Evaluation of Controlled Drug Delivery Systems


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This slide outlines the evaluation methods of various Controlled Drug Delivery Systems (CDDS) used in the pharmaceutical industry. The controlled Drug Delivery Systems release the drug to the plasma at a controlled, pre-determined level to ensure prolonged and adequate drug supply for a longer time. The slide analyses the various evaluation methods, its pharmacokinetic properties and applications of the evaluation methods in various scenario.

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Evaluation of Controlled Drug Delivery Systems

  1. 1. EVALUATION OFCDDSPresented by:Muhammed Fahad1st M.PharmDept. of PharmaceuticsAl-Shifa College ofPharmacy
  2. 2.  Mainly used is in-vitro dissolutiontests. Dissolution studies together withbioavailability studies—used to predictin-vitro-in-vivo correlation (IVIVC).INTRODUCTION2
  3. 3. DISSOLUTION STUDIESCriteria: Reproducibility of medium Proper choice of the medium Maintenance of sink conditions Dissolution rate as a function of pH3
  4. 4. Parameters to be taken care of:1. Lack of dose dumping2. Complete drug release from thedosage form—at least 75-80% to bereleased at the last sampling interval3. pH dependence/independence of thedosage formDISSOLUTION STUDIES4
  5. 5. In-Vitro-In-Vivo Correlations(IVIVC)Different degrees of correlations exist: Correlation Level A Correlation Level B Correlation Level C5
  6. 6. Correlation Level A Highest level of correlation (ideal). relationship exist. Here, direct comparison of in-vitrodissolution curve with plasma drugconcentration–time curve can bedone. Advantage: simply perform in-vitrotests.6
  7. 7.  Correlation is less than Level A. Mean Residence Time (MRT) of thedrug in body and mean dissolutiontime in vitro are determined andcorrelated.Correlation Level B7
  8. 8.  Weakest level of correlation—onlypartial relationship between absorptionand dissolution exist. Uses a single point in the dissolutioncurve to correlate to plasma drugconcentration–time data. E.g. t50%, t90%Correlation Level C8
  9. 9. Pharmacokinetic Studies Various types of pharmacokineticstudies may be required by the FDA. Extended-release dosage form shouldbe available in several dosagestrengths. Reference—full NDA-approvedconventional, immediate-releasedosage form given in equal daily dose Both single- and multiple-dose steady-state crossover studies are done. 9
  10. 10. Waivers: Done when 2 drug products are: In same dosage form. Proportionally similar in active & inactiveingredients. Differ only in strengths of the medication. Bioequivalence study of lower strength(s)can be waived. Only comparative in vitro dissolution test isrequired to establish bioequivalency.10Pharmacokinetic Studies
  11. 11. Case One: Extensivepharmacodynamic/pharmacokineticdata exist for the IR formulation of anER formulation. Both single- and multiple-dose steady-state crossover studies are required. Study also performed as fasting statevs fed state (high-fat meal).Pharmacokinetic Studies11
  12. 12. To determine: Need for labeling specifications ofspecial conditions w.r.t meals. Whether the absorption pattern of theER dosage compares to that for IR(conventional) form of the same drug.Pharmacokinetic Studies12
  13. 13. Case Two: Concerned with non-oral extended-release dosage forms. Usually require studies of Case butdoesn’t need fed state study. E.g. isoproterenol  form sulfateconjugation orally; i.v. forms 3-O-methylated derivative via COMT.Pharmacokinetic Studies13
  14. 14. Case Three: Involve generic equivalent of an NDA-approved, extended-release product. Establishment of bioequivalence isdone.Pharmacokinetic Studies14
  15. 15. Evaluation of In-VivoBioavailability DataPharmacokinetic Profile: Calculate Ka using Wagner-Nelsonmethod. Should not have significant dose-dumping. Bioavailability data shoulddemonstrate extended-releasecharacteristics.15
  16. 16. Rate of Drug Absorption:Evaluation of In-VivoBioavailability Data16
  17. 17. Occupancy Time:Evaluation of In-VivoBioavailability Data17
  18. 18. Evaluation of TDDSThickness: Using digital micrometer screw gaugeat 3 diff. places and the mean value iscalculated.Folding endurance: Folding endurance at the same place tillthe patch breaks.Tensile strength: Weight is gradually increased till thepatch breaks. 18
  19. 19. Evaluation of TDDSWeight variation: Individually weighing 10 randompatches.Drug content: Using suitable analytical methods.Percentage of moisture content: Weighed and placed in desiccatorcontaining activated silica at roomtemperature for 24 hours.19
  20. 20. Evaluation of TDDSPercentage of moisture uptake: Kept in dessicator for 24 hrs; exposedto 84% RH (saturated sol. of NH4Cl).In vitro diffusion studies:20
  21. 21. REFERENCE: Shargel. L, Applied Biopharmaceuticsand Pharmacokinetics, 5th edition, McGraw Hill, Singapore, 2005. Brahmankar. D. M, Biopharmaceuticsand Pharmacokinetics—A Treatise, 1stediton, Vallabh Prakashan, 2006.21
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