Development and in vitro evaluation of fast-dissolving oral films of ondansetron hydrochloride (original) (raw)
Related papers
2018
DOI: 10.21276/sjmps.2018.4.1.1 Abstract: The purpose of present research work was to fabricate patient friendly, immediate release oral film of ondansetron hydrochloride using hydrophilic excipients. The film was prepared by solvent casting method. Hydroxyethyl cellulose, polyvinyl alcohol and polyvinylpyrrolidone k30 along with different plasticizers (peg 400 and pg) were scrutinized for film formulation. The auxiliary excipients used were sodium saccharin and sodium lauryl sulphate. The final selection was done with hydroxyethyl cellulose as a film former and peg 400 as a plasticizer for the film. The drug loaded films of hydroxyethyl cellulose were evaluated for thickness, uniformity in drug content, folding endurance, disintegration time, in-vitro drug release studies, tensile strength and drugexcipient compatibility studies. Taste masking was done by novel sandwich technology (placing the ondansetron hydrochloride film between two listerine pocket pack films). This approach can...
Journal of Young Pharmacists, 2010
Ondansetron hydrochloride, a 5 HT3 antagonist is a powerful antiemetic drug which has oral bioavailability of 60% due to hepatic first pass metabolism and has a short half-life of 5 h. To overcome the above draw back, the present study was carried out to formulate and evaluate fast dissolving films of ondansetron hydrochloride for sublingual administration. The films were prepared from polymers such as polyvinylalcohol, polyvinyl pyrrolidone, Carbopol 934P in different ratios by solvent casting method. Propylene glycol or PEG 400 as plasticizers and mannitol or sodium saccharin as sweeteners were also included. The IR spectral studies showed no interaction between drug and polymer or with other additives. Satisfactory results were obtained when subjected to physicochemical tests such as uniformity of weight, thickness, surface pH, folding endurance, uniformity of drug content, swelling index, bioadhesive strength, and tensile strength. Films were also subjected to in vitro drug release studies by using USP dissolution apparatus. Ex vivo drug permeation studies were carried out using porcine membrane model. In vitro release studies indicated 81-96% release within 7 min and 66-80% within 7 min during ex vivo studies. Drug permeation of 66-77% was observed through porcine mucosa within 40 min. Higher percentage of drug release was observed from films containing the sweeteners. The stability studies conducted for a period of 8 weeks showed no appreciable change in drug content, surface pH, and in vitro drug release.
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...
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.
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...
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.
A REVIEW OF ORALLY FAST DISSOLVING FILM OF D2 RECEPTOR ANTAGONIST
The objective of the resent work was to formulate fast dissolving film of D 2 receptor antagonist so as to achieve higher oral bioavailability by minimizing the first pass metabolism and to enhance the compliance by elderly and pediatric patients. D 2 receptor antagonist being water insoluble drug pose a challenge in formulating fast dissolving film. So, in order to enhance the solubility solid dispersion were prepared using β-Cyclodextrin as carrier. The physical mixture and solid dispersion by kneading in the molar ratio 1:1, 1:2 and 1:3 of D 2 receptor antagonist and β-Cyclodextrin were prepare and evaluated for drug content, %yield and in vitro drug release.For preparing film, initially trial batches were prepared utilizing HPMC E3, E5 and E15 LV and pulllulan as film forming polymers and PEG 400 as plasticizer. Based on the trial batchesthe best film forming agent was selected. Optimization of films were done by factorial design taking concentration of polymer and PEG 400 as dependent variable and tensile strength, %elongation, elastic modulus, disintegration time and drug release at 2 min were taken as dependent variables. Polynominal equation were derived and validity of equation was checked by preparing and evaluating chek point batches. Surface plots were constructed and desdirability of the film was calculated and based on it optimized batch for both plain drug and solid dispersion film was determined. Mechanical properties and drug release was compared between the two films and based on it the best film was finally selected.
International Research Journal of Pharmacy, 2015
Granisetron Hydrochloride is an orally active, highly selective 5HT3 receptor antagonist used in the treatment of cancer chemotherapy induced nausea and vomiting. The present work aimed at preparing quick releasing films of Granisetron Hyrochloride with the purpose of developing a dosage form providing a very quick onset of action beneficial in managing several conditions of vomiting, aiding in the enhancement of bioavailability and convenient for administration without the problem of swallowing and need of water. Oral films of Granisetron Hydrochloride were prepared using Pullulan, HPMC E5 & HPMC E15 in different concentrations by solvent casting method. Initially placebo films were prepared and evaluated on certain physical parameters to optimize the type and concentration of the polymer. Formulations containing 5 & 7.5% of Pullulan & HPMC E15 showed the optimum results. In-vitro release studies revealed that formulation containing 5% Pullulan showed the maximum release of 92% in a matter of 90sec. Thus it was concluded that of the various polymers employed Pullulan has the excellent film forming property and the formulation S1 (containing 5% Pullulan) was the best formulation. Formulation S1 was then subjected to various evaluation parameters and stability studies. All the results obtained were satisfactory. Thus, Fast dissolving films of Granisetron Hydrochloride were successfully developed.