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Ahmadābād, India

Shah B.,Bv Patel Perd Center | Khunt D.,Indian National Institute of Pharmaceutical Education and Research | Bhatt H.,Indian National Institute of Pharmaceutical Education and Research | Misra M.,Indian National Institute of Pharmaceutical Education and Research | Padh H.,Sardar Patel University
European Journal of Pharmaceutical Sciences | Year: 2015

In the present investigation, Quality by Design (QbD) approach was applied on the development and optimization of solid lipid nanoparticle (SLN) formulation of hydrophilic drug rivastigmine (RHT). RHT SLN were formulated by homogenization and ultrasonication method using Compritol 888 ATO, tween-80 and poloxamer-188 as lipid, surfactant and stabilizer respectively. The effect of independent variables (X1 - drug: lipid ratio, X2 - surfactant concentration and X3 - homogenization time) on quality attributes of SLN i.e. dependent variables (Y1 - size, Y2 - PDI and Y3 - %entrapment efficiency (%EE)) were investigated using 33 factorial design. Multiple linear regression analysis and ANOVA were employed to indentify and estimate the main effect, 2FI, quadratic and cubic effect. Optimized RHT SLN formula was derived from an overlay plot on which further effect of probe sonication was evaluated. Final RHT SLN showed narrow size distribution (PDI- 0.132 ± 0.016) with particle size of 82.5 ± 4.07 nm and %EE of 66.84 ± 2.49. DSC and XRD study showed incorporation of RHT into imperfect crystal lattice of Compritol 888 ATO. In comparison to RHT solution, RHT SLN showed higher in-vitro and ex-vivo diffusion. The diffusion followed Higuchi model indicating drug diffusion from the lipid matrix due to erosion. Histopathology study showed intact nasal mucosa with RHT SLN indicating safety of RHT SLN for intranasal administration. © 2015 Elsevier B.V. All rights reserved.

Shep D.,Troikaa Pharmaceuticals Ltd | Ojha A.,Bv Patel Perd Center | Patel S.,Bv Patel Perd Center | Nivsarkar M.,Bv Patel Perd Center | And 3 more authors.
Current Clinical Pharmacology | Year: 2011

Objectives: Diclofenac a non-steroidal anti-inflammatory drug (NSAID) is widely used for the management of various musculoskeletal conditions. An injectable test formulation of diclofenac sodium (75 mg/mL) was prepared to facilitate reduction in injection volume as compared to already marketed formulations of diclofenac sodium (75 mg/3mL). The objective of this study was to compare the bioavailability of test formulation with the reference formulation given intramuscularly in healthy volunteers. Methods: This two way randomized crossover study was performed in 14 healthy, adult, Indian, male human subjects to compare bioavailability. The formulations were administered intramuscularly (intragluteal) to the volunteers in a two way randomized fashion with a wash out period of 6 days. Blood samples were collected till 6.0 h following drug administration. The samples were analyzed using pre-validated HPLC method. Results: The mean C max and T max for the test and reference formulations were 2.14 μg/mL, 1.91 μg/mL and 0.49 h, 0.50 h respectively. The mean AUC 0-t for test and reference formulations were 3.79 μg.h/mL, and 3.43 μg.h/mL respectively. The mean AUC 0-∞ for test and reference formulation were 4.03 μg.h/mL and 3.65 μg.h/mL respectively. The mean (90% CI) C max, AUC 0-t and AUC 0-∞ ratio (Test:Reference) were 1.15 (100.25-132.99), 1.10 (100.34-119.96) and 1.09 (100.78- 118.88), respectively. Conclusion: The test formulation shows a comparable AUC 0-t and AUC 0-∞ but a higher C max in comparison to the reference when given intra-gluteally. The lower volume of the test formulation offers advantage of injection at other sites, like deltoid region. Absence of propylene glycol in the test formulation could be advantageous in terms of improved tolerability. Hence, such formulations of previously well established molecules provide a new direction towards developing better and convenient dosing alternatives. © 2011 Bentham Science Publishers Ltd.

Abiramasundari A.,Bv Patel Perd Center | Joshi R.P.,Bv Patel Perd Center | Jalani H.B.,Bv Patel Perd Center | Sharma J.A.,Bv Patel Perd Center | And 4 more authors.
Journal of Pharmaceutical Analysis | Year: 2014

The stability of the drug actarit was studied under different stress conditions like hydrolysis (acid, alkaline and neutral), oxidation, photolysis and thermal degradation as recommended by International Conference on Harmonization (ICH) guidelines. Drug was found to be unstable in acidic, basic and photolytic conditions and produced a common degradation product while oxidative stress condition produced three additional degradation products. Drug was impassive to neutral hydrolysis, dry thermal and accelerated stability conditions. Degradation products were identified, isolated and characterized by different spectroscopic analyses. Drug and the degradation products were synthesized by a new route using green chemistry. The chromatographic separation of the drug and its impurities was achieved in a phenomenex luna C18 column employing a step gradient elution by high performance liquid chromatography coupled to photodiode array and mass spectrometry detectors (HPLC-PDA-MS). A specific and sensitive stability-indicating assay method for the simultaneous determination of the drug actarit, its process related impurities and degradation products was developed and validated. © 2014 Xi'an Jiaotong University.

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