Informatics Publishing Limited

Mercy Mathew ¹, Ravikumar ², Simila Madathil ¹, Anju Govind ¹, V. B. Narayana Swamy ³

Affiliations
1 Karavali College of Pharmacy, Mangalore, IN
2 Department of Pharmaceutics, Karavali College of Pharmacy, Mangalore, IN
3 Department of Pharmacognosy, Karavali College of Pharmacy, Mangalore, IN

Abstract

The present study aimed at Formulation Development and Evaluation of controlled release tablets of Cinitapride for the treatment of ulcer. Cinitapride is a gastroprokinetic agent and antiulcer agent of the benzamide class. It act as an agonist of the 5- HT₁ and 5- HT₄ receptors and an antagonist of the 5- HT₂ receptors. It is used in the treatment of gastrointestinal disorders associated with motility disturbances such as gastro esophageal reflux disease, non- ulcer dyspepsia and delayed gastric emptying. The matrix tablets of Cinitapride were prepared using wet granulation. Physical characterization of tablet and powder blends used to form the matrix tablet was under taken using a range of experimental techniques. Granules were evaluated for Bulk density, Tapped density, Compressibility index and Hausner's ratio. Tablets were tested for weight variation, hardness, thickness and friability as per official procedure. The tablets were evaluated for in-vitro drug release profile. Dissolution studies of Cinitapride controlled release tablets in media with different dissolution media 0.1N HCl, Phosphate buffer pH (6.8) as per US Pharmacopoeia. The dissolution data revealed that the ratio of polymers is very important to achieve a optimum formulation. The formulation of Cinitapride CR tablets shown that formulation F23 with Methocel K100M (20%) shown good drug release profile. Formulation F23, shown similar dissolution profile when compared with the marketed product (Cintapro). Stability study of the formulation F23 indicated no significant difference in release profile after a period of 3 months.

Keywords

Cinitapride, Gastritis, Methocel K4M, K15M and K100M, Carbopol, and Methyl Cellulose.

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Simila Madathil ¹, Ravi Kumar ², Anju Govind ¹, Mercy Mathew ¹, V. B. Narayana Swamy ³

Affiliations
1 Karavali College of Pharmacy, Mangalore, IN
2 Department of Pharmaceutics, Karavali College of Pharmacy, Mangalore, IN
3 Department of Pharmacognosy, Karavali College of Pharmacy, Vamanjoor, Mangalore, IN

Abstract

Plant products serve as an alternative to synthetic products because of local accessibility, eco friendly nature and lower price compared to imported synthetic products. Natural gums and mucilage have been widely explored as pharmaceutical excipients. Tablet disintegration has received considerable attention as an essential step in obtaining fast drug release. The present work was carried out to study the disintegration properties of Plantago Ovata mucilage powder by formulating orally disintegrating tablets of Trimetazidine hydrochloride by direct compression method. Disintegrant property of above disintegrants was evaluated by comparing their formulations with the formulations of various superdisintegrants extracted Mucilage was subjected to toxicity studies for its safety and preformulation studies for its suitability as a disintegrating agent. The extracted mucilage is devoid of toxicity. No chemical interaction between drug and excipients was confirmed by FTIR and DSC studies. Mouth dissolving tablets of Trimetazidine hydrochloride were prepared and compared with different concentrations viz; 0.5, 1, 1.5, 2.0 and 2.5% (w/w) of Plantago Ovata mucilage powder, cross carmellose sodium and sodium starch glycolate. Thirty six formulations were prepared by using different diluents and evaluated for physical parameters such as thickness, hardness, friability, weight variation, drug content, disintegration time and drug dissolution. The formulated tablets had good appearance and better drug release properties. The study revealed that Plantago Ovata mucilage powder was effective as disintegrant in low concentrations (1%). The mucilage was found to be a superior disintegrating agent than sodium starch glycolate and cross carmellose sodium. Studies indicate that the extracted mucilage may be a good source of pharmaceutical adjuvant, specifically a disintegrating agent.

Keywords

Fast Dissolving Tablet, Trmetazidine Dihydrochloride, Superdisintegrant, Direct Compression, Plantago Ovate, Sodium Starch Glycolate, Cross Carmellose Sodium, Cross Povidone.

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