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THE PHARMA REVIEW (AUGUST 2008)

Rapidly Disintegrating Oral Tablets of Alfuzosin

M.V Rampure, S.A Raju, S.B Shirsand, P.V. Swamy and D.Nagendrakumar

Abstracts: In the present work, rapidly disintegrating tablets of Alfuzosin were prepared by effervescent method with a view to enhance patient compliance. Three superdisintegrants i.e., crospovidone, croscarmellose and sodium starch glycolate along with mixture of Sodium bicarbonate and anhydrous citric acid in different ratios were used and directly compressible mannitol (Pearlitol SD 200) was used as a diluent to enhance the mouth feel. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity and in-vitro dispersion time. Based on in-vitro dispersion time (approximately 9 s). Three promising formulations were tested for in-vitro drug release pattern (in pH 6.8 phosphate buffer), short term stability (at 40/75% RH for three months) and drug-excipient interaction (IR spectroscopy). Among the promising formulations, the formulations ECP3 (containing 10% w/w of crospovidone and mixture of 24% w/w of sodium bicarbonate and 18% w/w of anhydrous citric acid) emerged as the overall best formulation (t50% =1.5 min) based on the in-vitro drug release compared to control formulation (t50%=15 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in-vitro dispersion time (p< 0.05).
 
Introduction
Many patients find it difficult to swallow tablets and hard gelatin capsules and thus does not comply with prescription, which results in high incidence of non-compliance and ineffective therapy. It is estimated that 70% of the population is affected by this problem. Recent advances in novel drug delivery systems (NDDS) aim to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance. One such approach is rapidly disintegrating tablets. Alfuzosin (AZ) is an alpha-adrenoceptor blocker used in the management of hypertension and it also relieves symptoms of urinary obstructions in benign prostatic hyperplasia.5 The concept of formulating rapidly disintegrating oral tablets containing AZ offers a suitable and practical approach in serving desired objective of rapid disintegration and dissolution characteristics with increased bioavailability.
 
Materials and Methods
Alfuzosin was obtained from Dr Reddy’s Labs, Hyderabad and croscarmellose sodium (CCS) crospovidone(CP), sodium starch glycolate(SSG), directly compressible mannitol (Pearlitol SD200) were gift samples from Ranbaxy, Mumbai. Sodium stearyl fumarate (SSF) and aspartame were generous gifts from Strides Arco Labs, Bangalore. Sodium bicarbonate and citric acid were procured from Ranbaxy Chemicals, New Delhi. All other chemicals used were of analytical reagent grade.

 

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