Pankaj Nerkar
@rcpatelpharmacy.co.in
Asso Prof at Pharmaceutics department
RCPIPER, Shirpur
EDUCATION
Ph. D in Pharmacy from K B C NMU Jalgaon
RESEARCH INTERESTS
Formulation and Evaluation of NDDS such as micelles, nanoparticles, liposomes etc.
Scopus Publications
Scholar Citations
Scholar h-index
Scholar i10-index
Scopus Publications
Raju Onkar Sonawane, Savita Dattatraya Patil, Chandrakantsing Vijaysing Pardeshi, Hitendra Shaligram Mahajan, and Pankaj Padmakar Nerkar
Informa UK Limited
Abstract The aim of the present investigation is to develop zaltoprofen-loaded extended-release (ER) pellets formulation by an extrusion-spheronization technique using glyoxalated pre-gelatinized starch (GPS) complex as a novel matrix-forming polymer. The prime objective was to prepare an efficient and robust ER drug delivery system of zaltoprofen. Pellets were characterized by physicochemical, morphological, and solid-state characterization. The formulation was also analyzed for in-vitro drug release and in-vivo pharmacokinetic parameters. The FTIR analysis confirmed the GPS complex formation through the formation of the hemiacetal group while the ketone groups of glyoxal are abolished. Optimized formulation G5 containing 5:8 ratio of GPS complex and MCC showed 99.03 ± 2.12 percent cumulative drug releases in 14 h. The in-vivo study showed decreased C max and increased t 1/2 compared to bulk zaltoprofen, and hence would be a viable alternative for ER-type formulations. In the author’s opinion, the GPS-based ER pellet formulation would be an excellent delivery system for zaltoprofen.
Aditya A. Joshi and Pankaj P. Nerkar
Informa UK Limited
Abstract A detailed review to analyze the anti ulcer proton pump inhibitor (PPI) drugs, particularly for determination of their concentration percentage (assay) by analytical methods developed on analytical instruments i.e., UV visible Spectrophotometer, High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography, and Hyphenated techniques. The review includes literature survey of PPI drugs namely omeprazole (OPZ), lansoprazole (LPZ), pantoprazole (PPZ) rabeprazole (RPZ), dexlansoprazole (DLPZ), esomeprazole (EPZ), dexrabeprazole (DRPZ), ilaprazole (IPZ), and tenatoprazole (TPZ). The examined literature survey addressed chromatographic (HPLC and UPLC) and UV visible spectrophotometric methods with LC-MS/MS methods used in pure forms, pharmaceutical formulations, and human plasma and other biological fluids for their estimation. In case of validation parameters mostly Linearity, Recovery study, LOD and LOQ was considered and mentioned.
Pankaj Padmakar Nerkar, Sameer Ansari, and Shailesh Chalikwar
BSP Books Private Limited
A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (acid, base) oxidation, photolysis and thermal degradation and the stressed samples were analysed by the developed method. The method was validated for the precision, accuracy, linearity and robustness. The developed stability indicating method for enzalutamide was validated as per ICH guidelines.
Pankaj Padmakar Nerkar, Vaishali Badjuar, Pradyum Ige, Hitendra Mahajan, and Sameer Ansari
BSP Books Private Limited
This manuscript describes the development and validation of a simple, isocratic, and accurate reversed-phase HPLC method for the assay of tramadol in bulk powder form and tablet formulations. The chromato-graphic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5μm) column using acetonitrile: methanol: phosphate buffer pH 3.4 adjusted with orthophosphoric acid: (20:10:70, v/v) as a mobile phase, at a flow rate of 1 mL/min and detection at 271 nm. The linear range for tramadol were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.999. The retention time was found to be 4.47 min for tramadol that was subjected to stress conditions, such as hydrolysis, oxidation, photolysis and thermal degradation, and the stressed samples were analyzed using the above methodology. The method was validated for the precision, accuracy, linearity and robustness. The developed stability-indicating method for tramadol was validated as per ICH guidelines.
Hitendra S. Mahajan, Bhushankumar V. Tatiya, and Pankaj P. Nerkar
Elsevier BV
Pradum Pundlikrao Ige, Rohit Ravindra Badgujar, Pankaj Padmakar Nerkar, Hitendra Shaligram Mahajan, Raju Onkar Sonawane, and Sanjay Javarilal Surana
Informa UK Limited
ABSTRACT Drug which shows extensive first pass effect is difficult task that, needs to be solved by formulators in the pharmaceutical science. The low oral bioavailability (49%) of flutamide may be due to poor wettability, low aqueous solubility and extensive first pass effect. The aim of present investigation was to prepare flutamide loaded microspheres and incorporate it into suppositories for rectal delivery to avoid first pass effect and enhance residence time. Flutamide loaded mucoadhesive microspheres of Ocimum Basilicum mucilage (OBM) were prepared using spray drying and characterized by percent production yield, encapsulation efficiency, particle size, zeta potential, polydispersity index, DSC, SEM, XRPD, in vitro drug release and stability studies. Moreover, ex vivo mucoadhesion was investigated using falling liquid film technique to determine the adhesion of microspheres to sheep rectal mucosa. The microspheres had nearly spherical shape and size about 2.53 μm. The encapsulation efficiency and mucoadhesion of optimized formulation MBF10 were found to be 69.6 ± 2.3% and 89.01 ± 2.18%, respectively. Percent CDR of optimized flutamide loaded mucoadhesive microspheres was found to be 88.7 ± 1.3 at 7 h. In conclusion, OBM microparticles based suppository could be used to deliver drug through rectal delivery.
