Pushparaj, Cheemakurthi (2012) Solubility Enhancement of BCS Class II Drug By Solid Dispersion Technique – Fabrication and Evaluation. Masters thesis, C L Baid Mehta College of Pharmacy, Chennai.
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Abstract
This present investigation is to enhance solubility of raloxifene hydrochloride by formulating as solid dispersions.To effectuate this formulation, solubility trials are performed with different carriers to enhance the solubility, dissolution rate and consequently bioavailability of the drug. Carriers like polyethylene glycol, polyvinyl pyrrolidine, polyvinyl alcohol, polaxamer, polyplasdone, sugars, cellulose polymers and cyclodextrins. Further various molecular weight grades of these polymers are used to prepare the solid dispersion. The main objectives of this study are To prepare the solid dispersion of raloxifene hydrochloride using different carriers by solvent evaporation technique, To analyse the drug and carrier interactions by FTIR study. To evaluate the solubility and invitro drug release of solid dispersions. To prepare the immediate release tablets. To evaluate the drug release from the tablets prepared with solid dispersion by invitro dissolution studies. The objective of this study was to prepare Raloxifene hydrochloride solid dispersions with an aim to improve the solubility and dissolution rate by using different carriers. Raloxifene hydrochloride is a selective estrogen receptor modulator used as anti osteoporotic agent in post menopausal. It is available as pale yellow crystalline and is practically not soluble in water. Based on the biopharmaceutical properties RLX was selected as a drug candidate for improving its solubility and dissolution rate. Solid Dispersions were prepared using various carriers by solvent evaporation method. They were evaluated for flow properties and drug release studies. Preformulation studies were performed on RLX and carriers used in the formulations and they found to be compatible. Characterization was done by FTIR study and interpreted that they were compatible without interactions. Solid dispersions prepared by solvent evaporation method using different carriers at 1:1 ratio and they showed enhanced solubility as compared to API. Carriers, ß-cyclodextrin, polaxomer and polyplasdone showed enhanced dissolution rate. The flow properties such as angle of repose and carr’s index were evaluated and found to be excellent flow characteristics and fair compressibility index. The direct compression process was found to be suitable for compressing solid dispersions as tablets. Evaluation of tablets was performed and they were in specified limits. Based on the dissolution profiles of solid dispersions and their tablets it is concluded that solubility of raloxifene hydrochloride is enhanced using inclusion complex (ß-cyclodextrin), hydrophilic polymer (PVA) and surfactant (polaxomer).
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Raloxifene; Hydrochloride; Bioavailability; Polyvinyl pyrrolidine; cyclodextrins |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 18 Aug 2017 07:16 |
| Last Modified: | 18 Aug 2017 07:16 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/2683 |
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