Santhanamariammal, C (2017) Formulation and Evaluation of Prednisolone Retention Enema as Dispersible Tablet with Vehicle. Masters thesis, Sankaralingam Bhuvaneswari College of Pharmacy, Sivakasi.
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Abstract
AIM AND OBJECTIVE: To formulate and evaluate Prednisolone retention enema as dispersible tablet with vehicle. Prednisolone is a type of medicine called corticosteroid. It decreases immune system’s response in various diseases to reduce symptoms such as pain, swelling and allergic type reactions. Prednisolone is 4 times more potent than hydrocortisone, also more selective glucocorticoid. It reduces inflammation by stopping cells from releasing chemicals that normally help to produce immune and allergic responses47-49. Riboflavin is an integral component of two enzymes FAD (flavin adenine dinucleotide) and FMN (flavin mononucleotide). FAD and FMN are involved in the activity of electron transport chain, an essential component of energy metabolism. Prednisolone decreases the inflammation by inhibiting the migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It suppresses the immune system by reducing the activity and protection of the lymphocytes and eosinopril. Riboflavin helps in this place to increase the energy metabolism in lymphocytes and eosinopril50. The objectives of this study are following To formulate dispersible tablet and vehicle as enema formulation. To select excipients and find any incompatibility between the drug and excipients. To formulate Prednisolone dispersible tablet and vehicle. To perform the precompression and tablets evaluation parameters. To select the best formulation of dispersible tablet. To prepare rectal suspension using best formulation of dispersible tablet. To perform in-vitro drug release study for rectal suspension. To conduct Microbiology studies for the rectal suspension. To perform stability studies for the selected formulation of dispersible tablet.Formulation of vehicle solution for suspending Prednisolone dispersible tablet Formulation of rectal suspension using selected formulation of dispersible tablet. Evaluation of rectal suspension Appearance, Colour, pH, Viscosity, In-vitro drug release study, Microbiological evaluation. Accelerated stability studies.SUMMARY: This work demonstrate that the formulation and evaluation of Prednisolone retention enema as the dispersible tablet with vehicle for the effective treatment of UC. It was carried out by performing the preformulation studies, formulation of Prednisolone dispersible tablet, formulation of vehicle, evaluation parameters, microbiology studies, in-vitro release studies and stability studies. For pure Prednisolone, preformulation studies such as angle of repose, bulk density, tapped density, compressibility index, Hausner’s ratio, moisture content and particle size analysis were performed. The preformulation results revealed that the Prednisolone having poor flow properties, so it may requires glidants. The moisture content showed within 1% and the particle size was found to be fine powder. Drug – excipients incompatibility study was performed by physical observation. That there were no physical changes between drug and excipients. Thus it was concluded that the excipients selected for the formulation were compatible with Prednisolone. Prednisolone dispersible tablets were formulated by direct compression method, wet granulation method and slugging method using crospovidone as superdisintegrant. The formulated powder/granule blend was evaluated for precompression parameters like angle of repose, bulk density, tapped density, Hausner’s ratio, compressibility index and moisture content. The results obtained indicate that F6 formulation formulated by slugging method has good flow property. The moisture content was within 1%. The formulated tablets were evaluated for hardness, thickness, weight variation, friability, disintegration time, wetting time, water absorption ratio, in-vitro dispersion time, uniformity of dispersion and drug content. All these parameters were found to be within the limits for F6 formulation. IR spectroscopic analysis was carried out to determine the compatibility of drug and excipients. The IR spectrum showed that the drug was compatible with excipients, which was used in the F6 formulation. From the data’s obtained from precompression parameters and tablet evaluation F6 formulation was selected for further studies. The rectal suspension was prepared by using F6 formulation. pH and viscosity of the rectal suspension were carried out and the pH was found to be 6.2 and the viscosity was found to be 55.9 cps. In-vitro drug release of Prednisolone from F6 formulation in rectal suspension was 99.07 ± 0.02 % at 60 minutes. The microbiology studies for the rectal suspension with F6 formulation were carried out to determine the presence/absence of microorganisms in the formulation. The results showed that there was absence of microorganisms in F6 formulation in rectal suspension. So the formulation was microbiologically stable. The accelerated stability studies were performed for F6 formulation at three different temperatures such as 40 ± 20 C, 280 ± 20 C and 450 ± 20 C for a period of three months. In this storage condition for the three months period, there were no changes in all the tablets physical parameters. The accelerated stability studies of F6 formulation in rectal suspension (in vitro drug release) was also performed by stored in three different storage conditions for the period of three months. The results showed that there were no changes in percentage drug release.CONCLUSION: Formulation and evaluation of Prednisolone retention enema as dispersible tablet with vehicle for the effective treatment of UC was successfully carried out. Preformulation studies of powder/granules, formulation of Prednisolone dispersible tablets, formulation of vehicle, tablets evaluation parameters, in-vitro release study, microbiological evaluation and accelerated stability studies (three different temperatures) were performed. From all the above observations it was concluded that the formulation F6 by slugging method was better one compared to the other formulations. Thus it can be concluded that the Prednisolone retention enema as dispersible tablet with vehicle possesses promising future delivery of rectal formulation of drugs in suspension form for the effective treatment of UC.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Prednisolone Retention Enema ; Dispersible Tablet ; Vehicle |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Dec 2017 09:25 |
| Last Modified: | 19 Dec 2017 09:25 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4475 |
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