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Sherje A.P.,Narsee Monjee Institute of Management and Higher Studies | Tawade A.P.,STESs Sinhgad Institute of Pharmacy | Vyas M.,STESs Sinhgad Institute of Pharmacy
International Journal of PharmTech Research | Year: 2010

Two simple, accurate and precise spectrophotometric methods have been developed for simultaneous determination of satranidazole and ofloxacin in pharmaceutical fixed dosage form. The method A involves formation and solving of simultaneous equation using 297.3 and 317.0 nm as the wavelengths of detection while method B is two wavelength method where 281.5nm, 309.0nm were selected as λ1 and λ2 for determination of satranidazole and 300.0 nm, 333.1nm were selected as λ1 and λ2 for determination of ofloxacin. Both the methods were validated statistically and recovery studies were carried out. The Beer's law limits for each drug individually and in mixture was within the concentration range of 5-25 μg/ml. Linearity of satranidazole and ofloxacin were in the range of 80-120% of the label claim. The proposed methods have been applied successfully to the analysis of the cited drugs either in pure form or in pharmaceutical formulations with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.

Aswar U.M.,STESS Sinhgad Institute of Pharmacy | Mohan V.,Indus Biotech Private Ltd
Indian Journal of Pharmacology | Year: 2012

Objective: Cissus quadrangularis L. (C. quadrangularis L.) (Vitaceae) has been reported in Ayurveda for its antiosteoporotic activity. The study separated the phytoestrogen-rich fraction (IND-HE) from aerial parts of C. quadrangularis L. and evaluated its effect on osteoporosis caused by ovariectomy in rats. Materials and Methods: IND-HE was separated from the ethanol extract of C. quadrangularis. Ovariectomized female Wistar rats were divided into four groups (n = 6). Group 1: Control (distilled water), Group II: IND-HE (75 mg/kg p.o.), Group III: IND-HE (100 mg/kg p.o.) were treated once daily for 8 weeks and Group IV: standard estradiol group, received estrogen (1 mg/kg, s.c. bi-weekly). The effects on body weight were determined. DEXA (Dual energy-emission X-ray absorptimatory analysis) of whole body bone and femur was carried out. Blood was removed and analyzed for biochemical parameters. After sacrificing the animals, biomechanical study of right tibia and histopathology of pelvic bone was carried out. Results: IND-HE showed presence of phytoestrogen-rich fraction. IND-HE (75 and 100 mg/ kg) and estrogen treatment showed statistically significant increase in bone thickness, bone density and bone hardness. IND-HE (75 and 100 mg/kg) and estrogen treatment significantly increased serum estradiol. IND-HE (100 mg/kg) (P<0.05) and estrogen treatment increased serum vitamin D3 and serum calcium compared to control. Alkaline phosphatase was significantly reduced by IND-HE (100 mg/kg p.o.) and estrogen treatment. Histopathology and DEXA results indicated that IND-HE (75 and 100 mg/kg) prevented bone loss. Discussion and Conclusion: These findings confirm that phytoestrogen-rich fraction (IND- HE) possess good antiosteoporotic activity.

Aswar U.M.,STESs Sinhgad Institute of Pharmacy | Kalshetti P.P.,Maharashtra Institute of Pharmacy | Shelke S.M.,Bharati Vidyapeeth Deemed University | Bhosale S.H.,Bharati Vidyapeeth Deemed University | Bodhankar S.L.,Bharati Vidyapeeth Deemed University
Asian Pacific Journal of Tropical Biomedicine | Year: 2012

Objective: To study the derivatives of 1,2,4-triazino[5,6-b]indole-3-thione for antidepressant activity in olfactory bulbectomized (OBX) rats. Out of various derivatives tested for acute tail suspension test, the two derivatives showing prominent action were selected for bilateral olfactory bulbectomy model of chronic depression in rats. Methods: The sub acute effects of 14-day oral pretreatment of two derivatives labeled as 3a (70 mg/kg) and 3r (70 mg/kg), imipramine (20 mg/kg), fluoxetine (30 mg/kg) and moclobemide (15 mg/kg) were evaluated on bilateral bulbectomy induced rise in body weight, hyperphagia, hyperactivity, and on sexual dysfunction. The serum sodium concentration, body temperature, and heart rate were also recorded. Results: The derivatives 3a and 3r showed reversal of drop in body weight, reversed OBX induced hyperactivity, normalized body temperature, heart rate, and serum sodium concentration. In elevated maze test, moclobemide, 3a, 3r treatment significantly reduced time spent in open arm as compared to OBX rats. 3a and 3r also improved sexual behavior parameters. Conclusions: The present study shows promising antidepressant action and provides a proof of concept for the chronic treatment of 3a, 3r to treat depression. © 2012 Asian Pacific Tropical Biomedical Magazine.

