The contract development and manufacturing organisation (CDMO), bought a BD3000 capsule banding machine from Italian firm Dott. Bonapace to expand into liquid-filled capsules. Liquid-in-capsule formulations are favoured over powders and semi-solids when drug compounds are particularly potent or poorly soluble.
The Columbia Laboratories subsidiary also added a second capsule-filling machine to quadruple capacity and increase weight accuracy and fill weight range.
Liquid-in-capsule formulations are used when drug compounds are particularly potent or poorly soluble.
Capsules are popular in early phase trials, where dosage flexibility is needed. “We can manufacture for relatively small scale early stage trials and also now have the enhanced capacity that allows us to scale up to Phase III,” said Rob Harris, Chief Technical Officer.
Excipients: gelatine vs vegetarian
Molecular Profiles uses both gelatine and HPMC (hydroxypropyl methylcellulose, a semi-synthetic polymer) capsule shells, depending on clients’ drug formulation.
Harris told us that “cultural sensitivities” – religious and moral objections to animal excipients – are one of the reasons for increased interest in gelatine alternatives such as HPMC.
But zoonotic diseases are not an issue for the gelatine supply chain, he said:
“All excipients and actives are now provided with a BSE/TSE [bovine/transmissible spongiform encephalopathies] statement, which confirms either that no materials of animal origin were used during the manufacture of the product, or that the animals from which the product was derived were healthy.”
Additionally, clients can specify preferences for porcine- or bovine-derived gelatine.
HPMC shells come with their own pros and cons: the capsules contain less water than gelatine, so can offer an advantage if APIs (active pharmaceutical ingredients) are sensitive to water. They also avoid the osmosis associated with gelatine capsules, which can draw out water from the casing and make shells brittle.
“The slight disadvantage with HPMC capsules is that they take longer to disintegrate compared with gelatin capsules,” Harris told us.
This is the latest investment by Molecular Profiles after the company purchased GMP hot melt extrusion (HME) technology earlier this year for processing poorly soluble molecules.