Abstract
In this study we formulate Raloxifene hydrochloride, edicated chewing gum to overcome first pass metabolism of it so bioavability increase of drug. We take polyvinyl acetate as chewing gum base. Aspartame, mannitol and sucrose as sweetener. Glycerin as a plasticizer. Beta-cyclodextrine as solubility enhancer and taste masking agent. First we evaluate the API by its melting point after we derived its calibration curve. After this we select proper ratio of Beta-cyclodextrine and API. After we study drug and excipients compatibility by using FTIR. XRD study perform for API and formulation. After we formulate our formulation and perform post-evaluation study like hardness, weight variation, % drug content and % drug release. From all formulation F5 formulation shows best % drug release and % drug content. After we perform stability study for our formulation and after study no major change show in formulation. And in last we perform buccal permeability study. On basis of all study results we can say that our formulation is successfully formed.
 Keywords: Raloxifene hydrochloride, Medicated chewing gum, Buccal permeation, Osteoporosis.
Highlights
IntroductionIn case of BCS class II drugs major problem is solubility
A BCS class II drug has lower solubility and higher permeability
The λmax of Raloxifene hydrochloride in pH 6.8 simulated saliva buffer was determined to be 285 nm, So absorbance are taken at 285 nm
Summary
In case of BCS class II drugs major problem is solubility. We take Raloxifene hydrochloride which is BCS class II drug and having extensive first pass metabolism to the glucuronide conjugates. In this study we formulate medicated chewing gum of this drug. Beneficial side of this project is drug is protect from first pass metabolism, use of sweetener we can improve formulations taste, solubility and dissolution enhance of drug and became more patients compliance. In this study we try to formulate and evaluate medicated chewing gum of Raloxifene hydrochloride
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