Encap Drug Delivery are the global leader in encapsulation solutions and a centre of excellence in Liquid-Fill two piece capsules. With 20 years experience in this field, we understand the challenges that can be faced when dealing with in oral drug delivery systems, and will support and assist in helping to provide the correct solution.

There is an increased demand for new and different ways to formulate and manufacture in the shortest timeline and most cost-effective route possible.

Liquid Filled Hard Shell Capsules can provide the answer and come with the following advantages:

• Water Content - The Soft Gel manufacturing process involves the filling of product between two gelatine ribbons prior to sealing them together through the application of heat and pressure. The capsules formed at this stage and incredibly flexible due to water in gel mass. This is not acceptable for moisture sensitive products.

• Placticisers - Soft Gels contain placticisers (glycerin and PEG) which can migrate into the capsule content or can aid migration of the fill into the shell.

• Fill Vehicles - Thermo softening vehicle (melting at 40 degrees C) not acceptable for Soft Gel filling. Low MW PEGs and propylene glycol possible in Soft Gel but not in Hard Shell Capsules.

• Microbial Growth - Soft Gels are more susceptible to microbial growth due to moisture content.

• Shell permeability - Soft Gels are more susceptible to moisture and gas transmission and can be an issue to oxidation sensitive products.

• Cost - Soft Gel filling speeds are slow (~12k/hour) and tray drying can take from days to weeks. Increased cost of Hard Shell Capsules are off-set by processing efficiencies.

• Coating - Soft Gels may be more difficult to coat (enteric) than Hard Shells.

• Manufacturing Capacity - Soft Gel manufacturing capacity limited to a relatively small number of manufacturers. Hard Shell technology transfer between manufacturers relatively straight forward process.

• Layer Formulations - Possible in Hard Shell Capsules.

• Materials and development timelines - Less materials required for Hard Shell Capsules development and shorter timelines.

• Clinical Studies - Soft Gels require different formulations or different capsule sizes for different doses  - delaying development, manufacturing and stability or issues with clinical blinding.