Nandhini, B (2019) Formulation and Evaluation Studies of Floating Drug Delivery System Containing Cefaclor Antibiotic. Masters thesis, Annai JKK Sampoorani Ammal College of Pharmacy, Komarapalayam.
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Abstract
Drug delivery system plays a pivotal role in the therapeutic efficacy of any drug therapy. This work was aimed to prepare and evaluate a novel drug delivery system of a therapeutically effective and proven drug. In this work, floating drug delivery administration has been selected because floating drug delivery administration appears to be an ideal for the systemic drug delivery. Cefaclor is an effective simple antibiotic drug. Therefore the objective of this thesis was to develop a new floating drug delivery system of Cefaclor, which can be administered through the oral route, particularly to achieve rapid relief by fast onset of action; to increase bioavailability and to avoid the second dose of administration. The work started with the preformulation followed by different trials of formulations. The compatibility study observations showed that, chemically Cefaclor remained unaffected by excipients. • This project of final blend of Cefaclor floating matrix tablets were studied for angle of repose, tapped density, bulk density, compressibility index and Hausner’s ratio. The value of Carr’s Index from 5-16 indicates excellent to good flow of powder. Similarly value of Hausner ratio (< 1.25) and Angle of repose (< 25o) indicates good flow properties of drug. • The absorption maximum of Cefaclor was studied using UV spectrophotometry and found at 264 nm as the max. Using the absorption maxima, linearity was performed and plotted from the concentrations of 5-30 μg/ml was performed and the regression coefficient of the curve was found to be 0.9976. Eleven batches of floating tablet were formulated using Cefaclor 250 mg with hydrophilic polymers, effervescent agent, filler, lubricant and anti-adherent with or without different proportions. • Various formulations show good flow properties. Results of angle of repose (210.22′ – 240.18′), Bulk density (0.337-0.372), tapped density (0.384-0.423), Carr’s index (11.25-17.33) and Hausner’s ratio (1.109-1.195) shows satisfactory results, which is need for better bioavailability. • Evaluation results for hardness of various batches of prepared formulations (10.2 –11.1 kg / sq cm) and friability (0.205 – 0.325 %) indicates that the floating tablets having sufficient strength to withstand the physical abrasion. Tablets of all the batches were passed in the weight variation test as per the limits prescribed in IP (5% deviation is allowed for average weight of tablet X ≥ 250 mg). • In vitro buoyancy study of Cefaclor floating tablets F7 to F11 was found to be satisfactory. It was observed that as the amount of polymer increases the floating lag time decreases. • In vitro dissolution study Formulation F11 is selected as optimized formulation among all the formulations, which shows 94.91 % sustained release at the end of 12 h. Formulation F11 is selected as optimized formulation among all the formulations, which swelled to 121.38 % at the end of 8 hours. • The selected formulation were packed in wide mouth bottle. They were then stored at 25 ºC ± 2 ºC/60% RH, 40 ºC ± 2 ºC/75% RH for 3 months chamber and also evaluated for their physical appearance, drug content, drug dissolution and other studies at specified intervals of time. Long term testing 25 ºC + -2 ºC/60% RH + -5% accelerated testing 40 ºC + -20 ºC/75% RH + -5% for months registered conditions 5 ºC + -3 ºC. Stability studies for the present work carried out at 25 ºC + -2 ºC/60% RH, 40 ºC + -2 ºC/75%. RH for the selected formulation for three months and 5 ºC + -3 ºC refrigerated conditions for 14 days. In the present study the floating tablets of Cefaclor showed better gastric cytoprotection when compared with conventional dosage form. This may be due to its extended duration of release and action. Floating drug delivery of Cefaclor has been an equivalent dose of Cefaclor and the target concentration achieved more rapidly and with less variability in plasma concentrations compared with eternal formulations.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261710804 |
| Uncontrolled Keywords: | Evaluation Studies,Floating Drug, Delivery System, Containing, Cefaclor Antibiotic. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Thavamani K |
| Date Deposited: | 30 Mar 2022 12:46 |
| Last Modified: | 30 Mar 2022 12:48 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19119 |
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