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Evaluation of Controlled Drug Delivery Systems
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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 ...

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 Evaluation of Controlled Drug Delivery Systems Presentation Transcript

  • EVALUATION OFCDDSPresented by:Muhammed Fahad1st M.PharmDept. of PharmaceuticsAl-Shifa College ofPharmacy
  •  Mainly used is in-vitro dissolutiontests. Dissolution studies together withbioavailability studies—used to predictin-vitro-in-vivo correlation (IVIVC).INTRODUCTION2
  • DISSOLUTION STUDIESCriteria: Reproducibility of medium Proper choice of the medium Maintenance of sink conditions Dissolution rate as a function of pH3
  • 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
  • In-Vitro-In-Vivo Correlations(IVIVC)Different degrees of correlations exist: Correlation Level A Correlation Level B Correlation Level C5
  • 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
  •  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
  •  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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Case Three: Involve generic equivalent of an NDA-approved, extended-release product. Establishment of bioequivalence isdone.Pharmacokinetic Studies14
  • Evaluation of In-VivoBioavailability DataPharmacokinetic Profile: Calculate Ka using Wagner-Nelsonmethod. Should not have significant dose-dumping. Bioavailability data shoulddemonstrate extended-releasecharacteristics.15
  • Rate of Drug Absorption:Evaluation of In-VivoBioavailability Data16
  • Occupancy Time:Evaluation of In-VivoBioavailability Data17
  • 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
  • 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
  • Evaluation of TDDSPercentage of moisture uptake: Kept in dessicator for 24 hrs; exposedto 84% RH (saturated sol. of NH4Cl).In vitro diffusion studies:20
  • 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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