Preparation and characterization of sustained release film and tablet using physicochemically modified rice starch
Preparation and characterization of sustained release film and tablet using physicochemically modified rice starch
- 주제(키워드) glutinous rice starch , thermally modified rice starch , spray-dried thermally modified rice starch , crosslinking , film , sustained release
- 발행기관 아주대학교
- 지도교수 이범진
- 발행년도 2016
- 학위수여년월 2016. 2
- 학위명 석사
- 학과 및 전공 일반대학원 약학
- 실제URI http://www.dcollection.net/handler/ajou/000000021576
- 본문언어 영어
- 저작권 아주대학교 논문은 저작권에 의해 보호받습니다.
초록/요약
The aim of this study was to investigate a novel, biodegradable, spray-dried, thermally modified rice starch (SDTMR) as a film-forming agent and retardant polymer for preparing the solid dosage form. Films were prepared by the solvent casting method, and tablets were prepared by direct compression of drug-loaded powder. Sarpogrelate HCl was chosen as the model drug. Calcium chloride (CaCl2) and magnesium chloride (MgCl2) were utilized as crosslinking agents to obtain the desired effect. The size, surface morphology and crystallinity of starch powders (glutinous rice starch (GR), thermally modified rice starch (TMR) and SDTMR) were characterized by a particle size analyzer, scanning electron microscopy (SEM) and powder x-ray diffraction (PXRD). The surface morphology and roughness of the starch films were characterized by confocal laser scanning microscopy (CLSM). The tensile strength and elongation of the film were determined by a texture analyzer. The physical properties of tablets, such as weight, thickness and hardness were also measured. Swellability and erosion of the tablets were then analyzed by gravimetric evaluation. In vitro dissolution testing was performed in gastric fluid (pH 1.2 buffer) and intestinal fluid (pH 6.8 buffer). The crystallinity of TMR and SDTMR was transformed from the crystalline to the amorphous state. The SDTMR film had a smoother surface than the TMR and GR films. In pH 6.8 buffer, SDTMR film crosslinked with CaCl2 showed a significantly higher sustained drug release compared to SDTMR crosslinked with MgCl2. In conclusion, physicochemically modified rice starch provides a promising approach to prepare pharmaceutical film and tablets with sustained release.
more목차
1. Introduction 1
2. Materials and methods 9
2.1. Materials 9
2.2. Preparation of rice starch 9
2.2.1. Preparation of thermally modified glutinous rice starch (TMR) 9
2.2.2. Preparation of spray-dried thermally modified glutinous rice starch (SDTMR) 9
2.3. Preparation of drug-loaded starch film and tablet 10
2.3.1. Preparation of drug-loaded starch film 10
2.3.2. Preparation of drug-loaded starch tablet 11
2.3.3. Tablet compression 11
2. 4. Characterization 16
2.4.1. Characterization of modified rice starch 16
2.4.1.1. Particle size analysis 16
2.4.1.2. Scanning electron microscopy (SEM) 16
2.4.1.3. Powder x-ray diffraction (PXRD) 16
2.4.1.4. Loss-on-drying (LOD) 17
2.4.1.5. pH measurement 17
2.5.1. Characterization of starch film and tablet 17
2.5.1.1. Thickness evaluation 17
2.5.1.2. Tensile strength and Elongation of film 17
2.5.1.3. Viscosity measurement 18
2.5.1.4. Confocal laser scanning microscopy (CLSM) 18
2.5.1.5. Swelling and erosion studies of tablet 18
2.5.1.6. Drug content determination of film 20
2.5.1.7. In vitro dissolution study 20
2.5.1.8. High performance liquid chromatography (HPLC) analysis of Sarpogrelate HCl 20
3. Results and discussion 23
3.1. Characterization of modified rice starch 23
3.1.1. Particle size of modified rice starch 23
3.1.2. Surface image of modified rice starch 23
3.1.3. Crystal structure of modified rice starch 25
3.1.4. Water content of modified rice starch 27
3.1.5. pH measurement of modified rice starch 27
3.2. Characterization of film and tablet 29
3.2.1. pH measurement and viscosity of film 29
3.2.2. Photographs and roughness of film surface without drug 31
3.2.3. Photographs and roughness of film surface with drug 34
3.2.4. Mechanical properties of film 38
3.2.5. Crystal structure of drug-loaded film 40
3.2.6. Physical properties of tablet with drug 42
3.2.7. In vitro dissolution studies of film and tablet 44
3.2.8. Swelling and erosion studies of tablet 51
4. Conclusions 54
5. References 55
국문초록 59
감사의글 61
