R.C. Mashru

Publications (9)8.77 Total impact

• Article: A novel intravaginal delivery system for itraconazole: in vitro and in vivo evaluation.

  N B Dobaria, R C Mashru, A C Badhan, A R Thakkar
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  ABSTRACT: The purpose of the present study was to formulate and systematically evaluate in vitro, ex vivo and in vivo performances of itraconazole containing bioadhesive vaginal film. We introduce here a novel intravaginal delivery system for itraconazole based on solid dispersion of itraconazole and hydroxypropyl methylcellulose E15 that improve drug solubility and produce bioadhesive system in presence of other ingredients. Solid dispersions of itraconazole were prepared with hydroxypropyl methylcellulose by a spray drying method and characterized by X-ray diffraction and differential scanning calorimetry. The film was prepared using a solvent evaporation technique. In the in vitro antimicrobial study, it was found that solid dispersion containing formulation improves antimicrobial action of itraconazole. From the ex vivo retention study, it was found that the bioadhesive polymers hold the film upto 7 hours on the vaginal mucosa. In vivo antifungal activity tested against Candida albicans vaginitis in female rats, was found to significantly improve the therapeutic benefit of the drug. At 6 days post-dose, the c.f.u. of Candida albicans was more than 10(3) fold decreased in film treated groups without affecting the morphology of vaginal mucosa. These studies suggested that bioadhesive vaginal film is a novel approach for delivery of itraconazole as topical drug delivery system for treating vaginal candidiasis.
  Current Drug Delivery 05/2009; 6(2):151-8.
• Article: Simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical formulations with the use of four rapid derivative spectrophotometric methods.

  H N Dave, R C Mashru, A R Thakkar
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  ABSTRACT: Four simple, rapid, accurate, precise, reliable and economical spectrophotometric methods have been proposed for simultaneous determination of salbutamol sulphate (SS), bromhexine hydrochloride (BH) and etofylline (ET) in pure and commercial formulations without any prior separation or purification. They were first derivative zero crossing spectrophotometry (method 1), simultaneous equation method (method 2), derivative ratio spectra zero crossing method (method 3) and double divisor ratio spectra derivative method (method 4). The ranges for SS, BH and ET were found to be 1-35 microg mL(-1), 4-40 microg mL(-1) and 5-80 microg mL(-1). For methods 1 and 2, the values of limit of detection (LOD) were 0.2314 microg mL(-1), 0.4865 microg mL(-1) and 0.2766 microg mL(-1) and the values of limit of quantitation (LOQ) were 0.7712 microg mL(-1), 1.6217 microg mL(-1) and 0.9221 microg mL(-1) for SS, BH and ET, respectively. For method 3, LOD values were 0.3297 microg mL(-1), 0.2784 microg mL(-1) and 0.7906 microg mL(-1) and LOQ values were 0.9325 microg mL(-1), 0.9282 microg mL(-1) and 2.6352 microg mL(-1) for SS, BH and ET, respectively. For method 4, LOD values were 0.3161 microg mL(-1), 0.2495 microg mL(-1) and 0.2064 microg mL(-1) and LOQ values were 0.9869 microg mL(-1), 0.8317 microg mL(-1) and 0.6879 microg mL(-1) for SS, BH and ET. The precision values were less then 2% R.S.D. for all four methods. The common excipients and additives did not interfere in their determinations. The results obtained by the proposed methods have been statistically compared by means of Student t-test and by the variance ratio F-test.
  Analytica chimica acta 08/2007; 597(1):113-20. · 4.31 Impact Factor
• Article: Development and evaluation of fast-dissolving film of salbutamol sulphate.

  R C Mashru, V B Sutariya, M G Sankalia, P P Parikh
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  ABSTRACT: The objective of this work was to prepare and optimize the fast-dissolving film of salbutamol sulphate, which can be useful in an acute attack of asthma. The film was prepared using a solvent evaporation technique and is taken through the sublingual route. The film contains polyvinyl alcohol as a polymer, glycerol as a plasticizer, and mannitol as filler. A 33 full factorial design was utilized for the optimization of the effect of independent variables such as amount of polyvinyl alcohol, amount of glycerol, amount of mannitol on the mechanical properties, and % drug release of film. The multiple regression analysis of the results led to equations that adequately describe the influence of the independent variables on the selected responses. Polynomial regression equations and contour plots were used to relate the dependent and independent variables. The experimental results indicated that polymer concentration, plasticizer concentration, and filler concentration had complex effects on film mechanical behavior and % drug release. Furthermore, the desirability function was employed in order to determine the best batch out of all 27 batches of the factorial design. The % relative error was calculated, which showed that observed responses were in close agreement with the predicted values calculated from the generated regression equations. It was found that the optimum values of the responses for fast release film could be obtained at medium levels of polyvinyl alcohol and glycerol, and a high level of mannitol. The prepared film was clear, transparent, and had a smooth surface. The concept of similarity factors Sd was used to prove similarity of dissolution between distilled water and simulated saliva (pH 6.8) or simulated gastric fluid (pH 1.2).
  Drug Development and Industrial Pharmacy 02/2005; 31(1):25-34. · 1.49 Impact Factor
• Article: Effect of pH on in vitro permeation of ondansetron hydrochloride across porcine buccal mucosa.

