Formulation and evaluation of taste masked orally disintegrating ondansetron hydrochloride tablet (original) (raw)
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Mouth Disintegrating Tablets of Taste-Masked Ondansetron HCl
Ondansetron HCl is used in the management of nausea and vomiting induced by cytotoxic chemotherapy and radio-therapy and is bitter drug. The purpose of research work was focused on taste masking of the Ondansetron HCl and further development of the drug in mouth disintegrating tablets. Ion exchange resins, Indion 204 and Indion 234 were used with a view to mask the taste of the drug. Tablet formulations were prepared using wet granulation and direct compression tech-niques. All formulations were subjected to post compression parameters like uniformity of thickness, hardness, friability test, weight variation and drug content uniformity, all these parameters were within pharmacopoeial limits. Formulations FW 6 and FD 2 showed 102.34 ± 1.34 and 101.94 ± 1.54 % of drug release after 15 min, respectively. Volunteer did not feel bitter taste with these formulations (FW 6 and FD 2). These selected formulations were subjected for stability studies and were found to be stable for 3 month at...
Taste Masking and Formulation of Ondansetron Hydrochloride Mouth Dissolving Tablets
International Journal of Drug Delivery Technology, 2015
This study was done to mask the bitter taste of ondansetron HCl using complexing agent, a polacrilex resin: Tulsion 335 and subsequently forming mouth dissolving tablet using superdisintegrants: Croscarmellose sodium and sodium starch glycollate. A preliminary screening was done. Batch process, a most preferential method for drug loading with ion exchange resins was selected. The process was optimized for drug: resin ratio to get maximum drug loading. A ratio of drug: resin at 1:3 was selected. Taste evaluation was carried out by selecting volunteers. Drug resin complex (DRC) was evaluated for drug release. The resultant DRC was formulated by direct compression into mouth dissolving tablet using microcrystalline cellulose PH 102, as diluent and croscarmalose sodium and sodium starch glycolate as superdisintegrants and aspartame was used as sweetening agent to enhance palatability. Thirteen formulations were developed by using superdisintegrants: croscarmellose sodium and sodium star...
AAPS PharmSciTech, 2007
The purpose of this research was to mask the intensely bitter taste of ondansetron HCl and to formulate a rapiddisintegrating tablet (RDT) of the taste-masked drug. Taste masking was done by complexing ondansetron HCl with aminoalkyl methacrylate copolymer (Eudragit EPO) in different ratios by the precipitation method. Drug-polymer complexes (DPCs) were tested for drug content, in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF was considered taste-masked and selected for formulation RDTs. The complex with drug-polymer ratio of 8:2 did not show drug release in SSF; therefore, it was selected. The properties of tablets such as tensile strength, wetting time, water absorption ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and disintegration characteristics of tablets. Polyplasdone XL-10 7% wt/wt gave the minimum disintegration time. Tablets of batch F4 containing spray-dried mannitol and microcrystalline cellulose in the ratio 1:1 and 7% wt/wt Polyplasdone XL-10 showed faster disintegration, within 12.5 seconds, than the marketed tablet (112 seconds). Good correlation between in vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDT in human volunteers revealed considerable taste masking with the degree of bitterness below threshold value (0.5) ultimately reaching to 0 within 15 minutes, whereas ondansetron HCl was rated intensely bitter with a score of 3 for 10 minutes. Tablets of batch F4 also revealed rapid drug release (t 90 , 60 seconds) in SGF compared with marketed formulation (t 90 , 240 seconds; P G .01). Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity.
Ondansetron Hydrochloride is a potent antiemetic drug indicated for the treatment and/or prophylaxis of postoperative or chemotherapy-or radiotherapy-induced emesis. It is extremely bitter in taste. The purpose of this research was to mask the bitter taste of Ondansetron Hydrochloride with carbopol by neutralization method. The effect of variables like type of alkali, concentration of alkali, grades of carbopol and concentration of carbopol on bitterness level was studied. Results showed that neutralization of drug with equimolar sodium hydroxide and subsequent complexation with 0.6% carbopol 971G gave effective taste masking. The drug polymer complex was used to formulate orodispersible tablets by direct compression method using three different superdisintegrants like croscarmellose sodium, crospovidone and Kyron T-314. The prepared tablets were evaluated for the parameters like general appearance, thickness, hardness, weight variation, friability, wetting time, water absorption ra...
Evaluation of Taste Masking of Ondansetron Using Insent Taste Sensing System
International Research Journal of Pharmacy
The most important evaluation required for taste masked dosage forms is the complete masking of bitter or unacceptable taste of drug. It is very important to evaluate and quantify the bitter taste of drug and masking effects of taste masking agents used in formulation. Ondansetron was studied as model bitter drug. Insent Taste Sensing system was used to assess the bitterness of drug, taste masking potential of Neotame and its comparison to human sensory taste panel. Bitterness sensor specially designed by Insent for Ondansetron was used to measure its bitterness. Ondanse tron solutions showed linear response to this sensor in range of 0.008 mM to 0.164 mM. Bitterness of Quinine hydrochloride solution was compared with Ondansetron solutions and sensor response indicated 0.01mM of Ondansetron corresponds to 0.1mM of Quinine hydrochloride. Quinine as standard bitter drug was taste evaluated in the concentration of 0.013 mM to 0.1 mM using human sensory panel and bitterness score was assigned. The concentration in the range of 0.045 mM to 0.1 mM corresponding to Bitterness score 4, 5, and 6 was evaluated with different Neotame concentrations (0.001 to 0.0003 mM). Suitability of Neotame as taste masking agent for Ondansetron was evaluated and it was observed that it reduces bitterness intensity measured as Change in Membrane Potential (CPA values) due to adsorption perceived as "After taste" from 22.47 mv to 16.54 mv.
