Bency Susan, Varghese (2017) Formulation and Evaluation of Colon Targeted Matrix Tablets of Ibuprofen. Masters thesis, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi.
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Abstract
AIM AND PLAN: The aim of present study was to formulate the colon targeted matrix tablet of Ibuprofen and to evaluate the formulation for various parameter to release the active ingredient after predetermine time in a predetermine location with better pharmaceutical and therapeutic properties. Ibuprofen is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties. Ibuprofen has pharmacologic actions similar to those of other prototypical NSAIA, which are thought to act through inhibition of prostaglandin synthesis. The half-life of Ibuprofen is 2-4 hours. It is used in the management of many inflammatory conditions. The increasing incidence of ulcerative colitis has been reported from western countries and other parts of the world. Even in India this disease is diagnosed to be more common. Though, there is need to study the disease and its complications from our country. Inflammatory bowel disease is an uncommon but important health problem. It is particularly likely to affect young people. The present investigation deals with development of effective and stable enteric coated matrix tablet of Ibuprofen for the effective treatment of inflammatory bowel diseases. To formulate Ibuprofen matrix tablets and coated with enteric polymer. To evaluate the formulated tablets as per requirements of IHS standards. To evaluate the most satisfactory formulation. To select the best formulation based on in-vitro studies for colon targeting. To perform stability studies on the most satisfactory formulation.SUMMARY:The present work involves the formulation of colon targeted matrix tablet of Ibuprofen by using direct compression method. Literatures regarding, Ibuprofen tablet dosage form preparation, excipients selection, manufacturing method, etc., has been collected and reviewed. In this work, selection of excipients was done based on a literature review. Excipients include Eudragit S100, Ethyl cellulose, Lactose, Talc, Magnesium stearate. Quantities of the excipients were selected by performing FT-IR method which is an IHS of Fourrts India Laboratory. Preformulation studies have also been performed to study the nature of API and compatibility of API with excipients by physical observation and FT-IR studies. The result showed that API was compatible with all the excipients selected. The tablets were formulated by direct compression method using the selected excipient quantities. The formulated tablets were tested for both pre-compression parameters and post compression parameters as per requirements of standards. Pre-compression parameters such as bulk density, tapped density, compressibility index, Hausner’s ratio and compressibility index. The results obtained indicate that it has good flow property for direct compression. The formulated Ibuprofen matrix tablets were coated with enteric polymer Eudragit FS 30D by pan coating method. The prepared tablets were evaluated for weight variation, hardness, thickness, friability, drug content, disintegration time and in-vitro dissolution studies. All these parameters were found to be within the standard limits. Comparative studies of coated Ibuprofen tablets and uncoated Ibuprofen tablets are evaluated for the hardness, thickness, in-vitro dissolution studies and disintegration time. Out of six formulations, the formulation F6 showed 98.51% drug release at 24 hrs. Since it provide greater protection to the core under acidic condition while at the same time show the fastest drug release under intestinal pH. So the formulation F6 was considered as the confirmatory trial and it was subjected for stability studies up to three months of accelerated stability 400C ± 2C0, 75 % ± 5 % RH and found to be within limits.CONCLUSION: Preformulation studies were performed to study the nature of API and compatibility of API with excipients by physical observation and FT-IR studies. The results showed that there was no interaction between API and all the excipients selected. The Ibuprofen matrix tablets were successfully formulated by direct compression method using the selected excipient quantities. The formulated tablets were evaluated for both pre-compression and post-compression parameters as per requirements of standards. And the results were complied with the pharmacopoeia specification. The formulated Ibuprofen matrix tablets were coated with enteric polymer Eudragit FS 30D by pan coating method. From among the entire batches, formulation F6 showed 98.51% drug release at 24 hrs. Since it provide greater protection to the core under acidic condition while at the same time show the fastest drug release under intestinal pH. So the trial F6 was considered as best formulation. From the results obtained, it can be concluded that formulation F6 containing enteric coated matrix tablet of Ibuprofen would be a promising formulation to achieve the purpose which treat inflammatory bowel diseases (ulcerative colitis) without any gastric irritation or ulcers, which is useful for patients having pre history of ulcerative colitis.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Colon Targeted Matrix Tablets ;Ibuprofen |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Dec 2017 07:38 |
| Last Modified: | 19 Dec 2017 07:38 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4474 |
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