Wockhardt Research Center

Aurangābād, India

Wockhardt Research Center

Aurangābād, India
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Chudiwal S.S.,Wockhardt Research Center
Pharmaceutical Development and Technology | Year: 2016

The objective of the present study was to design and develop drug-device combination product in particular flunisolide nasal spray (FNS) using quality by design (QbD) approach. Quality target product profile (QTPP) of FNS was defined and critical quality attributes (CQAs), i.e. viscosity (cp) (Y1) and D50 droplet size distribution (DSD) (μm) (Y2) were identified. Potential risk factors were identified using a fish bone diagram and failure mode effect analysis (FMEA) tools. Plackett–Burman and Box–Behnken designs were used for screening the significant factors and optimizing the variables range, respectively. It was observed that viscosity (cp) (Y1) was significantly impacted by formulation variables X1: propylene glycol (PG) (%) and X2: polyethylene glycol (PEG) 3350 (%), while D50 DSD (μm) (Y2) was significantly impacted by formulation variables X1: PG (%), X2: PEG 3350 (%) and device variable X8: delivery volume (μl). A design space plot within which the CQAs remained unchanged was established at laboratory scale. In conclusion, this study demonstrated how QbD based development approach can be applied to the development of drug-device combination products with enhanced understanding of the impact of formulation, process and device variables on CQAs of drug-device combination products. © 2016 Informa UK Limited, trading as Taylor & Francis Group


Sonanis M.C.,Wockhardt Research Center
International Journal of Pharmacy and Pharmaceutical Sciences | Year: 2011

A novel stability-indicating Ultra high-performance liquid chromatography (UPLC) method has been developed and validated for the simultaneous estimation of Aspirin and Dipyridamole in the capsule dosage form. Chromatographic separations were carried using Hypersil Gold C18, Column (1.9μm, 100 mm ×2.1 mm) with a mobile phase composition of triethylamine phosphate buffer (pH 2.5) and methanol in the ratio 50:50% (V/V) have been delivered at a flow rate of 0.5 mL min -1 and the detection was carried out using UV detector at wavelength 230 nm. The retention time for Aspirin and Dipyridamole were 0.83 and 1.62 minute respectively. The correlation coefficient values in linearity were found to be 0.9999 for both at concentration range 2.509-50.190 μg mL -1 and 20.093-401.860 μg mL -1 respectively. The recovery results were found in the range from 99.47-101.08%. The results of study showed that the proposed RP-UPLC method is a simple, accurate, precise, rugged, specific, robust, Ultra fast and reproducible, which may be useful for the routine estimation of Aspirin and Dipyridamole in pharmaceutical dosage form.


Sonanis M.C.,Commerce and Science College | Rajput A.P.,Wockhardt Research Center
International Journal of Pharmacy and Pharmaceutical Sciences | Year: 2011

A novel stability-indicating Ultra high-performance liquid chromatography (UPLC) method has been developed and validated for the quantitative determination of potential impurities in Brimonidine tartrate drug substance and drug product. A simple reverse phase MS compatible assay method has a unique advantage over the other methods. The output from UPLC system is directly applied to hyphenate mass spectrometry (MS). The elution pattern of impurities in UV detector is correlated with the TIC (Total ion current) of Mass spectrometry detector, which enables rapidly identification of impurities. Chromatographic separation of impurities achieved on the C18 column. The variable mixture of aqueous buffer containing a mixture of 20mm ammonium acetate pH 6.0 ± 0.05 (adjusted with acetic acid) and Methanol with Acetonitrile as a mobile phase delivered at a flow rate of 0.3 ml/min and the detection was carried out using UV detector at wavelength 247 nm. The chromatographic resolution between Brimonidine and its potential impurities was found to be greater than 2. The responses was determined and (correlation coefficient) regression r values were obtained greater than 0.998 for all known related components and Brimonidine.The method was capable of detecting all known impurities at a level of 0.003 % with respect to 0.400 mg/ml sample concentration with injection volume of 1.5μL. The Brimonidine tartrate samples were treated for thermal, acid, base and oxidative stress conditions as per ICH and peak purity was checked at each conditions. The drug was subjected to stress conditions as prescribed by the ICH. Degradation was found to occur slightly under oxidative stress conditions but the drug was stable to aqueous, acidic, and basic hydrolysis, and photolytic and thermal stress conditions. The inter and intraday precision for all known impurities were found to be within acceptable limits. The test solution was found to be stable upto 24 hrs.


