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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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