Hitendra S. Mahajan, Milind S. Mahajan, Pankaj P. Nerkar, and Anshuman Agrawal
Informa UK Limited
Abstract The central nervous system (CNS) is an immunological privileged sanctuary site-providing reservoir for HIV-1 virus. Current anti-HIV drugs, although effective in reducing plasma viral levels, cannot eradicate the virus completely from the body. The low permeability of anti-HIV drugs across the blood–brain barrier (BBB) leads to insufficient delivery. Therefore, developing a novel approaches enhancing the CNS delivery of anti-HIV drugs are required for the treatment of neuro-AIDS. The aim of this study was to develop intranasal nanoemulsion (NE) for enhanced bioavailability and CNS targeting of saquinavir mesylate (SQVM). SQVM is a protease inhibitor which is a poorly soluble drug widely used as antiretroviral drug, with oral bioavailability is about 4%. The spontaneous emulsification method was used to prepare drug-loaded o/w nanoemulsion, which was characterized by droplet size, zeta potential, pH, drug content. Moreover, ex-vivo permeation studies were performed using sheep nasal mucosa. The optimized NE showed a significant increase in drug permeation rate compared to the plain drug suspension (PDS). Cilia toxicity study on sheep nasal mucosa showed no significant adverse effect of SQVM-loaded NE. Results of in vivo biodistribution studies show higher drug concentration in brain after intranasal administration of NE than intravenous delivered PDS. The higher percentage of drug targeting efficiency (% DTE) and nose-to-brain drug direct transport percentage (% DTP) for optimized NE indicated effective CNS targeting of SQVM via intranasal route. Gamma scintigraphy imaging of the rat brain conclusively demonstrated transport of drug in the CNS at larger extent after intranasal administration as NE.
Pradum Pundlikrao Ige, Pravin Rajput, Chandrakantsingh Pardeshi, Rajendra Kawade, Bramhanand Swami, Hitendra Mahajan, Pankaj Nerkar, Veena Belgamwar, Sanjay Surana, and Surendra Gattani
Springer Science and Business Media LLC
Pankaj Padmakar Nerkar and Surendra Ganeshlal Gattani
Springer Science and Business Media LLC
Pradum Pundlikrao Ige, Nilesh Ashok Bachhav, Hitendra Shaligram Mahajan, Pankaj Padmakar Nerkar, and Surendra Ganeshlal Gattani
Bentham Science Publishers Ltd.
Pankaj Nerkar and Surendra Gattani
Informa UK Limited
Lepidium sativum Linn. (Cruciferea) is known as garden cress or cress. Venlafaxine is prescribed in schizophrenia and anxiety. It shows a tendency of hepatic first-pass metabolism, which affects its bioavailability. The objective of this study is the extraction of cress seed mucilage and development of buccal mucoadhesive microparticles of venlafaxine based on the mucilage using a spray-drying technique. The optimized formulation was evaluated in vitro and the bioavailability of the same formulation in rabbits was assessed. Cress seed mucilage was extracted and used to prepare microparticles with varying concentrations in formulations F1–F5 (1–5% w/w) using a spray-drying technique. The microparticles were evaluated for yield, particle size, incorporation efficiency, swelling property, in vitro mucoadhesion, and in vitro drug release. Microparticles were characterized by differential scanning colorimetry, scanning electron microscopy, and X-ray diffraction studies. In vivo evaluation was carried out in rabbits. Formulation F5 showed maximum mucoadhesion (88.38 ± 1.46%), greater incorporation efficiency (89.42 ± 2.52%), and the highest swelling index (0.93 ± 0.01) compared to the other formulations. F5 showed a marked increase in bioavailability after buccal administration (52.55%) compared to an oral route (39.40%). Time to reach C max of 23.49 ± 0.33 ng/mL was 120 min for buccal microparticles in comparison to oral solution, which took 180 min to reach C max of 17.98 ± 1.14 ng/mL. Cress seed mucilage is suitable for production of the mucoadhesive microparticles using a spray-drying method because significant improvement in bioavailability by buccal mucoadhesive microparticles was observed.
