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FORMULATION, INVITRO AND INVIVO EVALUATION OF TASTE MASKED ORAL DISINTEGRATING TABLETS OF FAMOTIDINE
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| Author:
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NAGADANI. SWARNALATHA, VIDYAVATHI MARUVAJALA, KIRAN KUMAR
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| Abstract:
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The present research work was aimed at masking of the bitter taste of Famotidine and development of an orally
disintegrating tablet (ODT) of the taste-masked drug by invitro and invivo evaluations in comparison with marketed
tablets. In this present study, Eudragit EPO was used as the taste masking agent and sodium starch glycolate,
crospovidone and croscarmellose sodium were used as superdisintegrants. Wet granulation method was used to
prepare taste masked granules of Famotidine using different ratios of Famotidine and Eudragit EPO (1:1, 1:1.5, 1:2).
The optimum ratio (1:2) of drug and Eudragit EPO was selected based on taste masking effect to prepare ODT of
Famotidine using different percentages (3%, 6%, 9%) of three super disintegrants (FF1-FF9) by direct compression
method. These were evaluated for thickness, weight variation, hardness, friability, disintegration time, wetting time,
water absorption ratio, %drug content and invitro drug release. Then desirability function (DF) was calculated using
disintegration time, t90% as significant parameters. The best formulation (FF9) showed highest DF value due to less
disintegration time and 100% invitro drug release with in 10mins. Thus, FF9 was selected as the best among the
prepared formulations to which stability studies were conducted. From the stability studies, it was confirmed that FF9
tablets are stable as there were no changes in the results of different parameters after storage at 40º±2ºC and RH
75%±5% for 3 months in a stability chamber. Invivo studies were performed on rabbits with the best selected
formulation to find Cmax, tmax, AUC, Kel and t1/2. The total bioavailability (AUC0-24 and AUC0-a) was increased for
test formulation compared to reference formulation (Fluxid). From the results of invivo pharmacokinetic studies, it
was concluded that, Famotidine was successfully prepared as ODT with increased AUC and decreased tmax than
marketed formulation.
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| Keyword:
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HPLC, Famotidine, Ranitidine, Internal standard. INTRODUCTION During the last decade, oral disintegrating tablets have received ever more demand [1]. Drugs that are showing great absorption from oral mucosa and are intended for instant pharmacological action are well suitable to formulate into ODT [2]. Difficulties in swallowing of tablet and pill also occur while water isn't available, in diarrhoea, cough, allergic condition and bronchial contamination [3]. About third of the population (in particular pediatric and geriatric) has swallowing difficulties, resulting in to poor compliance with oral pill drug remedy which leads to reduced average remedy effectiveness. For those motives, tablets that can swiftly dissolve or disintegrate within the oral cavity have attracted an extremely good deal of attention due to avoiding of swallowing difficulties. Maximum oral disintegrating tablets should include substances to mask the bitter taste of the active ingredient. The taste masked active ingredient can be easily swallowed by saliva along with the soluble and insoluble excipients [4, 5]. As it will be a soft paste or liquid form, and thus it becomes
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2019.11.02.047
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