DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR ESTIMATION OF CARBAMAZEPINE IN BULK AND TABLET DOSAGE FORM

Objective: To develop and validate simple, accurate, rapid, precise, reproducible and cost effective spectrophotometric method for the quantitative estimation of carbamazepine in a pharmaceutical formulation.Methods: The developed UV spectrophotometric method for the quantitative estimation of carbamazepine is based on measurement of absorption at maximum wavelength 284 nm using methanol as a solvent. The stock solution of carbamazepine was prepared, and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of carbamazepine shows absorption maxima at 284 nm.Results: The drug obeyed beer lambert's law in the concentration range of 2-14 µg/ml with regression 0.9997 at 284 nm. The overall % recovery was found to be 99.99% which reflects that the method was free from the interference of the impurities and other excipients used in the formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.1568 and 0.1746 respectively which is<2% hence proved that method is precise.Conclusion: The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of carbamazepine in tablet dosage form as well bulk dosage form.Keywords: Carbamazepine, UV Spectrophotometry, Method development, Validation, ICH guidelines, Methanol

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF ANTI-ASTHMATIC AGENT USING VARIOUS POLYMERS

The objective of the present study was to develop matrix tablets of salbutmol sulphate sustained release dosage form, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Compatibility study was performed through Fourier Transformer Infrared spectroscopy revealed that there no interaction between drug and polymers. Matrix tablets were prepared by wet granulation method using different concentration of Hydroxypropylmethylcellulose K100M (HPMC K100M), HPMC K15M and Ethyl Cellulose (EC). Prepared formulations were subjected to Pre-compression parameters like angle of repose, bulk and tapped density, Hausner’s ratio and car’s index and post-compression parameters like hardness, friability, thickness, % drug content, weight variation, swelling index. All the formulations resulted in acceptable limits. Tablets were subjected to In-Vitro drug release in 0.1 N HCl (pH 1.2) for first 2 hours followed by phosphate buffer (pH 6.8) for remaining 10 hours. In-vitro drug release data were fitting to zero order and Higuchi equation indicated that diffusion along with erosion could be the mechanism of drug release. It was observed that formulation F2 containing HPMC K100M exhibited the best release profile and able to sustain the drug release for prolong period of time. Swelling study suggested that when the matrix tablets come in contact with the dissolution medium, they take up water and swells, forming a gel layer around the matrix and simultaneously erosion also takes place. KEYWORDS: Matrix tablet, salbutmol sulphate, Hydroxypropylmethylcellulose K100M, Hydroxypropylmethylcellulose K15M and Ethyl Cellulose

Recent trends and future of pharmaceutical packaging technology

The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years. The market is now reckoned to be worth over $20 billion a year. As with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs. Constant innovations in the pharmaceuticals themselves such as, blow fill seal (BFS) vials, anti-counterfeit measures, plasma impulse chemical vapor deposition (PICVD) coating technology, snap off ampoules, unit dose vials, two-in-one prefilled vial design, prefilled syringes and child-resistant packs have a direct impact on the packaging. The review details several of the recent pharmaceutical packaging trends that are impacting packaging industry, and offers some predictions for the future

Design and development of controlled porosity osmotic tablet of diltiazem hydrochloride.

The present work aims towards the design and development of extended release formulation of freely water-soluble drug diltiazem hydrochloride (DLTZ) based on osmotic technology by using controlled porosity approach. DLTZ is an ideal candidate for a zero-order drug delivery system because it is freely water-soluble and has a short half-life (2-3 h). Sodium chloride (Osmogen) was added to the core tablet to alter the solubility of DLTZ in an aqueous medium. Cellulose acetate (CA) and sorbitol were used as semipermeable membrane and pore former, respectively. The effect of different formulation variables namely concentration of osmogen in the core tablet, % pore former, % weight gain, pH of the dissolution medium and agitation intensity on the in vitro release was studied. DLTZ release was directly proportional to % pore former and inversely proportional to % weight gain. The optimized formulation (F8) delivered DLTZ independent of pH and agitation intensity for 12 h at the upper level concentration of % pore former (25% w/w) and middle level concentration of % weight gain (6% w/w). The comparative study of elementary osmotic pump (EOP) and controlled porosity osmotic pump revealed that it superior than conventional EOP and also easier and cost effective to formulate

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF ANTI-ASTHMATIC AGENT USING VARIOUS POLYMERS

The objective of the present study was to develop matrix tablets of salbutmol sulphate sustained release dosage form, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Compatibility study was performed through Fourier Transformer Infrared spectroscopy revealed that there no interaction between drug and polymers. Matrix tablets were prepared by wet granulation method using different concentration of Hydroxypropylmethylcellulose K100M (HPMC K100M), HPMC K15M and Ethyl Cellulose (EC). Prepared formulations were subjected to Pre-compression parameters like angle of repose, bulk and tapped density, Hausner’s ratio and car’s index and post-compression parameters like hardness, friability, thickness, % drug content, weight variation, swelling index. All the formulations resulted in acceptable limits. Tablets were subjected to In-Vitro drug release in 0.1 N HCl (pH 1.2) for first 2 hours followed by phosphate buffer (pH 6.8) for remaining 10 hours. In-vitro drug release data were fitting to zero order and Higuchi equation indicated that diffusion along with erosion could be the mechanism of drug release. It was observed that formulation F2 containing HPMC K100M exhibited the best release profile and able to sustain the drug release for prolong period of time. Swelling study suggested that when the matrix tablets come in contact with the dissolution medium, they take up water and swells, forming a gel layer around the matrix and simultaneously erosion also takes place. KEYWORDS: Matrix tablet, salbutmol sulphate, Hydroxypropylmethylcellulose K100M, Hydroxypropylmethylcellulose K15M and Ethyl Cellulose