Karunanithy, R (2021) Development and Evaluation of Multi-Layer Controlled Release Tablet of Pentoxifylline. Masters thesis, C. L. Baid Metha College of Pharmacy, Chennai.
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Abstract
In the present study an attempt was made to prepare Pentoxifylline Extended release tablet for the treatment of Peripheral artery disease. CHAPTER 1: begins with a general introduction presenting an overview of about extended release drug delivery systems. In the part of introduction, the advantages, disadvantages, mechanism of extended release systems and matrix tablets were discussed thoroughly. CHAPTER2: described the literature related to this work was surveyed and a brief discussion had been given on each literature. CHAPTER 3 : detailed the aim and objective of the present study. CHAPTER 4: described the plan of the work. CHAPTER 5: gives information on the selection of drugs and excipients; thereby pentoxifylline is suitable candidate for extended release dosage form. CHAPTER 6: deals with the materials and methods used in the present study was given. This chapter covers the details of the experimental methods including evaluation of the core and coated tablets, evaluation of physical mixture, determination of swelling index and also about release kinetics. CHAPTER 7: Includes the results and detailed discussion of all the formulations, all the qualitative and quantitative parameters were analyzed and tabulated. The drug excipient compatibility study was done and found to have no interactions. The precompression parameters (bulk density, tap density, Carrs index, and angle of repose) of the prepared tablets were within the ranges given by official standards, indicating that the physical mixture was found to be free-flowing. In vitro dissolution studies were done for Felodipine Extended release tablet prepared with different concentration of polymer HPMC K4M low viscosity grade and HEC high viscosity grade. Formulation F8 was found to be 94.75% drug release at the end of 12th hours which was within the USP limits. The kinetic of drug release for formulation F8 was calculated and plotted. The formulation F8 follows zero order release kinetics and the drug release mechanism was found to be non-fickian (anomalous) diffusion. The optimized formulation was compared with marketed product and showed similar release profile. The optimized tablets, F8 were selected for stability studies were carried out according to ICH guidelines at 40ºC /75 % RH for a specific time period indicated that the physical parameters and drug release characteristics were not altered significantly showing good stability on storage. CONCLUSION: Pentoxyfylline multi-layered tablets consist of 400 mg prepared by wet granulation technique that can provide zero-order release where the tablet core coated with a hydrophilic and hydrophobic layer as barrier layer with 4, 6, and 8 % of weight gain. Three batches with different ratio of polymer were prepared for every proposed weight gain so as to make 9 batches (3X3). It is evident that an increase in the cover area of the core tablet results in a decrease of drug release from the system since the cover acts as a barrier hindering the contact of the liquid with the core surface and decreases dissolution rate and provided controlled release. The formulation containing 8% of polymer (6% of HPMC K4M and 2% of HEC) (F8 batch) followed the desired release profile and selected for further studies. The optimized formulation follows zero order release pattern (R2.9942 with rate of release 7%/hr) and the drug release mechanism was non-fickian (anomalous transfer). Therefore, swelling and diffusion mechanisms were found to be responsible for the prolonged release of pentoxifylline from formulated matrix tablets. The optimized formulation compared with marketed formulation, were found to have a similar In vitro release profile, which is confirmed by f1 and f2 values. In terms of physical properties and drug content, the formulation (F8) was found to be stable for 3 months under accelerated conditions.
| Item Type: | Thesis (Masters) |
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| Additional Information: | 261910010 |
| Uncontrolled Keywords: | Development, Evaluation, Multi-Layer Controlled Release Tablet, Pentoxifylline. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Subramani R |
| Date Deposited: | 01 Nov 2022 02:58 |
| Last Modified: | 01 Nov 2022 02:58 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20853 |
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