02-02-2013, 02:37 PM
Domperidone nasal gel using natural mucoadhesive agent obtained from tamarind seeds.
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Abstract.
A new Nasal drug delivery system of Domperidone has been developed as decent drug delivery by using natural mucoadhesive agent extract from TamarindusindicaL.Themucoadhesive strength, pH, viscosity and gelling property of this natural mucoadhesive agent was found to be higher in comparison to synthetic polymers, hydroxy propyl methyl cellulose (HPMC) and carbopolwhich are conventionally used for similar purpose. . In vitro drug release characteristic through franz-diffusion cell using excised bovine nasal membrane was also found to be better in comparison to the above synthetic polymers. Now patient friendly, needle free dosage form may replace the Domperidone injections/ tablets in future.
Introduction:
Generally nose is the important part of body for inhalation process. But when it is used as the route of drug delivery attained the great attraction for various drugs. Because nose provides faster and higher level of drug absorption with possibility of self-administration.[1]
The aim of this study was to develop a nasal delivery system of domperidone with a natural mucoadhesive agent extracted from tamarind seeds.
An adult nasal cavity has about a 20 ml capacity with a large surface area (about 180 cm2) for the drug absorption afforded by the microvillus present along the pseudo-stratified columnar epithelia cells of the nasal mucosa. [2]
A new nasal drug delivery system of domperidone has been developed with a natural mucoadhesive agent from Tamarindusindica L. The mucoadhesive strength, viscosity and gelling property of this natural mucoadhesive agent was found to be higher in comparison to synthetic polymers.
Domperidone is a potent antiemetic, antimigraine drug effective for preventing different kinds of emesis. Its conventional dosage form such as tablet and suspension give poor bioavailability (18%) due to extensive first pass effect, whereas on rapid i.v. injectionit has been shown to cause cardiac arrhythmias [3]. In these conditions, the intranasal delivery seems to be an attractive alternative.
Extraction and Isolation of Mucoadhesive Material.:
Tamarind seeds (250 g) were soaked in double distilled water at room temperature and then boiled with sufficient amount of double distilled water under stirring condition in a water bath until slurry was prepared. Then the slurry was cooled and kept in refrigerator overnight to settle out un-dissolved materials. The upper clear solution was decanted off and centrifuged at 1000 rpm for 30 minutes. The supernatant was separated and concentrated at 50-55º C on a water bath to a third of its original volume. Solution was cooled down to room temperature and was poured into thrice volume of acetone by continuous stirring. The precipitate was washed repeatedly with acetone and dried.
Determination of pH and Viscosity:
The pH and viscosity of 1% w/v solution of the tamarind seed extract were measured in Toshcon pH Meter and Toki sangyo Viscometer TV-10, respectively and values were compared with 1% w/v solutions of the synthetic polymers HPMC and carbopol 934.
Characterization of mucoadhesive property of tama-rind extract:
The mucoadhesive property of tamarind seed extract was determined by Shear stress method (8) and Park and Robinson Method (9) and results were compared with synthetic polymers. In this study 0.5% w/v solutions of the polymers were used for shear stress method and 1% w/v solutions of the polymers for Park & Robinson method.
Release studies of drug from gel:
The franz diffusion cell (12) was used for the drug release study. The diffusion chamber with an exposed tissue surface area of 2.54cm2 is filled with 100ml of phosphate buffer solution of pH 6.0. The excised nasal mucosal membrane was secured over the mouth of the upper tube keeping mucus side exposed to gel. For equilibration the mucosae werePre-incubated with preheated buffer for ~30 min. Domperidone containing gel (1mg/ml) placed on the membrane were dispersed in 100 ml of phosphate buffer solution of pH 6.0 and stirred at a constant rate by a PTFE-coated magnetic bar at 600 min-1. Cells were kept under a constant oxycarbon flow (95% O2, 5% CO2). Throughout the studies the buffer solution in the chamber was maintained at 37°C connecting the franz diffusion cell with water bath. At pre-determined period of time 1ml of sample was taken and simultaneously replaced with same volume of pre-warmed (37°C) fresh buffer solution. The collected samples were diluted suitably and drug concentration estimated using Spectrophotometer.
Conclusion:
Conclusion was reached that mucoadhesive agent extractfrom tamarind seed more suitable at low concentration than other mucoadhesive agent such as Carbapol, HMC. Natural mucoadhesive agent is edible, it is easily biodegradable and non-allergic like many synthetic agents used for similar purpose.Domperidone is given in the form of injection or tablet to many patients in hospitals and nursing homes. But these are not suitable due various factors such as first pass metabolism; clearance etc. and nasal gel formation is the best formulation for anti-emetic domperidone. This work will definitely add a new dimension to newer drug delivery systems that is nasal gel drug delivery system. So in future for domperidone tablet or injection will not require nasal gel gives sufficient absorption with very low toxic effect.