Formulation and In-vitro Evaluation of Sublingual Tablets of Ondansetron Hydrochloride using Coprocessed Excipients (original) (raw)
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In the present work orodispersible tablets of Ondansetron hydrochloride were formulated by effervescent and sublimation method using factorial design. In the effervescent method, crospovidone (1.31%-4.68%) was used as superdisintegrant whereas citric acid (7.95%-18.04%) and sodium bicarbonate (5.22%-28.77%) were used as effervescent agent. In the sublimation method, crospovidone (1.58%-4.41%) was used as superdisintegrant whereas camphor (6.34%-17.35%) was used as subliming agent. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, disintegration time and In Vitro drug release pattern. Total 15 batches were formulated by effervescent method and 9 batches were formulated by sublimation method. Disintegration time of the formulations prepared by effervescent method was found between 13-36 secs whereas formulations prepared by sublimation method showed disintegration time between 7-39 secs. Among all the formulations, the formulation (S6) prepared by sublimation method using crospovidone 4% and camphor 8% was found to have the minimum disintegration time (7 seconds). Finally, it was concluded that Orodispersible tablet of Ondansetron Hydrochloride can be successfully formulated using effervescent and sublimation method and can be used as a novel drug dosage form for pediatric and geriatric with improved patient compliance and enhanced bioavailability.
Formulation Development and Evaluation of Ondansetron Hydrochloride sustained release Matrix tablets
2009
The objective of the present study was to develop sustained release matrix tablets of Ondansetron hydrochloride [5mg] formulated employing Hydroxy Propyl Methyl Cellulose polymer and the sustained release behaviour of the tablets was investigated. Tablets were prepared by wet granulation methods. The granules were evaluated for angle of repose, bulk density and drug content .The tablets were subjected to thickness, diameter, weight variation test, hardness, friability, drug content and in vitro release studies. Formulation was optimized on the basis of acceptable tablet properties and in vitro drug release. The results of dissolution studies indicated that formulation FV (drug to polymer ratio 1:3) the most successful of the study, exhibited drug release pattern very close to theoretical release profile. All the formulations (except FV) exhibited diffusion – dominated drug release. The mechanism of drug release from FV was diffusion coupled with erosion.
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...
Asian Journal of Applied Science and Technology (AJAST), 2021
Objective: The aim of this study was to develop a simple method for manufacturing oral dispersible tablets of ondansetron hydrochloride using direct compression method and to study the effect of different types and concentration of natural disintegrant (Isabgol mucilage, fenugreek mucilage and dehydrated banana powder) on the disintegrating characteristics of the tablets. Method: Disintegrants extracted from Isabgol, fenugreek and banana powder were used in formulation of tablet using placket burman design in minitab. Then 13 different formulations (F1- F13) were prepared varying the concentration of selected natural disintegrant (Isabgol mucilage extract 6-15%). Formulated tablets were investigated for weight variation, hardness, thickness, disintegration, drug content, friability. Result: The result obtained from disintegration study of tablets prepared using natural disintegrant obtained from isabgol mucilage indicates that the Isabgol with concentration 11.47% shows the disintegration time of 27 seconds. Conclusion: Orodispersible tablet of ondansetron hydrochloride was found to be effective with natural disintegrant obtained from isabgol mucilage
International journal of pharmaceutics, 2015
The objective of the present study was to develop pH-independent/dependent sustained release (SR) tablets of ondansetron HCl dihydrate (OND), a selective 5-HT3 receptor antagonist that is used for prevention of nausea and vomiting caused by chemotherapy, radiotherapy and postoperative treatment. The challenge with the OND API is its pH-dependent solubility and relatively short elimination half-life. Therefore, investigations were made to solve these problems in the current study. Formulations were prepared using stearic acid as a binding agent via a melt granulation process in a twin-screw extruder. The micro-environmental pH of the tablet was manipulated by the addition of fumaric acid to enhance the solubility and release of OND from the tablet. The in vitro release study demonstrated sustained release for 24h with 90% of drug release in formulations using stearic acid in combination with ethyl cellulose, whereas 100% drug release in 8h for stearic acid-hydroxypropylcellulose matr...
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.
Yakugaku Zasshi-journal of The Pharmaceutical Society of Japan, 2009
The objective of this investigation was to prepare orodispersible tablets (ODTs) of ondansetron HCl using a direct compression method. A combination of glycine and chitosan was used as a disintegrating system and these tablets were compared for mechanical strength and disintegration time with those containing superdisintegrants. The Plackett-Burman screening design was used to screen the independent variables [concentration of glycine (X 1 ), concentration of chitosan (X 2 ), concentration of ondansetron HCl (X 3 ) and tablet crushing strength (X 4 )] which were found to actively in‰uence the dependent variables [disintegration time in the oral cavity (DT), wetting time (WT), and water absorption ratio (WAR)]. Further, a central composite design was used to formulate additional ODTs of ondansetron HCl for estimating response in the extended spherical domain. The regression analysis (performed using Statistica-7.0) of quad-raticˆt revealed that DT or WT and WAR were 99％ and 98％ correlated with active factors (X 1 , X 2 or X 3 ), respectively. The data showed that disintegration time of optimized ondansetron HCl ODTs was not signiˆcantly diŠerent (p＜ 0.05) from ODTs prepared using Croscarmellose sodium or Crospovidone.
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...
Formulation and Evaluation of Oral Disintegrating Tablets of Ondansetron Hydrochloride
Research Journal of Pharmaceutical Dosage Forms and Technology, 2019
Objective: The main objective of the study was to formulate the oral disintegrating films loaded with atenolol by solvent-casting method and to carry out its evaluation studies. Methods: The films were prepared using the film-forming hydrophilic polymer like hydroxypropyl methylcellulose (E-5) and super disintegrant like pectin in various proportions.The formulated oral films were characterized for Fourier transform infrared (FTIR) and morphological evaluations. Various physicochemical parameters such as weight variation, folding endurance, surface pH, in vitro disintegration, and in vitro dissolution studies were carried out. Results: FTIR studies revealed that there was no drug-polymer interaction. The morphological evaluation of films showed that all the films were homogenous and transparent. The folding endurance test ensured that the films had sufficient brittleness and by weight variation test, it was inferred that all the films were within the deviation. The surface pH study showed the pH of the films was around neutral pH. The drug was well distributed in all the films. The films disintegrated within 120 s and the fastest being disintegrated in 30 s. Based on all the evaluation parameters, F6 had shown optimal performance and remarkable increase in drug release of 94.38% in 2 min. Conclusion: Thus, formulated oral disintegrating films can be termed as an alternative approach to deliver atenolol.