D2S07-Kokate+He-v1.2-FINAL.pdf

1、Common Manufacturing Process Deficiencies for Complex Dosage Forms(TDS,MDI,DPI)Amit Kokate&Vicky HeOffice of Pharmaceutical Manufacturing AssessmentOPQ/CDER|US FDASBIA GDF April 2026www.fda.govwww.fda.gov2Opinions expressed in this presentation are those of the speakers and do not necessarily reflec

2、t the views or policies of the FDADisclaimer www.fda.govwww.fda.gov3OverviewTransdermal SystemsManufacturing unit operationsManufacturing control strategyCommon process related deficiencies&considerationsDry Powder Inhalers(DPI)and Metered Dose Inhalers(MDI)Manufacturing unit operations and process

3、risksCommon process related deficiencies&considerations Conclusionswww.fda.govwww.fda.gov4Transdermal Systems Typical Unit OperationsBlend API&excipients(e.g.,adhesives,permeation enhancers)MixingCoating/Drying/Laminating(CDL)ConvertingSlitting cut to appropriate widthDie-cutting to individual patch

4、esPouching(heat sealing)Mixture applied on a substrate(e.g.,release liner)Solvent removal(oven)Combine multiple layers into a single laminateEditing(removal of flagged defective portions)Image credit:British J Pharmacology,Volume:172,Issue:9,Pages:2179-2209,First published:05 January 2015,DOI:(10.11

5、11/bph.13059)www.fda.govwww.fda.gov5Transdermal Systems Typical Process ParametersMixingMixing speedMixing timeTemperatureDeaeration,oxygen/light controlsCDLDie gapLine speedAir flow rateZone temperature,humidityLamination pressureConvertingCutting speedDie pressureDwell timeSealing conditions(tempe

6、rature,pressure,time)www.fda.govwww.fda.gov6Transdermal Systems Typical In-process TestsMixingAppearanceAssay/Blend uniformityViscosity%SolidspHDegradation productsCDLFilm appearance(continuous monitoring for defects)Microscopic appearanceCoat weightContent uniformityCritical excipient contentResidu