1. Dissolution tester Pharma test GembH (Germany) Pharma test GembH (Germany)

2. 용출 시험의 정의 용출 시험이라 함은 정제, 산제, 좌제 등의 제형을 용매가 채워진 정해진 규격의 vessel 에 투입하여 녹아 나오는 정도를 측정하는 것으로, 이때 시간에 따라 녹아 나오는 정도에 대한 정보는 인체 내에서의 활성 물질의 반응과 제품의 제형에 대한 품질관리에 매우 중요한 자료가 된다.

3. 품질관리 용출 되는 정도의 곡선이 주어진 기준 곡선과 부합하는가 ? 용출 되는 활성성분의 양이 주어진 각각의 시간에 따라 주어진 그래프와 일치 하는가 ? Example: Dissolved amount: After 5 min = 30 % OK/NOK? After 20 min = 80% OK/NOK? After 50 min = 85% OK/NOK?

4. 연구 및 개발부 Pharmaceutical oral dosage form (tablet, etc.) In vivo Drug release Dissolution Characteristics (time, where is the dosage form dissolving, dissolution curve etc.) ?

5. 약전에 주어진 규격 Shaft Material, Size and Wobble Vessel Material and Dimension Paddle Dimension Stirring Speed (± 4%) Sampling Position Centring of Stirring Tool Paddle Position Temperature (37 ± 0.5 °C) Media must be deaerated

6. 용출 결과에 영향을 끼치는 인자들 TypeRatingInfluence degree TemperatureNot too significantlinear Speedsignificant10-30% Vibrationreasonable5-10% Centricityreasonable± 5-15% Dissolved Gassignificant± 50% Media pHreasonable± 5-10% Media Contaminationsignificant± 20-45% Sampling positionNot too significant± 1-3%

7. 기계적인 인자의 calibration Calibration parameter Usp24 tolerances Point of measurement Proposed tolerances Proposed frequency Height check 25±2 ㎜ Paddle/basket bottom 25±2 ㎜ At time of use if vessels are removed Basket wobble ±1 ㎜ as run out Bottom of basket rim ≤1.0 ㎜ total run out Every 3 months Rotational speed ±4%Not applicable±1 rpmEvery 3 months Vessel/shaft centering 2 ㎜ from center line Center line 2 ㎜ from center line Every 3 months Vessel temperature 37±0.5°CNot applicable37±0.5°CAt time of use Bath levelLevelBase plateLevelEvery 3 months Shaft wobbleno significant wobble 2 ㎝ above top of paddle blade ≤0.5 ㎜ total run out Every 3 months Paddle/basket dimensions See USP Upon receipt

8. Vessel dimensionsSee USP Upon receipt Degassing technique NCDA2 passes calibration Not applicableNCDA2 passes calibration Once per year Proposed parameters under investigation Paddle/basket examination NoneNot applicableNo gross defects as determined by visual inspection At time of use Shaft verticalityNoneAbove vesselVertical as measured by a bubble level Every 3 months Visual inspection of belts; check ball bearings NoneNot applicableBelts are tight, clean, free of cracks, properly aligned; shaft turns freely Every 3 months VibrationNoneBase plate while operating at 100 rpm ≤  0.2mil Every 3 months

9. 약전에 의한 용출법 Apparatus 1 Apparatus 2 Apparatus 3 Apparatus 4 Used for Tablets, Capsules, especially when the media is changed during the test run Standard Apparatus, used for solid dosage forms BioDiss: Used when the medium and the pH is changed continuously Used for lipophilic solid dosage forms suppositories and soft capsules

10. Apparatus 5 Apparatus 6 Disks and Extraction cells are used to test transdermal patches. The Rotating cylinder is used to Test Transdermal patches. PTSWO: Special Tester for Suppositories, Soft Gels and similar products

11. 탈기, 용매의 제조 “ The United States Pharmacopoeia (USP) ” recognises that dissolved gases in the Dissolution Media may affect Dissolution Test Results and recommends that gases should be removed before the test is performed ” (USP23/NF18) Prepared Medium to reproducible standards USP prescription of : Heating, Circulating and Vacuum The Temperature of the Media must be in the range of 37 +/- 0,5 °C

12. 탈기의 중요성 Particle with associated air bubble. The dissolution process is highly influenced.

13. Media preparation system

14. PT-DDS 4

15. 용출기의 구성 실례 1. Auto sampling system 2. Flow through cell

16. 3. On-line UV analyze 4. On-line LC analyze

17. Pharma test 용출기의 우수점 Vibration absorber

18. Drawer Staggered Start PHARMA TEST offers a staggered start feature since more than 28 years now. Stirrer clamp screw

19. Stirrer drive Built-in Printer A built-in printing center which will print a Test Log (speed, temperature, sampling sequence, detected errors) but also a PQ slip which can be used to record the Qualification Results of the Dissolution Bath

20. interchange 의 편리성 pH meter(option) 가 부착되 어 있어 용매의 pH 를 monitoring 할 수 있음 paddle 의 회전축에 다공판 을 설치하여 paddle 의 회전 에 따른 pulse 를 감지하여 rpm 을 자동으로 조정. 자체에 validation program 과 calibration program 이 내 장 Self-diagnostic system 독일에서 생산되고 pharma test 사에서 품질과 성능을 인증하는 제품임