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- 주제어 : Orally disintegration film (ODF) (검색결과 2 건)
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권민주,강한,안준현,조원경,선보경,황성주 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.4
Commercially available orally disintegrationfilms (ODF) for erectile dysfunction were Viagra L 50 and100 mg by Pfizer Pharmaceuticals Korea Ltd., and Mvix S50 and 100 mg by SK Chemicals Co. The comparativestudies of physical property, disintegration and dissolutiontime of four ODFs were carried out to evaluate film formulation. For film physical property, thickness and weightuniformity, tensile strength, dissolving pH, hygroscopicity,morphology, flexibility and polymeric characteristics wereinvestigated. In vitro disintegration studies were implementedby six methods. Conventional disintegration methodwas carried out using USP disintegration apparatus. One sidedisintegration method and both side disintegration methodwere performed by using shaking water bath. Slide framedisintegration method was conducted by contact anglemeasurement. Mouth disintegration method was performedby using two different mediums. One medium was a-amylasefree medium, another was add a-amylase. In vitro dissolutionstudies were carried out using pH 2.0 HCl and pH6.8 PBS. The results were validated statistically. Filmthickness of Mvix S 50 and 100 mg was thinner than that ofViagra L 50 and 100 mg, respectively. Film tensile strengthof Mvix S 50 mg and 100 mg was much higher than that ofViagra L 50 and 100 mg. However, Viagra L 50 and100 mg were more flexible so that it is easier to carry andstore. High hygroscopicity and high porosity in Viagra Lcould contribute to disintegrate film quickly. In six kinds ofdisintegration studies, both Viagra L 50 and 100 mgshowed not only muche faster disintegration time but alsomuch faster dissolution rate.
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불용성 미립자를 이용한 천문동 추출물 함유 분산형 구강붕해필름 개발
정형식,장현상,조영호,이계원 한국생물공학회 2019 KSBB Journal Vol.34 No.3
The purpose of this study is to develop an oral disintegrationfilm (ODF) containing A. cochinchinensis extractusing the insoluble microparticle. ODF was evaluated parameterssuch as physical appearance, thickness, weight variation,surface pH, folding endurance, morphology study byscanning electron microscopy (SEM), swelling ratio and invitro disintegration time. As no unaccountable peaks wereobserved by FT-IR and differential scanning calorimetry (DSC)analysis, so it was confirmed that the purity of developed formulationsand no interaction of excipients with A. cochinchinensisextract. A. cochinchinensis extract loaded film was composedof polymer (pullulan and pectin, 10:1), plasticizer (PEG 400),insoluble microparticle (coral calcium) of < 75 μm and preparedby casting method. It was showed good folding enduranceand peelability. Also it was rapidly disintegrated within 1minutes without irritation in the mouth. Furthermore, it wasstable for at least 3 month when stored at 40±2oC, 70±5% relativehumidity. Therefore, this study can be a guide on developmentprocess condition of ODF containing natural products.
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