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Empty Hard Capsules

Empty hard capsules are the most versatile delivery vehicle for pharmaceutical APIs, nutraceuticals and powdered plant extracts. They can be handfilled with a batch size of a few hundred or filled with automated machines with a capacity of more than 100,000 capsules per hour. Hard capsules are commonly available in sizes of between 0.15 ml and 1.4 ml, in different colours and made of different materials (gelatine, pullulan, HPMC, HPS). Preferably, they are filled with powders, granules, pellets or mini-tablets, but they also can be used for non-aqueous liquids and pastes. Capsules are especially suitable for powders with poor flow and compression characteristics, e.g., plant extracts.


Quality

All our capsules are manufactured according to GMP and are suitable for nutraceutical and pharmaceutical uses. They all feature excellent machinability on both high-speed and semi-automatic filling machines. The capsules undergo strict quality control and are checked for critical (e.g., large split, hole, crush), major (e.g., bubble, bad edge, dented ends) and minor defects (e.g., small bubble, small split, starred end). The acceptance quality levels are for critical 0.01%, for major 0.1% and for minor defects 0.4%. All capsule types are certified Kosher and Halal.


Available Materials and Sizes

We offer gelatine and HPMC from size #1 to #00 in transparent and white. Other sizes, e.g., #000, and colours are available upon request. We also offer special grades like acid-resistant (enteric) or organic-certified capsules.

SIZE
#00 #0 #1
Volume (ml)
Length (mm)
Weight (mg)
0.95 0.68 0.50
23.5 21.5 19.5
140 110 85

These are approximate values. Exact values for each capsule type are available upon request.


Materials

Even though all polymers used for hard-capsule manufacturing are chemically very stable, all capsule types are sensitive to moisture and heat, which can lead to deformation of the capsule body and alter release characteristics. Recommended storage conditions are 15 to 25 °C at 35% to 65% rh. The filling should be done around 22 °C and 50% rh. It might be necessary to equilibrate the capsules to these conditions for several hours before the filling process.

MATERIALS
Gelatine HPMC
Source
Process
Label
Relative Oxygen Permeability
Loss On Drying
bovine or fish wood pulp
hydrolysis chemical modification
food vegan, use in org. products acc. to (EC) No 889/2008
9 300
12% - 16% 2% - 7%


Gelatine

Gelatine is the most common and most versatile material for the manufacturing of hard capsules. It is a safe and well understood natural protein that is suitable for both pharmaceutical and nutraceutical use. Gelatine hard capsules are very cost efficient and easy to handle, have low oxygen permeability and exhibit a fast dissolution profile. They are less suitable for moisture-sensitive drugs because of their rather high residual water content of 12% to 16%; cross-linking with aldehydes can also occur leading to a changed release profile. Our gelatine hard capsules are produced from Rousselot gelatine.


HPMC

HPMC hard capsules were developed to offer a vegetarian alternative to gelatine. HPMC is a semi-synthetic, water-soluble derivative of the naturally occurring polymer cellulose. The capsules feature low residual water content and good water-vapour resistance. They are less brittle than gelatine capsules, especially at low humidity, but in general they have lower mechanical stability. HPMC (E 464) is listed in Annex VIII of Regulation (EC) No 889/2008 as material that can be used for the encapsulation of foodstuff labelled as organic.


 
Specifications Gelatine Capsules MSDS Gelatine Capsules
Specifications HPMC Capsules MSDS HPMC Capsules



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