Hot Melt Extrusion in the. Containing Antiretroviral Drugs. May 18 th 2010
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1 Hot Melt Extrusion in the Production of Intra-vaginal Rings Containing Antiretroviral Drugs May 18 th 2010 Andrew Loxley 1
2 Introduction to Particle Sciences 2
3 Intra-vaginal Rings 3
4 Intra-vaginal Rings - Designs 4
5 Intra-vaginal Rings - Designs 5
6 Intra-vaginal Rings Drug Release Profiles In vitro In vivo 6
7 HIV - Global Prevalence in Adults 7
8 HIV/AIDs and Microbicides 8
9 The Driving Force ARV-loaded IVRs could protect women from infection from HIV+ partners 9
10 Ethylene Vinyl Acetate (EVA) 1000 ethylene Vinyl acetate 100 Melt index (g) 10 1 ~ 7 40 wt% % vinyl acetate 10
11 Lab Scale Preparation of Dapivirine / Maraviroc IVRs Micronize drug powder(s) Melt EVA in a Banbury batch mixer Add API in one shot Mix Polymer + drug Cool Grind (liquid (q N 2 2) Injection mold crumb to form IVRs 11
12 In-vitro Drug-release from Experimental Combination ARV IVRs 12
13 Potential Issues at the Lab-scale API degradation API API Sample Process Temp ( C) Average Degradants (% based on API) API API + EVA API + EVA API + EVA + 50ppm BHEB API + EVA + 75ppm BHEB API + EVA + 100ppm BHEB Small # of IVRs per batch not readily scalable Not sure if performance (especially drug release) will be the same as commercial scale IVRs 13
14 Manufacturing Dapivirine / Maraviroc IVRs Micronize drug powder(s) Blend Drugs + excipients Feed APIs and Polymer to Mixer Hot Melt Compounding/Extrusion Mix Polymer + drug blend Extrude drug-loaded polymer Cut extrudate and glue ends to form IVRs Pelletize extrudate Injection mold pellets to form IVRs 14
15 Developing IVR Manufacturing Processes Blend Drugs + excipients Assay 30 min, top 30 min, middle 30 min, bottom 60 min, top 60 min, middle 60 min, bottom 90 min, top 90 min, middle 90 min, bottom 120 min, top 120 min, middle 120 min, bottom 15
16 Developing IVR Manufacturing Processes Blend Drugs + excipients 16
17 Developing IVR Manufacturing Processes EVA 3 kg/h, 1.3% Dapivirine, 5.6% Maraviroc Blend Drugs + excipients Feed APIs and Polymer to Mixer 17
18 Developing IVR Manufacturing Processes EVA 3 kg/h, 1.3% Dapivirine, 5.6% Maraviroc Blend Drugs + excipients Feed APIs and Polymer to Mixer 18
19 Developing IVR Manufacturing Processes Blend Drugs + excipients Feed APIs and Polymer to Mixer Mix Polymer + drug blend 19
20 Developing IVR Manufacturing Processes Powder / Polymer Mixing Blend Drugs + excipients Feed APIs and Polymer to Mixer Considerations: * thermal stability of API * thermal stability of polymer * residence time * mixing efficiency and homogeneity / API solubility in polymer (DSC?) Mix Polymer + drug blend 20
21 Developing IVR Manufacturing Processes Benefits of HME over Batch Processes Blend Drugs + excipients Feed APIs and Polymer to Mixer Mix Polymer + drug blend Lower Processing Temperature and shorter residence time Reduced API degradation Reduced Polymer degradation Batch Batch + 50ppm BHEB HME Continuous process Easy conversion to pellets Higher throughput Product uniformity 21
22 Developing IVR Manufacturing Processes Blend Drugs + excipients Feed APIs and Polymer to Mixer Mix Polymer + drug blend Die options single orifice double orifice diameter Choice of conveyor belt Choice of cooling (water, air ) Extrude drug-loaded polymer 22
23 Developing IVR Manufacturing Processes Blend Drugs + excipients Feed APIs and Polymer to Mixer Mix Polymer + drug blend Extrude drug-loaded polymer Pellets required to feed Injection Molder Choice of pelletizer Effect of speed etc on pellet size and uniformity Collection of pellets Assay pellets Pelletize extrudate 23
24 Developing IVR Manufacturing Processes Process Development time temperature injection rate cooling Mold design gate sprue removal push pins Injection mold pellets to form IVRs 24
25 In-vitro Drug Release Results Compare Banbury batch IVRs with ZSE18Nissei IVRs for release of Dapi and DS Dapivirine Release from 4mm Combination Rings EVA2803 Loading: 25 mg/ring/ i Maraviroc Release from 4mm Combination Rings EVA2803 Loading: 300 mg/ring Daily Rele ease / μg Banbury batch IVR Daily Rele ease / μg Banbury batch IVR ZSE18-Nissei IVR ZSE18-Nissei IVR Time / d Time / d 25
26 Regulatory Considerations For human clinical trials cgmp raw materials purchasing, qualification, storage, handling personnel qualifications qualified equipment (IQ, OQ, PQ) validated analytical methods validated production processes MOC not additive, reactive nor absorptive validated cleaning procedures required QBD development approach (design space) QA oversight of production Batch record Stability study following ICH guidelines 26
27 Conclusions Batch-wise compounding is suitable for small scale formulation development There are issues associated with small scale processing that may not be observed at production scale Hot Melt Extrusion requires upstream process development (powder blending, powder feeding) May reduce degradation of key materials Yields uniform, high quality compound Is readily scaled to commercial volumes Is the process of choice for EVA matrix IVRs 27
28 Acknowledgements PSI Jason McConnell Onajite Okoh Jigar Patel Matthew Bigert Christopher Morgan Leistritz K-Tron Scheck-Accurate 28
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