2015
The purpose of this work was to develop taste masked fast dissolving tablets of Ondansetron HCl that overcomes principle drawback of such formulations, which is slow disintegration and inadequate mechanical strength. In the present work taste masked Ondansetron HCl fast dissolving tablets were formulated and optimized by using different ratio of MCC in MCC: Lactose combination and different concentration of Ac-Di-Sol. A 3 2 full factorial design and statistical models were applied to optimize the effect of two factors. It was observed that the responses, i.e., disintegration time and hardness were affected by both the factors. The statistical models were validated and can be successfully used to prepare fast dissolving tablets of Ondansetron HCl with rapid disintegration (24 seconds) and excellent mechanical strength (4.4 kg/cm 2 ). Pharmacokinetic studies in rats showed statistically insignificant difference (p>0.05) between OFDT1 and marketed product (Ondem MD 8), concluded tha...
Taste-masking assessment of orally disintegrating tablets of valsartan using ion exchange resin
2018
Oral disintegrating tablets are novel attractive dosage form that disintegrate or dissolve in the buccal cavity within seconds without use of water. The major drawback in designing of this dosage form is unpleasant taste of active entity. Valsartan isan antihypertension drug used in treatment of high blood pressure, congestive heart failure (CHF) and post-myocardial infarction (MI). It is characterized by its bitter taste which effects the patient’scompliance. The aim of present research work is taste-masking assessment of orally disintegrating tablets of valsartan using ion exchange resin(indion 254). The drug was characterized according to different compendia methods, on the basis of identification by UV spectroscopy, pH, organoleptic properties and other tests. Drug-Resin compatibility and drug polymer compatibility was carried out by FTIR. The values of pre-compression parameters assessed, were within specified limits and showed good free flowing properties. The data obtained of...
Taste Mask, Design and Evaluation of an Oral Formulation Using Ion Exchange Resin as Drug Carrier
AAPS PharmSciTech, 2008
The purpose of this research was to mask the bitter taste of Diphenhydramine Hydrochloride (DPH) using cation exchange resins. Indion 234 and Tulsion 343 that contained crosslinked polyacrylic backbone were used. The drug resin complexes (DRC) were prepared by batch process by taking drug: resin ratios 1:1, 1:2, and 1:3. The optimum drug: resin ratio and the time required for maximum complexation was determined. The drug resinates were evaluated for the drug content, taste, micromeritic properties drug release and X-ray diffraction (PXRD). Effervescent and dispersible tablets were developed from optimum drug: resin ratios of 1:2 and 1:1. The formulations were evaluated for uniformity of dispersion, disintegration time, and in vitro dissolution. The X-ray diffraction study confirmed the monomolecularity of entrapped drug in the resin beads. The taste evaluation depicted the successful taste masking of DPH with drug resin complexes. The drug release of 95% in 15 min was observed for effervescent and dispersible tablets.
International Journal of Applied Pharmaceutics
Objective: This study aimed to mask the bitter taste of itopride HCl using the solid dispersion method by solvent evaporation technique and formulate an oral disintegrating tablet (ODT) by direct compression method using different co-processed excipients. Methods: Nine formulae of solid dispersion were prepared to mask the bitter taste of Itopride HCl using Eudragit EPO® and mannitol at different ratios after compatibility studies using infrared spectroscopy (IR). The prepared formulae were subjected to different physicochemical characterization, in vivo taste evaluation, and drug content. The best-selected formulae were used to formulate 10 different ODTs. The prepared tablets were evaluated through hardness, drug content, in vivo-in vitro disintegration, IR, wetting time, and finally, dissolution studies. The selected formula was subjected to a pharmacokinetic study compared to the brand. Results: F5, drug: Eudragit EPO® (1:2) and F8, Drug: Mannitol: Eudragit EPO® (1:1:2) formulae...
INTERNATIONAL RESEARCH JOURNAL OF PHARMACY TASTE MASKING IN PHARMACEUTICAL: AN UPDATE
Taste is an important factor in the development of dosage form. Nevertheless it is that arena of product development that has been overlooked and undermined for its importance. The problem of bitter and obnoxious taste of is a challenge to the pharmacist in the present scenario. Taste is an important parameter governing compliance. Several oral pharmaceuticals and bulking agents have unpleasant, bitter-tasting components. In numerous cases, the bitter taste modality is an undesirable trait of the product or formulations and can considerably affect its acceptability by consumers. Bitter characteristics found in such systems have been eliminated or minimized by various known processes, but no universally applicable technology for bitterness inhibition has ever been recognized. The desire of improved palatability in these products has prompted the development of numerous formulations with improved performance and acceptability Taste masking technologies offer a great scope for invention and patents. Several approaches like adding flavors and sweeteners, use of coating polymers for inhibiting bitterness, microencapsulation, prodrug formation, formation of inclusion and molecular complexes, solid dispersion system, addition of effervescent agents and application of ion exchange resins have been tried by the formulators to mask the unpleasant taste of the bitter drugs. The present review attempts to give a brief account of different technologies of taste masking with respect to dosage form and novel methods of evaluation of taste masking effect.