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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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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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