Studying the Interaction of Moisture and Pharmaceutical Materials. Dr. Peter Moir Relequa Analytical Systems Ltd
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1 Studying the Interaction of Moisture and Pharmaceutical Materials Dr. Peter Moir
2 Moisture Material Interactions
3 Sir William Thomson (1871) Hydrostatic communication between liquid surfaces. From: "On the equilibrium of vapour at a curved surface of liquid,
4 Sir William Thomson (1871)
5 Sir William Thomson (1871)
6 W.J. Scott Water relations of food spoilage microorganisms it is not the absolute amount of water present in food that resulted in microbial growth, but it is the amount of water that is available to the microorganism free-water as opposed to bound-water free-water is measured as Water Activity
7 Water Activity / Equilibrium Relative Humidity (ERH) Aw = 1.0 or ERH 100% Pure Water
8 Micro-organism Aw required for growth (%) Pseudomonas spp Escherichia coli 0.96 Bacillus subtilis 0.95 Clostridium botulinum, 0.94 types A and B Candida utilis 0.94 Botrytis cinerea 0.93 Most spoilage bacteria 0.90 Most spoilage yeasts 0.88 Penicillium patulum 0.81 Most spoilage molds 0.80 Aspergillus conicus 0.70 Aspergillus echinulatus 0.64 Zgosaccharomyces rouxii 0.62 Xeromyces bisporus 0.61 From: Jay, J.M Modern Food Microbiology Chapman & Hall, International Thomson Publishing. New York
9 Water Activity To Date First described for microbial growth in food Built into US CFRs for microbial safety in food USP <1112>: Application of Water Activity Determination to Nonsterile Pharmaceutical Products
10 Water Activity To Date EP WATER - SOLID INTERACTIONS: DETERMINATION OF SORPTION-DESORPTION ISOTHERMS AND OF WATER ACTIVITY Published April 2011
11 Water Activity Equipment Rotronic Aqualab
12 Water Activity Measurement Material is placed in a sealed chamber Material is allowed to reach equilibrium Record %RH %RH
13 Water Vapour Measured as Relative Humidity
14 Relative Humidity Why Relative? Maximum amount of water vapour in air = Saturation
15 Relative Humidity Temperature dependent
16 Relative Humidity Measurement of the relative amount of actual water vapour in air to the saturation amount at a particular temperature Vapour Pressure H 2 O Saturation Vapour Pressure H 2 O X 100 = %RH
17 Relative Humidity Condition ICH Stability Guidelines Amount of Water g/l Difference from 25 C/60%RH 25 C/60%RH C/60%RH 18.1 x C/65%RH 19.6 x C/75%RH 37.9 x C/75%RH 22.6 x1.6
18 Moisture - Material Interactions Nearly every material interacts with moisture. Interaction depends on: %RH of the surrounding air The equilibrium point of the air moisture interaction
19 Moisture - Material Interactions Moisture Equilibrium Point %RH
20 %RH Moisture Interactions 80 Moisture Uptake Profile Decreasing %RH
21 %RH Moisture Interactions 50 Moisture Release Profile Increasing %RH
22 Water Activity Limitations Tablets ERH = 40% Ambient %RH = 60% 60%RH 40%RH Aw =0.40 Start Point Finish Point
23 Water Activity Limitations Tablets ERH = 40% Ambient %RH = 30% 30%RH 32%RH Aw =0.32 Start Point Finish Point
24 Water Activity Limitations Natural fluctuations in ambient %RH Dependency on moisture content Leads to inconsistent results Failed attempts at In-Process Control for moisture using Aw
25 Overcoming Aw Limitations Relequa WVEP Measurement Material is placed in a chamber at elevated %RH Material is allowed to reach equilibrium Record %RH
26 %RH Moisture Interactions 80 Moisture Uptake Profile Decreasing %RH WVEP 55
27 Pharmaceutical Applications
28 Pharmaceutical Applications
29 Pharmaceutical Applications Practical Example Lipitor 10mg Tablets de-blistered and repacked 3 different types of PVC blister thermoform with same 25µm aluminium lidding Stored at: 25ºC/60%RH, 40ºC/75%RH Moisture Profiling Analysis Initial, 1, 2, 3 and 7 days
30 Pharmaceutical Applications Practical Example 1 day storage 7 days storage
31 Moisture Profiling and Packaging Water Vapour %RH WVEP Vp ext Vp int ΔVp
32 Acknowledgments Thank You Paul O Leary Eng Dept, WIT Mathematical Modelling Michael McCarthy Eng Dept, WIT Software Development Relequa Q1 Scientific, Waterford ICH Storage Des O Callaghan, Pharma-Assist, Clonmel Blister Packing
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