Design and Optimization of Taste Masked Fast Dissolving Tablet of Ondansetron Hcl using Full Factorial Design (original) (raw)
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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.
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...
The demand for fast dissolving tablets of OndansetronHCl has been growing during the last decade specially for the geriatric and pediatric patients. OndansetronHCl is a recognized as antiemetic drug, so development of an FDT OndansetronHCl and to evaluate the effect of various concentrations of superdisintegrant and binder on its disintegration time and release profile was the prime objective of this research work. Methods: Tablets were prepared by high pressure homogenization followed by direct compression. 22 factorial design was applied in which concentration of superdisintegrant and binder were taken as independentvariables and disintegration time and percentage release were taken as dependent variables. The prepared tablets wereevaluated for weight variation, hardness, friability, disintegration time, content uniformity, and % drug release. Direct compression process was selected for this formulation of ODT tablets, because porous nature is more in direct compression blend than...
Development and Evaluation of Ondansetron Orally Disintegrating Tablets
British Journal of Pharmacy, 2018
Orally disintegrating tablet (ODT) has number of advantages like faster onset of action, ease of administration, rapid disintegration and dissolution etc. A novel attempt has been made to develop orally disintegrating tablets of Ondansetron by using two approaches, one is soluble hydrophilic matrix by superdisintegrant and other is effect of sweetener on the formulation. Direct compression method was employed for making orally disintegrating tablets. The formulated orally disintegrating tablets have rapid disintegration property for better patient compliance. Formulated tablets were evaluated for physical parameters along with wetting time, disintegration time, drug content and "in vitro" dissolution. In first approach it was found that batch F7 containing Crospovidone (Polyplasdone XL 10) 10 mg showed minimum disintegration time (i.e. approx. 7.00 seconds) with maximum drug release. Wetting time for batch F7 was found to beminimum (i.e. 12 seconds). In second approach of selection of sweetener batch F 10 containing Sodium saccharin was found better in terms of Impurity study (Relative Substances study).Impurity was found within the specified limit compared to other two sweeteners. Stability study was carried out on optimized formulation. Overall batch containing 10 mg Crospovidone (Polyplasdone XL 10) along with Sodium Saccharin was foundstable both physically and chemically.
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...
International Journal of Pharmacy and Pharmaceutical Sciences, 2019
Objective: The aim of the present study was to prepare the ondansetron hydrochloride Mouth Dissolving Tablets (MDTs) followed by its comparison with ethical and non-ethical (generic) marketed tablets. Methods: Prior to the formulation, drug excipient compatibility study was carried out by FTIR spectroscopy. The λmax was determined by UV spectroscopy. The ondansetron hydrochloride MDTs were prepared by direct compression method using Sodium Starch Glycolate (SSG) as super disintegrant and camphor as a sublimating agent. Then the prepared MDTs were subjected to evaluation of post compression parameters such as thickness and diameter, weight variation, wetting time, hardness, friability, disintegration and dissolution. The results obtained were compared with that of ethical and non-ethical marketed ondansetron hydrochloride 4 mg tablets. Results: The λmax was found at 310 nm. FTIR study revealed that excipients used in the prepared formulations are compatible with the drug. The thickne...
The Journal of Pharmaceutical Sciences and Medicinal Research, 2021
In the present time, a mouth dissolving tablets become popular over conventional oral solid dosage form as it overcome common problem associated with conventional oral tablet dosage form such as issue in swallowing tablets in paediatric as well as geriatric population as well as avoid first pass metabolism and provide quick onset of action as it starts to absorb directly from oral cavity. Ondansetron HCl is used to prevent nausea and vomiting. In case of vomiting as well as in nausea, drug must require to act quickly to treat therapeutic condition of patient in need thereof. Therefore, combining Mouth dissolving technology with Ondansetron HCl as active pharmaceutical ingredient could be potential strategy to provide quick onset of action without swallowing entire tablet. Therefore, aim of the present research work is to fabricate mouth dissolving tablets of Ondansetron HCl using different concentration, i.e. 3%, 5% and 9%w/w, of different water insoluble super-disintegrants, namely...
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...