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Psy 6510 Final Exam

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Ameya J. Limaye PMCY 6510 Take Home Final Exam A. Reference drug product: Janumet XR (sitagliptin phosphate and metformin HCl extended release tablets) Selected dosage strength: 50mg sitagliptin, 500mg metformin (once daily for naïve patients currently not treated with metformin) B. Active pharmaceutical ingredients: 1. Sitagliptin: Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Inhibition of DPP-4 prevents breakdown of GLP-1and GIP and allows for an extended stimulation of insulin secretion, along with inhibition of glucagon secretion. This drives overall blood glucose towards a normal value. IUPAC name: (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H- [1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric …show more content…

It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl …show more content…

Limaye PMCY 6510 Take Home Final Exam Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. Metformin belongs to BCS class III with high solubility and low permeability. This also allows for designing a controlled release formulation of metformin hydrochloride. However, due to the high dose amounts and dosing frequency, it has been a challenge to develop once daily metformin formulation. Metformin hydrochloride exists in a single stable crystalline form. There is one known polymorph of metformin hydrochloride, which exists only in a metastable state and hence is out of consideration of this formulation. C. Rationale: Selected dosage form is an extended release oral tablet. Metformin has a relatively short biological half-life of around 5-7 hours. Steady levels of metformin are required for a sustained suppression of glucagon release and insulin sensitization. This warrant multiple doses of metformin everyday for a patient each with a strength of at least 500mg. Majority of the patients being treated for the type 2 diabetes also take metformin in conjugation with some other therapeutic such as sulfonylureas or DPP-4 inhibitors. Hence, formulating an extended release dosage form of metformin along with a DPP-4

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