Research Journal of Pharmaceutical Dosage Form and Technology

Pankaj P. Pawar ¹, Dipti G. Phadtare ²

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN

Abstract

Analytical methods development and validation play important roles in the discovery, development, and manufacture of pharmaceuticals. Simple, precise and accurate UV spectroscopic method has been developed and validated for estimation of Lornoxicam loaded solid SMEDDS. UV spectroscopic method which is based on measurement of absorption of UV light, the spectra of Lornoxicam SMEDDS in 0.1N NaOHshowed maximum wavelength at 375nm and calibration curve were plotted over the concentrations ranging from 5-50ug/ml of Lornoxicam SMEDDS with correlation coefficient 0.999 validation was performed as per ICH Q2 (R1) guidelines for linearity, accuracy, precision and recovery. The proposed method was validated.

Keywords

Lornoxicam, 0.1N NaOH, Spectrophotometer and Validation.

Full Text

     

Pankaj P. Pawar ¹, Dipti G. Phadtare ²

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN

Abstract

Ultrasound contrast agents are highly echogenic micro bubbles with many unique properties. Micro bubbles can basically improve the sensitivity of conventional ultrasound imaging to the microcirculation. The resonance of micro bubbles in response to an incident ultrasound pulse results in nonlinear harmonic emission that serves as the signature of micro bubbles in micro bubble-specific imaging. Inertial cavitations and destruction of micro bubbles can produce a strong mechanical stress enhancing the permeability of the surrounding tissues, and can further increase the extravasations of drugs from the blood into the cytoplasm or interstitium. Stable cavitations by high-frequency ultrasound can also mildly increase tissue permeability without causing any damage even at a high acoustic pressure. It is cheap, widely available and portable. Using Doppler methods, flow information can be obtained easily and non-invasively. It is arguably the most physiological modality, able to image structure and function with less sedation than other modalities. This means that function is minimally disturbed, and multiple repeat studies or the effect of interventions can easily be assessed. Ultrasound is also unique in being both an imaging and therapeutic tool and its value in gene therapy has received much recent interest. Ultrasound biomicroscopy has been used for in utero imaging and can guide injection of virus and cells. Ultra high frequency ultrasound can be used to determine cell mechanical properties. The development of micro bubble contrast agents has opened many new opportunities, including new functional imaging methods, the ability to image capillary flow and the possibility of molecular targeting using labeled micro bubbles.

Keywords

Ultrasound Mediated Drug Delivery System, Diagnostic Application, Ultrasonography, 3D Ultrasound, Micro Bubbles, Contrast Imaging, Molecular Imaging, Targeted Therapy, Controlled Drug Release.

Full Text

     

Dipti G. Phadtare ¹, Amol R. Pawar ², R. B. Saudagar ¹, Govind K. Patil ³

Affiliations
1 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
2 Department Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, IN
3 University Institute of Chemical Technology, NMU, Jalgoan, IN

Abstract

The aim of present work research work was formulation and evaluation of stable montelukast sodium sublingual tablet. Since The thermal stress testing study of Monte in solutions at 65°C showed that it is highly stable in NaOH solution, while it degrades rapidly in both acidic and H₂O₂ solutions. Hence lyophilization technology was adopted to increase the stability of montelukast sodium. Before lyophilization three trials were carried out to optimize the process parameters in which Trial 2 was considered as optimized process. The Lyophilization was carried out in nine different batches by varying the total cycle time, freezing and holding time, primary drying and secondary drying time by maintaining the quantities of all the active pharmaceutical ingredients constant and selection of cryoprotectant ratio. An optimized lyophilization cycle of 56 hours has been achieved. The optimized lyophilized product was subjected to Tablet compression. In this process the batch-9 formulation was considered as an optimized Formulation for compression with the process. All the in-vitro evaluation parameters complies the limits as per the specification. Stability studies were conducted and from the result it was concluded that the optimized formulation was found to be stable. Finally, it is concluded that the lyophilization is a suitable technique to increase the stability and bioavailability of Montelukast sodium.

Keywords

Montelukast Sodium, Sodium Hydroxide, Hydroxypropyl Beta Cyclodextrin, Lyophilization, Freezing, Primary Drying, Secondary Drying.

Full Text