Karpagavalli, P (2017) Formulation and Evaluation of Repaglinide Immediate Release Tablets with Improved Dissolution Using Solid Dispersion Technique. Masters thesis, J.K.K. Nattraja College of Pharmacy, Kumarapalayam.
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Abstract
AIM AND OBJECTIVE: The aim of the present work is to investigate the possibility of obtaining immediate release tablet of repaglinide with improved dissolution using Solid dispersion technique. Basic goals in the immediate release tablets are to increase patient compliance, ease of administration, safety and appropriate dosing. Orally disintegrating formulations are provide benefits for pharmaceutical companies like lifecycle management , line extension, market expansion, cost effective drug development programs. Immediate release tablet has perceived faster onset of action. repaglinide is a white or half white powder, relatively insoluble in water. It is a class 2 drug according to BCS Classification Solubility and dissolution was improved by formulating solid dispersion. The advantage of this delivery system, in the present study were made to formulate immediate release tablet repaglinide, which is useful to reduce sudden increased glucose level in the treatment of non- insulin dependent diabetes mellitus (NIDDM). The direct compression was used to compress the tablets as it is easy way to manufacture tablets. Conventional equipments, commonly available excipients and limited number of processing steps are involved in direct compression and so manufacturing cost is low. Tablets produced by direct compression are relatively strong and hardness and have less friability. In the present study immediate release drug delivery system of repaglinide were successfully developed in the form of mouth dissolving tablets with improved dissolution characteristic by forming solid dispersion with PEG 6000, which offers a suitable and practical approach in serving desired objective of faster disintegration and dissolution characteristics with increase bioavailability. Immediate release tablets of repaglinide were prepared by using natural superintegrants like microcrystalline cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate and their combination as superdisintegrants. Superdisintegrants work as an auxiliary or as a facilitator of the flowability and compressibility of the mixture and contribute to the immediate release of the tablet, due to its high solubility in water. For the repaglinide formulation, batch No. 2 was chosen as it has disintegration time around 5-35 seconds and hardness3.5 Kg/Cm2. IR spectra of drug with other excipients has not shown any interaction and also selected formulation was stable after stability studies. CONCLUSION The solubility and dissolution rate of repaglinide can be enhanced by formulating SDs of repaglinide with PEG 6000.The solubilization effect of PEG 6000, reduction of particle aggregation of the drug, formation of microcrystalline or amorphous drug, increased wetability and dispersibility, and alteration of the surface properties of the drug particles might be responsible for the enhanced solubility and dissolution rate of repaglinide from its SD and to some extent in PMs. No endothermic peak of repaglinide was present in of SDs with PEG 6000 suggesting the absence of crystalline repaglinide. From FTIR spectroscopy, it was concluded that there was no well defined chemical interaction between repaglinide and PEG 6000 in SDs and in PMs, as no important new peaks could be observed. The identical composition of Superdisintegrants showed that a substantial shorter time require for disintegration can be obtained and immediate release tablet were prepared. The repaglinide immediate release tablet (F2) showed 78.72% drug release within first 5 min. and 99.50% drug release with in 30 min. The results showed that the formulation satisfied the objective of fast disintegration, dissolution, % friability, hardness, wetting time, water absorption ratio, ease of administration and safety. Success of the present study recommends a detailed investigation in to in-vivo studies for its effective use in clinical practice.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Repaglinide ; Immediate Release Tablets ; Solid Dispersion Technique |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Dec 2017 07:22 |
| Last Modified: | 19 Dec 2017 07:22 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4468 |
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