  R C Mashru, Vijay B Sutariya, Mayur G Sankalia, Jolly M Sankalia
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  ABSTRACT: The influence of drug concentration, pH in donor chamber, and 1-octanol/buffer partition coefficient on transbuccal permeation of ondansetron hydrochloride (pKa, 7.4) across porcine buccal mucosa was studied by using an in-line Franz type diffusion cell at 37 degrees C. The pH was adjusted to several values and the solubility of the drug in different pH was measured. Solubility of ondansetron hydrochloride decreases with increasing pH. The permeability of the drug was evaluated at different donor pH and drug concentrations. Permeability of un-ionized (Pu) and ionized (Pi) species of drug was calculated by fitting the data to a mathematical model. The steady state flux increased linearly with the donor concentration (r2 = 0.9843) at pH 7.4. The permeability coefficient and the partition coefficient of the drug increased with increasing pH. The values of Pu and Pi were 4.86 x 10(-6) cm/sec and 7.18 x 10(-7) (c)m/sec, respectively. The observed permeability coefficients and the permeability coefficients calculated from the mathematical model at various pH showed good linearity (r2 = 0.9799). The total permeability coefficient increased with increasing the fraction of un-ionized form of the drug. The drug permeated through buccal mucosa by a passive diffusion process. The non-ionized species of drug penetrated well through buccal mucosa and the permeation was a function of pH. Transbuccal delivery is a potential route for the administration of ondansetron hydrochloride.
  Pharmaceutical Development and Technology 02/2005; 10(2):241-7. · 1.36 Impact Factor
• Article: Characterization of solid dispersions of rofecoxib using differential scanning calorimeter

  R. C. Mashru, V. B. Sutariya, M. G. Sankalia, P. Yagnakumar
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  ABSTRACT: Solid dispersions were prepared to enhance the dissolution rate of rofecoxib. Differential scanning calorimetry (DSC) and X-ray diffraction (XRD) were used for the characterization of solid dispersions of polyvinyl pyrrolidone (PVP):talc:drug (3:1:1) and hydroxypropyl methylcellulose (HPMC):talc:drug (4:1:1). The DSC study indicated that PVP solid dispersion showed formation of fusion solution while HPMC solid dispersion showed no intermolecular fusion during the preparation of solid dispersions by spray dry process. The dissolution profiles and the calculated times for 75 and 90% drug release showed that dissolution rate of rofecoxib was improved in solid dispersions as compared to pure drug and physical mixtures. The DSC and XRD were successfully employed to find out the crystalline state of drug in the both solid dispersions. PVP solid dispersion gave better dissolution rate than HPMC solid dispersion. The drug was transformed from crystalline to amorphous form in PVP solid dispersion which was further conformed by XRD and DSC. The PVP:talc:drug solid dispersion can be used for the dissolution enhancement and thereby bioavailability of rofecoxib.
  Journal of Thermal Analysis and Calorimetry 01/2005; 82(1):167-170. · 1.60 Impact Factor
• Source

  Available from: ugr.es

  Article: Administración transbucal del sulfato de salbutamol: Determinación in vitro de las rutas de transporte bucal

  V.B. Sutariya, R.C. Mashru, M.G. Sankalia, J.M. Sankalia
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  ABSTRACT: Se estudió la influencia de la concentración de fármaco, el pH del compartimento dador y el coeficiente de partición 1-octanol/tampón en la permeación transbucal del sulfato de salbutamol (pKa 1 = 9,3; pKa 2= 10,3) a través de mucosa bucal porcina utilizando una célula de difusión de Franz en línea a 37 ºC. El pH se ajustó a varios valores y la solubilidad del fármaco se midió en distintos pH. La solubilidad del sulfato de salbutamol descendió al aumentar el pH. Se evaluó la permeabilidad del fármaco a diferentes concentraciones de fármaco y pH dador. Se calculó la permeabilidad de especies ionizadas (Pi) y no ionizadas (Pu) del fármaco. El flujo de estado estable aumentó de forma lineal con la concentración dadora (r r2==0,9683) con pH 7,4. El coeficiente de partición y permeabilidad aumentaron al aumentar el pH. Los valores de Pu y Pi del sulfato de salbutamol fueron 8,89 · 10 10--6 cm·s s--1 y 2,49 · 10 10--6 cm·s s--1 1, respectivamente. El coeficiente de permeabilidad total aumentó al aumentar la fracción de la forma no ionizada del fármaco. El fármaco penetró a través de la mucosa bucal mediante un proceso de difusión pasivo. El coeficiente de partición y la dependencia del pH de la permeabilidad del fármaco indicaron que el sulfato de salbutamol se transportó principalmente a través de la ruta paracelular mediante un mecanismo de partición.
  Ars pharmaceutica, ISSN 0004-2927, Vol. 46, Nº. 4, 2005, pags. 337-352.
• Source

