Abstract
FORMULATIONS AND IN VITRO EVALUATION STUDIES OF BUCCAL ADHESIVE RANOLAZINE TABLETS USING NATURAL EDIBLE MUCOADHESIVES

Dr. Teelavath Mangilal* and Dr. K. S. K Rao Patnaik

ABSTRACT

Mucilage’s of plant origin have been used widely as demulcent because of their unique properties to bind with the mucus membrane. Isolation of water-soluble components from the natural edible sources was carried out by cold/hot aqueous extraction process followed by the organic solvent precipitation. The yield of PD, PJ, AA and AE was ≈5.5, 4.99, 3.49, 3.88 % w/w respectively to the initial weight. The isolated mucoadhesive materials obtained from natural sources were proved to be safe and free from toxic or adverse effects. Swollen volumes after 24 hours of hydration was found to be 12.1, 12.4, 13.3, and 18.3 indicating their moderate swellability compared to 27.4 of CP 934 P, 25.7 of sodium alginate, 1.2 of guar gum and 6.4 of HPMC. The moisture sorption capacities of PD & PJ are very less. The loss on drying of PD, PJ and AA & AE were less than the official limit of 6%. The isolated mucoadhesive material possessed comparable shear and tensile strengths to the commercially available GRAS category polymers and higher than the other natural polymers such as sodium alginate and guar gum. Adhesive cups were studied for their mucoadhesive strengths by using the specially fabricated apparatus. Tensile, shear and peel strengths were calculated after five minutes of contact time. The AC 18, AC 17, AC 19 and AC 22 formulations exhibited residence times of 4.98, 4.82 and 5.08 hours respectively. AC 17, AC 18, AC 19 and AC 22 formulations from the investigated materials were selected for further studies. The thickness of NBATs using the isolated material falls between 1.14 to 1.28 mm and weight between 32.8 to 39.8 mm, suggesting its suitability for ease of administration without any discomfort. Results such as percent friability (0.21 to 0.87%) and hardness (3.11 to 4.42 g/cm2) were found to be within the recommended values. The observed parameters such as duration of stay of the dosage form, its intactness at the affixed site, duration of maintenance of its structural integrity, palatability, effect on salivary secretion, discomfort to talk due to swelling or stickiness, possible irritation during and after removal of dosage form and feeling of dryness, bitterness etc. The photomicrographs suggest that considerable damage was not found after the administration of NBATs. The FTIR Spectra’s of Ranolazine, NBATs 3, 7, 11, and 15 suggest that Ranolazine has not undergone any unacceptable interactions with the mucoadhesive polymers isolated from the natural edible sources. The DSC thermographs suggest that there are no significant interactions between the Ranolazine with the additives used in the formulation, thus the additives used and the methods adopted are acceptable. Results in vitro dissolution studies suggest that the NBATs could release the drug following first order in formulations without the inclusion of mucoadhesive material in the core tablets, but followed Higuchi diffusion or Korsmeyer – Peppas patterns after the inclusion of the same. In vitro dissolution studies was found that less than 4% of drug diffused through the backing layer in four hours of study compared to 5.87% in sodium alginate and 6.18% in guar gum. The results suggest that the mucoadhesive material under investigation has not allowed the drug to diffuse through its backing layer enabling unidirectional release pattern.

Keywords: Mucilages of plant, Ranolazine, Mucoadhesive polymers, sodium alginate and guar gum, First order, Higuchi diffusion or Korsmeyer – Peppas, Male New Zealand albino rabbits.


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