http://dkr.cdri.res.in:8080/xmlui/handle/123456789/30 Sun, 19 Apr 2026 13:38:04 GMT 2026-04-19T13:38:04Z http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1690 Reinvestigating nanoprecipitationvia Box Benhken Design: A systematic approach Singh, Yuvraj; Ojha, Preeti; Srivastava, Mukesh; Chourasia, M K This work demonstrates Box Benhken design (BBD)’s capability in exploring scientific principles governing a process, different from its use in process optimization. We have investigated nanoprecipitation (NP) of temozolomide with polycaprolactone. Five factors, surfactant, stirring speed (SS), dropping rate (DR), phase volume ratio (PVR) and drug polymer ratio (DPR) were varied over three levels. Corresponding particle size (238.9±42.24 nm), zeta potential (ZP, -5.92±3.15 mV) poly dispersity index (PDI, 0.176±0.06)) and entrapment efficiency (EE, 65.74±9.83%) were put into different polynomial equations. Analysis of variance, lack of fit tests and regression analysis was applied on these equations to determine theone with best fit. This selected equation was subsequently adapted as the model to describe influence of factors on NP. 3D response surface plots corresponding to models and diagnostic plots relatable to normality of residuals were also constructed. In conclusion, application of BBD efficiently strategized experimental foray conducted to elucidate nanoprecipitation. Thu, 01 Jan 2015 00:00:00 GMT http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1690 2015-01-01T00:00:00Z http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1685 Development, characterization and toxicological evaluations of phospholipids complexes of curcumin for effective drug delivery in cancer chemotherapy Khatik, Renuka; Dwivedi, Pankaj; Shukla, Ankita; Srivastava, Pallavi; Rath, S K; Paliwal, S K; Dwivedi, A K The purpose of present study was to prepare and characterize the complexes between curcumin (CU) phosphatidlycholine (PC) and hydrogenated soya phosphatidlycholine (HSPC) and to evaluate their anticancer activity. These CU–PC and CU–HSPC complexes (CU–PC-C and CU–HSPC-C) were evaluated for various physical parameters like FT-IR spectroscopy, melting point, solubility, scanning electron microscopy (SEM) and the in vitro drug release study. These data confirmed the formation of phospholipids complexes. The in vitro hemolysis study showed that the complex was non-hemolytic. The anti-cancer potential of the complexes was demonstrated by MTT assay in MCF 7 cell line. This increase may be due to the amphiphilic nature of the complexes, which significantly enhances the water and lipid solubility of the CU. Unlike the free CU (which showed a total of only 90% drug release at the end of 8 h), complex showed around 40-60% release at the end of 8 h in dissolution studies. It showed that (when given in equimolar doses) complexes have significantly decreased the amount of CU available for absorption as compared with CU free drug. Both the CU-PC-C and CU-HSPC-C was found to be non-toxic at the dose equivalent to 2000 mg/kg of body weight of CU in the toxicity study. Acute and subacute toxicity studies confirmed the oral safety of the formulation. A series of genotoxicity studies was conducted which revealed the non genotoxicity potential of the developed complexes. Thus it can be concluded that the phospholipids complexes of CU may be a promising candidate in cancer therapy Fri, 01 Jan 2016 00:00:00 GMT http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1685 2016-01-01T00:00:00Z http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1669 Assay method for quality control and stability studies of a new antithrombotic agent (S007-867) Khandelwal, Kiran; Pachauri, S D; Singh, S; Pandey, R R; Ahmed, Hafsa; Dwivedi, Pankaj; Arya, Abhishek; Kumar, A; Dikshit, D K; Dwivedi, A K A substituted 5-(piperidine-1-carbonyl)pyrrolidin-2-one (CDRI compound S007-867) is a potent antithrombotic candidate drug under development at our Institute. An HPLC method for determination of S007-867 with its intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as specificity, limit of detection (LOD), lower limit of quantification (LLOQ), linearity, precision, robustness, and accuracy were determined according to International Conference on Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on C18 Lichrospheres column (250mm, 4mm, 5μm, Merck) using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in an isocratic elution. The eluents were monitored by a photo diode array detector at 220 nm. Based on signal to noise ratio of 3 and 10 the LOD of S007-867 was 0.98 µg/mL, while the LLOQ was 3.9 µg/mL. The calibration curves were linear in the range of 3.9–125 µg/mL. Precision of the method was determined by inter- and intra-assay variations within the range. Wed, 01 Jan 2014 00:00:00 GMT http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1669 2014-01-01T00:00:00Z http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1655 Stability Indicating Studies on NMITLI 118R (Standardized Extract Of Withania somnifera Dunal.) Ahmad, Hafsa; Khandelwal, Kiran; Pachauri, S D; Sanghwan, R S; Dwivedi, A K Background: Withania somnifera Dunal (Ashwagandha) is an Indian medicinal plant of great medicinal value; used in many clinically proven conditions. NMITLI-118R a candidate drug under a CSIR networking project is a chemotype of W. somnifera’s root extract which has been used for the present study. Objectives: The present investigation aimed at development and validation of a simple isocratic RP-HPLC system for detection and estimation of Withanolide A (marker compound) and its analytical application for stability indicating studies on NMITLI-118R. Material and methods: A validated RP-HPLC method for Withanolide A was established on Waters HPLC system and the same was used on NMITLI-118R for quantification and fingerprinting purposes and establishing forced degradation, isothermal stress tests, drug-excipient testing protocols as per ICH guidelines. Results: A validated method was established which could detect the marker at a retention time of around 6.3 mins with a linearity range of 2-100 µg/mL, varying amounts of the said marker were estimated in 4 different batches of NMITLI-118R. Photostability as per ICH guidelines suggested slight loss of active constituent and maximum degradation was afforded with alkali followed by acid and then peroxide in the forced degradation studies. Maximum amount of active constituent could be detected in samples with ethyl cellulose and the least with hydroxy propyl cellulose in the drug-excipient studies. Conclusion: The method developed here was simple and rapid. The various stability indicating studies carried out in the present investigation would be useful for formulation development and were suggestive of deciding the recommended storage conditions for NMITLI-118R. Wed, 01 Jan 2014 00:00:00 GMT http://dkr.cdri.res.in:8080/xmlui/handle/123456789/1655 2014-01-01T00:00:00Z