APSD SERVICES USING THE A3G
A3G has demonstrated that it can produce very high precision data very fast. This data has been published at the RDD (Respiratory Drug Delivery) meeting in Nice, France. For those customers who do not wish to make capital investments and yet need to get high precision data quickly, there is an alternative—outsource it to Lab Automate—we become your analytical laboratory. Existing ACI methods are quite easily ported to the A3G, as internally it uses the ACI without modifying it. We work closely with customers to port the methods. If at some point of time customers require to bring the system in-house, we will sell the system to them, so that their needs continue to be met uninterrupted.
HIGH PRECISION DATA
Recovery of Beclomethasone Dipropionate (n=3)
Sample | Area (mV.s) | ||||
Trial 1 | Trial 2 | Trial 3 | Mean | %RSD | |
Mouth Piece + Induction Port + Entrance Cone | 633916 | 667525 | 694897 | 665446 | 4.59 |
IP 1+S0 | 106631 | 92958 | 100562 | 100050 | 6.85 |
IP 2+S1 | 21901 | 23074 | 24430 | 23135 | 5.47 |
IP 3+S2 | 26202 | 25218 | 24759 | 25393 | 2.90 |
IP 4+S3 | 128433 | 125085 | 125093 | 126203 | 1.53 |
IP 5+S4 | 473662 | 455849 | 465866 | 465125 | 1.92 |
IP 6+S5 | 695762 | 681555 | 693435 | 690250 | 1.10 |
IP 7+S6 | 310304 | 306707 | 309955 | 308988 | 0.64 |
IP 8 +S7 | 151644 | 156621 | 155060 | 154441 | 1.65 |
IP =Impaction Plate. IP1 is below Stage 0, IP2 is below Stage 1, and in this manner, finally, IP8 is below Stage 7
Recovery of Fluticasone Propionate using GSK Flovent. The sample prep was done using the A3G and the Chromatography was done by ZYDUS PHARMACEUTICALS.
(GSK Flovent pMDI) Fluticasone Propionate ACI | ||||||||||
RUN 1 | RUN 2 | RUN 3 | RUN 4 | RUN 5 | RUN 6 | RUN 7 | RUN 8 | |||
Sr. No. | Sample name | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | % LC-220 mcg | %RSD |
1 | Mouthpiece Adaptor | 5.81 | 5.68 | 5.29 | 5.69 | 5.69 | 5.85 | 5.45 | 5.64 | 3.27 |
2 | Induction Port | 48.24 | 45.32 | 45.87 | 45.56 | 47.96 | 44.13 | 41.74 | 43.02 | 4.97 |
3 | Cone | 0.12 | 0.13 | 0.13 | 0.12 | 0.14 | 0.1 | 0.1 | 0.12 | 11.79 |
4 | Impaction Plate-1 + Stage 0 | 3.03 | 2.83 | 2.88 | 2.76 | 2.9 | 3.06 | 2.69 | 3.45 | 8.04 |
5 | Impaction Plate-2 + Stage 1 | 1.86 | 3.3 | 3.39 | 3.44 | 3.7 | 3.45 | 3.52 | 3.75 | 18.23 |
6 | Impaction Plate-3 + Stage 2 | 5.05 | 5.11 | 5.31 | 5.55 | 5.92 | 5.63 | 5.62 | 5.82 | 5.76 |
7 | Impaction Plate-4 + Stage 3 | 14.3 | 14.84 | 15.32 | 16.25 | 16.22 | 15.27 | 15.41 | 15.92 | 4.38 |
8 | Impaction Plate-5 + Stage 4 | 15.05 | 14.95 | 15.5 | 16.32 | 15.86 | 15.39 | 15.49 | 15.78 | 2.86 |
9 | Impaction Plate-6 + Stage 5 | 5.53 | 5.29 | 5.4 | 5.75 | 5.71 | 5.5 | 5.57 | 5.5 | 2.72 |
10 | Impaction Plate-7 + Stage 6 | 0.7 | 0.67 | 0.68 | 0.72 | 0.72 | 0.72 | 0.68 | 0.72 | 3.09 |
11 | Impaction Plate-F + Stage 7 | 0.2 | 0.28 | 0.2 | 0.25 | 0.28 | 0.27 | 0.24 | 0.24 | 13.09 |
12 | Stage-F | 0.17 | 0.22 | 0.24 | 0.25 | 0.22 | 0.2 | 0.19 | 0.21 | 12.26 |
Mass Balance | 100.06 | 98.62 | 100.21 | 102.66 | 105.32 | 99.57 | 96.7 | 100.17 | 2.58 |
The low RSD reported for sample recovery suggest that the A3G yields reproducible data, even in locations where there is low drug deposition, because even small changes in drug recovery can result in higher RSDs.