Albert, Johny (2017) Formulation and Evaluation of Immediate Release Tablets of Metoclopramide Hydrochloride. Masters thesis, Cherraan’s College of Pharmacy, Coimbatore.
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Abstract
INTRODUCTION: An ideal dosage regimen in the drug therapy of any disease is the one which immediately attains the desired therapeutic concentration of drug in plasma (or at the site of action) and maintains it constant for entire duration of treatment. This is possible through administration of conventional dosage form in a particular dose at a particular frequency. Thus drug may administered by variety routes in variety of dosage form. Oral route is most common and popular route of administration of drug is oral route because of its systemic effect, patient compliance, less expensive to manufacture. Tablet provides high precision dosing. Tablet form is the most widely used dosage form because of self-administration and ease in manufacturing. In most of the cases immediate on set of action is required as compare to conventional therapy. To achieve the rapid onset of action and eliminate the drawbacks of conventional therapy immediate release dosage form is now a days popular and used as an alternative oral dosage form. Immediate release tablet are very quickly after administration. Basic approach used in development is the use of superdisintegrants which provide rapid disintegration of tablet after administration. Aim of the Study: The main aim of the present study is to develop a pharmaceutically equivalent, low cost, quality improved formulation of immediate release dosage form of Metoclopramide Hydrochloride 10 mg for the treatment of emesis. Evaluation and optimization of process parameters as well as finished dosage form also form part of this work comparable to innovator product. The term “immediate release” pharmaceutical formulation includes any formulation in which the rate of release of drug from the formulation or the absorption of drug, is neither appreciably, nor intentionally, retarded by galenic manipulations. These tablets which disintegrate rapidly and get dissolved to release the medicaments. It may be provided for by way of an appropriate pharmaceutically acceptable diluent or carrier, which diluent or carrier does not prolong, to an appreciable extent, the rate of drug release or absorption. Objective: The main objective of this study was: A. To formulate and evaluate immediate release of Metoclopramide hydrochloride tablets. B. To study the release profile of the dosage form and to compare their drug release profiles with the innovator. C. To determine the best fit dissolution profile for dosage form. D. To study the stability of dosage form. SUMMARY: The present study was under taken to formulate and evaluate the immediate release tablets of Metoclopramide hydrochloride by using wet granulation technique with various disintegerants. The study involves pre-formulation ofdrug and excipients, formulation, evaluation and stability studies. Nine formulations of metoclopramide were prepared by using various disintegerant in different concentration. The optimized formulation was selected according to the result found from the evaluation parameter of each formulation. Estimation of drug was carried out spectrometrically by UV method. Pre-formulation study involving FTIR showed no interaction between drug and excipients. The selected drug Metoclopramide was taken and formulated with different concentration of starch, talc and sodium starch glycolate. The tablets were prepared by wet granulation method and then it is punched after subjecting the blend to pre-compression parameters like Angle of repose (25.070), Bulk density (0.63gm/cm), Tapped density(0.72g/cm3), Carr’s Index (12.5%), Hausner ratio (1.14). The results obtained were satisfactory. The Post compression parameters like Hardness (3.7kg/cm2), Weight variation (101.6%), Friability (0.69%), Drug content analysis (99.86%), Disintegeration time (30sec) and In-vitro dissolution studies (99.10 at 15 min) were also carried out and tabulated. Among all these formulations F7 was selected as optimized formulation. The selected optimized formulation was characterized with stability studies. These tablets were subjected to pre-compression parameters and post-compression parameters. These results were compared with the predetermined optimized formulation results. The formulation was found to be stable. The prepared in-vitro dissolution studies of prepared immediate release tablet were compared with that of marketed formulations and were found to be better than them. CONCLUSION: The Present study was conducted to formulate and evaluate the immediate release tablet of Metoclopramide hydrochloride. Pre-formulation study was carried out initially with study of selection of superdisintegrants was done and different formulations were prepared using sodium starch glycolate and starch as disintegerants. Immediate release tablet of Metoclopramide hydrochloride was prepared by wet granulation method. The tablet disintegrated rapidly and has an acceptable friability and hardness. In vitro drug release from the tablets shows significantly improved drug dissolution. Hence it could be concluded that the superdisintegrant based on immediate release tablet of Metoclopramide hydrochloride would be quite effective in emesis, providing quick onset of action on administration.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg. No.261511001 |
| Uncontrolled Keywords: | Immediate Release Tablets ; Metoclopramide ; Hydrochloride |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 26 Mar 2018 06:18 |
| Last Modified: | 26 Mar 2018 06:18 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6604 |
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