  Available from: ugr.es

  Article: Evaluación y optimización simultánea de papaína inmovilizada en gránulos de alginato entrecruzado mediante un diseño factorial 3x3 y la función de deseabilidad

  M.G. Sankalia, R.C. Mashru, J.M. Sankalia, V.B. Sutariya
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  ABSTRACT: En este artículo se investiga el entrecruzamiento del alginato sódico con iones de calcio a través de la gelación ionotrópica para capturar la papaína mediante disolventes «benignos para el entorno». Se empleó un diseño factorial completo 3x3 para investigar el efecto de las tres variables del proceso, que son la concentración de alginato sódico, la concentración de cloruro cálcico y el tiempo de endurecimiento sobre el porcentaje de captura, el tiempo necesario para la liberación de un 50% (T50) y un 90% (T90) de la enzima, la distribución y el ángulo de reposo. Los gránulos se prepararon mediante el uso de un dispositivo de goteo para el vertido de gotas de solución de alginato sódico que contiene la enzima en la solución de cloruro cálcico agitada magnéticamente. Además, se empleó la función de deseabilidad para optimizar el proceso sometido a estudio. Se demostró que los valores óptimos de las respuestas se pueden obtener en los niveles inferiores de las tres variables del proceso. La caracterización topográfica se realizó mediante microscopía electrónica de barrido (SEM) y la captura se confirmó a través de una calorimetría diferencial de barrido (DSC). Se concluyó que la selección adecuada de concentración de alginato con control de la velocidad de liberación y su potencial interactivo para el entrecruzamiento es importante y determina el tamaño y la forma general de los gránulos, los perfiles de patrón de disolución y duración, la sensibilidad al pH y la capacidad de carga de la enzima.
  Ars pharmaceutica, ISSN 0004-2927, Vol. 45, Nº. 3, 2004, pags. 253-279.
• Article: Pepsina capturada en gránulos gelificados de k-carragenato reticulados mediante actividad ionotrópica para una mejora de la estabilidad: optimización y caracterización fisicoquímica mediante el diseñode Box-Behnken

  M.G. Sankalia, J.M. Sankalia, V.B. Sutariya, R.C. Mashru
  Ars pharmaceutica, ISSN 0004-2927, Vol. 48, Nº. 3, 2007, pags. 213-247.
• Article: Simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical formulations with the use of four rapid derivative spectrophotometric methods

  H.N. Dave, R.C. Mashru, A.R. Thakkar
  [show abstract] [hide abstract]
  ABSTRACT: Four simple, rapid, accurate, precise, reliable and economical spectrophotometric methods have been proposed for simultaneous determination of salbutamol sulphate (SS), bromhexine hydrochloride (BH) and etofylline (ET) in pure and commercial formulations without any prior separation or purification. They were first derivative zero crossing spectrophotometry (method 1), simultaneous equation method (method 2), derivative ratio spectra zero crossing method (method 3) and double divisor ratio spectra derivative method (method 4). The ranges for SS, BH and ET were found to be 1–35 μg mL−1, 4–40 μg mL−1 and 5–80 μg mL−1. For methods 1 and 2, the values of limit of detection (LOD) were 0.2314 μg mL−1, 0.4865 μg mL−1 and 0.2766 μg mL−1 and the values of limit of quantitation (LOQ) were 0.7712 μg mL−1, 1.6217 μg mL−1 and 0.9221 μg mL−1 for SS, BH and ET, respectively. For method 3, LOD values were 0.3297 μg mL−1, 0.2784 μg mL−1 and 0.7906 μg mL−1 and LOQ values were 0.9325 μg mL−1, 0.9282 μg mL−1 and 2.6352 μg mL−1 for SS, BH and ET, respectively. For method 4, LOD values were 0.3161 μg mL−1, 0.2495 μg mL−1 and 0.2064 μg mL−1 and LOQ values were 0.9869 μg mL−1, 0.8317 μg mL−1 and 0.6879 μg mL−1 for SS, BH and ET. The precision values were less then 2% R.S.D. for all four methods. The common excipients and additives did not interfere in their determinations. The results obtained by the proposed methods have been statistically compared by means of Student t-test and by the variance ratio F-test.
  Analytica Chimica Acta.