Drug

The aim of this research work was to Evaluation of Some Natural Polymer used as Sustained Release Matrix Tablet, any pharmaceutical formulation contains two ingredients one is the active ingredient and other is an excipients. An excipients help in the manufacturing of dosage form and it also improves physicochemical parameters of the dosage form. Polymers play an important role as excipients in any dosage form. They influence drug release and should be compatible, non-toxic, stable, economic etc. and develop a fixed Dose Combination product in a two different strength using same blend for both the strengths of tablet as a SR tablet formulation. In the tablet, Extended Release layer consist of Antihypertensive Drug belonging to class β-selective adrenergic blocking agent without partial agonist or membrane stabilizing properties. Extended release preparation provides sustained release and reduces the chances of tough related side effects. In selected cases of extended release preparation of this drug used in treatment of hypertension and congestive heart failure. The clinical studies have shown beneficial role of this drug as an extended release preparation. The main objective of the present study was to develop, formulate and evaluate a matrix tablet by using hydrophilic natural retardant polymers which would retard drug release in upper GI tract and should start releasing the drug when it reaches the alkaline environment of small intestine. Okara and Tramarind Gum Mucilage were investigated as the model hydrophilic retardant polymers. Wet granulation method was and nine batches of tablets were prepared. The prepared tablets were subjected for pharmacopoeial and non-pharmacopoeial evaluation parameters including loose and tapped bulk density, compressibility index, hausner ratio, angle of repose, friability, hardness, thickness, weight variation, % drug content and in-vitro drug release studies. It can be concluded that the combination of hydrophilic polymers that are retardant in nature are better suited for sustained and controlled drug delivery system than the hydrophilic polymer alone.

Complex of Carboxymethyl cellulose (CMC) sodium salt and β-cyclodextrin (β-CD) were evaluated as sustained release polymers. Diclofenac sodium (DS), CMC sodium salt and β-CD were taken for the preparation of spray dried sustained release microparticles in the different ratio of 1: 0.125:0.125, 1:0.188:0.187 and 1: 0.25: 0.25 (wt/wt) respectively. The DS loaded microparticles were evaluated for particle size, surface morphology by atomic force microscopy (AFM), structural interaction by Fourier transform infrared spectroscopy (FTIR) and thermal characterization by differential scanning calorimetry(DSC). These microparticles further formulated into the tablet dosage form and evaluated for different parameters. Several kinetic models were employed to evaluate the possible changes in the release mechanism. The drug: polymer ratio of 1:0.25:0.25 shows better result of sustained release than the other ratios. The particle size of the optimized microparticles was found to be in the range of 300 nm to 5 µm. FTIR and DSC result reveals the complex formation between DS, CMC sodium and β-CD. X-ray diffraction results indicated that the degree of crystallinity was reduced and most of the drug existed in amorphous state. . The reported method is easy and reproducible and can be used for the batch scale production.