Agilent 8453 Spectrophotometer and UV-visible ChemStation for Dissolution Testing. Solution Bundles for automated Dissolution Testing

Transcription

1 Agilent 8453 Spectrophotometer and UV-visible ChemStation for Dissolution Testing Solution Bundles for automated Dissolution Testing

2 General considerations UV benefits Simple, rugged and reliable equipment - lower investment and maintenance costs - lower downtime Online measurements and fast results Ease of operation and faster validation - less operator time UV disadvantages No physical separation of components Only compounds with a sufficient extinction coefficient can be analyzed No direct identification of impurities or decomposition products 2

3 General considerations LC benefits Physical separation and identification of entire formulation - most information about test Several different detectors applicable - larger variety of formulations can be analyzed LC disadvantages More complex equipment - less reliable and higher price More parameter to control Extra column, solvent and vials required - higher costs per analysis Longer analysis time 3

4 Agilent Dissolution Solution UV Analysis Dissolution Testing Solution based on: 8453 Spectrophotometer 3 different sampling systems (automated) ChemStation for UV-Visible Spectroscopy Design Goals: Compatibility Scalability Flexibility Ease-of-learning and Ease-of-use Regulatory Compliance Tools Page 4 of 14

5 How are samples analyzed? Sampling Concentration at defined time points for ingredient(s) On-line monitoring (fiber optics) : no sample transfer Manual sampling: sample collection by operator Fraction collector: automatic sample drawing and storage Off-line sample analysis On-line analysis: real-time acquisition, fast analysis required, immediate results 5

6 General considerations off-line Advantages No direct link to analytical instrument Less complexity of setup Analytical equipment not tied to dissolution run Sample storage with the ability of repetitive analysis Allows for longer analysis time even with short sampling times Disadvantages Vials for storage required Requires non decomposing ingredients Results typically available after completion of the run 6

7 On-line analysis Advantages Immediate results Automated runs Higher reproducibility, reliability of results Frees valuable operator time Disadvantages Instrument tied to dissolution tester Requires short measurement and analysis time Investment cost 7

8 On-line sampling with the 8453 G1127A Multicell based Sampling (parallel) Advantages Fast cycle time (< 2 min) No medium loss (closed loop system) No cross-contamination Simultaneous sampling (compatible with "basket" method) Disadvantages Multiple flow cells Most expensive sampling system 8

9 On-line sampling with the 8453 G1128A Valve based Sampling (sequential) Advantages Single cell Reliable Less expensive Disadvantages Longer cycle times between time points (5, 7.5 or 10 min cycle) Medium loss (to waste) Potential sample carryover Vessel-to-vessel delay (may be incompatible with "basket" method) 9

10 On-line sampling with the G1129A Multi- Apparatus Valve Sampling (sequential, parallel) Advantages Single cell Reliable Lowest cost per apparatus Disadvantages Longer intervals between time pts. (5, 7.5 or 10 min cycle) Lost medium Potential sample carryover Vessel-to-vessel delay (may be incompatible with "basket" method) 10

11 Agilent UV-Visible Spectroscopy Systems The 8453 Spectrophotometer Agilent 8453 UV-Vis Spectrophotometer nm Wavelength Range - 1nm Slit Width, 1nm Sampling Interval second Full Spectrum Scan - Fully EP & USP compliant -> improved Resolution, lower Stray Light - Instrument logbooks -> GLP Key advantage: spectral information by default Acquisition as fast as a single reading on conventional equipment 11

12 Spectrophotometer Instrument Design Conventional single-beam Spectrophotometer Diode Array Spectrophotometer Monochromator Detector Polychromator Sample Detector Exit slit Dispersion element Entrance slit Dispersion element Light source Entrance slit Light source Sample 12

13 UV-Visible ChemStation Software Product Structure Advanced Add-on product Advanced Security Pack Add-on product Dissolution Add-on product Dissolution Testing Multibath Dissolution Testing Combined Report General Purpose Base product Security Pack Add-on product Biochemical Analysis Add-on product Kinetics Thermal Denaturation Standard Execute Advanced Verification and Diagnostics 13

14 Dissolution Testing Mode Main Screen 14

15 Agilent Bath Driver Concept Agilent 8453 Spectrophotometer Sample transfer LAN, GPIB RS232 Agilent ChemStation DDE Connection Data transfer Bath Driver DDE Connection 15

16 Dissolution Apparatus Control Agilent Apparatus Driver G7900AA Via Dissolution method Direct Control Dialog Online Monitoring and Check of apparatus parameter Variable Data Reading Frequency Data Integration into a single results file Supported Apparatus Models: Agilent 708-DS/709-DS VK 7025 VK 7000/

