Flow Through Dissolution Testing

Presentation on Flow Through Dissolution Test Apparatus

1. Flow through dissolution testing Prepared By: Apoorva Bauskar Guided By: Dr ( Mrs ) S.P. Mahaparale Class: S.Y.M.Pharm (Quality Assurance Techniques) Roll No: 617 1

2. INTRODUCTION Dissolution: Drug is released from the solid dosage forms (granules, tablets, capsules etc.) and immediately go into molecular solution. Dissolution testing : Standard technique to assess drug release from tablets and capsules. In-vitro method for assuring batch-to-batch uniformity. Quality control procedure for comparing release profiles of different batches of finished products. 2

3. FLOW THROUGH DISSOLUTION TEST APPARATUS 3

4. RESERVOIR AND WATER BATH Reservoir consists of dissolution medium. Water Bath: C ontrol the temperature in the cell. 4

5. DISSOLUTION AND RELEASE MEDIA Conventional buffers. Media proposed by the pharmacopeias . Biorelevant media. Media can be changed during the experiment with the hel p of medium selector. Need of deaeration in the media. 5

6. PUMP & FLOW PATTERNS Peristaltic and pulsating piston pumps are used. Sinusoidal pulse rate: 120 ± 10 pulses per minute. Pulse rate remains constant independent of the selected flow rate and need for further stirring is also eliminated due to the pulsating pattern of the pump. Flow Rates: 4, 8, and 16 mL/min. Flow rates vary according to specifications of pump. 6

7. F low should be maintained at ±5% of the nominal value. Two types of patterns observed Turbulent pattern: without glass beads. Laminar pattern: use of glass beads. Laminar Flow: P articles moving in parallel to one other in the flow direction. Turbulent Flow: Rapid movement of fluid particles in all direction within the flow direction. 7

8. OPEN MODEL FLOW THROUGH DISSOLUTION TEST APPARATUS Fresh solvent from the reservoir continuously passing through the cell. Selected for samples requiring high volume of media 8

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10. CLOSED MODEL FLOW THROUGH DISSOLUTION TEST APPARATUS Required when fixed volume of liquid is recycled. Selected when a low volume of medium is required. 10

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12. FILTERS Location: Inner top of the cell. Use: Retain undissolved material. Glass fiber filters: Single or combination of different pore sizes. Glass wool Filters: Dosage forms with insoluble and/or sticky particles. Appropriate selection of the filter is required for efficient filtration and to avoid backpressure created by filter resistance. 12

13. SAMPLING Collected samples analyzed : UV vis spectrophotometer or a fiber -optic probe. Also collected in fractions and analyzed by HPLC. Automated Sample Collection for ensuring consistency. On-line automation: Sample is measured by UV. Off-line automation: The sample is collected automatically and analyzed afterwards. 13

14. DATA COLLECTION Open mode: D ata collected represents the amount dissolved/released at specific time intervals and is in noncumulative form. It is then converted into cumulative form. Closed Mode: Data collected in cumulative form. 14

15. FEATURES OF FLOW THROUGH CELL SYSTEM F low rate changes within a single run. Sink conditions are maintained , due to the continuous flow of fresh medium, when the system operates in the open-loop configuration . Study of samples with low drug loading feasible when the system operates in the closed-loop configuration. Release from dosage forms over extended periods can be studied 15

16. Controlled hydrodynamic environment, and intra- lumenal hydrodynamics are more efficiently simulated compared with other in vitro setups. Hydrodynamics not affected by media change and sampling. Development of in vitro–in vivo correlations can be easier as a single profile corresponding to the release of the drug in the entire gastrointestinal tract. 16

17. ADVANTAGES Laminar flow characteristics over a wide range of solvent flow rates. Infinite sink ideal for low solubility drugs. Differential rather than cumulative time profile of dissolved drug concentration. Dwell time of dosage form in medium is minimal, reducing risk of drug degradation. pH modification of dissolution medium is easy. Samples for analysis easily obtained without altering dissolved drug concentration 17

18. DISADVANTAGES Large volumes of media required to maintain flow rate. Risk of clogging of filters. Validation of flow rate during testing is difficult. 18

19. REFERENCES The United States Pharmacopeia and National Formulary USP 32–NF 27; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2009. Prabhu NB, Marathe AS, Jain SK, Singh PP, Sawant K, Rao L, Amin PD. Comparison of Dissolution Profiles for Sustained Release Resinates of BCS Class I Drugs Using USP Apparatus 2 and 4: A Technical Note. AAPS PharmSciTech . 2008; 9(3): 769-773 . D C Baun,G C Walker,Apparatus for Determining the Rate of Drug Release from Solid Dosage Forms,J Pharm Sci 58(5):611–616,1969 19

20. Higuchi W. Analysis of data on the medicament release from ointments. Journal of pharmaceutical sciences 1962; 51:802-804 . Yu LX, Carlin AS, Amidon GL, Hussain AS. Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs. International journal of pharmaceutics 2004; 270:221-227. 20

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