Advertorial
(Ku et al., 2011), and underscores the superior performance of Vcaps Plus capsules.
Ideally suited for moisture sensitive compounds
While gelatin capsules have been effectively used for over a hundred years, due to their excellent flexibility and highly desirable dissolution properties, they are not typically the polymer choice for moisture sensitive compounds. Vcaps Plus capsules on the other hand have a three-fold lower moisture content than gelatin capsules and are less hygroscopic. That equates to fewer broken capsules due to brittleness and less of a chance of drug degradation compared to gelatin capsules.
Improved stability at high and low temperatures Capsugel in-house studies and an independent study conducted at Wyeth (Ku et al., 2010) have demonstrated the superior stability of Vcaps Plus capsules. An exposure of up to one week to temperatures ranging from 4°C to minus 18°C did not change the appearance or performance of unfilled Vcaps Plus capsules in closed high- density polyethylene (HDPE) bottles.
The same stability was found with empty Vcaps Plus capsules in fully- filled glass bottles that were heated for 24 hours to temperatures ranging from 40°C to 60°C.
In long-term storage condition studies, including a 6-month storage at 40°C and 75% relative humidity and 2 years at either 25°C and 65% relative humidity or 30°C and 70% relative humidity, Vcaps Plus capsules disintegration and dissolution characteristics remained unchanged.
The wider temperature capabilities of Vcaps Plus capsules make them the perfect choice for longer term storage and when used in progressively unpredictable home environments.
Superior machinability
Traditional and second-generation HPMC capsule attributes have been compared on many common high-speed capsule filling machines (Ku et al., 2010). With respect to filling and rejection rates, Vcaps Plus capsules performed much like gelatin capsules and were superior to traditional HPMC products. In addition, Vcaps Plus capsules can be adapted for use with liquid compounds.
Wide regulatory and industry acceptance
Vcaps Plus capsules are manufactured in certified ISO 9001 facilities and in accordance with IPEC’s (International Pharmaceutical Excipient Council) Good Manufacturing Practice (GMP) Guide for Bulk Pharmaceutical Excipients. They are acceptable for use in pharmaceutical and dietary supplement oral dosage applications in major markets of the US, Canada, EU, Japan, and Australia. In addition, Vcaps Plus capsules are certified Kosher Ko and Halal by IFANCA, and are approved for vegetarians by the Vegetarian Society.
References
Ku, S.M., Li W., Dulin, W., Donahue, F., Cadé, D., Benameur, H., Hutchison, K., Performance qualification of a new hypromellose capsule: Part I. Comparative evaluation of physical, mechanical and processability quality attributes of Vcaps® Plus, Quali-V and gelatin capsules. Int. J. Pharm. Vol. 15; 386(1-2):30-41, 2010.
Ku, M.S., Lu, Q., Li, W., Chen, Y., Performance qualification of a new hypromellose capsule: Part II. Disintegration and dissolution comparison between two types of hypromellose capsules. Int. J. Pharm. Vol. 15; 416(1):16-24, 2011.
Secondary gelling systems create variability while Vcaps Plus capsules, without gelling agents, provide ionic and pH independence in dissolution.
Figure 1
Influence of gelling systems on HPMC capsules in dissolution testing 100
10 20 30 40 50 60 70 80 90
0 0 3 6
9 12 15 18 21 24 27 30 35 40 45 50 55 60 75 Time in minutes
pH 1.2 USP pH 6.8 USP pH 6.8 JP2 Simulated milk fluid pH 1.2 – 2 g KCI/L pH 1.2 – 9 g KCI/L
Figure 2
In vitro dissolution of caffeine in Vcaps® 100
10 20 30 40 50 60 70 80 90
0 0 3 6
9 12 15 18 21 24 27 30 35 40 45 50 55 60 75 Time in minutes
Plus capsules
pH 1.2 USP pH 6.8 USP pH 6.8 JP2 Simulated milk fluid pH 1.2 – 2 g KCI/L pH 1.2 – 9 g KCI/L
For more information about Vcaps®
Plus capsules visit
VcapsPlus.com.
% Caffeine dissolved
% Caffeine dissolved
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