17 Dissolution Testing Mode Single Component Quantification Standard Unlimited number of standards Choice of four calibration curve types Single, average or three-point background correction Advanced Any combinations of wavelengths Any spectral processing (e.g. derivative + smooth) Least squares or Maximum Likelihood fit Single or multi-wavelength values 17

18 Dissolution Testing Mode Multi-component Quantification Advanced (only) Unlimited number of standard spectra Any spectral processing (e.g. derivative) Calibration with pure component standards or with mixed component standards Least squares or Maximum Likelihood fit Graphical and statistical evaluation tools standard deviation for each analyte the standard deviation of calibration Can eliminate the need for chromatographic separation 18

19 Agilent UV-visible ChemStation Dissolution Software Summary Rich Data Analysis features Full Spectral Acquisition support Match Factor for Sample Integrity checking Multi-ingredient Formulation Analysis Excipient Corrections On-line Control and Monitoring Open System Architecture via apparatus driver Flexibility and Scalability Sampling System independent Method Security Pack Software for 21 CFR Part 11 compliance 19

20 8453 Systems Overview Dissolution Features Off-line Sampling Multicell Sampling Valve Sampling Multibath Sampling Apparatus Driver G7900AA applicable Minimum Cycle Time Volume loss/ measurement No Yes Yes Yes, individual per apparatus Any > ~1 minute, free adjustable 5, 7.5 and 10 minutes 5, 7.5 and 10 minutes 3-10 ml none 3-7 ml 3-7 ml Dosage Dropping Any Simultaneous Staggered Staggered 20

21 8453 Systems Ordering Product Numbers 8453 with PC, Printer and Base Software Dissolution Software Apparatus Driver Sampling System Off-line Sampling Multicell Sampling Valve Sampling Multibath Sampling G1815A G1815A G1815A G1815A G1118AA G1118AA G1118AA G1118AA NA G7900AA G7900AA G7900AA None or 89090A Sipper G1811A Autosampler G1127A G1128A G1129A (2 apparatus), G1130A (adds apparatus) Apparatus NA 708-DS 708-DS DS, + additional 21

22 Where selling Agilent Dissolution Equipment? Pharmaceutical Value Chain Disease Discovery Drug Discovery Drug Development Clinical Trials Manufacturing & Post Market Surveillance Business Strategy Lead Compound Selection Process Research & Scale UP Phase I Trials Manufacturing Disease Understanding Target Identification Generate Compound Evaluate Compound Optimize Compound Stability & Formulation Safety Testing Exploratory Drug Candidate (EDC) Phase II Trials Phase III Trials Post Market Survey Phase IV Trials Target Validation Discovery Testing Investigational New Drug (IND) New Drug Application (NDA) Bioavailability Informatics 22

23 Agilent System (R&D) Drug Development Process Research & Scale UP Stability & Formulation Safety Testing EDC IND System configuration 8453 Pharmaceutical System G1815AA Dissolution Software G1118AA Apparatus Driver Software G7900AA Fast Sampling system G1127A 708-DS Dissolution apparatus New bundled system: G7922A Features/Benefits Research 8453 Dissolution System Single apparatus, automated on-line UV dissolution testing system Acquisition of complete spectra for flexible re-evaluation of result during method development Flexible reports and vessel grouping (e.g. 3/3) Meets all USP/EP specifications and 21 CFR part 11 (electronic records and signatures) Control and monitoring of dissolution baths of all major manufacturers 23

24 Agilent System (QA) Drug Development Process Research & Scale UP Stability & Formulation Safety Testing EDC IND Features/Benefits Single and Multi Apparatus dissolution testing (maximum 4) Less expensive compared to parallel sampling No cell difference compensation required System configuration 8453 Pharmaceutical System G1815AA Dissolution Software G1118AA Apparatus Driver Software G7900AA (per apparatus) Valve based sampling ( >= 5 minutes) G1128A (single) or G1129A (dual) + G1130A (additional one) 708-DS Dissolution apparatus (up to 4) New bundled systems: G7920A, G7921A Value 8453 Dissolution System Multi-apparatus 8453 Dissolution System Flexible reports and vessel grouping (e.g. 3/3) Meets all USP/EP specifications and 21 CFR part 11 (electronic records and signatures) Control and monitoring of dissolution baths of all major manufacturers 24

25 Options available with Bundled 8453 Dissolution Systems Option #890 Delete Printer Customers apply networked printers Option #695 Delete PC Customers have their preferred PC/IT equipment vendor Option #900 System without 708-DS apparatus Customers require a specially configured apparatus Customers want to automate existing equipment Option #910 Replace 708-DS with 709-DS apparatus Customer wants bathless apparatus 25

26 Agilent Systems Summary Easy ordering structure of online 8453 Dissolution Systems Sampling according to needs suitable for pharmaceutical formulation development as well as quality control New brochure available PN EN 26