표제지
개요
목차
Ⅰ. 서론 11
1.1. 개요 11
1.2. 친수성 매트릭스 제제 특징 12
1.3. 첨가제 영향 12
1.4. 모델 약물 13
1.5. 연구목적 13
Ⅱ. 실험 재료 및 방법 14
2.1. 실험 재료 및 시약 14
2.2. Matrix 제조를 위한 HPMC 선정 15
2.3. HPMC 팽윤 비교 15
2.4. 첨가제 선정 16
2.5. 첨가제의 상대적 용해 속도 비교 16
2.6. 첨가제에 따른 제제 설계 연구 17
2.7. FST2204 제제(FST2204/Matrix) 제조 17
2.8. FST2204/Matrix 정제 내 첨가제 영향 확인을 위한 용출 시험 18
2.9. FST2204/Matrix (RB100 - RB106) 정제 성상 관찰 18
2.10. PEG 6000 사용량에 따른 FST2204/Matrix 용출 시험 19
2.11. 첨가제 2 종 혼합에 따른 FST2204/Matrix 용출 시험 20
2.12. HPMC 2910 점도에 따른 FST2204/Matrix 용출 시험 21
Ⅲ. 결과 및 고찰 22
3.1. HPMC 정제 특성 22
3.2. HPMC 정제 팽윤 양상 22
3.3. 첨가제 정제 특성 23
3.4. 첨가제 상대적 용해 속도 비교 24
3.5. 첨가제 유형에 따른 FST2204/Matrix 정제 특성 25
3.6. 첨가제 유형에 따른 FST2204/Matrix 정제 용출 특성 26
3.7. PEG 사용량에 따른 FST2204/Matrix 정제 용출 특성 28
3.8. 첨가제 2종 혼합에 따른 FST2204/Matrix 정제 용출 특성 29
3.9. HPMC 2910 점도에 따른 FST2204/Matrix 정제 용출 특성 30
Ⅳ. 결론 31
참고문헌 60
Abstract 64
Table 1. Excipients sample for relative swelling volume comparison 33
Table 2. Tablet design of Hydrophilic excipients for relative disintegration time. 34
Table 3. Design of FST2204/Matrix formulation by excipients type. 35
Table 4. Design of FST2204/Matrix formulation according to used amount of Polyethylene glycol 6000 36
Table 5. Formulation design according to amount of HPMC 2910 6 cps usage. 37
Table 6. Formulation design based on HPMC 2910 grade. 38
Table 7. Physical properties of tablet according to HPMC 2280 grade (n = 3). 39
Table 8. Relative swelling thickness comparison of tablet. 40
Table 9. Physical properties of excipients tablet (n = 3). 41
Table 10. Time to takes disintegration a tablet (n = 3). 42
Table 11. P20000 disintegration time depending on whether sinker is used or not (n = 3). 43
Table 12. Physical Properties of FST2204/Matrix tablets with excipients (n = 3). 44
Table 13. Dissolution rate depending on the type of water-soluble excipients at 50 rpm for 8 h (n = 3). 45
Table 14. Dissolution rate depending on the type of water-soluble excipients at 100 rpm for 4 h (n = 3). 46
Table 15. Dissolution rate according to used amount of Polyethylene glycol 6000 (n = 3). 47
Table 16. Dissolution rate according to used amount of HPMC 2910 48
Table 17. Dissolution rate according to HPMC 2910 viscosity (n = 3). 49
Figure 1. Chemical structure depiction of FST2204 50
Figure 2. Flowchart of FST2204/Matrix manufacturing process 51
Figure 3. Swelling pattern of the tablet according to HPMC 2208 grade 52
Figure 4. Photographs of HM8-4M, HM8-15M, HM8-100M tablet after the comparison swelling test during 12 h. The part marked with the arrow remains in powder form. 53
Figure 5. Disintegration process of Polyethylene glycol 6000. Dissolution following by surface erosion was shown. 54
Figure 6. Dissolution profile of FST2204 from FST2204/Matrix (RB100 - RB106) in 0.05M phosphate buffer (pH 6.8). The dissolution test was conducted in USP... 55
Figure 7. Dissolution profile of FST2204 from FST2204/Matrix (RB100 - RB106) in 0.05M phosphate buffer (pH 6.8). The dissolution test was conducted in USP... 56
Figure 8. Picture of FST2204/Matrix (RB100 - RB106) in pH 6.8 buffer at 3 h during dissolution test to confirm the table swelling 57
Figure 9. Dissolution profile of FST2204 from FST2204/Matrix (P6-0, P6-1, P6-2, P6-3, P6-4) in pH 6.8 buffer. The experiment was conducted in USP Apparatus 2... 58
Figure 10. Dissolution profile of FST2204 from different FST2204/Matrix (PHM-0, PHM-1, PHM-2) in pH 6.8 buffer at 100 rpm for 2.5 h (USP Apparatus 2).... 59