Pund S.,STESs Sinhgad Institute of Pharmacy | Shete Y.,STESs Sinhgad Institute of Pharmacy | Jagadale S.,STESs Sinhgad Institute of Pharmacy
Colloids and Surfaces B: Biointerfaces | Year: 2014

Simultaneous analysis of the effect of multiple formulation ingredients on the critical physico-chemical properties of lipid based nanoemulsifying cilostazol was studied using integrated quality by design approach. Cilostazol is a poorly soluble drug belonging to class II of the biopharmaceutics classification system. To improve the solubility and in turn bioavailability of cilostazol, a lipid based nanoemulsifying cilostazol was developed.Self nanoemulsifying system comprising of Capmul MCM (oily solubilizer), Tween 80 (surfactant); and Transcutol HP (cosolvent) was developed. A 23 full factorial experimental design was employed to optimize simultaneously the effect of levels of these three components on physico-chemical responses (viz. globule size, span, zeta potential, solubility, and dissolution efficiency at 30min) of nanoemulsifying cilostazol. Graphical analysis using Pareto charts and Bayesian analysis along with mathematical modelling of the results allowed the identification and quantification of the formulation variables active on the selected responses. A polynomial equation fitted to the data was used to predict the composition with optimum responses.The optimum formulation was a mixture of Capmul MCM, Tween 80 and Transcutol HP; 3:5:5 parts by weight. Optimized composition on dilution with water showed globule size; 215.2. nm with a span of 0.42. The nanoemulsifying formulation showed equilibrium solubility and dissolution efficiency; 9.82. mg/ml and 83.3% respectively, indicating significant improvement in comparison to pristine cilostazol. Interaction between oil and the cosolvent significantly affected the globule size and the span of the resultant nanoemulsion. Zeta potential was independent of selected formulation variables. The optimized formulation was adsorbed onto Neusilin US2 without affecting nanoemusifying ability of lipid based cilostazol composition. © 2013 Elsevier B.V.

Datar P.A.,STESs Sinhgad Institute of Pharmacy | Aher S.B.,STESs Sinhgad Institute of Pharmacy
Journal of Saudi Chemical Society | Year: 2012

Thiazolidinediones are well known for causing reduction in blood glucose levels. A number of thiazolidinediones have been approved for clinical use in diabetes. Present research work is based on the synthesis of thiazolidinedione derivatives that were designed previously using 2D QSAR for antidiabetic activity. Thiazolidine-2,4-diones derivatives having carboxylic ester appendages at N-3 and 5-substituted benzylidene were studied and the syntheses of only four derivatives were performed that were predicted to have promising antidiabetic activities. Their effect on hypoglycemic activity was performed using a sucrose loaded model. Compounds 5a and 5b were found to have prominent activities at 100 mg/kg by oral route administration. © 2012.

Gawande V.,STESs Sinhgad Institute of Pharmacy | Bothara K.,STESs Sinhgad Institute of Pharmacy
Journal of Planar Chromatography - Modern TLC | Year: 2014

The present research work was aimed to determine the stability of cefprozil monohydrate (CEFZ) as per various stress degradation conditions recommended by International Conference on Harmo - nization (ICH) guideline Q1A (R2). Forced degradation studies were carried out for hydrolytic, oxidative, photolytic, and thermal stress conditions. The drug was found susceptible for degradation under all stress conditions. Separation was carried out by using high-performance thin-layer chromatographic system (HPTLC). Aluminum plates precoated with silica gel 60 F254 were used as the stationary phase. The mobile phase consisted of ethyl acetate-acetone- methanol-water-glacial acetic acid (7.5:2.5:2.5:1.5:0.5 v/v). Densitometric analysis was carried out at 280 nm. The system was found to give compact spot for cefprozil monohydrate (0.45 RF). The method was validated for precision, accuracy, specificity, and robustness. The linear regression analysis data showed good linear relationship in the concentration range of 200-5000 ng band-1 for cefprozil monohydrate. Percent recovery for the drug was found to be in the range of 98.78-101.24. The method was found to be reproducible with % relative standard deviation (% RSD) for intra- and inter-day precision to be <1.5% over the said concentration range. The method has been successfully applied in the analysis of drug in tablet dosage form. Three unknown degradation products formed under various stress conditions were isolated by preparative HPTLC and characterized by mass spectroscopic studies. © Akadémiai Kiadó, Budapest.

