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THE PHARMA REVIEW
(MARCH 2009) |
Formulation Design of Fast
Disintegrating Tablets of Prochlorperazine Maleate by
Sublimation Method
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Shirsand SB, Para MS, Swamy
PV, Nagendra Kumar D, Sunil F |
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Abstract: In the present work, fast
disintegrating tablets of prochlorperazine maleate were
designed with a view to enhance patient compliance by
sublimation method. In this method, camphor was used as
the subliming agent (up to 30% w/w), crospovidone and
croscarmellose sodium (2-8% w/w) was used as
superdisintegrant. Estimation of prochlorperazine
maleate in the prepared tablet formulations was carried
out by extracting the drug with methanol and measuring
the absorbance at 254.5 nm. The prepared formulations
were further evaluated for hardness, friability, drug
content uniformity, in vitro dispersion time, wetting
time and water absorption ratio,. Based on in vitro
dispersion time (approximately 10-15 s), two promising
formulations (one from each super-disintegrant) were
tested for in vitro drug release pattern in pH 6.8
phosphate buffer. Short-term stability (at 40șC/ 75% RH
for 3 months) and drug-excipient interaction (IR
spectroscopy). Among the two promising formulations, the
formulation (SCP3) containing 8% w/w of crospovidone and
30% w/w camphor as the subliming agent emerged as the
overall best formulation (t50%=6 m) based on drug
release characteristics in pH 6.8 phosphate buffer
compared to commercial conventional tablet formulation
(t50%=17.4 m). Short-term stability studies on the
promising 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 “Fast Dissolving Tablets (FDT)”.
Prochlorperazine maleate (PCZM) is a phenothiazine
antipsychotic and widely used in prevention and
treatment of nausea, vomiting including that associated
with migraine or drug-induced emesis. The concept of
formulating fast dissolving tablets containing
prochlorperazine maleate offers a suitable and practical
approach in serving desired objective of faster
disintegration and dissolution characteristics with
increased bioavailability.
Materials
Prochlorperazine maleate was a gift sample from Mehta
Pharmaceuticals, Mumbai. Cros-carmellose sodium (CCS)
and Crospovidone (CP) were gift samples from Wockhardt
Research Centre, Aurangabad. All the other ingredients
were of analytical grade.
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