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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.

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Dipti G. Phadtare ¹, Manisha N. Gaika ², Smita S. Aher ³

Affiliations
1 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik- 422213, Maharashtra, IN
2 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik- 422213, Maharashtra, IN
3 Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik- 422213, Maharashtra, IN

Abstract

The present study was aimed to develop a nanoemulsion based nasal spray of Azelastine hydrochloride for improved bioavailability by circumventing the hepatic first pass metabolism and patient compliance. The aim of the present study was to prepare and evaluate different formulations of Azelastine Hydrochloride in nanoemulsion based using castor oil as oil phase, polysorbate 80 and cremophor RH 40 as surfactant used. Castor oil was selected as oil phase due to it's good solubilising capacity. The prepared formulations were characterized by pH, Drug content, Viscosity, Stability study etc. pH of all the formulations were found to be within the range between 5-7 and the nasal mucosa can tolerate the above mentioned pH of the formulations. Five different formulations were formulated with various values of oil (0.5-5%), Water (10-50%) and surfactant.The results indicated that the nanoemulsion system studied would be a promising tool for enhancing the nasal delivery of Azelastine hydrochloride.

Keywords

Azelastine Hydrochloride, Nasal Nanoemulsion, Polysorbate 80.

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Rajashri R. Kulkarni ¹, Dipti G. Phadtare ², Ravindra B. Saudagar ²

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

Abstract

Many of the newly invented drugs are poorly soluble and they create major problems during formulation and shows poor bioavailability. The problem is even more complex for drugs which belong to BCS class 2 category. To overcome these problems nanotechnology is used to improve the solubility as well as bioavailability of poorly soluble drugs. The reduction of drug particles into submicron range leads to a significant increase in dissolution rate and therefore enhances bioavailability. Nanosuspension contains submicron colloidal dispersion of the pharmaceutical active ingredient particles in a liquid phase stabilized by surfactant. Nanosuspension can be prepared by using stabilizers, organic solvents and other additives such as buffers, salts, polyols, osmogent and cryoprotectant. Nanosuspensions can be delivered by oral, parenteral, pulmonary and ocular routes. Nanosuspensions not only solves the problem of poor solubility and bioavailability but also alter the pharmacokinetics of the drug and thus improving safety and efficacy. This review article mainly focuses on preparation of nanolsuspensions by various techniques with their advantages and disadvantages, formulation consideration, characterization and their applications in drug delivery.

Keywords

Nanosuspension, Bioavailability, Solubility, Nanotechnology, Poorly Soluble Drugs, Drug Delivery.

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Rajashri R. Kulkarni 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

Microneedle technology is an attractive method to overcome the epidermis and effectively transport therapeutics transdermally. The fabrication of all type of needles is described with their mechanism of permeation. Microneedle patches showed efficacy in piercing the skin and delivering the drugs having high molecular weight and hydrophilic in nature. There are various advantages of microneedle transdermal drug delivery methods over other techniques which help to make it successful delivery system. It is a novel method of incorporating drug in microneedles having tremendous scope and various applications.

Keywords

Microneedle Patch, Transdermal Drug Delivery, Mechanism.

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Rajashri R. Kulkarni ¹, Dipti G. Phadtare ², Ravindra B. Saudagar 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 Fluticasone propionate. It is a selective agonist at the glucocorticoid receptor. UV spectroscopic method which is based on measurement of absorption of UV light, the spectra of Fluticasone propionate in methanol showed maximum wavelength at 236nm and calibration curve were plotted over the concentrations ranging from 2-22ug/ml of Fluticasone propionate with correlation coefficient 0.9812 validation was performed as per ICH Q2 (R1) guidelines for linearity, accuracy, precision and recovery. The proposed method was validated.

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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.

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Dipti G. Phadtare ¹, Amol R. Pawar ², Rajashri R. Kulkarni ¹, Govind K. Patil ³

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

Abstract

Analytical method development and validation play an important role in the discovery, development and manufacture of pharmaceuticals. This research paper described a simple, selective, linear, precise and accurate UV Spectroscopic method was developed and validation for the estimation of Montelukast sodium from bulk and tablet formulations.

Keywords

Montelukast Sodium, Validation, UV Spectrometry, Methanol.

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Dipti G. Phadtare ¹, Amol R. Pawar ², Rajashri R. Kulkarni ¹, Govind K. Patil ³

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

Abstract

A high performance liquid chromatography method has been developed and validated method for the simultaneous estimation of Montelukast sodium in bulk and tablet dosage form. The method was carried out using Princeton SPHER ULTIMA C18 100A 5μ 250*4.6 mm using OPA: Methanol (10:90 v/v) as mobile phase at flow rate 1ml/min. HPLC separation was carried out at 284 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r² = 0.9982 and 0.9979 for Montelukast sodium in bulk and tablet dosage form respectively in the concentration range of 1-6 μl/ml for Montelukast sodium in bulk and tablet dosage form. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 0.0011 and 0.0033 μg/ml. the proposed HPLC method can be applied for identification and quantitative determination of Montelukast sodium in bulk and tablet dosage form.

Keywords

Montelukast Sodium, Tablet, HPLC, Validation.

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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.

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