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KMID : 0370220230670060360
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Yakhak Hoeji
2023 Volume.67 No. 6 p.360 ~ p.371
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Formulation and Dissolution Behavior of a New OROS Tablet containing Sarpogrelate Hydrochloride
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Park Jin-Su
Gil Myung-Chul
Cho Young-Ho
Lee Gye-Won
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Abstract
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Sarpogrelate hydrochloride (SGH) is a drug that improves ischemic symptoms such as ulcers, pain, and feelingof cold caused by chronic arterial occlusion, and has a short half-life of 0.6 to 0.8 hours. Also, reference drug (SarpodipilⓡSR tablet) is affected by drug release depending on pH. To overcome this, the osmotic controlled release oral deliverysystem (OROS) utilizes push-pull osmotic pump (PPOP) technology that can achieve zero-order drug release over 24 hoursby osmotic pressure. OROS tablet is double-layer tablet consisting of a drug layer (L200-PEO) and a push layer (H5,000-PEO). OROS tablet coated with a semi-permeable film has a orifice of a certain size made by a laser drill, so that thedrug is released at a constant rate. The dissolution of the OROS tablet was not affected by the amount of sodium chloridein the drug layer and the number of orifice, but was affected by amount of coating, cellulose acetate (CA) : polyethyleneglycol 3350 (PEG 3350) ratio and the size of orifice. Accordingly, as the amount of coating increased and PEG 3350decreased, the dissolution rate decreased. The developed OROS tablet (formulation C), unlike the reference drug, is notaffected by pH, showing high similarity factors of 76.0, 86.1, and 91.2 at pH 1.2, pH 4.0, and pH 6.8 when comparedto distilled water. In conclusion, we developed OROS tablet containing SGH, showing zero-order release that continuouslyreleases the drug for 24 hours regardless of pH, and confirmed the factors affecting dissolution.
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KEYWORD
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Sarpogrelate hydrochloride, OROS, Similarity factor, Zero-order release, PEO, PEG 3350
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