Sherje A.P.,Narsee Monjee Institute of Management and Higher Studies | Anand R.,STESs Sinhgad Institute of Pharmacy | Sriram W.,STESs Sinhgad Institute of Pharmacy | Vanshiv S.D.,STESs Sinhgad Institute of Pharmacy
International Journal of ChemTech Research | Year: 2010

The present investigation illustrates the application of mixed hydrotropy. There was significant synergistic effect on enhancement in solubility of a poorly water soluble drug by mixing two hydrotropic agents.The enhancement in solubility of nitazoxanide was more than 10 and 12 folds in 1M sodium benzoate solution (SB) and 1M sodium salicylate (SS) solution, respectively as compared to its solubility in distilled water. The enhancement in the solubility of nitazoxanide in a mixed hydrotropic solutions (SB-SS) containing 1M sodium benzoate and 1M sodium salicylate was more than 17 folds. Thus, a mixed hydrotropic solution of sodium benzoate and sodium salicylate was employed to carry out spectrophotometric analysis precluding use of organic solvents. The tablets containing nitazoxanide were analyzed successfully. Recovery studies and statistical data proved accuracy, reproducibility and the precision of the proposed method. The presence of hydrotropic agents did not interfere in the analysis.

Pund S.,STESs Sinhgad Institute of Pharmacy | Thakur R.,STESs Sinhgad Institute of Pharmacy | More U.,STESs Sinhgad Institute of Pharmacy | Joshi A.,tel Perd Center
Colloids and Surfaces B: Biointerfaces | Year: 2014

Resveratrol, a dietary non-flavonoid polyphenolic phytoalexin, has gained attention in cancer chemoprevention. However, poor aqueous solubility and cellular bioavailability has limited its therapeutic application. We formulated a lipid based delivery system of resveratrol with self nanoemulsifying ability. Several edible and safe lipids, surfactants and cosolvents were screened for solubilization of resevratrol. Developed formulation comprised of Acrysol K 150 as a lipid and mixture of Labrasol and Transcutol HP as the surfactant system, as these components showed higher solubility. Pseudoternary phase diagram was constructed to identify the region of nanoemulsification. The formulations showed rapid emulsification with an average globule diameter; 85. nm to 120. nm and slight negative zeta potential. The nanocompositions exhibited cloud point above 55. °C and were stable toward the gastrointestinal pH and thermodynamic stress testing. As compared to pristine resveratrol, the developed delivery system showed significant increase in vitro cytotoxicity in MCF-7 breast cancer cells. In vivo chick chorioallantoic membrane assay revealed enhanced antiangiogenic activity of composition with high lipid level. Briefly, lipid based nanoemulsifying resveratrol dramatically enhanced the anticancer and antiangiogenic activities, thus increasing its potential application in cancer chemotherapy. © 2014 Elsevier B.V.

PubMed | STESs Sinhgad Institute of Pharmacy
Type: Journal Article | Journal: Indian journal of pharmaceutical sciences | Year: 2015

The present research work was carried out to determine stability of cefditoren pivoxil, an orally absorbed prodrug that is rapidly hydrolysed by intestinal esterases to the active cephalosporin cefditoren. Cefditoren was subjected to stress conditions recommended by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q1A (R2). Cefditoren pivoxil was susceptible for degradation under acidic, alkaline and neutral hydrolytic conditions while it was stable under photolytic and thermal stress conditions. Separation of cefditoren and degradation products were carried out by using HPLC. The unknown degradation products were characterized by liquid chromatography-mass spectrometry/time of flight studies. Structures were proposed for each fragment based on best possible molecular formula and complete degradation pathways were reported for cefditoren and its degradants.

PubMed | STESs Sinhgad Institute of Pharmacy
Type: Journal Article | Journal: International journal of pharmaceutics | Year: 2015

The present study is a mechanistic validation of proof of concept of effective topical delivery of leflunomide (LFD) nanoemulgel for localized efficient treatment of psoriatic lesions as well as melanoma affected skin regions. Hyperproliferation of keratinocytes in psoriasis and symbiotic relationship between keratinocytes and melanocytes, justifies the need of dual acting treatment. LFD is recently introduced significantly effective disease modifying anti-rheumatic drug and has been considered valuable for the treatment of psoriatic arthritis as well as melanoma. Current available treatments for psoriasis and melanoma are inefficient due to systemic side effects, poor transcutaneous permeation and thus present a challenge for development of novel colloidal carriers. We newly reformulated LFD as a nanoemulgel based on self nanoemulsifying technique using Capryol 90, Cremophor EL, Transcutol HP as nanoemulsifying components and Pluronic F127 as a gelling agent. This thermodynamically stable nanoemuslsifying preconcentrate after gelation showed mean globule size, 123.7 nm and viscosity 9620 93 cp. Complete mechanical characterization was carried out using Texture Analyzer and hardness, adhesiveness and springiness index were found to be 523 gms, 431 gms and 1.02, respectively. Ex vivo permeation through rat abdominal skin revealed significant improvement in flux, apparent permeability coefficient, steady state diffusion coefficient and drug deposition in skin due to nanoemulsification of LFD. The in vitro cytoxicity of LFD nanoemulgel in human HaCaT, melanoma A375 and SK-MEL-2 cell lines showed significantly enhanced therapeutic response. In gist, LFD nanoemulgel for trancutaneous delivery will reduce the overall dose and drug consumption, by effectively localizing at the applied target site and will ultimately minimize systemic side effects.

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