Hitendra S. Mahajan, Vinod Tyagi, Gopal Lohiya, and Pankaj Nerkar
Informa UK Limited
The aim of this study was to investigate the potential application of thermosensitive gels formed by a xyloglucan polysaccharide derived from tamarind seed for nasal drug delivery. Xyloglucan that had been partially degraded by β-galactosidase to eliminate 45% of galactose residues formed gels at concentrations of 2.5% w/w at gelation temperatures decreasing over the range 27–28°C. The in vitro release of ondansetron hydrochloride from the enzyme-degraded xyloglucan gels followed higuchi kinetics over a period of 5 h at 34°C by anomalous transport mechanism. The ex vivo permeation of ondansetron hydrochloride from the gels was sustained. Histological examination of nasal mucosa following a single administration of the gels showed no evidence of mucosal damage. Finally, the bioavailability study in rabbits revealed that the absolute bioavailability of ondansetron hydrochloride was significantly increased from 28.64% in the case of the oral drug solution to 52.79% in the case of the nasal in situ gel. The results of this study suggest the potential of the enzyme-degraded xyloglucan gels as vehicles for nasal delivery of drugs.
Pankaj Padmakar Nerkar and Surendra Ganeshlal Gattani
Springer Science and Business Media LLC
D. M DHUMAL, A. A SHIRKHEDKAR, P. P NERKAR, and S. J SURANA
SciELO Agencia Nacional de Investigacion y Desarrollo (ANID)
A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for simultaneous estimation of Moxifloxacin Hydrochloride (MOX) and Dexamethasone Sodium Phosphate (DSP) in Ophthalmic Solution. The method was carried out on a Qualisil RP C-8 (250 mm x 4.6 mm, 5 μm) column with a mobile phase consisting of Methanol: Water (75:25 v/v) pH adjusted to 3.0 with ortho-phosphoric acid of aqueous phase and flow rate of 1.0 mL min -1. Detection was carried out at 240 nm. The retention time for MOX and DSP was found to be 2.22, and 7.26 min, respectively. The MOX and DSP followed linearity in the concentration range of 10 - 60 µg mL-1 and 2- 12 µg mL-1 with r2= 0.99, respectively. The amounts of both these drugs estimated by proposed method were found to be in good agreement with label claim. The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The LOD and LOQ were found to be 0.30 µg mL-1 and 0.91 µg mL-1 for MOX and 0.10 µg mL-1 and 0.30 µg mL-1 for DSP. The proposed method can be used for routine analysis of both these drugs simultaneously in their combined dosage form.
Hitendra S. Mahajan, Bhushankumar V. Tatiya, and Pankaj P. Nerkar
Elsevier BV
Rikisha Jaysukhbhai Boghra, Pranita Chandrakant Kothawade, Veena Shailendra Belgamwar, Pankaj Padmakar Nerkar, Avinash Ramrao Tekade, and Sanjay Javerilal Surana
Pharmaceutical Society of Japan
The objective of present work was to enhance the solubility and bioavailability of poorly aqueous soluble drug Irbesartan (IBS). The solid dispersions were prepared by spray drying method using low viscosity grade HPMC E5LV. Prepared solid dispersions were characterized by dissolution study, fourier transform infrared spectroscopy (FT-IR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC) and X-ray diffraction studies (XRD). Results of the SEM, DSC and XRD study showed the conversion of crystalline form of IBS to amorphous form. The dissolution rate was remarkably increased in case of solid dispersion compared to pure IBS. Solubility and stability of solid dispersion was increased due to surfactant and wetting property, slowing devitrification and having anti-plasticization effect of HPMC E5LV. In vivo studies were performed in healthy rabbits (New Zealand grey) and compared with plain IBS. Solid dispersions showed increase in relative bioavailability than the plain IBS suspension. In conclusion, the prepared solid dispersions showed remarkable increase in solubility, dissolution rate and hence bioavailability of poorly water soluble drug Irbesartan.
Pankaj Padmakar Nerkar and Surendra Gattani
Informa UK Limited
The purpose of the present research work was to extract linseed mucilage, use it as a mucoadhesive agent and to develop mucoadhesive microspheres for buccal delivery with an intention to avoid hepatic first-pass metabolism, by enhancing residence time in the buccal cavity. Linseed mucilage was extracted and used to prepare microspheres with varying concentrations of mucilage from formulation F1–F4 (1–2.5%) by spray-drying technique. The microspheres were evaluated for the yield, particle size, incorporation efficiency, swelling property, in vitro mucoadhesion, in vitro drug release, histological study, and stability. Microspheres were characterized by differential scanning colorimetry, scanning electron microscopy, and X-ray diffraction study. Further, the bioavailability study using the New Zealand rabbits was carried out. Formulation F4 showed the maximum mucoadhesion 89.37 ± 1.35%, 92.10 ± 1.37% incorporation efficiency, highest swelling index 0.770 ± 1.23. F4 showed a marked increase in the bioavailability after buccal administration (51.86 ± 3.95) as compared to oral route (39.60 ± 6.16). Also it took less time to reach maximum plasma concentration of 21.38 ± 1.05 ng/ml as compared to oral solution where it required 180 min to reach maximum plasma concentration of 17.98 ± 1.14. It is concluded from the results that linseed mucilage can be used in the production of the mucoadhesive microspheres.