformation of crystalline to amorphous form. Oral bioavailability study in Wistar rats revealed that LPV proliposome exhibited 2.24 and 1.16 fold higher bioavailability than pure LPV and available commercial formulation of LPV/RTV (lopinavir+ritonavir), respectively. Stability study of the optimized LPV loaded proliposome was performed as per ICH guideline and was found to be stable for period of 6. months. Overall results of the study indicate that the proliposome offers advantages of enhanced oral bioavailability for poorly soluble LPV. © 2016.


Patel A.,Kadi Sarva Vishwavidyalaya University | Shelat P.,Kadi Sarva Vishwavidyalaya University | Lalwani A.,Kadi Sarva Vishwavidyalaya University
Drug Delivery and Translational Research | Year: 2014

The present research was aimed at development and evaluation of self-nanoemulsifying drug delivery system (SNEDDS) for improving bioavailability of nelfinavir mesylate (NFV), a protease inhibitor exhibiting pH dependent solubility and variable oral bioavailability. Maisine 35-1, Cremophor RH-40, and Labrasol were identified as oil, surfactant, and co-surfactant that had best solubility for NFV. Scheffe's mixture design was used to optimize the amount of components in liquid self-nanoemulsifying drug delivery system (L-SNEDDS) by taking their amounts as independent variable, whereas globule size, drug loading, and percent transmittance were taken as dependent variable. Optimized NFV-L-SNEDDS was then adsorbed on Neusilin US2 to form solid self-nanoemulsifying drug delivery system (S-SNEDDS). NFV loaded L-SNEDDS and S-SNEDDS were characterized for various physicochemical properties, and solid-state properties were determined through differential scanning calorimetry, X-ray diffraction, and scanning electron microscopy studies. In vitro dissolution using simulated gastric fluid and simulated intestinal fluid, ex vivo drug release study, and in vivo study were performed for pure NFV and NFV-S-SNEDDS. NFV-S-SNEDDS showed more than 90 % drug release in 20 min during drug release studies irrespective of pH of the dissolution medium. In vivo study revealed significant difference between release of NFV from suspension and NFV-L-SNEDDS and NFV-S-SNEDDS when given to rabbits (p < 0.001). NFV-L-SNEDDS and NFV-S-SNEDDS were subjected to stability study as per ICH guidelines, and NFV-S-SNEDDS was found to be stable during the period of study. S-SNEDDS could serve as a potential drug delivery system for NFV. © 2014 Controlled Release Society.


Movaliya V.,Kadi Sarva Vishwavidyalaya University | Zaveri M.,Kadi Sarva Vishwavidyalaya University
International Journal of Pharmaceutical Sciences Review and Research | Year: 2014

Medicinal plants may serve as a vital source of potentially useful new compounds for the development of effective therapy to combat a variety of kidney problems. Many herbs have been prove to be effectual as nephroprotective agents while many more are claimed to be nephroprotective but there is lack of any such scientific evidence to support such claims. Developing a satisfactory herbal therapy to treat severe renal disorders requires systematic investigation of properties like acute renal failure, nephritic syndrome and chronic interstitial nephritis. Herbal medicines possess curative properties due to the presence of their chemical components. The present review is aim to elucidate the one of the Pasanabheda category plant, Aerva javanica possessing nephroprotective activity. The present review includes ethnomedicinal, pharmacognostical, phytochemical and different pharmacological activity of the plant Aerva javanica.


Movaliya V.,Kadi Sarva Vishwavidyalaya University | Zaveri M.,Kadi Sarva Vishwavidyalaya University
International Journal of Pharmaceutical Sciences Review and Research | Year: 2014

Aerva javanica belonging to family (Amaranthaceae) roots and flowers are reported to possess medicinal properties against rheumatism and kidney problems. The present work is to evaluate the nephroprotective effect of Aerva javanica by cisplatin induced renal toxicity in adult male albino rats of Sprague Dawley strain. The effect of hexane, ethyl acetate and n-butanol fractions of alcoholic extract were evaluated at 200 mg/kg, 180 mg/kg and 270 mg/kg body weight dose respectively in rats against nephrotoxicity induced by administration of cisplatin through intra peritoneal route. Various serum parameters were studied along with histopathological examination of kidneys in each treatment group. The fractions were compared to the ursolic acid at the dose of 150 mg/kg as a standard drug. Hexane fraction of alcoholic extract was found to have significant nephroprotective activity. The levels of urea, creatinine, albumin and total protein in the serum were normalized after treatment with hexane fraction of alcoholic extract at 200mg/kg body weight dose. The hexane fraction of alcoholic extract at the dose of 200 mg/kg shows similar result as compared to the reference standard ursolic acid. The hexane fraction of alcoholic extract of root of A. javanica possesses marked nephroprotective activity and thus can have a promising role in the treatment of acute renal injury.


