Abstract
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 thickness and diameter was in the range of 2.646 to 3.27 mm and 6.0 to 8.12 mm, respectively. Friability was in the range of 0.43 to 0.88 % and had a slightly higher friability (1.27%) for sublimated tablets. Wetting time and disintegration time were in the range of 15 to 40 sec and 23 to 50 sec, respectively. The 100 % drug release was found within 180 sec for all the codes. These results were then compared with non-ethical film coated ondansetron marketed tablets.
 Conclusion: Ondansetron hydrochloride MDT 4 mg tablets prepared in the laboratory were under specified IP limits. The experimental findings demonstrated that any of these ethical and non-ethical tablets of ondansetron hydrochloride can be selected, advised by the physician or pharmacist, as per the patient’s need and economical status.
Highlights
Oral administration of tablets is still the best choice of method to treat various disorders over several novel drug delivery systems [1]
Absorption maxima of ondansetron hydrochloride Standard plot of ondansetron hydrochloride is shown in fig
The FTIR spectrum obtained for ondansetron hydrochloride and the data are shown in fig. 5 and table 5 respectively
Summary
Oral administration of tablets is still the best choice of method to treat various disorders over several novel drug delivery systems [1]. For testing the quality of a finished tablet product, evaluation parameters such as hardness, friability, disintegration time, and dissolution profile study are more precise since it reflects the therapeutic effectiveness and bioavailability of the drug [5]. Some of the studies showed dissimilar results in post compression parameters among different marketed products that contain same active pharmaceutical ingredients [6,7,8]. In some conditions tablets with same drug or drug content may not be giving a same therapeutic response, which may be due to the different rate and extent of absorption, varying purity of the drug, and by using various types of excipients etc. [9,10,11] These reports demonstrate the importance of comparative study of different marketed products with the same active ingredients
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