Advertorial 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
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.
For more information about Vcaps®
Plus capsules visit
VcapsPlus.com.
% Caffeine dissolved
% Caffeine dissolved
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