DRUG DISCOVERY AND DEVELOPMENT 35
Fig. 2. The Gamlen Tablet Press.
granulation is clearly seen, with little difference in product quality between dry granulation and direct compression. Tis is a common observation.
In one study 10 different wet granulations of a clinical trial material at 25 per cent drug loading were compared. Te tabletability differences were substantial (Fig. 3). Interestingly, the worst formulation was very similar in behaviour to the unprocessed drug; the best material was twice as compressible as the worst.
Tis enabled the selection of the best formulation that met the challenging dissolution requirements for the product.
Te Gamlen Tablet Press is suited to studying the ejection behaviour of materials prepared on the small scale. Te ejection profile (force and displacement) of each tablet is recorded, from which both the ejection stress and the work of ejection can be calculated. Tis is useful for selecting well-lubricated formulations and processes. Te range of ejection and detachment
forces for different direct compression agents is substantial.
Small-scale formulation is an important phase of the development process, and essential for generation of the data needed to support the new requirements of QbD. It leads to more robust and reliable process, resulting in real patient benefits.
For more information ✔ at
www.scientistlive.com/eurolab
Dr Michael Gamlen is Managing Director of Gamlen Tableting Ltd, Biocity Nottingham, UK.
www.gamlen.co.uk
Fig. 3. Tabletability of 10 formulations of a clinical trial material.
www.scientistlive.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92