Research Journal of Pharmaceutical Dosage Form and Technology

R. K. V. Naga Sudha ¹, G. Padmini ¹, T. E. G. K. Murthy ¹

Affiliations
1 Bapatla College of Pharmacy, Bapatla-522101, Guntur (District), Andhra Pradesh, IN

Abstract

A novel co-processed excipient containing different ratios of lactose: maize starch were prepared and tested their suitability for development of direct compressible tablets of Rizatriptan benzoate. Rizatriptan is a 5-HT1 agonist, used in the treatment of migraine headaches, The Rizatriptan dose is 10mg, so it is suitable for direct compression but it has poor flow, poor disintegration, and poor compressibility. To overcome these problems, the tablets were formulated by using co-processing excipients (lactose and maize starch). Co-processed excipients with α-lactose monohydrate and Maize starch in different ratios (100:0, 0:100, 50:50, 60:40, 70:30, 80:20, and 90:10) were fabricated by wet granulation technique and its influence on blend fluidity, friability of the tablet and dissolution characteristics of Rizatriptan benzoate from direct compressible tablets were studied. The flow properties of the blends were determined by Carr's index and Hausner's ratio. Higher proportion of lactose and maize starch individually imparted low flowability, low disintegration properties, and failed to meet the friability. Optimized co-processed formulation containing lactose and maize starch in the ratio of 90:10 was found to be more acceptable to formulate Rizatriptan benzoate tablets.

Keywords

Rizatriptan Benzoate, 5-HT1 Agonist, Co-Processed Excipients, Wet Granulation Technique, Direct Compressible Tablets.

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R. K. V. Naga Sudha ¹, V. Sai Kishore ¹, Ch. Venu Babu ¹, E. Jitendranath ²

Affiliations
1 Bapatla College of Pharmacy, Bapatla -522101, Guntur (District), Andhra Pradesh (State), IN
2 AKRG College of Pharmacy, Vijayawada, A.P, IN

Abstract

Solifenacin Succinate is used in the treatment of over active bladder with symptoms of urge urinary incontinence, urgency, and increased urinary frequency, and anti spasmodic. Solifenacin Succinate was launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements. Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two dosage strengths namely a 5 or 10 mg once-daily tablet. Ten different trial batches were carried out using different concentrations of excipients like binder (Methocel E5 premium LV), super disintegrant (sodium starch glycolate, cross carmellose sodium, cross povidone), lubricant (Magnesium stearate), glidant (Aerosil) by direct compression technique. The pre-compression parameters and post compression parameters of Solifenacin Succinate tablets were evaluated. The tablets were evaluated for in-vitro drug release studies. Based on similarity factor f2 cross povidone (1.17%), Methocel E5 premium LV (3%), Magnesium starate (1.47%), Aerosil (0.529%) was selected.

Keywords

Solifenacin Succinate, Urinary Incontinence, Overactive Bladder, Muscarinic Receptor Antagonist, Direct Compression.

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