Barot B.S.,Kadi Sarva Vishwavidyalaya University | Parejiya P.B.,Kadi Sarva Vishwavidyalaya University | Patel H.K.,Kadi Sarva Vishwavidyalaya University | Gohel M.C.,JKK Nataraja Dental College and Hospital | Shelat P.K.,Kadi Sarva Vishwavidyalaya University
AAPS PharmSciTech | Year: 2012

The aim of the present investigation was to evaluate microemulsion as a vehicle for dermal drug delivery and to develop microemulsion-based gel of terbinafine for the treatment of onychomycosis. D-optimal mixture experimental design was adopted to optimize the amount of oil (X1), Smix (mixture of surfactant and cosurfactant; X2) and water (X3) in the microemulsion. The formulations were assessed for globule size (in nanometers; Y1) and solubility of drug in microemulsion (in milligrams per milliliter; Y2). The microemulsion containing 5.75% oil, 53.75% surfactant-cosurfactant mixture and 40.5% water was selected as the optimized batch. The globule size and solubility of the optimized batch were 18.14 nm and 43.71 mg/ml, respectively. Transmission electron microscopy showed that globules were spherical in shape. Drug containing microemulsion was converted into gel employing 0.75% w/w carbopol 934P. The optimized gel showed better penetration and retention in the human cadaver skin as compared to the commercial cream. The cumulative amount of terbinafine permeated after 12 h was 244.65±18.43 μg cm-2 which was three times more than the selected commercial cream. Terbinafine microemulsion in the gel form showed better activity against Candida albicans and Trichophyton rubrum than the commercial cream. It was concluded that drug-loaded gel could be a promising formulation for effective treatment of onychomycosis. © 2011 American Association of Pharmaceutical Scientists.


Movaliya V.,Kadi Sarva Vishwavidyalaya University | Zaveri M.,Kadi Sarva Vishwavidyalaya University
International Journal of Pharmaceutical Sciences Review and Research | Year: 2012

The indigenous plant which is selected in the present study was Aerva javanica belonging to family Amaranthaceae. A. javanica roots and flowers are reported to possess medicinal properties against rheumatism and kidney problems. A. javanica is used as Pasanabheda means one which breaks the kidney stone and in Gujarati it is commonly known as Patharphod. To establish pharmacognostical and phytochemical quality control parameters of root of A. javanica. Pharmacognostical evaluation including examination of morphological and microscopical characters, determination of quality control parameters such as ash values, extractive values, moisture content and foreign matter were carried out. Phytochemical screening including qualitative chemical examinations was also carried out. Hence, the present attempt was undertaken to investigate the pharmacognostical studies of A. javanica root. The study revealed the presence of cork, indistinct phellogen, 6 to 7 layer of phelloderm present in the periderm region with secondary structures of stellar region in the root of the A. javanica. In the crude powder structures mainly observed were cork, fibers, calcium oxalate crystals, vessels with bordered pits and ray cells. Phytochemical screening of root of A. javanica showed the presence of phytoconstituents like flavonoids, alkaloids, tannins, etc. The morphological, physicochemical and histological study to establish the authenticity of A. javanica root and can help to identify the plant from its other species.


Shah B.,Kadi Sarva Vishwavidyalaya University | Deshpande S.,Kb Institute Of Pharmaceutical Education And Research
Value in Health Regional Issues | Year: 2014

