Formulation Design of Fast  Disintegrating Tablets of  Prochlorperazine Maleate by Sublimation Method

Shirsand SB, Para MS, Swamy PV, Nagendra Kumar D, Sunil F

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).

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.

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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