Gupta S.,Wockhardt Research Center | Patel R.J.,Gujarat University
Journal of Controlled Release | Year: 2013

Emulgel is an emerging topical drug delivery system to which if more effort is paid towards its formulation & development with more number of topically effective drugs it will prove a boon for derma care & cosmetology. Emulgels are either emulsion of oil in water or water in oil type, which is gelled by mixing it with gelling agent. Incorporation of emulsion into gel increases its stability & makes it a dual control release system. Due to lack of excess oily bases & insoluble excipients, it shows better drug release as compared to other topical drug delivery system. Presence of gel phase makes it a non greasy & favors good patient compliance. These reviews give knowledge about Emulgel including its properties, advantages, formulation considerations, and its recent advances in research field. All factors such as selection of gelling agent, oil agent, emulsifiers influencing the stability and efficacy of Emulgel are discussed. All justifications are described in accordance with the research work carried out by various scientists. These brief reviews on formulation method have been included. Current research works that carried out on Emulgel are also discussed and highlighted the wide utility of Emulgel in topical drug delivery system. After the vast study, it can be concluded that the Emulgels appear better & effective drug delivery system as compared to other topical drug delivery system. The comprehensive analysis of rheological and release properties will provide an insight into the potential usage of Emulgel formulation as drug delivery system. © 2013 Elsevier B.V. All rights reserved.


Rajput A.P.,P.A. College | Sonanis M.C.,P.A. College | Sonanis M.C.,Wockhardt Research Center
Journal of Chemical and Pharmaceutical Research | Year: 2012

A chiral liquid chromatographic method was developed for the enantiomeric purity of Fesoterodine Fumarate in drug substance as well as in drug product. The chromatographic separation was achieved on Chiralpak IC-3, column using a mobile phase system consisting of n-hexane, isopropyl alcohol and diethyl amine in the ratio of 950:50:1 (v/v/v). The mobile phase was pumped through column at the flow rate of 1 mL min-1. Addition of diethyl amine in the mobile phase enhanced chromatographic efficiency and resolution between the enantiomers. The resolution between the enantiomers was found to be more than three. The developed method was subsequently validated and proved to be accurate, specific and precise. The experimentally established limit of detection and quantification for (S) enantiomer of Fesoterodine were found to be 0.509 μg mL-1 and 1.316 μg mL-1 respectively for 20 μl injection volumes. The percentage recoveries of (S)-enantiomer was ranged between 95 to 105 % in drug product as well as in drug substance. The proposed method was found to be suitable and accurate for the quantitative determination of chiral purity of Fesoterodine Fumarate in drugs substance as well as in drug product.


Chudiwal S.S.,Wockhardt Research Center
Drug Development and Industrial Pharmacy | Year: 2016

The objective of this study was to provide quality by design (QbD) approach for development of suspension type nasal spray products. Quality target product profile (QTPP) of test product budesonide nasal suspension (B-NS) was defined and critical quality attributes (CQAs) were identified. Critical formulation, process and delivery device variables were recognized. Risk assessment was performed by using failure mode and effect analysis (FMEA) methodology. Selected variables were further assessed using a Plackett Burman screening study. A response surface design consisting of the critical factors was used to study the interactions between the study variables. Formulation variable X2: median particle size of budesonide (D50) (µ) has strikingly influenced dissolution (%) (Y1), while D50 droplet size distribution (µm) (Y2) was significantly impacted by formulation variable X1: Avicel RC 591 (%) and process variable X4: homogenization speed (rpm). A design space plot within which the CQAs remained unchanged was established at lab scale. A comprehensive approach for development of B-NS product based on the QbD methodology has been demonstrated. The accuracy and robustness of the model were confirmed by comparability of the predicted value generated by model with the observed value. © 2016 Informa UK Limited, trading as Taylor & Francis Group


Patent
Wockhardt Research Center | Date: 2015-03-03

The invention relates to self emulsifying drug delivery system based compositions of rhein or diacerein, or salts or esters or prodrugs thereof which are bioequivalent to a 50 mg diacerein formulation marketed under the trade name Art 50. The compositions exhibit no variability in fed and fasted state conditions. The compositions also result in significant reduction in side effects such as, soft stools effects as compared to Art 50. The invention also relates to methods for preparing such compositions.


Patent
Wockhardt Research Center | Date: 2014-04-15

The present invention relates to stable pharmaceutical compositions comprising entacapone, levodopa and carbidopa, or pharmaceutically acceptable salts or hydrates thereof. The invention also relates to processes for the preparation of such compositions.


Patent
Wockhardt Research Center | Date: 2014-08-27

The invention relates to pharmaceutical compositions comprising unmicronized fenofibrate in admixture with a wetting agent and one or more pharmaceutically acceptable excipients, wherein the admixture is not comicronized before processing. The invention also relates to processes for the preparation of such compositions.


Patent
Wockhardt Research Center | Date: 2014-04-05

The invention relates to pharmaceutical compositions comprising rhein or diacerein or salts or esters or prodrugs thereof, optionally with one or more pharmaceutically acceptable excipients. The invention also relates to the methods for preparing such compositions.

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