Therapeutic Areas

A brilliant intuition behind IBSA’s R&D activities: the softgel capsule

A journey into the beating heart of IBSA’s production, where scientific research meets manufacturing excellence.

In this video, we explore how strategic decisions – inspired by the concept of “drugs in the best form” – are reflected in production processes, creating care systems that enhance people’s health and well-being.

Listening to patients’ needs and striving to provide concrete answers: this is IBSA’s mission. Softgel capsules are a prime example of this commitment.

THE INNOVATIVE PEARLTEC TECHNOLOGY

Many active pharmaceutical ingredients (APIs) have poor biopharmaceutical properties, such as low solubility in water or low permeability through the mucous membranes, skin and the intestine.

Oral administration of certain drugs in solid form poses a technical challenge, since some APIs may be oily or poorly water-soluble.

IBSA recognised the need to adapt a technology initially developed for food supplements and apply it to medicinal products. By extending this approach across various therapeutic areas, IBSA focused on the development of PEARLtec technology.

Softgel capsules

 

This technology enables the incorporation of a liquid matrix into a continuous soft gelatine shell, thus forming the softgel capsule. Thanks to PEARLtec technology, it is therefore possible to take a liquid solution in solid form, guaranteeing dosage uniformity, in particular for formulations with very low concentrations.

Once in the stomach, the gelatine capsule dissolves, releasing the already-dissolved active ingredient, which is then rapidly absorbed.

Levothyroxine (T4), vitamin D and diclofenac are just some of the active ingredients available in softgel capsules that IBSA provides in therapeutic areas with significant social impact – areas that have long seen little innovation in dosage forms.

STAGES OF THE PRODUCTION PROCESS

IBSA’s thyroid hormone (T4) softgel capsules are produced at the Manno manufacturing site in Switzerland. Production includes several stages:

  • weighing and preparation of excipients, which are dispensed into storage containers;
  • preparation of the two components of the capsule through turbo-emulsifiers: the shell and the fill;
  • encapsulation, based on PEARLtec technology, which is the core of the process: a syringe pump injects the active ingredient, previously formulated into a mass called filler, into the forming capsule. This creates transparent capsules made of two heat-sealed shells, ensuring product stability and integrity;
  • drying, which is divided into dynamic drying – during which the capsules acquire their final shape – and static drying, where capsules are weighed daily for about a week until they fall within specific parameters; 
  • inspection – automated or visual, to detect any defects;
  • marking (laser), to engrave the dosage. 

THE IMPORTANCE OF A SIMPLE, EFFECTIVE THERAPY

Softgel capsules

For patients with chronic conditions who face daily therapy, it is essential to have access to simple and effective solutions. 

While the treatment goal is shared by all pharmaceutical companies, IBSA investigates the unmet needs related to known active ingredient, in order to develop drugs in the best form, offering real responses to patients in terms of convenience, ease of intake and absorption, thereby improving therapy adherence.