Development and Evaluation of Gastro Retentive Floating Drug Delivery System of Ondansetron Hydrochloride

The Aim of the present study was to develop & evaluate Gastro-retentive floating Tablet of Ondansetron hydrochloride. The Objective was to calibrate and validate the UV- spectroscopy analytical method and to prepare and optimize the GR Floating tablets of Ondansetron hydrochloride in terms of dissolution release profile. The FDDS of the drug can minimize the fluctuation of drug plasma levels and result to associated adverse reactions, dosing frequency, and improved patient compliance. Conventionally, Ondansetron hydrochloride is taken up 2-3 times daily in the treatment of nausea and vomiting. Gastro retentive floating tablet of Ondansetron hydrochloride is better suited for treatment of postoperative nausea vomiting. In the present study, nine Gastro retentive Floating tablet formulations (F1, F2.....F9) of Ondansetron hydrochloride were prepared by the method of direct compression and polymers HPMC K15 were used and Guargum and Chitosan, in different quantity to normalise their effect on the’ release profile of drug . Target release profile was >80% release of drug in 12 hours. Tablets were evaluated for various parameters namely: thickness, weight variation’, friability, hardness, assay, in-vitro buoyancy study & drug release. Formulation F8 containing Chitosan (26.66% w/w), Guargum (26.66% w/w) and Sod. Carbonate (25.83% w/w) had the desirable release profile. Keywords: Ondansetron hydrochloride; Gastro retentive floating tablet, Chitosan, Guar gum, Drug release

Fast-dissolving Sublingual Nanofibers of Ondansetron Hydrochloride: Formulation, Physicochemical Characterization, and Clinical Evaluation on Post-cataract Surgery Patients

Objective: Ondansetron hydrochloride (OND) is an antiemetic agent belongs to the 5-HT3 receptor antagonist class administrated widely in relieving nausea and vomiting which is the most common complication occurred after surgery. This study aimed to design and evaluate the physicochemical along with clinical effects of fast-dissolving nanofiber (FDN) of OND administrated sublingually to enhance the bioavailability, effectiveness, and patient compliance compared to orally disintegrating tablets (ODT). Methods: Nanofibers were prepared by the electrospinning method, using polyvinyl alcohol and alpha-cyclodextrin as polymers and sodium saccharin as the sweetener. Physicochemical and mechanical characteristics of nanofibers were examined then the clinical evaluation was performed. Eighty patients volunteering for cataract surgery were randomly divided into two groups, one received FDN, and the other treated with ODT of OND after recovery and in case of relieving nausea. The severity of nausea was assessed using a visual analogue scale in the 6 and 24 h intervals after drug administration. The SPSS 25.0 statistical software and statistical tests were used to analyze the obtained data. Results: Nanofibers possessed a mean diameter of 159 ± 30 nm beside suitable physicochemical and mechanical characteristics. Statistical evaluations showed that both FDN and ODT formulations had an equal anti-emetic effect (P>0.05) on reducing the severity of nausea but the FDN formulation caused significantly higher levels of patients’ satisfaction (P<0.05) compared to the ODT. Conclusions: Although both formulations had an almost equal anti-emetic effect, due to the benefits of this novel formulation including rapid disintegration, the ODT can be replaced by FDN.

Development, characterization, in vitro and ex vivo evaluation of antiemetic transdermal patches of ondansetron hydrochloride and dexamethasone

The idea of delivering drugs through skin is old, as the use is reported back in 16th century B.C. The husk of the castor oil plant in water was placed on an aching head. Today the transdermal drug delivery is well accepted for delivering drugs to the systemic circulation. The aim of this study was to design a compound transdermal patches containing ondansetrone HCL and dexamethasone for the treatment of nausea and vomiting in case of chemotherapy and regular symptom of nausea and vomiting. In the present work, an attempt has been made to develop a matrix-type transdermal therapeutic system comprising of Ondansetron-HCl and Dexamethasone in different ratios of hydrophilic and hydrophobic polymeric combinations with 15% w/v plasticizer and 5% w/v penetration enhancer were mixed with the polymer solution polymer were using solvent evaporation technique. The patches were further subjected to various characterization studies for prepared transdermal patches along with the thickness, tensile strength, folding endurance, % elongation, % moisture content, % moisture uptake, % drug content, In vitro drug permeation study on Franz diffusion cells. Obtained results showed no physical-chemical incompatibility between drugs and polymers. On the basis of results obtained from, tensile strength (18±0.16), folding endurance (126 ± 1 to 68 ± 2), % moisture content (2.9±0.4), % moisture uptake, % drug content (92.41 to 98.9 %), TPEC (Transdermal Patches of Ethyl Cellulose) was selected as optimized formulation. In vitro release of the selected batch, TPEC-1 followed by zero-order and formulation showed 62.69 % drug diffusion within 10 hours. Conclusively, the patches were considered to deliver drugs safely through the skin for a longer period often.

Novel potentiometric sensors for determination of ondansetron hydrochloride in pure and dosage form

A new and sensitive potentiometric method has been developed and characterized for four novel sensors responsive to ondansetron hydrochloride.