Objective: To assess the influence of diabetes on health-related quality of life (HRQOL) in patients with coronary artery disease (CAD) and identify predictors of health status at 1-year follow-up after an acute coronary event. Methods: A prospective cohort study in patients diagnosed with CAD at a tertiary care hospital from India. The EuroQol five-dimensional (EQ-5D) questionnaire was administered at 1-year follow-up. Multivariate stepwise liner regression was used to assess predictors of EQ visual analogue scale (VAS) and EQ-5D questionnaire utility scores. Respondents reporting problems on the EQ-5D questionnaire were stratified by the presence of diabetes at baseline for comparison. Results: Of 960 (30% diabetic) patients with CAD enrolled in a main study cohort, 306 (76% males, 21% diabetic) responded to the HRQOL questionnaire at 1 year. Diabetic patients reported more difficulties/problems than did nondiabetic patients for EQ-5D questionnaire dimensions (mobility, 12.3% vs. 4.1%, P = 0.03; usual activities, 56.9% vs. 41.3%, P = 0.03; pain/discomfort, 50.8% vs. 17.8%, P < 0.001; anxiety/depression, 33.8% vs. 14.9%, P < 0.001), except for self-care (12.3% vs. 17.5%, P = 0.35). Mean ± SD EQ VAS and EQ-5D questionnaire utility scores were significantly lower for patients with CAD with diabetes versus those without diabetes (0.75 ± 0.15 vs. 0.83 ± 0.15, P = 0.0002, and 67.8 ± 8.8 vs. 73.6 ± 5.4, P = 0.0001, respectively). Presence of diabetes, use of beta-blockers on discharge, and treatment strategy significantly influenced the VAS score, whereas myocardial infarction as final diagnosis and the presence of prior CHF predicted worse EQ-5D questionnaire utility scores. Conclusions: The poorer HRQOL as assessed by the EQ-5D questionnaire among patients with CAD who had diabetes highlights the need of individualized treatment programs to improve outcomes in this most vulnerable population. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Mishra T.,Kadi Sarva Vishwavidyalaya University | Shrivastav P.S.,Gujarat University
The Scientific World Journal | Year: 2014

Objectives. HIV protease inhibitors are used in the treatment of patients suffering from AIDS and they act at the final stage of viral replication by interfering with the HIV protease enzyme. The paper describes a selective, sensitive, and robust method for simultaneous determination of three protease inhibitors atazanavir, darunavir and ritonavir in human plasma by ultra performance liquid chromatography-tandem mass spectrometry. Materials and Methods. The sample pretreatment consisted of solid phase extraction of analytes and their deuterated analogs as internal standards from 50 μL human plasma. Chromatographic separation of analytes was performed on Waters Acquity UPLC C18 (50 × 2.1 mm, 1.7 μm) column under gradient conditions using 10 mM ammonium formate, pH 4.0, and acetonitrile as the mobile phase. Results. The method was established over a concentration range of 5.0-6000 ng/mL for atazanavir, 5.0-5000 ng/mL for darunavir and 1.0-500 ng/mL for ritonavir. Accuracy, precision, matrix effect, recovery, and stability of the analytes were evaluated as per US FDA guidelines. Conclusions. The efficiency of sample preparation, short analysis time, and high selectivity permit simultaneous estimation of these inhibitors. The validated method can be useful in determining plasma concentration of these protease inhibitors for therapeutic drug monitoring and in high throughput clinical studies. © 2014 Tulsidas Mishra and Pranav S. Shrivastav.


Patel H.K.,Kadi Sarva Vishwavidyalaya University | Barot B.S.,Kadi Sarva Vishwavidyalaya University | Parejiya P.B.,Kadi Sarva Vishwavidyalaya University | Shelat P.K.,Kadi Sarva Vishwavidyalaya University | Shukla A.,Kadi Sarva Vishwavidyalaya University
Colloids and Surfaces B: Biointerfaces | Year: 2013

The aim of the present investigation was to evaluate microemulsion as a vehicle for dermal drug delivery and to develop microemulsion based gel (MBC) of clobetasol propionate (CP) for the effective treatment of vitiligo. D-Optimal mixture experimental design was adopted to optimize the amount of oil (X1), Smix (mixture of surfactant and cosurfactant) (X2) and water (X3) in the microemulsion. The formulations were assessed for globule size (nm) (Y1) and solubility of CP in microemulsion (mg/ml) (Y2). The microemulsion containing 3% oil, 45% Smix and 50% water was selected as the optimized batch (ME). The globule size and solubility of CP in ME were 18.26nm and 36.42mg/ml respectively. Transmission electron microscopy showed that ME globules were spherical in shape. Carbopol 934P was used to convert microemulsion containing drug into gel form without affecting its structure. Ex-vivo permeation studies showed that cumulative amount of CP permeated (Qn) from ME, MBC and market formulation (MFCP) at 8h after application were 53.6±2.18, 28.43±0.67 and 37.73±0.77μgcm2 respectively. MBC showed greater retention of CP in to skin layers than ME and MFCP. Skin irritation studies showed MBC to be significantly less irritating than MFCP. Photomicrographs and scanning electron micrographs of skin sections treated with MBC showed significant changes in the skin structure, which was attributed to the interaction of microemulsion components with skin resulting in permeation enhancement and retention of CP into skin layers. It was concluded that CP loaded gel could be a promising formulation for effective treatment of vitiligo. © 2012 Elsevier B.V.

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